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U.S. label record↗Endocrine↗

Leuprolide↗

Related names in cited records: Leuprolide acetate↗

A GnRH agonist. This profile cites a U.S. label record.↗

Citation markers ↗ open the public records supporting the adjacent statements.

Profile update · July 27, 2026

We rewrote the profile summary to describe the cited public record more directly. The cited sources and status did not change. 1

This version supersedes public version 1.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Leuprolide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

Status sources checked through July 22, 2026. See status sources and coverage →

What do the reviewed human studies say?

Human evidence reviewed August 19, 2026 · Review version 1.

Review source snapshots checked August 19, 2026 · Integrity checked August 19, 2026.

A bounded review of two randomized comparisons involving leuprolide: one pelvic-pain trial and one androgen-deprivation trial using leuprolide as the active comparator.↗↗

What the reviewed sources report

In the reviewed pelvic-pain trial, both treatment groups improved without a significant between-group difference. In the prostate-cancer trial, the oral comparator produced more sustained testosterone suppression than leuprolide; that biochemical endpoint does not establish a difference in cancer survival.↗↗

What remains unresolved?

  • How do the compared approaches affect long-term patient-important outcomes, harms, and treatment persistence beyond the reviewed follow-up windows?↗↗

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Leuprolide acetate injection · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

The cited injection label covers palliative treatment of advanced prostate cancer. Other leuprolide formulations and gynecologic or pediatric indications require their own product records. Label: indications and usage ↗

Which safety limits matter?

The label describes initial testosterone increases and possible worsening of cancer symptoms, including urinary obstruction or spinal cord compression. It also addresses severe skin reactions, hypersensitivity, hyperglycemia or diabetes, cardiovascular events reported with GnRH agonists, QT prolongation and potential fetal harm. Label: contraindications, warnings, precautions ↗

Label edition and source pins

U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.

Leuprolide acetate kit · SPL version 10 · published 2026-07-06

Label ZIP SHA-256: 86f3963f5e8c460c7214ef2ac8e45182d3919a279b0fa097bf03eb2c5632471d. Extracted XML SHA-256: 62478327ea5fa12911efbec7eef842d246d0987362191dbd644223838558fcdb.

Open versioned label context data →

Reviews summarize selected studies; their scope and limitations are shown above.

Inside the official reviews

Reviewed 2026-09-19 · Preserved version 1

This application relied on a formulation-specific bridge

FDA’s Camcevi review describes a 505(b)(2) application relying in part on prior findings for Lupron, with supporting clinical bridging data. It is not a new trial of every leuprolide formulation or indication. FDA PDF pp. 13 ↗

More findings, study links and document coverage

The pivotal study was uncontrolled

The reviewed trial enrolled 137 patients with advanced prostate cancer in a single-arm, open-label design. Without a randomized comparator, it cannot establish superiority over other androgen-deprivation treatments. FDA PDF pp. 13 ↗

Testosterone suppression was the primary endpoint

FDA evaluated whether testosterone suppression was achieved and maintained from day 28 through day 336. That endpoint is distinct from demonstrating longer survival or better patient-reported quality of life in this trial. FDA PDF pp. 13, 18 ↗

The extension was a smaller safety follow-up

An additional 30 patients continued into the safety extension after day 336. They should not be counted as an independent confirmatory trial or as long-term observations for all original participants. FDA PDF pp. 13 ↗

Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.

Document coverage

Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.

One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗

Inspect documents, application identities and source pins

Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.

  • Camcevi: FDA selected application review ↗

    Selected sections reviewed · fda-leuprolide-review-2021 · Document/feed date: 2021-05-12

    Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.

    Verified: Camcevi · NDA 211488 · Document dated 2021-05-12. Identity checked on PDF pp. 2.

    Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.

    Retrieved 2026-09-19. Read PDF pages: 2, 13, 18 of 167. SHA-256: d115a3d1c53c53ff80dfe0b6f5cd9f6caa5d963733f45199d78bb049105f5db4.

