U.S. label record. The cited DailyMed label identifies Lanreotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Three selected reports address lanreotide in neuroendocrine tumors and acromegaly. The CLARINET extension follows participants from the original trial and is not an independent randomized experiment.↗↗↗
What the reviewed sources report
CLARINET found longer progression-free survival, without a demonstrated overall-survival or quality-of-life difference. The acromegaly study reported tumor and hormone changes but did not reject its prespecified primary null hypothesis.↗↗↗
What remains unresolved?
How do formulation, indication and prior-treatment differences affect applicability?↗↗↗
What do complete trial reports and current labels add about harms and longer follow-up?↗↗↗
The cited label covers specified acromegaly, gastroenteropancreatic neuroendocrine tumor and carcinoid-syndrome settings. Indications and outcomes differ across those populations. Label: 1 ↗
Which safety limits matter?
Warnings include gallstones and complications, altered glucose control, reduced heart rate, thyroid abnormalities, and fat malabsorption or steatorrhea. These label risks are distinct from event rates in an individual trial. Label: 1, 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.
Label ZIP SHA-256: 549b28079c4ff34c485706fc6353164f8e1903e90a1ec7f10f97482b441b0bfe. Extracted XML SHA-256: c8c3f515d19dbbec43ebb5353991467b8f96123d3e513e3e183fd915087f874b.
The tumor study measured progression-free survival
FDA’s December 2014 review describes a 204-participant, randomized, double-blind placebo-controlled trial in unresectable or metastatic, well- or moderately differentiated gastroenteropancreatic neuroendocrine tumors. The primary endpoint combined radiological progression or death. FDA PDF pp. 32, 36 ↗
More findings, study links and document coverage
Delayed progression did not establish longer survival
FDA found longer progression-free survival with lanreotide. Overall-survival data were immature with no apparent difference between groups at that assessment, so these outcomes should not be treated as interchangeable. FDA PDF pp. 32 ↗
Most participants had stable disease before entry
Nearly all participants had stable disease before randomization. That population limits extrapolation of the result to every rapidly progressing tumor or tumor subtype. FDA PDF pp. 32 ↗
The safety account is indication-specific
The reviewed tumor study reported glucose abnormalities, bradycardia and gallbladder findings. Its exposure and population differ from the earlier acromegaly program; this supplement is not a complete review of every lanreotide use. FDA PDF pp. 40 ↗
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.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Identity/name search without publication-type filtering; primary human reports, extensions, combinations and other reports require separate eligibility decisions. Known selected reports were recovered.
1259 retrieved · 3 included · 0 excluded · 1256 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"lanreotide"[Title/Abstract] OR "Somatuline"[Title/Abstract]
Full-text appraisal and screening of unassessed records remain open.
Registry comparison, additional aliases and references, and regulator reconciliation require separate checks.
Showing 25 of 1259 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 33052555 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT00353496.
PubMed 25014687 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT00353496.
PubMed 24423301 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT00690898.
PubMed 42721062 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42642161 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42703492 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42675372 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42723843 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42729617 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42621460 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42206253 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42053775 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42597314 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42476150 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42442850 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42319153 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41308086 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42365543 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42359578 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42320793 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42030411 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41965092 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42395255 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41964795 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41948193 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
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.
3 retrieved · 3 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
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 3 of 3 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
FDA NDA022074 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LANREOTIDE ACETATE.
FDA ANDA217193 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LANREOTIDE ACETATE.
FDA NDA215395 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LANREOTIDE 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.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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.
