PeptideScanner
U.S. label record↗Rare disease↗

Setmelanotide↗

Related names in cited records: Imcivree↗

A melanocortin-4 receptor 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 Setmelanotide 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.

Publisher notices are registered for this reviewed source set. Inspect the notices and their scope →

A bounded review of sponsor-funded Phase 3 studies in rare genetic obesity syndromes: two small single-arm trials with withdrawal periods and one randomized trial followed by an open-label period.↗↗

What the reviewed sources report

The reviewed studies reported substantial weight reductions in some participants with specific genetic diagnoses. The cohorts were very small, and the Bardet-Biedl and Alström trial reported inconclusive results for the Alström subgroup.↗↗

What remains unresolved?

  • How durable are benefits and harms across each genetic subgroup, and which baseline features predict response in these exceptionally small populations?↗↗

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Imcivree · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

The label covers acquired hypothalamic obesity from age four, and Bardet-Biedl syndrome or specified genetically confirmed POMC, PCSK1 or LEPR deficiency from age two. It explicitly excludes general polygenic obesity and specified benign genetic variants. Label: 1 ↗

Which safety limits matter?

Warnings address sexual-arousal effects, depression or suicidal ideation, serious hypersensitivity, pigmentary changes and new or darkened nevi. For acquired hypothalamic obesity, the label adds acute adrenal insufficiency and, with central diabetes insipidus, sodium imbalance. Label: 4, 5 ↗

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.

IMCIVREE (setmelanotide) solution · SPL version 14 · published 2026-04-02

Label ZIP SHA-256: 3a9024abc434e828923d30e4f860e834f3887ceece2a7a47cdc1c8828105e6f1. Extracted XML SHA-256: b144f343fa74b6d436776a8f7fcb548db348e1c7ffcc8e567930b96cd3b1b812.

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

Small, genetically defined study populations

The 2020 FDA review reports at least 10% weight loss at one year in 8 of 10 participants with POMC/PCSK1 deficiency and 5 of 11 with LEPR deficiency. These small groups and their wide confidence intervals limit precision; the findings are not estimates for general obesity. FDA PDF pp. 20 ↗

More findings, study links and document coverage

Withdrawal evidence is not a year-long placebo comparison

The studies were mainly open-label. An initial-response requirement selected participants for a short blinded withdrawal period. FDA’s full-analysis estimates also included early nonresponders, avoiding the larger effects obtained from a responder-enriched subset. FDA PDF pp. 4, 20, 21 ↗

Hunger findings were less secure than weight findings

FDA considered the hunger results suggestive but insufficient to establish substantial evidence of an effect. The review cites subjective assessment, open-label expectations, missing data and limitations of the measurement instruments. FDA PDF pp. 5 ↗

Keep the original indication separate from later expansions

This reading covers the original POMC/PCSK1 and LEPR submission, not every subsequently approved population. Its small safety database also limits conclusions about uncommon or long-term harms. FDA PDF pp. 2, 5 ↗

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 25 inventoried documents; 24 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.

Selected English EMA PDFs from the retained September 15, 2026 title-matched document feed, plus independently retrieved FDA approval-package documents where listed. Candidate entries are not verified product/application matches. This is a bounded inventory, not a complete FDA, national or worldwide source search. 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.

Remaining work

  • Appraise the later Bardet–Biedl syndrome and pediatric regulatory extensions separately.
  • Resolve the linked literature correction before treating the affected report as fully appraised.

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.

219 retrieved · 2 included · 0 excluded · 217 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Setmelanotide"[Title/Abstract] OR "RM-493"[Title/Abstract] OR "Imcivree"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:09:41.823675+00:00 · HTTP 200 · SHA-256 d6163eee371c6b214f57e1788ed49e9c9112dbcde46db1fd0329518010a02a0d.

  • 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.
  • Linked correction notices require comparison with the selected reports: PMID36702567 for PMID36356613. Their presence does not establish what changed.

