PeptideTrace
ApprovedSomatostatin AnalogueMetabolic

Lanreotide (Somatuline Depot, Somatuline Autogel)

A

Evidence Grade A — Regulatory approved. 1218 published studies. 106 registered clinical trials.

106 trials1,218 studiesUSEUCA

Medically reviewed by a licensed medical professional

Licensed Indications

  • Acromegaly
  • Carcinoid Syndrome
  • Gastroenteropancreatic Neuroendocrine Tumors

User Experience Reports

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Overview

Lanreotide (sold as Somatuline Depot) is a monthly injection used to control hormone overproduction in acromegaly (a condition where the pituitary gland makes too much growth hormone) and to slow the growth of certain neuroendocrine tumours — rare cancers that often develop in the digestive system or pancreas. Its prefilled syringe can be given at home, avoiding the need for clinic visits for each dose.

Also Known As

Lanreotide is also known by these brand and alternate names:

Research Activity

1,218studies
Human 924
Animal 36
In-vitro 84
Reviews 305

1,218 published studies: 924 human, 36 animal, 84 in-vitro, 305 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CAPrescription drug

Summary

Lanreotide is marketed as Somatuline Depot (approved 2007 for acromegaly; 2014 for GEP-NETs; 2017 for carcinoid syndrome). The CLARINET trial was a landmark study that demonstrated lanreotide significantly prolonged progression-free survival in patients with GEP-NETs — the risk of disease progression or death was reduced by 53% compared to placebo.

CLARINET was particularly important because it included patients with stable disease, establishing that somatostatin analogues have anti-tumour activity beyond just symptom control. The practical advantage of lanreotide over octreotide LAR is its deep subcutaneous injection (which patients can do at home) compared to octreotide LAR's intramuscular injection (which often requires a clinic visit). Both agents are considered clinically equivalent for acromegaly.

Mechanism of Action

Lanreotide works through the same somatostatin pathway as octreotide — suppressing growth hormone release from the pituitary and reducing hormone secretion from neuroendocrine tumours. It also has direct anti-tumour effects, slowing the growth and proliferation of tumour cells. The formulation is designed as a supersaturated gel that forms a depot under the skin, slowly releasing medication over a full month from a single injection.

Research Summary

The landmark CLARINET trial demonstrated that lanreotide reduced the risk of disease progression or death by 53% in patients with gastroenteropancreatic neuroendocrine tumours, including those with stable disease. This was important because it proved that drugs in this class have genuine anti-tumour effects — not just symptom control. Lanreotide is considered clinically equivalent to the other main somatostatin analogue, octreotide LAR, for acromegaly. The practical difference is that lanreotide's deep subcutaneous injection can be self-administered at home, whereas octreotide LAR requires an intramuscular injection typically given by a healthcare professional. Biosimilar development is underway which could improve access and reduce costs. Current research focuses on combination strategies and identifying which tumour patients are most likely to respond.

Clinical Trials

PeptideTrace tracks 106 registered clinical trials for Lanreotide sourced from ClinicalTrials.gov.

NCT00916916N/AUnknown

Lanreotide Levels in Acromegaly

Cedars-Sinai Medical Center
NCT07534371N/AActive, Not Recruiting

Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort Study

West China HospitalEndpoint: PFSCompletion: 2026-07-01
NCT07087054Phase IIIRecruiting

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Crinetics Pharmaceuticals Inc.Endpoint: Participants will record the number of flushing per day in a daily diary to assess the efficacy of paltusotine vs placebo in reducing flushing episodes.Completion: 2030-01-01
NCT06807437Phase IIIRecruiting

Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula

SWOG Cancer Research NetworkEndpoint: Incidence of postoperative pancreatic fistula (POPF)Completion: 2027-11-01
NCT05701241Phase IVRecruiting

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

University Hospital, AntwerpEndpoint: the difference in progression-free survival (PFS) in patients continuing or stopping second-line therapy with SSAs, as assessed by the blinded local investigator on cross-sectional imaging, according to RECIST 1.1 criteria per substudyCompletion: 2034-04-01
View all 106 trials on ClinicalTrials.gov →

