At a glance
- Lanreotide is an FDA-approved drug, marketed as Somatuline, Lanreotide (first approval: August 30, 2007).
- PubMed lists 1,296 publications mentioning it, including 82 randomized controlled trials and 49 animal-only studies.
- ClinicalTrials.gov lists 118 registered studies testing it (11 active).
- FDA's adverse event system (FAERS) holds 11,978 reports mentioning it; 7,951 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA022074 | SOMATULINE DEPOT | Approved, marketed | August 30, 2007 | IPSEN PHARMA |
| NDA215395 | LANREOTIDE ACETATE | Approved, discontinued | December 17, 2021 | INVAGEN PHARMS |
| ANDA217193 | LANREOTIDE ACETATE | Approved, discontinued | May 21, 2024 | INVAGEN PHARMS |
| ANDA218217 | LANREOTIDE ACETATE | Approved, marketed | September 18, 2026 | AMNEAL |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Lanreotide for the prevention of postoperative pancreatic fistula (S2408): study protocol for a multicenter randomized controlled trial.
- Endoscopic transsphenoidal surgery for a somatotroph pituitary neuroendocrine tumor associated with an infraoptic course of the anterior cerebral artery: A case report.
- Carcinoid Heart Disease Presenting as Cardiogenic Shock: A Case Report.
- Lanreotide, a Somatostatin Analogue, in Advanced Merkel Cell Carcinoma: A Prospective Single-Arm Phase II Study.
- Targeting autolysin ATL of Streptococcus suis: structural insights and inhibition by lanreotide acetate.
- Somatostatin analogues for ADPKD: ending the confusing story of mGFR and eGFR.
- Multiple endocrine neoplasia type 1 with concurrent Cushing's disease, prolactinoma, and multifocal pancreatic neuroendocrine tumors including insulinoma: a case report.
- Case Report: Pasireotide treatment in neonatal congenital hyperinsulinism due to a homozygous ABCC8 mutation.
- Pregnancy in a patient with metastatic functioning midgut neuroendocrine tumor receiving lanreotide after peptide receptor radionuclide therapy.
- Neuroendocrine tumors of unknown primary: a case report and review of tumors with gastroenteropancreatic features.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 118
- Active
- 11
- With posted results
- 34
Conditions studied
Show 40 more studies
All 118 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 11,978
- Serious
- 7,951
- With death outcome
- 1,911
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.