Showing 25 of 219 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 36356613 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT03746522.
    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 7b5354b639322709facbb381c2df8b0849df463946623456b329b9ce8d42032e.

  2. PubMed 33137293 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT02896192; NCT03287960.
    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 04d73cd4656ccf5ac7e3429077a068278bbe91f299a004c2a5a3b9cdad044c9c.

  3. PubMed 42737637 — not screened: Name-query match awaiting clinical eligibility screening.
  4. PubMed 42697206 — not screened: Name-query match awaiting clinical eligibility screening.
  5. PubMed 42626294 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42611594 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42672527 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42592034 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 42538728 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 42528856 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 42499770 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 42498078 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 42496807 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 42479131 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 42466340 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 42418774 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 42340853 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 42339090 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 42329358 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 42325616 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 42475468 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 42259622 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 42209772 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 42205046 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 42114845 — 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.

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

Search terms, record decisions and remaining work

products.active_ingredients.name:"SETMELANOTIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:27.731150+00:00 · HTTP 200 · SHA-256 fd53e36b37518d650a6b24297a35acfa8a100f90579d1d2cccf87d2a51af3fb8.

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

  1. FDA NDA213793 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: SETMELANOTIDE 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: ["Setmelanotide", "Imcivree"]

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/005089 — include: EMA feed product Imcivree; 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.

32 retrieved · 14 included · 0 excluded · 18 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Setmelanotide", "Imcivree"]

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

  1. EMA 52006 — include: Document linked by EMA product number; content unappraised. Imcivree : EPAR - All authorised presentations
  2. EMA 52007 — include: Document linked by EMA product number; content unappraised. Imcivree : EPAR - Public assessment report
  3. EMA 52010 — include: Document linked by EMA product number; content unappraised. Imcivree : EPAR - Orphan maintenance assessment report (initial authorisation)
  4. EMA 56230 — include: Document linked by EMA product number; content unappraised. Imcivree-H-C-005089-II-0002-G : EPAR - Assessment report - Variation
  5. EMA 56231 — include: Document linked by EMA product number; content unappraised. Imcivree : EPAR - Orphan maintenance assessment report (post authorisation)
  6. EMA 64908 — include: Document linked by EMA product number; content unappraised. Imcivree-H-C-005089-P46-009 : EPAR - Assessment report
  7. EMA 52988 — include: Document linked by EMA product number; content unappraised. Imcivree : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  8. EMA 52008 — include: Document linked by EMA product number; content unappraised. Imcivree : EPAR - Risk management plan
  9. EMA 73856 — include: Document linked by EMA product number; content unappraised. Imcivree-VR-0000288021 : EPAR - Assessment report - Variation
  10. EMA 73857 — include: Document linked by EMA product number; content unappraised. Imcivree : Orphan maintenance assessment report (post authorisation)
  11. EMA 52004 — include: Document linked by EMA product number; content unappraised. Imcivree : EPAR - Medicine overview
  12. EMA 72292 — include: Document linked by EMA product number; content unappraised. Imcivree : EPAR - Procedural steps taken and scientific information after authorisation
  13. EMA 52005 — include: Document linked by EMA product number; content unappraised. Imcivree : EPAR - Product information
  14. EMA 65061 — include: Document linked by EMA product number; content unappraised. Imcivree-H-C-005089-II-0018 : EPAR - Assessment report - Variation
  15. EMA 14179 — not screened: Title-name match awaiting identity and document review. EU/3/16/1703: Public summary of opinion on orphan designation: Setmelanotide for the treatment of pro-opiomelanocortin deficiency
  16. EMA 31788 — not screened: Title-name match awaiting identity and document review. EU/3/16/1688: Public summary of opinion on orphan designation: Setmelanotide for the treatment of Prader-Willi syndrome
  17. EMA 43893 — not screened: Title-name match awaiting identity and document review. EU/3/18/2101: Public summary of opinion on orphan designation: Setmelanotide for the treatment of leptin receptor deficiency
  18. EMA 46421 — not screened: Title-name match awaiting identity and document review. EU/3/05/269: Public summary of positive opinion for orphan designation of setmelanotide for the treatment of Bardet Biedl syndrome
  19. EMA 47738 — not screened: Title-name match awaiting identity and document review. EU/3/19/2245: Public summary of opinion on orphan designation for setmelanotide for the treatment of Alström syndrome
  20. EMA 51223 — not screened: Title-name match awaiting identity and document review. CHMP summary of positive opinion for Imcivree
  21. EMA 55624 — not screened: Title-name match awaiting identity and document review. Questions and answers on the withdrawal of application to change the marketing authorisation for Imcivree (setmelanotide)
  22. EMA 55626 — not screened: Title-name match awaiting identity and document review. Withdrawal letter: Imcivree
  23. EMA 55632 — not screened: Title-name match awaiting identity and document review. CHMP post-authorisation summary of positive opinion for Imcivree (II-02-G)
  24. EMA 56223 — not screened: Title-name match awaiting identity and document review. Withdrawal assessment report for Imcivree
  25. EMA 63789 — not screened: Title-name match awaiting identity and document review. CHMP post-authorisation summary of positive opinion for Imcivree (II-18)

