PeptideTrace
ApprovedSomatostatin Analogue

Lanreotide

Somatuline Depot, Somatuline Autogel

A

Evidence Grade A — Regulatory approved. 1211 published studies. 115 registered clinical trials.

115 trials1,211 studiesUSEUCA

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.

Research Activity

1,211studies
Human 919
Animal 36
In-vitro 84
Reviews 302

1,211 published studies: 919 human, 36 animal, 84 in-vitro, 302 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

NCT00916916N/AUnknown

Lanreotide Levels in Acromegaly

Cedars-Sinai Medical Center
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
NCT05922579N/ATerminated

A Study to Collect the Somatuline® Injector Device Preferences of Patients Living With Neuroendocrine Tumor (NET) and Nurses Involved in the Care of Patients With NET

IpsenEndpoint: Attribute importanceCompletion: 2023-12-01
View all 115 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

Related Compounds

Exenatide

Approved
GLP-1 Receptor Agonist

Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.

Lixisenatide

Approved
GLP-1 Receptor Agonist

Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.

Pramlintide

Approved
Amylin Analogue

Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy. Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.