Remaining work

  • Review other leuprolide formulations and indications separately from Camcevi.
  • Reconcile the pivotal protocol, publication and longer follow-up before making patient-centered outcome claims.

Open versioned document coverage and study pins →

European medicine records · 1 products or applications

EMA medicine metadata checked 2026-09-15. These are product-specific centralized records; national European authorizations and full product-information assessments require separate coverage.

Application withdrawal and refusal are distinct from marketing authorization. A withdrawal status alone does not establish why it occurred. These metadata entries do not substitute for indication, population or safety details in the relevant product information.

Open versioned records and source-feed pins →

Research coverage and study families

Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.

Open machine-readable coverage and record decisions →

PubMed search

Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.

2971 retrieved · 2 included · 0 excluded · 2969 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Leuprolide"[Title/Abstract] OR "leuprorelin"[Title/Abstract] OR "Leuprolide acetate"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:09:38.867039+00:00 · HTTP 200 · SHA-256 a2c7525dc783bc2ad099df797c48514bdca4acf81cfeda16c7415ecd43ceb21c.

  • Retrieved IDs completely represent this query response, not all relevant literature. Additional aliases, references and non-PubMed sources require separate searches.
  • Unscreened records may include animal or cell experiments, reviews, secondary analyses, mixtures, protocols and unrelated name matches.
  • Study-family mappings use available declared registry IDs; unresolved mappings do not create independent trial counts. Full-text, corrections and registry comparison remain separate work.

Showing 25 of 2971 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 32469183 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT03085095.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 ff23e8f570d660744b13fbe1420af8f24b062e1dad2ce2b36eee4e240dd2a36b.

  2. PubMed 21300339 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: leuprolide-PMID21300339-registry-linkage-unresolved.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 acdc72872e6bd7de45be01788dfd401b16780ce2ac46cd3834a9299cbf8314c3.

  3. PubMed 42728640 — not screened: Name-query match awaiting clinical eligibility screening.
  4. PubMed 42719229 — not screened: Name-query match awaiting clinical eligibility screening.
  5. PubMed 42713047 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42708086 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42700293 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42685950 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 42682049 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 42617170 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 42615454 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 42615451 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 42613861 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 42591741 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 42574969 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 42529459 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 42469731 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 42427703 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 42423152 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 42421559 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 42415823 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 42406777 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 42399824 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 42388856 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 42369946 — not screened: Name-query match awaiting clinical eligibility screening.

FDA search

Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.

28 retrieved · 28 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"LEUPROLIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:18.395473+00:00 · HTTP 200 · SHA-256 fd6df635088f903d264f8807c125726ec88e89adce01f0bcd0e1bb0b3da39f61.

  • Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
  • This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.

Showing 25 of 28 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. FDA ANDA213829 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  2. FDA NDA205054 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  3. FDA ANDA075471 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  4. FDA NDA021731 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  5. FDA NDA021379 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  6. FDA ANDA078885 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  7. FDA NDA021088 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  8. FDA NDA213150 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  9. FDA NDA020263 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  10. FDA NDA203696 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE, NORETHINDRONE ACETATE.
  11. FDA NDA019732 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  12. FDA NDA219745 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE MESYLATE.
  13. FDA NDA213225 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  14. FDA NDA021488 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  15. FDA NDA211488 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE MESYLATE.
  16. FDA NDA020011 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  17. FDA ANDA217437 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  18. FDA ANDA215336 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  19. FDA ANDA074728 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  20. FDA ANDA212963 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  21. FDA NDA019010 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  22. FDA NDA019943 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  23. FDA ANDA215826 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  24. FDA NDA020517 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.
  25. FDA NDA020708 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LEUPROLIDE ACETATE.

EMA search

Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.

1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Leuprolide", "Leuprolide acetate", "leuprorelin"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EMEA/H/C/005034 — include: EMA feed product Camcevi; reported status: Authorised. Exact indication and decision documents remain unappraised.

EMA search

Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.