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.

6 retrieved · 6 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Setmelanotide", "Imcivree"]

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 6 of 6 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EU/3/23/2833 — include: EMA orphan feed identifies setmelanotide; designation status: Positive. Orphan designation is not marketing authorization.
  2. EMA EU/3/19/2192 — include: EMA orphan feed identifies setmelanotide; designation status: Positive. Orphan designation is not marketing authorization.
  3. EMA EU/3/19/2245 — include: EMA orphan feed identifies setmelanotide; designation status: Positive. Orphan designation is not marketing authorization.
  4. EMA EU/3/18/2101 — include: EMA orphan feed identifies setmelanotide; designation status: Positive. Orphan designation is not marketing authorization.
  5. EMA EU/3/16/1703 — include: EMA orphan feed identifies setmelanotide; designation status: Positive. Orphan designation is not marketing authorization.
  6. EMA EU/3/16/1688 — include: EMA orphan feed identifies setmelanotide; 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.

30 retrieved · 0 included · 0 excluded · 30 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Setmelanotide" OR "Imcivree" OR "RM-493"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:27:05.383211+00:00 · HTTP 200 · SHA-256 9c2d9112fe667221c199405d5336af5a23a90ec9b97a76546339e5618b42a7d3.

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

  1. ClinicalTrials.gov NCT06596135 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  2. ClinicalTrials.gov NCT05812183 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  3. ClinicalTrials.gov NCT03262610 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  4. ClinicalTrials.gov NCT03479437 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  5. ClinicalTrials.gov NCT03651765 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  6. ClinicalTrials.gov NCT05046132 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  7. ClinicalTrials.gov NCT03287960 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  8. ClinicalTrials.gov NCT02849977 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  9. ClinicalTrials.gov NCT06772597 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  10. ClinicalTrials.gov NCT02041195 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  11. ClinicalTrials.gov NCT03746522 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  12. ClinicalTrials.gov NCT04963231 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  13. ClinicalTrials.gov NCT05194124 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  14. ClinicalTrials.gov NCT04966741 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  15. ClinicalTrials.gov NCT05183802 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  16. ClinicalTrials.gov NCT02507492 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  17. ClinicalTrials.gov NCT02431442 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  18. ClinicalTrials.gov NCT03621007 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  19. ClinicalTrials.gov NCT05093634 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  20. ClinicalTrials.gov NCT06760546 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  21. ClinicalTrials.gov NCT03013543 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  22. ClinicalTrials.gov NCT01749137 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  23. ClinicalTrials.gov NCT07674290 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  24. ClinicalTrials.gov NCT04348175 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  25. ClinicalTrials.gov NCT01867437 — 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 Setmelanotide?