10 retrieved · 0 included · 0 excluded · 10 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 10 of 10 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA 25634 — not screened: Title-name match awaiting identity and document review. Lanreotide: List of nationally authorised medicinal products - PSUSA/00001826/201705
EMA 36352 — not screened: Title-name match awaiting identity and document review. EU/3/15/1514: Public summary of opinion on orphan designation: Lanreotide acetate for the treatment of autosomal dominant polycystic kidney disease
EMA 51091 — not screened: Title-name match awaiting identity and document review. Lanreotide: List of nationally authorised medicinal products - PSUSA/00001826/202005
EMA 53723 — not screened: Title-name match awaiting identity and document review. Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202105
EMA 56988 — not screened: Title-name match awaiting identity and document review. Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg productspecific bioequivalence guidance
EMA 56989 — not screened: Title-name match awaiting identity and document review. Overview of comments on 'Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance'
EMA 57366 — not screened: Title-name match awaiting identity and document review. Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202205
EMA 54970 — not screened: Title-name match awaiting identity and document review. Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance
EMA 62726 — not screened: Title-name match awaiting identity and document review. Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202305
EMA 6785 — not screened: Title-name match awaiting identity and document review. P/0302/2013: EMA decision of of 29 November 2013 on the granting of a product-specific waiver for lanreotide (acetate) (Somatuline LA and associated names) (EMEA-001503-PIP01-13)
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
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.
EMA EU/3/15/1514 — include: EMA orphan feed identifies Lanreotide 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.
124 retrieved · 0 included · 0 excluded · 124 awaiting a decision · 0 full-text appraisals
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 124 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT02020499 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00234572 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00543179 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00216372 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05048901 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01137682 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00729313 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03289741 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00353496 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02127437 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00630695 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07534371 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00774930 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03562091 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03792555 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07179926 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02685709 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01538966 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04198402 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02788578 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03112694 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05922579 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03083210 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00747500 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02288377 — 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 Lanreotide?
Three selected reports address lanreotide in neuroendocrine tumors and acromegaly. The CLARINET extension follows participants from the original trial and is not an independent randomized experiment.123
Bottom line from this bounded source set
CLARINET found longer progression-free survival, without a demonstrated overall-survival or quality-of-life difference. The acromegaly study reported tumor and hormone changes but did not reject its prespecified primary null hypothesis.123
Reviewed study record
CLARINET: neuroendocrine tumors
Design
Randomized, double-blind, placebo-controlled trial over 96 weeks.1
Population
204 people with advanced nonfunctioning, somatostatin-receptor-positive grade 1 or 2 neuroendocrine tumors; most had stable disease before enrollment.1
Outcomes reported
The hazard ratio for progression or death was 0.47 (95% CI 0.30–0.73). Overall survival and quality of life did not differ significantly. Treatment-related diarrhea occurred in 26% versus 9%.1
Limitations
The selected tumor grades, receptor status and largely stable baseline disease limit generalization. Progression-free survival is distinct from longer overall survival.1
Reviewed study record
CLARINET open-label extension
Design
Eligible original-trial participants entered an extension in which everyone received lanreotide.2
The continuous-treatment group had a reported median progression-free survival of 38.5 months. Adverse-event incidence was lower during extension than during the core study.2
Limitations
Selective extension enrollment, crossover and absence of a concurrent placebo group prevent an independent randomized long-term comparison.2
Reviewed study record
PRIMARYS: acromegaly
Design
48-week open-label, single-arm study with centrally assessed tumor volume.3
Population
90 treatment-naïve people with acromegaly and growth-hormone-secreting macroadenomas entered; 64 completed.3
Outcomes reported
The primary analysis found at least 20% tumor-volume reduction in 62.9% of 89 participants, but the prespecified null hypothesis was not rejected. Hormonal and symptom measures also improved.3
Limitations
No control group, attrition and differences between primary and sensitivity analyses limit causal interpretation. No gastrointestinal-intolerance withdrawals does not mean no adverse events.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1056/nejmoa1316158. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1007/s12020-020-02475-2. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1210/jc.2013-3318. 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 Lanreotide?
U.S. label record. The cited DailyMed label identifies Lanreotide 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.
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.
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.
A phase value is unavailable here for 11 selected records; this is not counted as “no phase.”
A status value is unavailable here for 11 selected records; this is not counted as a trial status.