29 retrieved · 9 included · 0 excluded · 20 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Leuprolide", "Leuprolide acetate", "leuprorelin"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 25 of 29 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA 55292 — include: Document linked by EMA product number; content unappraised. Camcevi : EPAR - Medicine overview
  2. EMA 55296 — include: Document linked by EMA product number; content unappraised. Camcevi : EPAR - Public Assessment Report
  3. EMA 63485 — include: Document linked by EMA product number; content unappraised. Camcevi-H-C-PSUSA-00010877-202307 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  4. EMA 58657 — include: Document linked by EMA product number; content unappraised. Camcevi : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  5. EMA 67619 — include: Document linked by EMA product number; content unappraised. Camcevi : EPAR - Procedural steps taken and scientific information after authorisation
  6. EMA 73706 — include: Document linked by EMA product number; content unappraised. Camcevi-X-0000258054 : EPAR - Assessment report - Variation
  7. EMA 55297 — include: Document linked by EMA product number; content unappraised. Camcevi : EPAR - Risk management plan
  8. EMA 55294 — include: Document linked by EMA product number; content unappraised. Camcevi : EPAR - All Authorised Presentations
  9. EMA 55293 — include: Document linked by EMA product number; content unappraised. Camcevi : EPAR - Product Information
  10. EMA 4034 — not screened: Title-name match awaiting identity and document review. Leuprorelin: List of nationally authorised medicinal products - PSUSA/00001844/201707
  11. EMA 5467 — not screened: Title-name match awaiting identity and document review. EU/3/16/1821: Public summary of opinion on orphan designation: Leuprorelin acetate for the treatment of congenital hypogonadotropic hypogonadism
  12. EMA 16609 — not screened: Title-name match awaiting identity and document review. Leuprorelin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001844/201707
  13. EMA 44708 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - Review of handling errors with depot formulations of leuprorelin medicines started
  14. EMA 44709 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - Notification
  15. EMA 44711 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - Annex I
  16. EMA 44712 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - List of questions
  17. EMA 47674 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - PRAC recommends new measures to avoid handling errors
  18. EMA 47675 — not screened: Title-name match awaiting identity and document review. Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors
  19. EMA 48131 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - New measures to avoid handling errors with leuprorelin depot medicines
  20. EMA 48132 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - Annex III
  21. EMA 48133 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - Timetable for the implementation of the CMDh position (Annex V)
  22. EMA 48134 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicinal products: new measures to avoid handling errors with leuprorelin depot medicines
  23. EMA 48468 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - Public assessment report to PRAC recommendation
  24. EMA 48520 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - Annex II
  25. EMA 48521 — not screened: Title-name match awaiting identity and document review. Leuprorelin-containing depot medicines Article-31 referral - Annex IV

EMA search

Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.

1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Leuprolide", "Leuprolide acetate", "leuprorelin"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EU/3/16/1821 — include: EMA orphan feed identifies leuprorelin acetate; designation status: Positive. Orphan designation is not marketing authorization.

ClinicalTrials.gov search

ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.

544 retrieved · 0 included · 0 excluded · 544 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Leuprolide" OR "Leuprolide acetate" OR "leuprorelin" OR "Camcevi"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:19.713059+00:00 · HTTP 200 · SHA-256 ec374fa28a9f949abdcce33588c564adda3bd47fde67ebac0061e33c6fe18c7f.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:21.040601+00:00 · HTTP 200 · SHA-256 cc84516a25e3bae14b51f0911cc3a1d2ca94f623fedee6898578157056fef8d4.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:22.423857+00:00 · HTTP 200 · SHA-256 6138a1ad186f1feeb48a13291c85bff960f6fcf9656fc072f9457fe4f52a0993.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:23.820317+00:00 · HTTP 200 · SHA-256 54990cacba001ddccf9edd5a895b11925ce1479c85deb1c1fb1d6b9503eff77e.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:25.122831+00:00 · HTTP 200 · SHA-256 63f75c53bea461b2e384d643ba70bb9af8c1ac21f660cac735e8cd7e688aa9d2.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:26.355748+00:00 · HTTP 200 · SHA-256 631fd79e7a94d1c6dd755cc9bb4e5b98ffe4677bef8d7335a3df1678c533405c.

  • Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
  • Other registries, unregistered studies and additional aliases remain outside this query.

Showing 25 of 544 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. ClinicalTrials.gov NCT02023463 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  2. ClinicalTrials.gov NCT03573648 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  3. ClinicalTrials.gov NCT03396978 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  4. ClinicalTrials.gov NCT03263299 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  5. ClinicalTrials.gov NCT06106932 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  6. ClinicalTrials.gov NCT00220350 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  7. ClinicalTrials.gov NCT01669291 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  8. ClinicalTrials.gov NCT05827081 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  9. ClinicalTrials.gov NCT00528866 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  10. ClinicalTrials.gov NCT01269125 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  11. ClinicalTrials.gov NCT00582556 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  12. ClinicalTrials.gov NCT00329043 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  13. ClinicalTrials.gov NCT00936390 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  14. ClinicalTrials.gov NCT02974270 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  15. ClinicalTrials.gov NCT05304169 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  16. ClinicalTrials.gov NCT02319837 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  17. ClinicalTrials.gov NCT04666129 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  18. ClinicalTrials.gov NCT07142551 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  19. ClinicalTrials.gov NCT01717053 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  20. ClinicalTrials.gov NCT01069094 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  21. ClinicalTrials.gov NCT01078545 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  22. ClinicalTrials.gov NCT02393482 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  23. ClinicalTrials.gov NCT02361905 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  24. ClinicalTrials.gov NCT00992251 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  25. ClinicalTrials.gov NCT02689921 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review

Supervised synthesis

What do selected human studies report about Leuprolide?

Manually reviewed August 19, 2026 · version 1

Browse all Human Evidence Reviews · Open preserved synthesis version 1 →

A bounded review of two randomized comparisons involving leuprolide: one pelvic-pain trial and one androgen-deprivation trial using leuprolide as the active comparator.12

Bottom line from this bounded source set

In the reviewed pelvic-pain trial, both treatment groups improved without a significant between-group difference. In the prostate-cancer trial, the oral comparator produced more sustained testosterone suppression than leuprolide; that biochemical endpoint does not establish a difference in cancer survival.12

Reviewed study record

Endometriosis-associated pelvic-pain trial

Design

A prospective, randomized, double-blind controlled trial compared leuprolide with continuous oral contraceptives over 48 weeks.1

Population

The trial enrolled 47 women with endometriosis-associated pelvic pain at academic medical centers in two U.S. cities.1

Outcomes reported

Pain and depression scores declined significantly from baseline in both groups, while the reported reductions did not differ significantly between groups.1

Limitations

The trial was small, and improvement within each group does not establish that the treatments were equivalent across broader populations or longer follow-up.1

Reviewed study record

HERO androgen-deprivation trial

Design

A sponsor-funded, randomized Phase 3 trial compared oral relugolix with leuprolide for 48 weeks; sustained testosterone suppression was the primary endpoint.2

Population

The trial randomized 930 men with advanced prostate cancer, including 308 assigned to leuprolide.2

Outcomes reported

Sustained testosterone suppression was reported for 96.7% of the relugolix group and 88.8% of the leuprolide group, meeting the trial's noninferiority and superiority criteria for that endpoint.2

Limitations

Leuprolide was the comparator, not the experimental treatment, and the primary result concerned testosterone suppression rather than cancer progression or survival.2

Reviewed source set

  1. PubMed · 21300339Randomized trial of leuprolide versus continuous oral contraceptives in the treatment of endometriosis-associated pelvic pain ↗PubMed PMID 21300339 · EFetch XML reviewed 2026-08-19 · payload SHA-256 acdc72872e6bd7de45be01788dfd401b16780ce2ac46cd3834a9299cbf8314c3
    No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1016/j.fertnstert.2011.01.027. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 32469183Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer ↗PubMed PMID 32469183 · EFetch XML reviewed 2026-08-19 · payload SHA-256 ff23e8f570d660744b13fbe1420af8f24b062e1dad2ce2b36eee4e240dd2a36b
    No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1056/nejmoa2004325. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps

Living status brief

What is the current status of Leuprolide?

