Approved

Lanreotide: Uses, Mechanism, and Side Effects

Molecular formulaC54H69N11O10S2
Molecular weight1096.3 g/mol
Registered trials125
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 understand how their treatment works and what to expect. Lanreotide is a long-established injectable therapy with a defined role across several hormone-related conditions.

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 125 registered trials have studied lanreotide, including combination regimens with other cancer therapies.
  • FAERS reports most commonly include diarrhea, fatigue, nausea, and injection site pain, alongside off-label use reports.
  • The drug does not carry a boxed warning.

What Lanreotide Is

Lanreotide is an octapeptide analog of natural somatostatin, a hormone that regulates the release of several other hormones in the body. Its mechanism of action is believed to mirror that of natural somatostatin, which generally works by suppressing excess hormone secretion. This action underlies its use in conditions marked by hormone overproduction, such as acromegaly and hormone-secreting tumors.

What Lanreotide Is Approved For

Lanreotide is indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to, or cannot undergo, surgery and radiotherapy. It is also approved for adults with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs, where it is used to improve progression-free survival. A third approved use is for adults with carcinoid syndrome, where lanreotide reduces the frequency of needing short-acting somatostatin analog rescue therapy. The label lists Lanreotide Acetate as the marketed brand name.

What The Evidence Shows

Lanreotide has been studied in more than 125 registered clinical trials. One completed Phase 2 trial evaluated lanreotide autogel combined with temozolomide in patients with thoracic neuroendocrine tumors. A separate Phase 2 trial, with an unknown current status, examined lanreotide combined with cabozantinib in patients with GEP-NETs. Other research has looked at switching patients from octreotide, a related somatostatin analog, to lanreotide.

Reported Side Effects

Reports submitted to FAERS reflect adverse event counts, not confirmed incidence or proven causation. The most frequently reported reactions involve gastrointestinal and general symptoms: diarrhea (1,415 reports), fatigue (972), nausea (725), and abdominal pain (568). Injection site pain (596 reports) and headache (502) are also commonly noted. Reports of death (1,221) and off-label use (1,461) appear among the most frequent entries, reflecting the broad population and settings in which the drug is used.

FAQ

What is lanreotide used for?
Lanreotide is approved for the long-term treatment of acromegaly when surgery or radiotherapy has not been adequate or is not an option. It is also approved for certain gastroenteropancreatic neuroendocrine tumors to improve progression-free survival, and for adults with carcinoid syndrome to reduce the need for short-acting rescue therapy.
How does lanreotide work?
Lanreotide is a somatostatin analog, meaning it mimics the natural hormone somatostatin. Its mechanism is believed to work similarly to natural somatostatin by helping regulate the release of other hormones in the body.
What are the most commonly reported side effects of lanreotide?
Adverse event reports most frequently mention diarrhea, fatigue, nausea, injection site pain, and abdominal pain. These figures come from FAERS reporting data, which reflects the number of reports submitted rather than confirmed incidence or direct causation.
Does lanreotide have a boxed warning?
No, according to the available label information, lanreotide does not carry a boxed warning.
Is lanreotide still being studied in clinical trials?
Yes, more than 125 trials have registered lanreotide as a study drug. Recent examples include trials combining it with other therapies such as temozolomide and cabozantinib in neuroendocrine tumor populations.
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 FAERS PubChem

Updated 2026-09-26