Manually reviewed August 19, 2026 · version 1

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

A bounded review of sponsor-funded Phase 3 studies in rare genetic obesity syndromes: two small single-arm trials with withdrawal periods and one randomized trial followed by an open-label period.12

Bottom line from this bounded source set

The reviewed studies reported substantial weight reductions in some participants with specific genetic diagnoses. The cohorts were very small, and the Bardet-Biedl and Alström trial reported inconclusive results for the Alström subgroup.12

Reviewed study record

POMC- and LEPR-deficiency trials

Design

Two sponsor-funded, single-arm, open-label Phase 3 trials included a placebo-controlled withdrawal sequence for participants who first met a weight-loss threshold.1

Population

The trials enrolled ten participants with POMC-deficiency obesity and 11 with LEPR-deficiency obesity, all at least six years old.1

Outcomes reported

At approximately one year, at least 10% weight loss was reported for eight of ten participants in the POMC trial and five of 11 in the LEPR trial.1

Limitations

The cohorts were exceptionally small and lacked a parallel control group for the primary one-year endpoint; withdrawal eligibility also depended on an initial response.1

Reviewed study record

Bardet-Biedl and Alström syndrome trial

Design

A sponsor-funded Phase 3 trial began with a 14-week double-blind randomized placebo-controlled period and continued with a 52-week open-label period.2

Population

The trial randomized 38 participants aged six years or older with obesity and Bardet-Biedl syndrome or Alström syndrome.2

Outcomes reported

After 52 weeks of treatment, 32.3% of participants aged at least 12 years with Bardet-Biedl syndrome reached at least 10% weight reduction; results were reported as inconclusive for Alström syndrome.2

Limitations

The primary endpoint followed the open-label period, the syndrome-specific groups were small, and the reported result should not be generalized beyond the defined genetic populations.2

Reviewed source set

  1. PubMed · 33137293Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials ↗PubMed PMID 33137293 · EFetch XML reviewed 2026-08-19 · payload SHA-256 04d73cd4656ccf5ac7e3429077a068278bbe91f299a004c2a5a3b9cdad044c9c
    No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1016/s2213-8587(20)30364-8. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 36356613Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period ↗PubMed PMID 36356613 · EFetch XML reviewed 2026-08-19 · payload SHA-256 7b5354b639322709facbb381c2df8b0849df463946623456b329b9ce8d42032e
    Publication update registered by CrossrefErratum ↗ · publisher metadata · February 1, 2023. Crossref metadata identifies the notice but does not by itself explain what wording changed.
Explore status sources, recent additions, and coverage gaps

Living status brief

What is the current status of Setmelanotide?

U.S. label record. The cited DailyMed label identifies Setmelanotide 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.

66Dated records37PubMed records14Trial records15Regulatory records

Evidence present

What records are connected here?

Evidence lanes
3
Source years
7
Drugs@FDA applications
1

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

Coverage gaps

What remains unknown or unsupported?

PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.

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 Setmelanotide?

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.

66Selected dated records
67Connected citations
7Populated source years2020–2026
3/4Record lanes present
Clinical trials14Open matching records →Literature metadata37Open matching records →Regulatory15Open matching records →Safety0No selected dated records

Registered human studies

Trial composition

5 of 14 selected trial records include at least one phase value; 5 of 14 include a status value in the retained structured contract.

156 public history versions connect to 12 of these trial records across 11 submitted years. Open the record-history collection →

6 exact source-declared trial-publication links connect selected NCT and PMID records. Open the exact graph →

PhasesPhase 3 3Phase 2 1Phase 4 1
Status at observationCompleted 2Recruiting 2Enrolling by invitation 1

A phase value is unavailable here for 9 selected records; this is not counted as “no phase.”

