Digestive & weight Somatostatin analog
Lanreotide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Lanreotide (sold as Somatuline Depot) is a long-acting somatostatin analog that suppresses growth hormone and gut hormones and slows the growth of certain neuroendocrine tumors. It is used for acromegaly and for gastroenteropancreatic neuroendocrine tumors, and in the CLARINET trial it significantly delayed tumor progression. It has been FDA-approved in the U.S. since 2007 and is given as a deep subcutaneous injection about once a month.
At a glance
- What it is
- A long-acting somatostatin analog peptide
- Approved for
- Acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome
- Key fact
- In the CLARINET trial it significantly prolonged progression-free survival versus placebo in metastatic neuroendocrine tumors
- Route
- Deep subcutaneous injection, about every four weeks
- Evidence strength
- FDA approved
Summary
Lanreotide is a long-acting somatostatin analog FDA-approved since 2007 for acromegaly and certain neuroendocrine tumors. Learn how it works and its risks.
What is lanreotide?
Lanreotide, sold under the brand Somatuline Depot (Somatuline Autogel outside the U.S.), is a synthetic cyclic octapeptide analog of somatostatin. Like octreotide it mimics the body's natural "off switch" for growth hormone and several gut hormones, but it is supplied as a long-acting gel in a prefilled syringe that maintains drug levels for weeks. It was developed under the code BIM-23014 and approved in the United States in 2007.
How does lanreotide work?
Lanreotide binds somatostatin receptors, primarily subtypes 2 and 5, on hormone-secreting and tumor cells. Activating those receptors suppresses growth hormone and insulin-like growth factor 1 and reduces the release of gut hormones. Beyond controlling hormone excess, somatostatin-receptor activation has an antiproliferative effect on well-differentiated neuroendocrine tumors, slowing their growth.
In acromegaly, that suppression lowers growth hormone and IGF-1 and improves symptoms; in neuroendocrine tumors, it both controls hormone-related symptoms and delays progression. In the CLARINET trial, lanreotide significantly prolonged progression-free survival compared with placebo in people with metastatic enteropancreatic neuroendocrine tumors:
| Group | Median progression-free survival |
|---|---|
| Lanreotide | Not reached |
| Placebo | 18 months |
The depot formulation is injected deeply under the skin about once a month.
Is it FDA-approved?
Editor’s note
Status: Yes. Lanreotide was approved by the FDA in 2007 for acromegaly, with the gastroenteropancreatic neuroendocrine tumor indication added in 2014 and a carcinoid syndrome indication following. It is marketed as the Somatuline Depot prefilled syringe.
Category: FDA-approved · Primary body area: Digestive & weight
Yes. Lanreotide was approved by the FDA in 2007 for acromegaly, with the gastroenteropancreatic neuroendocrine tumor indication added in 2014 and a carcinoid syndrome indication following. It is marketed as the Somatuline Depot prefilled syringe.
What is lanreotide prescribed for?
Lanreotide is prescribed for:
- Acromegaly
- Unresectable or metastatic gastroenteropancreatic neuroendocrine tumors, to slow progression
- Carcinoid syndrome, to reduce the need for short-acting somatostatin analogs
What are the side effects?
According to the prescribing information, common side effects include:
- Diarrhea and abdominal pain
- Nausea
- Gallstones
- Injection-site reactions
- Slowed heart rate
More serious considerations include:
- Gallbladder disease with long-term use
- Changes in blood glucose and thyroid function
- Cardiac conduction effects
Sources: FDA prescribing information for Somatuline Depot; the CLARINET trial (Caplin et al., New England Journal of Medicine, 2014, DOI: 10.1056/NEJMoa1316158), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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