U.S. label record. The cited DailyMed label identifies Leuprolide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.

215Dated records47PubMed records114Trial records48Regulatory records

Evidence present

What records are connected here?

Evidence lanes
4
Source years
32
Drugs@FDA applications
24

These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.

Latest source-dated record

What changed most recently at a cited source?

Clinical trials · source date September 3, 2026

ClinicalTrials.gov record NCT07801664↗Added to PeptideScanner September 9, 2026

Coverage gaps

What remains unknown or unsupported?

All four evidence lanes appear in this selected collection, but their presence does not establish completeness, agreement, research quality, safety, effectiveness, approval, availability, or suitability.

PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.

Open the complete timeline →Browse all connected recordsFollow via RSS
Explore the Evidence Map and record counts

Evidence Map v1

What kinds of records connect to Leuprolide?

Compare collection coverage →

This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.

215Selected dated records
216Connected citations
32Populated source years1985–2026
4/4Record lanes present
Clinical trials114Open matching records →Literature metadata47Open matching records →Regulatory48Open matching records →Safety6Open matching records →

Registered human studies

Trial composition

47 of 114 selected trial records include at least one phase value; 48 of 114 include a status value in the retained structured contract.

2,924 public history versions connect to 112 of these trial records across 22 submitted years. Open the record-history collection →

PhasesPhase 2 29Phase 1 8Phase 3 7Not applicable 5Phase 4 3
Status at observationCompleted 38Recruiting 5Active, not recruiting 4Not yet recruiting 1

A phase value is unavailable here for 67 selected records; this is not counted as “no phase.”

A status value is unavailable here for 66 selected records; this is not counted as a trial status.

PubMed bibliography

Publication composition

23 of 47 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

Publication typesJournal Article 20Clinical Trial 7Randomized Controlled Trial 5Research Support, Non-U.S. Gov't 5English Abstract 4Case Reports 3Letter 3Clinical Trial, Phase II 2Comment 2Research Support, U.S. Gov't, P.H.S. 2Review 2Comparative Study 1Multicenter Study 1

Bibliography fields unavailable here for 24 selected records; the records remain visible as metadata observations.

Regulatory and publication surfaces

What is structurally connected?

Drugs@FDA applications
24
FDA Federal Register documents
18
DailyMed SPL versions
6
Canonical profile
Published
Profile structured data
Published
Linked dated records
215

Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.

Profile publication history and record counts

Research hub

Explore the Leuprolide evidence record

Open all 215 records →
215Dated records
4Evidence types
215Cited public sources
32Source years

Change ledger

Recently changed for Leuprolide

Open all 216 events →

PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.

Record added

ClinicalTrials.gov record NCT07596212

PeptideScanner retained ClinicalTrials.gov record NCT07596212 at 2026-09-09T19:17:17.112Z. Its registry update date was 2026-08-24, and PeptideScanner's reviewed identity mapping was leuprolide.

PeptideScanner change date
September 9, 2026
Cited source date
August 24, 2026
Evidence lane
Clinical trials
Open the cited record →
Cited source
Record added

ClinicalTrials.gov record NCT07801664

PeptideScanner retained ClinicalTrials.gov record NCT07801664 at 2026-09-09T19:17:17.074Z. Its registry update date was 2026-09-03, and PeptideScanner's reviewed identity mapping was leuprolide.

PeptideScanner change date
September 9, 2026
Cited source date
September 3, 2026
Evidence lane
Clinical trials
Open the cited record →
Cited source
Record added

Failure to achieve castration levels in patients using leuprolide acetate in locally advanced prostate cancer.

PubMed lists PMID 16314038 in European urology as Journal Article, with publication-date metadata of 2005-11-15 (day precision). PeptideScanner associated the retained record with the identity slug leuprolide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

PeptideScanner change date
September 9, 2026
Cited source date
November 21, 2013
Evidence lane
Literature metadata
Open the cited record →
Cited source

Official-source collections

Source records for Leuprolide

Open the full research atlas →
PubMed47

23 with attributed title, venue, publication-date, and type metadata.