Regulatory Timeline

2007
Regulatory

Health Canada Market Authorisation

2007
Regulatory

FDA ORIG 1

2011
Regulatory

FDA SUPPL 3

2013
Regulatory

FDA SUPPL 6

2014
Regulatory

FDA SUPPL 7

2014
Regulatory

FDA SUPPL 9

2014
Regulatory

FDA SUPPL 4

2014
Regulatory

FDA SUPPL 11

2014
Regulatory

FDA SUPPL 10

2015
Regulatory

FDA SUPPL 12

2015
Regulatory

FDA SUPPL 13

2015
Regulatory

FDA SUPPL 14

2015
Regulatory

FDA SUPPL 15

2017
Regulatory

FDA SUPPL 17

2017
Regulatory

FDA SUPPL 20

2018
Regulatory

FDA SUPPL 18

2018
Regulatory

FDA SUPPL 22

2019
Regulatory

FDA SUPPL 24

2019
Regulatory

FDA SUPPL 21

2021
Regulatory

FDA ORIG 1

2023
Regulatory

FDA SUPPL 26

2024
Regulatory

FDA ORIG 1

2024
Regulatory

FDA SUPPL 32

2024
Regulatory

FDA SUPPL 8

2024
Regulatory

FDA SUPPL 7

Scientific Detail

Overview (Scientific)

Lanreotide is a synthetic cyclic octapeptide (8 amino acids) somatostatin analogue with preferential binding to SST2. It is formulated as a supersaturated aqueous solution in a prefilled syringe (Somatuline Depot/Autogel), allowing deep subcutaneous self-administration every 28 days.

Mechanism of Action (Scientific)

Lanreotide activates somatostatin receptor SST2 (with some SST5 affinity), inhibiting GH, glucagon, insulin, and GI hormones. Its antiproliferative effects on neuroendocrine tumor cells occur through both direct (cell cycle arrest, apoptosis) and indirect (anti-angiogenic) mechanisms. The deep SC formulation creates a local depot, providing sustained plasma levels over 28 days.

Summary (Scientific)

Lanreotide is marketed as Somatuline Depot (approved August 30, 2007 for acromegaly; December 16, 2014 for GEP-NETs; September 18, 2017 for carcinoid syndrome). The CLARINET trial (N=204; NEJM 2014) demonstrated lanreotide significantly prolonged PFS in GEP-NETs: median PFS not reached versus 18.0 months with placebo (HR 0.47; 95% CI 0.30–0.73; P<0.001). PFS at 24 months was 65.1% versus 33.0%—a 53% risk reduction. The prefilled syringe enables patient or caregiver self-injection.

Related Compounds

Linaclotide

Approved
Guanylate Cyclase-C Agonist

Linaclotide is marketed as Linzess (approved August 2012). It is taken as a daily oral capsule on an empty stomach, at least 30 minutes before the first meal. The recommended dose is 290 mcg for IBS-C and 72 or 145 mcg for chronic constipation. In clinical trials, approximately 34% of IBS-C patients met the composite improvement endpoint compared to 17% on placebo. Diarrhoea is the most common side effect (approximately 20%) and the leading reason for discontinuation. Linaclotide has a boxed warning against use in children under 6 years due to deaths in young mice, though no such events have been reported in humans. It competes with plecanatide (which targets the same pathway) and other IBS-C treatments.

Elamipretide

Approved
Mitochondria-Targeted Tetrapeptide (Approved)

Elamipretide (Forzinity) was approved by the FDA for Barth syndrome based on the TAZPOWER trial. The randomised crossover phase (12 patients) did not meet its primary endpoints, but the open-label extension (168 weeks) demonstrated durable improvements in walking distance and muscle strength that formed the basis for approval. Barth syndrome affects approximately 1 in 300,000–400,000 births. A larger Phase III trial in primary mitochondrial myopathy (218 patients, MMPOWER-3) did not meet its primary endpoint, and the drug was not approved for that broader indication. Elamipretide remains approved exclusively for Barth syndrome. See also SS-31 (#158) for the research compound context.

Glucagon

Approved
Counter-Regulatory Peptide Hormone

Glucagon has been available as an emergency injection since the 1960s and remains the standard rescue treatment for severe hypoglycaemia. Recent innovation has focused on making it easier to administer in emergencies. Baqsimi, approved in 2019, was the first needle-free option as a nasal powder. Gvoke, also approved in 2019, eliminated the need to mix and reconstitute the medication before injection — a significant advance since severe hypoglycaemia often impairs the ability to follow complex preparation steps. Dasiglucagon (Zegalogue), a next-generation stable liquid glucagon approved in 2021, further improved on the convenience of rescue administration. Beyond emergency rescue, glucagon's receptor is now a major research target — dual and triple agonists combining glucagon receptor activity with GLP-1 (such as survodutide and retatrutide) are in advanced clinical trials for obesity and metabolic disease.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.