A status value is unavailable here for 9 selected records; this is not counted as a trial status.

PubMed bibliography

Publication composition

14 of 37 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

Publication typesJournal Article 14Review 3Comment 2Research Support, Non-U.S. Gov't 2Clinical Trial 1Clinical Trial, Phase II 1Multicenter Study 1

Bibliography fields unavailable here for 23 selected records; the records remain visible as metadata observations.

Regulatory and publication surfaces

What is structurally connected?

Drugs@FDA applications
1
FDA Federal Register documents
4
DailyMed SPL versions
10
Canonical profile
Published
Profile structured data
Published
Linked dated records
66

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

Exact identifier graph

6 trial-publication links for Setmelanotide

Open the full graph →

These links come only from structured NCT and PMID identifiers declared by PubMed or ClinicalTrials.gov. They do not summarize the publications or establish findings.

Research hub

Explore the Setmelanotide evidence record

Open all 66 records →
66Dated records
3Evidence types
66Cited public sources
7Source years

Change ledger

Recently changed for Setmelanotide

Open all 67 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 NCT06760546

PeptideScanner retained ClinicalTrials.gov record NCT06760546 at 2026-07-30T16:23:45.658Z. Its registry update date was 2026-02-12, and PeptideScanner's reviewed identity mapping was setmelanotide.

PeptideScanner change date
September 9, 2026
Cited source date
February 12, 2026
Evidence lane
Clinical trials
Open the cited record →
Cited source
Record added

ClinicalTrials.gov record NCT07674290

PeptideScanner retained ClinicalTrials.gov record NCT07674290 at 2026-07-30T16:19:03.062Z. Its registry update date was 2026-06-29, and PeptideScanner's reviewed identity mapping was setmelanotide.

PeptideScanner change date
September 9, 2026
Cited source date
June 29, 2026
Evidence lane
Clinical trials
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Record added

Setmelanotide DailyMed SPL version 1

DailyMed lists Structured Product Labeling version 1 for the reviewed Setmelanotide label family with a published date of 2020-12-16. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

PeptideScanner change date
August 22, 2026
Cited source date
December 16, 2020
Evidence lane
Regulatory
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Cited source

Official-source collections

Source records for Setmelanotide

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PubMed37

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

Journal Article (14)Review (3)Comment (2)
  1. Development of Dysplastic Nevi in a Child with LEPR Deficiency Treated with Setmelanotide.Journal of clinical research in pediatric endocrinology · 2025 08 21
  2. Patient and caregiver experiences with a patient-support program for setmelanotide treatment of patients with Bardet-Biedl syndrome.Orphanet journal of rare diseases · 2025 06 08
  3. Setmelanotide for the treatment of severe early-childhood genetic obesity.The lancet. Diabetes & endocrinology · 2024 11 13
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ClinicalTrials.gov14

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

Recruiting history (72)Active Not Recruiting history (29)Completed history (22)
Current at observation (5)Completed at observation (9)
Obesity (2)Alstrom Syndrome (1)Bardet Biedl Syndrome (1)Phase 3 (3)Phase 2 (1)Completed (2)Recruiting (2)
Setmelanotide · Drug (5)Imcivree · Drug (2)
  1. NCT05093634Registry update August 6, 2026 · completed at observation
  2. NCT07496463Registry update July 23, 2026 · current at observation
  3. NCT06596135Registry update July 15, 2026 · completed at observation
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DailyMed SPL history10

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

  1. SPL version 14Published 2026-04-02 · ZIP SHA-256 3a9024abc434…
  2. SPL version 13Published 2025-12-22 · ZIP SHA-256 bd3173681d44…
  3. SPL version 12Published 2025-09-05 · ZIP SHA-256 1b6551ccd1b9…
  4. SPL version 9Published 2025-05-23 · ZIP SHA-256 820af867ea8d…
  5. SPL version 8Published 2025-05-19 · ZIP SHA-256 0c923dbdc6d2…
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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 November 25, 2020 to August 6, 2026.

