Lanreotide (brand names Somatuline Depot and Somatuline Autogel) is a long-acting somatostatin analog approved for acromegaly and for slowing progression of gastroenteropancreatic neuroendocrine tumors, with additional approval for carcinoid syndrome.

Is Lanreotide approved for medical use?

Lanreotide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved. Acromegaly (Somatuline Depot, August 2007); gastroenteropancreatic neuroendocrine tumors, to improve progression-free survival (December 2014); carcinoid syndrome (2017). European Union (EMA): Authorised and marketed in EU member states (nationally authorised; brand Somatuline Autogel). Australia (TGA): Registered on the ARTG as a prescription medicine (Somatuline Autogel, sponsor Ipsen), since September 2003.

Is Lanreotide legal in Australia?

Lanreotide in Australia (TGA): Registered on the ARTG as a prescription medicine (Somatuline Autogel, sponsor Ipsen), since September 2003.

Is Lanreotide banned in sport?

Lanreotide under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List; somatostatin analogs are not among the prohibited peptide-hormone classes.

Long-acting synthetic somatostatin analog (cyclic octapeptide)

Lanreotide

Approvedaka Somatuline, Somatuline Depot, Somatuline Autogel, BIM 23014

Lanreotide is a depot somatostatin analog administered by deep subcutaneous injection every 28 days. Beyond controlling growth hormone excess in acromegaly, the Phase 3 CLARINET trial showed it prolonged progression-free survival versus placebo in patients with metastatic enteropancreatic neuroendocrine tumors. It is approved in the United States, registered in Australia, and marketed in the European Union.

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Lanreotide vs Octreotide

Mechanism

Lanreotide is a long-acting copy of somatostatin that damps down hormone secretion and slows the growth of certain tumors. It is a synthetic cyclic octapeptide somatostatin analog with high affinity for somatostatin receptor subtypes 2 and 5; receptor activation inhibits growth hormone and IGF-1 secretion and exerts antiproliferative effects on neuroendocrine tumor cells.

Regulatory Status by Region

United States (FDA)Approved. Acromegaly (Somatuline Depot, August 2007); gastroenteropancreatic neuroendocrine tumors, to improve progression-free survival (December 2014); carcinoid syndrome (2017).
Australia (TGA)Registered on the ARTG as a prescription medicine (Somatuline Autogel, sponsor Ipsen), since September 2003.
European Union (EMA)Authorised and marketed in EU member states (nationally authorised; brand Somatuline Autogel).
WADANot listed on the WADA Prohibited List; somatostatin analogs are not among the prohibited peptide-hormone classes.

See the full regulatory status matrix

Key Studies

CLARINET trial (Caplin ME et al.) (opens in a new tab) (N Engl J Med 2014;371(3):224-233; DOI 10.1056/NEJMoa1316158; PMID 25014687; NCT00353496)
CLARINET study record (lanreotide Autogel 120 mg, Ipsen) (opens in a new tab) (ClinicalTrials.gov NCT00353496; Phase 3; non-functioning enteropancreatic neuroendocrine tumors)
FDA prescribing information: Somatuline Depot (lanreotide) injection (opens in a new tab) (DailyMed / FDA label; indications: acromegaly, GEP-NETs, carcinoid syndrome; labeler Ipsen Biopharmaceuticals)

Related Clinical Trials

Latest research

First Autopsy-confirmed Complete Remission of Metastatic Neuroendocrine Neoplasm of Tailgut Cyst After a Single Cycle of Alpha-Peptide Receptor Radionuclide Therapy With [ 225 Ac]Ac-DOTA-LM3. (opens in a new tab)
Clinical nuclear medicine · Jul 1, 2026
A case of small pancreatic neuroendocrine tumor of less than 10 mm showing metastasis to multiple organs. (opens in a new tab)
Clinical journal of gastroenterology · Jun 28, 2026
Safety and Efficacy of Once-Daily Oral Paltusotine in Acromegaly: ACROBAT Advance Open-Label Extension Up to 4 Years. (opens in a new tab)
The Journal of clinical endocrinology and metabolism · Jun 26, 2026

See all recent Lanreotide research

Common Questions

What is Lanreotide?: Lanreotide (brand names Somatuline Depot and Somatuline Autogel) is a long-acting somatostatin analog approved for acromegaly and for slowing progression of gastroenteropancreatic neuroendocrine tumors, with additional approval for carcinoid syndrome.
Is Lanreotide approved for medical use?: Lanreotide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved. Acromegaly (Somatuline Depot, August 2007); gastroenteropancreatic neuroendocrine tumors, to improve progression-free survival (December 2014); carcinoid syndrome (2017). European Union (EMA): Authorised and marketed in EU member states (nationally authorised; brand Somatuline Autogel). Australia (TGA): Registered on the ARTG as a prescription medicine (Somatuline Autogel, sponsor Ipsen), since September 2003.
How does Lanreotide work?: Lanreotide is a long-acting copy of somatostatin that damps down hormone secretion and slows the growth of certain tumors. It is a synthetic cyclic octapeptide somatostatin analog with high affinity for somatostatin receptor subtypes 2 and 5; receptor activation inhibits growth hormone and IGF-1 secretion and exerts antiproliferative effects on neuroendocrine tumor cells.
Is Lanreotide legal in Australia?: Lanreotide in Australia (TGA): Registered on the ARTG as a prescription medicine (Somatuline Autogel, sponsor Ipsen), since September 2003.
Is Lanreotide banned in sport?: Lanreotide under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List; somatostatin analogs are not among the prohibited peptide-hormone classes.