Lanreotide: the basics
What is it?
A long-acting prescription medicine that imitates somatostatin and reduces certain hormone signals.
Research paper ↗What do people claim it helps with?
Acromegaly control, treatment of selected neuroendocrine tumors and carcinoid-syndrome symptom control are supported uses for specific products.
What has research actually shown?
Human trials support hormone control in acromegaly. CLARINET found delayed progression in selected gastrointestinal and pancreatic neuroendocrine tumors; that is not a cure or evidence for all cancers.
Research paper ↗Has this been demonstrated in people?
Demonstrated in people, including controlled clinical trials for the uses described here. Evidence for one diagnosis does not establish benefit for every other claim.
Research paper ↗What side effects, risks and unknowns should I understand?
Diarrhea, abdominal discomfort, gallstones and injection reactions can occur. Blood sugar, heart rate and fat absorption can be affected.
Prescribing information ↗Is it an approved medicine?
Yes. Somatuline Depot has FDA-approved uses in acromegaly, selected gastroenteropancreatic neuroendocrine tumors and carcinoid syndrome. Some generic labels have narrower indications.
Prescribing information ↗Approval here means U.S. FDA approval and applies to a particular product, formulation and use. This is a starting overview, not a complete side-effect list. Sources checked 10 October 2026; independent scientific review pending.
How is it used or studied?
Long-acting prescription injection used with specialist assessment and monitoring.
Different routes and formulations can have different effects. A study of one product does not validate every product with the same peptide name.
A common misunderstanding
Neuroendocrine tumors are a particular cancer group; these findings do not apply to every cancer.
What should I ask a clinician?
- What diagnosis or goal are we trying to address, and what established options are available?
- Was the expected benefit shown in people like me, using this exact product?
- How could my medicines, health conditions or pregnancy plans affect the risks?
- What monitoring is needed, and what would tell us the treatment is helping or should be stopped?
What do the research words mean?
- Peptide
- A short chain of amino acids, the building blocks of proteins.
- Preclinical
- Research in cells, tissues or animals before dependable treatment evidence in people.
- Controlled trial
- A study comparing a treatment with another treatment or a placebo to help separate its effects from other explanations.
- Biomarker
- A measurement, such as a hormone level. A change does not necessarily mean someone feels better or lives longer.
Lanreotide Evidence & Clinical Profile
Established Clinical Trials
Lanreotide has been investigated in clinical contexts. Patient outcomes must be evaluated against study size, design, and control cohorts.
Laboratory & In Vivo Assays
Cellular and animal disease models examine receptor binding affinities and signaling cascades, which require human confirmation.
What is Lanreotide?
Lanreotide Acetate (Somatuline Depot) is An FDA-approved synthetic octapeptide somatostatin analogue formulated as a supersaturated aqueous gel for deep subcutaneous injection. Shown in the CLARINET trial to prolong progression-free survival in enteropancreatic neuroendocrine tumors, and used to control GH and IGF-1 in acromegaly. Aliases include: Somatuline, Somatuline Depot, BIM-23014.
- Sequence (one-letter)
- D-2Nal-c[CY-D-Trp-KVC]-T-NH2
- Molecular formula
- C54H69N11O10S2
- Molecular weight
- 1096.3 g/mol
- CAS Number
- 108736-35-2
- UNII Code
- 0G3DE8943Y
- PubChem CID
- 6918011
Identifiers are for the free base; the medicine contains lanreotide acetate (UNII IEU56G3J9C).
Identifiers checked against PubChem and FDA's Global Substance Registration System on 13 October 2026. FDA substance record ↗ · PubChem record ↗ See all names and codes in the peptide name index.
Clinical Trials & Human Cohorts
Human research can examine tolerability, symptoms or patient outcomes. The design and comparator determine what each result can establish.
Lanreotide in Metastatic Enteropancreatic Neuroendocrine Tumors [1]
What was reported
Statistically significant prolongation of progression-free survival (median not reached vs 18.0 months with placebo, HR 0.47).