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Profiles with overlapping source-year coverage

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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.

Glucagon7 shared source years308 dated records · 4 evidence typesSemaglutide7 shared source years237 dated records · 4 evidence typesLeuprolide7 shared source years215 dated records · 4 evidence typesLiraglutide7 shared source years167 dated records · 4 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 Setmelanotide 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

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  1. Clinical trials

    ClinicalTrials.gov record NCT05093634↗

    PeptideScanner retained ClinicalTrials.gov record NCT05093634 at 2026-08-13T05:52:27.024Z. Its registry update date was 2026-08-06, and PeptideScanner's reviewed identity mapping was setmelanotide.↗

  2. Literature metadata

    PubMed record PMID 42498078↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42498078 at 2026-08-10T10:49:10.787Z. PubMed recorded a metadata revision date of 2026-08-01 and an Entrez history date of 2026-07-24. PeptideScanner associated this retained record with the identity slug setmelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  3. Literature metadata

    PubMed record PMID 42538728↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42538728 at 2026-08-10T10:49:12.953Z. PubMed recorded a metadata revision date of 2026-08-01 and an Entrez history date of 2026-08-01. PeptideScanner associated this retained record with the identity slug setmelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  4. Literature metadata

    PubMed record PMID 42008191↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42008191 at 2026-08-10T10:49:08.851Z. PubMed recorded a metadata revision date of 2026-07-30 and an Entrez history date of 2026-04-20. PeptideScanner associated this retained record with the identity slug setmelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  5. Literature metadata

    PubMed record PMID 42528856↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42528856 at 2026-08-10T10:49:12.911Z. PubMed recorded a metadata revision date of 2026-07-30 and an Entrez history date of 2026-07-30. PeptideScanner associated this retained record with the identity slug setmelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  6. Literature metadata

    PubMed record PMID 41894554↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 41894554 at 2026-08-10T18:13:44.905Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2026-03-27. PeptideScanner associated this retained record with the identity slug setmelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  7. Clinical trials

    ClinicalTrials.gov record NCT07496463↗

    PeptideScanner retained ClinicalTrials.gov record NCT07496463 at 2026-08-10T18:10:04.219Z. Its registry update date was 2026-07-23, and PeptideScanner's reviewed identity mapping was setmelanotide.↗

  8. Clinical trials

    ClinicalTrials.gov record NCT06596135↗

    PeptideScanner retained ClinicalTrials.gov record NCT06596135 at 2026-08-10T18:10:03.859Z. Its registry update date was 2026-07-15, and PeptideScanner's reviewed identity mapping was setmelanotide.↗

  9. Literature metadata

    PubMed record PMID 42339090↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42339090 at 2026-08-10T18:13:52.307Z. PubMed recorded a metadata revision date of 2026-07-14 and an Entrez history date of 2026-06-24. PeptideScanner associated this retained record with the identity slug setmelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  10. Literature metadata

    PubMed record PMID 32213649↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 32213649 at 2026-08-10T18:13:32.288Z. PubMed recorded a metadata revision date of 2026-07-10 and an Entrez history date of 2020-03-28. PeptideScanner associated this retained record with the identity slug setmelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  11. Literature metadata

    PubMed record PMID 42418774↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42418774 at 2026-08-10T18:13:53.869Z. PubMed recorded a metadata revision date of 2026-07-09 and an Entrez history date of 2026-07-08. PeptideScanner associated this retained record with the identity slug setmelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  12. Literature metadata

    PubMed record PMID 42205046↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42205046 at 2026-08-10T18:13:50.682Z. PubMed recorded a metadata revision date of 2026-07-06 and an Entrez history date of 2026-05-28. PeptideScanner associated this retained record with the identity slug setmelanotide. 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