Journal Article (20)Clinical Trial (7)Randomized Controlled Trial (5)
  1. Development and Validation of a Stability-Indicating RS HPLC Method for Leuprolide Acetate and Its Related Substances: Characterization of Degradation Products With LC-MS.Biomedical chromatography : BMC · 2026 Jul
  2. Failure to achieve castration levels in patients using leuprolide acetate in locally advanced prostate cancer.European urology · 2005 11 15
  3. Leuprolide acetate given by a subcutaneous extended-release injection: less of a pain?Expert review of anticancer therapy · 2005 Aug
Explore all selected literature →
ClinicalTrials.gov114

2,924 public history versions across these dated registry records; status labels apply only to each cited observation.

Recruiting history (1853)Active Not Recruiting history (690)Completed history (215)
Current at observation (35)Completed at observation (79)
Prostate Cancer (19)Breast Cancer (4)Prostate Adenocarcinoma (3)Phase 2 (29)Phase 1 (8)Completed (38)Recruiting (5)
leuprolide acetate · Drug (14)Leuprolide · Drug (12)Leuprolide Acetate · Drug (10)
  1. NCT07801664Registry update September 3, 2026 · current at observation
  2. NCT07596212Registry update August 24, 2026 · current at observation
  3. NCT07455903Registry update August 6, 2026 · current at observation
Explore all selected trial records →Explore all public record history →
Drugs@FDA24

Original-submission application metadata connected by exact reviewed active-ingredient names.

  1. ANDA215826Full FDA chronology · original submission status AP 2025-11-13
  2. ANDA217437Full FDA chronology · original submission status AP 2025-06-09
  3. ANDA217957Full FDA chronology · original submission status AP 2024-10-17
  4. ANDA215336Full FDA chronology · original submission status AP 2022-10-28
  5. ANDA212963Full FDA chronology · original submission status AP 2022-06-06
Explore all selected FDA applications →Explore 424 dated submissions and 450 documents for Leuprolide →
FDA enforcement reports6

Recall-enforcement metadata connected only through exact application numbers already mapped to this reviewed profile.

  1. D-1178-2023Class III · report date 2023-10-04
  2. D-1287-2014Class II · report date 2014-05-07
  3. D-1288-2014Class II · report date 2014-05-07
  4. D-1289-2014Class II · report date 2014-05-07
  5. D-1290-2014Class II · report date 2014-05-07
Explore all exact FDA enforcement reports →
DailyMed SPL history6

Version metadata and exact historical ZIP receipts for the reviewed label family, without reproducing or interpreting label text.

  1. SPL version 10Published 2026-07-06 · ZIP SHA-256 86f3963f5e8c…
  2. SPL version 9Published 2025-12-29 · ZIP SHA-256 c979d44225f4…
  3. SPL version 7Published 2025-04-28 · ZIP SHA-256 282a2d471703…
  4. SPL version 6Published 2024-11-18 · ZIP SHA-256 65b040e4ce1b…
  5. SPL version 5Published 2023-03-07 · ZIP SHA-256 7e51494e11e4…
Explore all DailyMed label versions →

Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.

Evidence types

Coverage by source year

Selected records span April 9, 1985 to September 3, 2026.

Continue exploring

Profiles with overlapping source-year coverage

Open the research atlas →

These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.

Glucagon22 shared source years308 dated records · 4 evidence typesOctreotide22 shared source years160 dated records · 4 evidence typesTeriparatide21 shared source years149 dated records · 3 evidence typesExenatide19 shared source years119 dated records · 3 evidence types

These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.

Evidence summary

What the cited records say

The cited DailyMed label identifies Leuprolide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.

