Lanreotide
Somatostatin analog
Also Somatuline Depot, Somatuline, Somatuline Autogel, Lanreotide acetate, BIM 23014, BIM-23014
- Evidence
- AStrong human evidence
- FDA status
- FDA approvedas of 2026-10-26
- Route
- Injection
- Studies cited
- 1 human0 animal or cell
It is a monthly injection for a hormone illness called acromegaly and for slow-growing gut tumors. A trial of 204 patients showed it slowed tumor growth.
Sold for
Lanreotide is a prescription cancer and acromegaly drug, and it is not a wellness-market peptide; the talk about it is clinical, mostly about slowing neuroendocrine tumors.
Studies say
A placebo-controlled trial in 204 patients and the acromegaly trials behind the label support both approved uses, which is why it grades A.
Why grade A. The neuroendocrine tumor indication rests on CLARINET, a randomized, double-blind, placebo-controlled trial in 204 patients that showed longer progression-free survival. The acromegaly approval rests on earlier controlled trials summarized in the label. The citations here include one trial and the prescribing information; the open question is how lanreotide compares head to head with octreotide in tumor control, which CLARINET did not test. 12
FDA. Approved. Lanreotide is marketed in the US as Somatuline Depot for acromegaly (first approved 2007), for unresectable or metastatic gastroenteropancreatic neuroendocrine tumors, and for carcinoid syndrome. A therapeutically equivalent lanreotide injection from Cipla is also approved. 2
Written from 2 cited sources. Fact-checked 2026-10-27: 15 claims checked, 3 corrected. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Acromegaly and gut tumors
- Can a US doctor prescribe it?
- Yes, FDA approved for acromegaly, certain gut tumors and carcinoid syndrome.
- Properly tested in people?
- Yes, in controlled trials, including one of 204 patients.
Evidence checklist
- Randomised controlled trial CLARINET placebo-controlled trialyes
- Human study over 100 people CLARINET, 204 patientsyes
- More than one research group Mainly one trial plus label studiesno
- Clinical outcomes, not surrogate markers Progression-free survival in CLARINETyes
- Human safety data beyond case reports No excess serious events in 96 weeksyes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Lanreotide is a synthetic eight-amino-acid analog of somatostatin, a hormone the body uses to switch off the release of growth hormone and several gut hormones. Natural somatostatin lasts only a few minutes in the blood. Lanreotide was engineered to resist breakdown and is formulated as a deep subcutaneous depot that releases slowly for weeks. 2
In the US it is sold by Ipsen as Somatuline Depot in a prefilled syringe. The label covers three indications: acromegaly in people who have not responded to or cannot have surgery or radiotherapy, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that cannot be removed surgically, and carcinoid syndrome, where it reduces the need for short-acting octreotide rescue injections. 2
How it works
Lanreotide binds somatostatin receptors, with the highest affinity for subtypes 2 and 5. In the pituitary that binding suppresses growth hormone release, which lowers IGF-1, the hormone that drives the tissue overgrowth of acromegaly. Many neuroendocrine tumors carry large numbers of the same receptors; binding them slows hormone secretion from the tumor and, through downstream signaling, slows cell division. 2
The same receptor binding dampens secretion from the pancreas and gut, which is why the drug lowers serotonin-driven flushing and diarrhea in carcinoid syndrome and also why gallstones and loose stools are common side effects. 2
What human research shows
CLARINET randomized 204 patients with advanced, non-functioning, well or moderately differentiated GEP-NETs to lanreotide or placebo for 96 weeks. Median progression-free survival was not reached in the lanreotide arm and was 18 months with placebo, a 53 percent reduction in the risk of progression or death. Overall survival did not differ at the time of analysis, and the tumors studied were mostly slow-growing. 1
In acromegaly, the label summarizes two randomized multicentre studies. In the larger, one-year study of 108 patients, IGF-1 was in the normal range at the last measurement in 58% of lanreotide-treated patients and growth hormone was at or below 2.5 ng/mL in 51%, against 8% and 0% at baseline. 2
| Study | Model | Finding |
|---|---|---|
| CLARINET (Caplin 2014) | Humans, n=204, randomized double-blind placebo-controlled, 96 weeks | Lanreotide cut the risk of progression or death by 53 percent in advanced non-functioning GEP-NETs; median PFS not reached versus 18 months on placebo. 1 |
| Somatuline Depot prescribing information | FDA label summarizing controlled acromegaly and carcinoid syndrome trials | In a one-year acromegaly study, IGF-1 normalized in 58% of patients; in carcinoid syndrome lanreotide reduced the use of short-acting rescue octreotide. 2 |
Safety
The most common side effects in the label are diarrhea, abdominal pain, gallstones (cholelithiasis), and injection-site reactions. Lanreotide can lower blood sugar or raise it, slow the heart rate, and reduce thyroid function, so the label calls for monitoring of glucose, heart rate, and thyroid tests. Gallbladder problems are frequent enough that imaging is sometimes done before and during treatment. 2
CLARINET found no excess of serious adverse events compared with placebo over two years; diarrhea and hyperglycemia were the main differences. Long-term data on pediatric or pregnant patients are limited. 12
Questions for your clinician
- Is lanreotide or octreotide better for my tumor type, given no head-to-head trial?
- How often will glucose, heart rate and thyroid tests be checked?
- Should I have gallbladder imaging before or during treatment?
Questions people ask
Which conditions is lanreotide used to treat?
Three conditions: acromegaly when surgery or radiation has not worked or is not possible, gastroenteropancreatic neuroendocrine tumors that cannot be removed, and carcinoid syndrome. All three are on the US label. 2
How is lanreotide different from octreotide?
Both are somatostatin analogs that hit the same receptors. Lanreotide comes as a ready-to-use deep subcutaneous depot, while long-acting octreotide must be mixed and given into the muscle. The two have not been compared head to head for tumor control in a large trial. 12
Does lanreotide shrink tumors?
In CLARINET it mainly stopped tumors growing. Objective shrinkage was uncommon; the benefit was a longer time before progression, and overall survival had not separated when the trial was analyzed. 1
What are the common side effects?
Diarrhea, abdominal pain, gallstones, and injection-site lumps or pain. Blood sugar can move in either direction and the heart rate can slow, so the label asks for monitoring. 2