Approved

Lanreotide: Uses, Mechanism, Evidence, and Side Effects

Molecular formulaC54H69N11O10S2
Molecular weight1096.3 g/mol
Registered trials124
PubChem CID6918011
Brand namesLanreotide Acetate

Mechanism of Action

12.1 Mechanism of Action Lanreotide, the active component of Lanreotide Injection, is an octapeptide analog of natural somatostatin. The mechanism of action of lanreotide is believed to be similar to that of natural somatostatin.

Source: FDA label

Patients managing acromegaly or certain neuroendocrine tumors often want to know how their treatment works and what the evidence actually supports. Lanreotide is an established option in this space, with decades of clinical use behind its approval.

Key takeaways

  • Lanreotide is a somatostatin analog marketed as Lanreotide Acetate.
  • It is approved for acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome.
  • More than 120 clinical trials have studied lanreotide across its approved and investigational uses.
  • Commonly reported adverse events include diarrhoea, fatigue, nausea, and injection site pain.
  • The label does not carry a boxed warning.

What Lanreotide Is

Lanreotide is an octapeptide analog of natural somatostatin, a hormone the body uses to regulate growth hormone and other secretions. Its mechanism of action is believed to work similarly to natural somatostatin, helping to reduce excess hormone activity. It carries the PubChem identifier CID 6918011.

What Lanreotide Is Approved For

Lanreotide Injection, sold as Lanreotide Acetate, is approved for three main uses. It treats acromegaly in patients who have not responded adequately to, or cannot undergo, surgery or radiotherapy. It is also approved for adults with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs, where it aims to improve progression-free survival. The third approved use is for adults with carcinoid syndrome, where lanreotide reduces how often patients need short-acting somatostatin analog rescue therapy. The label does not include a boxed warning.

What the Evidence Shows

Lanreotide has been studied in 124 registered clinical trials. One phase 3 trial compared Lanreotide Autogel to Sandostatin LAR Depot for managing carcinoid syndrome symptoms, though it was terminated. A separate phase 2/3 trial completed enrollment to examine growth hormone, IGF-I, and somatostatin analogues in hepatocellular carcinoma, an area outside the drug's core approved indications.

Reported Side Effects

Reports submitted to FAERS describe a pattern dominated by gastrointestinal and general symptoms. Diarrhoea (1,415 reports) and nausea (725) were among the most frequently cited, alongside fatigue (972) and abdominal pain (568). Injection site pain (596) and headache (502) were also commonly reported, along with a substantial number of off-label use reports (1,461) and death reports (1,221). These figures represent report counts submitted to a passive surveillance system, not confirmed incidence or causation.

FAQ

What is lanreotide used for?
Lanreotide is approved to treat acromegaly in patients who have not responded well to surgery or radiotherapy. It is also approved for certain gastroenteropancreatic neuroendocrine tumors and for adults with carcinoid syndrome, where it can reduce the need for rescue therapy.
How does lanreotide work?
Lanreotide is a somatostatin analog, meaning it mimics the natural hormone somatostatin in the body. Its mechanism of action is believed to work similarly to natural somatostatin by helping regulate excess hormone secretion.
Does lanreotide have a boxed warning?
No, the current label for lanreotide does not carry a boxed warning.
What are the most commonly reported side effects of lanreotide?
The most frequently reported reactions in FAERS data include diarrhoea, fatigue, nausea, abdominal pain, and injection site pain. These are report counts from a passive surveillance system, not confirmed rates of occurrence caused by the drug.
How much clinical research exists on lanreotide?
Lanreotide has been evaluated in 124 registered clinical trials, spanning its approved indications and other investigational areas such as hepatocellular carcinoma.
This page is an editorial information resource. It does not sell, prescribe, or recommend any medication. Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.

Sources: FDA drug label (DailyMed) ClinicalTrials.gov FDA Adverse Event Reporting System (FAERS) PubChem

Updated 2026-09-19