What limits the conclusion
No significant differences in quality of life or overall survival; diarrhea was the most common treatment-related adverse event (26% vs 9%).
Effectiveness and tolerability of 3-year lanreotide Autogel treatment in patients with acromegaly [2]
What was reported
After 3 years, hormonal control (GH and age- and sex-normalized IGF-1) was achieved in 6 patients (46%); digestive adverse events became less frequent over time.
What limits the conclusion
Very small uncontrolled cohort; new cholelithiasis or sludge occurred in 5 patients (35%).
How the compound may work
Mechanisms describe how Lanreotide may affect biological processes. Laboratory findings and patient outcomes answer different questions.
Somatostatin Receptor Agonism
Lanreotide acts via somatostatin receptors to reduce growth hormone and IGF-I levels; the Autogel is a prolonged-release supersaturated aqueous gel formulation. [3]
Self-Assembling Nanotubes
Lanreotide spontaneously self-assembles into nanotubes; specific aromatic side chains and the spatial arrangement of hydrophilic and hydrophobic residues are essential for this architecture. [4]
Areas Being Studied
These research topics reflect active areas of scientific exploration, distinct from unverified commercial marketing claims.
Gastroenteropancreatic Neuroendocrine Tumors
Prolonged progression-free survival versus placebo in grade 1–2 enteropancreatic NETs. [1]
Acromegaly Therapy
Provided hormonal control and improved symptoms and quality of life in most patients in studies of up to 4 years. [3]
Compare the study designs.
| Study | Design / sample | Outcome type | Key limitation |
|---|---|---|---|
| CLARINET Phase 3 GEP-NET Trial · 2014 [1] | Randomized double-blind placebo-controlled multinational trial n = 204 |
Clinical endpoint evaluation | No significant differences in quality of life or overall survival; diarrhea was the most common treatment-related adverse event (26% vs 9%). |
| Acromegaly 3-Year Autogel · 2006 [2] | Extension of a previous trial (titrated dosing) n = 14 |
Clinical endpoint evaluation | Very small uncontrolled cohort; new cholelithiasis or sludge occurred in 5 patients (35%). |
Regulatory Status & Clinical Safety
Regulatory Classification
FDA approved (NDA 022074) as Somatuline Depot for acromegaly and GEP-NETs.
Safety Realities & Impurities
Safety depends on the molecule, formulation, route and evidence. A laboratory purity measurement alone cannot establish safety for human use.
Clinical Trials Registry Records
Official registry records from ClinicalTrials.gov. Study registration does not imply government endorsement or guaranteed efficacy.
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours [1]
- Planned enrollment
- 264 (patients)
- Posted results
- Available
- Sponsor
- Ipsen
- Last updated
- 2025
WADA & Anti-Doping Regulations
WADA Anti-Doping Status
Lanreotide is not prohibited under current World Anti-Doping Agency (WADA) regulations. However, athletes must ensure unregulated preparations or unverified vendor products do not violate Section S0 (Non-approved substances). Last verified: October 2026.
Research Timeline
-
2007
FDA Approval: Acromegaly
FDA approves Somatuline Depot (NDA 022074). [5]
-
2014
CLARINET Landmark
Reports significantly prolonged progression-free survival in enteropancreatic NETs. [1]
-
2014
FDA Approval: GEP-NETs
FDA approves an efficacy supplement extending use to gastroenteropancreatic NETs. [5]
What Researchers Still Don't Know
Long-term safety profiles
Multi-year observational data in broader heterogeneous cohorts remains uncharacterized.
Optimal dose-response thresholds
Comparative trials optimizing minimal effective exposure versus adverse event rates.
Formulation bioavailability
Differences between oral, subcutaneous, and modified peptide delivery vehicles.
References
Primary sources verified against PubMed / NLM and regulatory databases.
-
Landmark RCT
Lanreotide in metastatic enteropancreatic neuroendocrine tumors ↗ (external website)
- Clinical Cohort
- Review
- Biophysical Study
-
Regulatory
Drugs@FDA: Somatuline Depot (Lanreotide) NDA 022074 ↗ (external website)