Cited context

Related records

Organizations named in cited records

  • U.S. National Library of Medicine↗

Dated source history

Updates connected to this profile

Open the full cross-source timeline →

  1. Clinical trials

    ClinicalTrials.gov record NCT07801664↗

    PeptideScanner retained ClinicalTrials.gov record NCT07801664 at 2026-09-09T19:17:17.074Z. Its registry update date was 2026-09-03, and PeptideScanner's reviewed identity mapping was leuprolide.↗

  2. Clinical trials

    ClinicalTrials.gov record NCT07596212↗

    PeptideScanner retained ClinicalTrials.gov record NCT07596212 at 2026-09-09T19:17:17.112Z. Its registry update date was 2026-08-24, and PeptideScanner's reviewed identity mapping was leuprolide.↗

  3. Clinical trials

    ClinicalTrials.gov record NCT07455903↗

    PeptideScanner retained ClinicalTrials.gov record NCT07455903 at 2026-08-13T05:52:27.015Z. Its registry update date was 2026-08-06, and PeptideScanner's reviewed identity mapping was leuprolide.↗

  4. Literature metadata

    PubMed record PMID 39177865↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 39177865 at 2026-08-10T10:49:06.892Z. PubMed recorded a metadata revision date of 2026-08-04 and an Entrez history date of 2024-08-23. PeptideScanner associated this retained record with the identity slug leuprolide. These dates describe PubMed metadata history, not the article's original publication date.↗

  5. Literature metadata

    PubMed record PMID 41824265↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 41824265 at 2026-08-10T10:49:08.794Z. PubMed recorded a metadata revision date of 2026-08-03 and an Entrez history date of 2026-03-13. PeptideScanner associated this retained record with the identity slug leuprolide. These dates describe PubMed metadata history, not the article's original publication date.↗

  6. Clinical trials

    ClinicalTrials.gov record NCT05765500↗

    PeptideScanner retained ClinicalTrials.gov record NCT05765500 at 2026-08-10T18:10:03.862Z. Its registry update date was 2026-07-30, and PeptideScanner's reviewed identity mapping was leuprolide.↗

  7. Clinical trials

    ClinicalTrials.gov record NCT04484818↗

    PeptideScanner retained ClinicalTrials.gov record NCT04484818 at 2026-08-10T18:10:03.948Z. Its registry update date was 2026-07-28, and PeptideScanner's reviewed identity mapping was leuprolide.↗

  8. Clinical trials

    ClinicalTrials.gov record NCT06169124↗

    PeptideScanner retained ClinicalTrials.gov record NCT06169124 at 2026-08-13T05:56:16.370Z. Its registry update date was 2026-07-28, and PeptideScanner's reviewed identity mapping was leuprolide.↗

  9. Literature metadata

    PubMed record PMID 41712259↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 41712259 at 2026-08-10T18:13:42.694Z. PubMed recorded a metadata revision date of 2026-07-28 and an Entrez history date of 2026-02-19. PeptideScanner associated this retained record with the identity slug leuprolide. These dates describe PubMed metadata history, not the article's original publication date.↗

  10. Clinical trials

    ClinicalTrials.gov record NCT06378866↗

    PeptideScanner retained ClinicalTrials.gov record NCT06378866 at 2026-08-10T18:10:04.225Z. Its registry update date was 2026-07-20, and PeptideScanner's reviewed identity mapping was leuprolide.↗

  11. Literature metadata

    PubMed record PMID 42003759↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42003759 at 2026-08-10T18:13:48.759Z. PubMed recorded a metadata revision date of 2026-07-20 and an Entrez history date of 2026-04-20. PeptideScanner associated this retained record with the identity slug leuprolide. These dates describe PubMed metadata history, not the article's original publication date.↗

  12. Literature metadata

    PubMed record PMID 41931341↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 41931341 at 2026-08-10T18:13:46.810Z. PubMed recorded a metadata revision date of 2026-07-14 and an Entrez history date of 2026-04-03. PeptideScanner associated this retained record with the identity slug leuprolide. These dates describe PubMed metadata history, not the article's original publication date.↗

Public beta · Selective source coverageNot medical advice · No dosing or purchasing guidance