PubMed bibliography
Publication composition
22 of 46 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Publication typesJournal Article 17Clinical Trial 6Research Support, Non-U.S. Gov't 6Case Reports 5Letter 5Multicenter Study 5Clinical Trial, Phase II 1Clinical Trial, Phase III 1Comment 1Comparative Study 1Randomized Controlled Trial 1Review 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
3
FDA Federal Register documents
2
DailyMed SPL versions
3
Canonical profile
Published
Profile structured data
Published
Linked dated records
70
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.
PeptideScanner retained ClinicalTrials.gov record NCT02493517 at 2026-07-30T20:57:18.712Z. Its registry update date was 2019-01-29, and PeptideScanner's reviewed identity mapping was lanreotide.
PubMed lists PMID 8813476 in Digestion as Clinical Trial, Journal Article, Multicenter Study, with publication-date metadata of 1996 (year precision). PeptideScanner associated the retained record with the identity slug lanreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
FDA's dated enforcement report D-0290-2026 lists Class II and source status Ongoing for Cipla USA, Inc. PeptideScanner connects the report to reviewed application NDA215395 through exact openFDA application-number annotations.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
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.
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 Lanreotide 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.
PeptideScanner retained PubMed bibliographic metadata for PMID 41880072 at 2026-07-30T16:14:14.928Z. PubMed recorded a metadata revision date of 2026-06-27 and an Entrez history date of 2026-03-25. PeptideScanner associated this retained record with the identity slug lanreotide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 39933708 at 2026-07-30T16:14:10.854Z. PubMed recorded a metadata revision date of 2026-06-09 and an Entrez history date of 2025-02-11. PeptideScanner associated this retained record with the identity slug lanreotide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 38071418 at 2026-07-30T16:20:36.586Z. PubMed recorded a metadata revision date of 2026-05-18 and an Entrez history date of 2023-12-10. PeptideScanner associated this retained record with the identity slug lanreotide. These dates describe PubMed metadata history, not the article's original publication date.↗
PubMed lists PMID 39491674 in Journal of pharmaceutical sciences as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2024-11-02 (day precision). PeptideScanner associated the retained record with the identity slug lanreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 38206830 in The oncologist as Journal Article, Clinical Trial, Phase II, Research Support, Non-U.S. Gov't, Multicenter Study, Randomized Controlled Trial, with publication-date metadata of 2024-05-03 (day precision). PeptideScanner associated the retained record with the identity slug lanreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
FDA's dated enforcement report D-0422-2026 lists Class II and source status Ongoing for Cipla USA, Inc. PeptideScanner connects the report to reviewed application NDA215395 through exact openFDA application-number annotations.↗
FDA's dated enforcement report D-0423-2026 lists Class II and source status Ongoing for Cipla USA, Inc. PeptideScanner connects the report to reviewed application ANDA217193 through exact openFDA application-number annotations.↗
PeptideScanner retained ClinicalTrials.gov record NCT05048901 at 2026-07-30T16:20:49.324Z. Its registry update date was 2026-04-09, and PeptideScanner's reviewed identity mapping was lanreotide.↗
PeptideScanner retained ClinicalTrials.gov record NCT02127437 at 2026-07-30T16:20:49.305Z. Its registry update date was 2026-04-08, and PeptideScanner's reviewed identity mapping was lanreotide.↗
PeptideScanner retained ClinicalTrials.gov record NCT06807437 at 2026-07-30T16:22:22.334Z. Its registry update date was 2026-03-31, and PeptideScanner's reviewed identity mapping was lanreotide.↗
PubMed lists PMID 41071230 in Hormones (Athens, Greece) as Letter, with publication-date metadata of 2025-10-10 (day precision). PeptideScanner associated the retained record with the identity slug lanreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PeptideScanner retained ClinicalTrials.gov record NCT03946527 at 2026-07-30T16:22:22.335Z. Its registry update date was 2026-03-02, and PeptideScanner's reviewed identity mapping was lanreotide.↗