Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Lanreotide (Somatuline Depot): what the evidence says

Name: Lanreotide (Somatuline Depot)
Published: 2026-10-27

At a glance

What it is: an FDA-approved, long-acting cyclic octapeptide copy of somatostatin. ^R1 Approved for acromegaly, GEP-NETs and carcinoid syndrome. ^R2

What the evidence says: in acromegaly, a placebo-controlled study showed fast GH and IGF-1 drops. ^R3 In the CLARINET RCT it lengthened progression-free survival in metastatic NETs; overall survival did not differ. ^{R4, R5}

Biggest risks: gallstones, high or low blood sugar, slow heart rate, thyroid changes and fatty stools. ^R2

Rating


Human Human evidence	Strong: placebo-controlled acromegaly study ^R3; CLARINET RCT ^R4
Animal Animal / lab evidence	Not reviewed here
Regulatory	FDA-approved, NDA 022074 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page · not named on WADA's 2026 list ^{R1, R6, R7, R8, R9}
Established human dose	Labeled dosing only; see label ^R2

Evidence verdict: Acromegaly: Strong (FDA-approved) · GEP neuroendocrine tumors: Strong (CLARINET phase 3 RCT) · Carcinoid syndrome: Strong (FDA-approved) · Other uses: No human data

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: strong for labeled uses; no evidence for any other use.

What is it?

Somatostatin turns down growth hormone and many gut hormones. Lanreotide lasts weeks as a deep injection. ^R2 Related pages: Octreotide, Human growth hormone, Pegvisomant.

Does it work?

Human Acromegaly: GH fell >50% in 63% vs 0% on placebo after the first injection; about half normalized IGF-1 by 52 weeks. ^R3
Human CLARINET (NETs): longer progression-free survival vs placebo; no difference in quality of life or overall survival. ^R4

Is it safe?

Human Label warnings: gallstones, glucose changes, bradycardia, thyroid changes, steatorrhea. ^R2
Human Diarrhea in 26% vs 9% on placebo in CLARINET. ^R4

Gray-market products: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: prescription only (NDA 022074). ^R1 not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R7, R8, R9}
Sport: not named on WADA's 2026 list. ^R6

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
Acromegaly 2010	108 adults with acromegaly	Deep SC	Per study (escalation to 120 mg allowed)	52 weeks	GH and IGF-1 down	PMID 19639415
CLARINET 2014	204 adults with NETs	Deep SC	120 mg every 4 weeks	96 weeks	Longer PFS	PMID 25014687

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Drugs@FDA, Somatuline Depot (lanreotide), Ipsen, approved Aug 30, 2007, application NDA022074 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA022074
^R2 Somatuline Depot prescribing information, label published Oct 11, 2024 (DailyMed, checked Oct 26, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e4a41fd-a753-4362-87ee-8cc56ed3660d
^R3 Melmed S, et al. Pituitary. 2010. PMID 19639415
^R4 Caplin ME, et al. N Engl J Med. 2014. PMID 25014687
^R5 ClinicalTrials.gov NCT00353496, Ipsen, CLARINET phase 3 in enteropancreatic NETs, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT00353496
^R6 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R7 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R8 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R9 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Lanreotide (Somatuline Depot). Lanreotide is a specialist drug. Talk to an endocrinologist or oncologist. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).