Lanreotide (Somatuline Depot)

Summary

Lanreotide is an eight amino acid somatostatin analog, a lab-made version of the hormone that switches off growth hormone and many gut hormones, given as a deep slow release (depot) injection under the skin every 4 weeks. It is FDA approved for acromegaly (excess growth hormone in adults, 2007), gastroenteropancreatic neuroendocrine tumors (hormone-producing tumors of the gut and pancreas, 2014), and carcinoid syndrome (flushing and diarrhea caused by such tumors, 2017). In the CLARINET trial of 204 patients with nonfunctioning enteropancreatic neuroendocrine tumors, lanreotide 120 mg monthly reduced the risk of progression (tumor growth) or death by 53% versus placebo (hazard ratio 0.47), with median progression free survival, the typical time before tumor growth, not reached versus 18 months. It is a prescription drug; a generic depot has been available since 2021.

What is Lanreotide?

Lanreotide is a synthetic cyclic octapeptide analog of somatostatin (somatostatin receptor 2 and 5 agonist), long acting depot. It is also known as Somatuline Depot, Somatuline Autogel, Lanreotide acetate, BIM 23014.

How does it work?

Lanreotide binds somatostatin receptors 2 and 5 on pituitary somatotrophs and neuroendocrine tumor cells, suppressing growth hormone, IGF-1, and gut hormone secretion and slowing tumor proliferation through receptor mediated phosphatase activation and reduced growth factor signaling. The depot formulation is a supersaturated gel that releases drug over about 4 weeks.

FDA-approved uses of Lanreotide

Yes. The Somatuline Depot label covers long term treatment of acromegaly (excess growth hormone in adults) when surgery or radiotherapy has failed or is not possible (approved 2007); unresectable (not removable by surgery), well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors, which are hormone-producing tumors of the gut and pancreas, to improve progression free survival, the time before the tumor grows (2014); and carcinoid syndrome, the flushing and diarrhea these tumors can cause, where it reduces the need for short acting somatostatin analog rescue (2017). A generic lanreotide injection was approved in 2021. It is prescription only. [3]

What does the evidence say about Lanreotide?

CLARINET (n = 204) is the key randomized trial: progression free survival hazard ratio 0.47 (95% CI 0.30 to 0.73) for lanreotide 120 mg every 4 weeks versus placebo in metastatic or locally advanced nonfunctioning grade 1 or 2 enteropancreatic neuroendocrine tumors with Ki-67 under 10%. In acromegaly, the 2005 meta-analysis of long acting analog trials found lanreotide normalized growth hormone and IGF-1 in roughly half of patients, similar to octreotide.

Human evidence

Caplin 2014 (CLARINET): 204 patients randomized to lanreotide 120 mg or placebo every 28 days for 96 weeks; median progression free survival not reached with lanreotide versus 18.0 months with placebo, hazard ratio 0.47; estimated progression free survival at 24 months 65.1% versus 33.0%; overall survival did not differ. Freda 2005: pooled analysis of long acting somatostatin analog studies in acromegaly, in which lanreotide achieved growth hormone control in about 48% and IGF-1 normalization in about 47% of patients. The carcinoid syndrome indication rested on the ELECT trial (not cited here) showing fewer rescue octreotide doses.

Animal evidence

Preclinical work characterized receptor binding and hormone suppression in rodent and pituitary cell models and established the sustained release pharmacokinetics of the depot. No carcinogenicity signal relevant to approved dosing.

Key studies

Conditions studied

Is Lanreotide legal in the United States?

FDA and compounding status

FDA approved as Somatuline Depot in August 2007 for acromegaly, December 2014 for unresectable gastroenteropancreatic neuroendocrine tumors, and September 2017 for carcinoid syndrome. A generic lanreotide injection was approved in December 2021. Compounding is not permitted beyond patient specific exceptions because approved products exist.

WADA status

Not WADA prohibited. Not named on the current prohibited list. Athletes should still confirm against the list in force for their season.

Regulatory timeline

1. Aug 30, 2007FDA

   FDA approves Somatuline Depot (lanreotide) for acromegaly

   FDA approved lanreotide injection (Somatuline Depot), a somatostatin analog, for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery or radiotherapy.

   Regulatory: FDA approvedSource: Drugs@FDA: Somatuline Depot (lanreotide) NDA 022074

Full tracker for Lanreotide or the category-wide tracker.

Lanreotide dose on the FDA label

Doses below are quoted from the FDA label for its approved uses, plus the doses used in the pivotal trials where noted. The prescriber sets the dose; PeptideAgent does not recommend doses or protocols.

FDA label (Somatuline Depot, DailyMed; deep subcutaneous injection in the superior external quadrant of the buttock, given by a healthcare provider): acromegaly, 90 mg every 4 weeks for 3 months, then 120 mg if growth hormone or IGF-1 stays uncontrolled, 60 mg if growth hormone is 1 ng/mL or less with normal IGF-1, or 90 mg otherwise; patients controlled on 60 or 90 mg may be considered for 120 mg every 6 or 8 weeks. Gastroenteropancreatic neuroendocrine tumors: 120 mg every 4 weeks. Carcinoid syndrome: 120 mg every 4 weeks, with no extra dose for patients already treated for GEP-NETs. The label adjusts the acromegaly starting dose for renal or hepatic impairment.

Routes reported

What are the side effects and interactions of Lanreotide?

Side effects

Interactions

Contraindications

How do people access Lanreotide legally?

Typical cost: Brand Somatuline Depot lists at roughly 6,000 to 9,000 USD per monthly injection; generic lanreotide is lower but still several thousand USD. Insurance and Medicare Part B or D typically cover it for approved indications, and a manufacturer assistance program exists.

• Rules by state
• Verified provider directory

Compare Lanreotide

• Octreotide vs lanreotide

Frequently asked questions

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

Sources

Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.