Is lanreotide FDA-approved, and what does the research show?

What is lanreotide?

Lanreotide is a synthetic peptide of eight amino acids, closed into a ring by a sulfur bridge, built to act as somatostatin does ¹. Somatostatin is a hormone that holds back the release of other hormones, insulin and glucagon among them ¹. The label calls lanreotide "a synthetic cyclical octapeptide analog of the natural hormone, somatostatin" ¹. Ipsen sells it in the United States as Somatuline Depot, a prolonged-release gel in a prefilled syringe, a formulation the CLARINET paper calls Autogel ², ¹, ³.

It treats three conditions ¹. Treatment of acromegaly aims to bring growth hormone and IGF-1, insulin-like growth factor 1, back to normal ¹; acromegaly itself is a disorder of excess growth hormone. Gastroenteropancreatic neuroendocrine tumors, GEP-NETs, are "a type of cancer" that starts in the gastrointestinal tract or the pancreas, in the words of the label's patient leaflet ¹. Carcinoid syndrome is the flushing and diarrhea such tumors can cause ¹. Octreotide, a related short-acting somatostatin analog, is a different molecule with its own page ¹.

Is lanreotide FDA-approved?

Yes. Lanreotide is approved by FDA as the prescription medicine Somatuline Depot, with initial U.S. approval in 2007 ¹. Drugs@FDA, the public register of approved drug applications, carries Ipsen Pharma's NDA 022074, its new drug application, approved on August 30, 2007, with marketing status "Prescription" ². The 2007 approval was for acromegaly alone ⁴. FDA added the tumor use by a supplement, an addition to that application, approved December 16, 2014, and the carcinoid syndrome use by one approved September 15, 2017 ², ⁵, ⁶.

The label approves it for three uses, in these words ¹. First, "the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option" ¹. Second, "the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival" ¹. Unresectable means the tumor cannot be removed by surgery, and progression-free survival is the time a patient lives before the tumor grows or the patient dies ³, ¹.

Third, "the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy" ¹. Rescue therapy is the short-acting injection, octreotide in the trial, that a patient takes when symptoms break through ¹.

A second application carries the same molecule. NDA 215395, a Lanreotide Injection from InvaGen Pharmaceuticals, was approved December 17, 2021, for acromegaly and GEP-NETs, with the carcinoid use added September 16, 2024 ⁷, ⁸, ⁹. Drugs@FDA lists all three strengths of that product as "Discontinued" as of November 9, 2026, the date of its data ⁷.

Two abbreviated applications (ANDAs), the route for generic copies of an approved drug, also exist ¹⁰. InvaGen's ANDA 217193 was approved May 21, 2024, and is listed as discontinued as of the same November 6, 2026 data ¹⁰. Its label carries the same three uses ¹¹. Amneal's ANDA 218217 was approved September 18, 2026, with marketing status "Prescription" ¹⁰.

The label lists no indication for weight, body composition or anything outside those three uses ¹. Weight decrease appears in it as an adverse reaction, reported by 8 percent of Study 1's patients in its first 20 weeks ¹. It also appears as a sign of fat malabsorption in a 2024 warning ¹. The route to it is a licensed clinician's prescription, and the label says the injection is "intended for administration by a healthcare provider" ¹. The label was last revised in July 2024 ¹.

See the FDA status of every peptide, updated weekly.

How does lanreotide work?

Lanreotide acts on the body's somatostatin receptors, and the label says its mechanism "is believed to be similar to that of natural somatostatin" ¹. It binds most strongly to somatostatin receptor types 2 and 5, and activity there "is the primary mechanism believed responsible for GH inhibition," GH being growth hormone ¹. Its main measured effect is a fall in growth hormone and in IGF-1 ¹. Those are the two blood markers the label uses to judge acromegaly and its treatment ¹.

After a single injection of Somatuline Depot, growth hormone falls rapidly and stays down for at least 28 days ¹. In the carcinoid syndrome trial, it lowered urinary 5-HIAA, a marker of the syndrome, compared with placebo ¹.

Like somatostatin, it also holds back insulin and glucagon, several gut hormones, gallbladder contraction and bile secretion, and the nighttime rise in thyroid-stimulating hormone ¹. In healthy subjects it reduces and delays insulin release after meals, "resulting in transient, mild glucose intolerance" ¹. These actions sit behind the label's warnings on blood sugar, gallstones and thyroid function ¹. This account is the label's, for an approved drug, from studies in patients and healthy subjects ¹.

What does the research show?

The evidence for lanreotide's approved uses is at the top tier: FDA approval rests on the label's four trials; Study 3 is CLARINET, published in a journal ¹, ¹², ³. Studied in people with acromegaly: Study 1, in the label, enrolled 108 patients with active acromegaly and ran for a year ¹. It opened with a four-week phase that was double-blind, so neither patient nor clinician knew who had the drug, and placebo-controlled, so some received an inactive injection ¹.

A 16-week fixed-dose phase followed, then a 32-week dose-titration phase, in which the dose was adjusted step by step ¹. At week 4, 52 of the 83 patients on lanreotide (63 percent) had cut their mean growth hormone by more than half, against none of the 25 on placebo ¹. At week 16, with the placebo group now on lanreotide, 72 percent of the 107 treated had done so ¹.

By the last visit, 58 percent of them had a normal age-adjusted IGF-1 ¹. Forty-one percent had both a normal IGF-1 and a mean growth hormone at or below 2.5 ng/mL ¹. Median growth hormone fell from 10.27 to 2.43 ng/mL ¹.

Study 2 was a 48-week, open-label, uncontrolled study, with no blinding and no comparison group, of 63 patients whose IGF-1 was at least 1.3 times the upper limit of normal ¹. By the end, 27 of 63 (43 percent) had a normal age-adjusted IGF-1 ¹. Twenty-four (38 percent) had both a normal IGF-1 and a growth hormone at or below 2.5 ng/mL ¹. Mean IGF-1 fell from 2.5 to 1.3 times the upper limit of normal ¹.

Studied in people against placebo for tumor progression: CLARINET, published in July 2014, randomized 204 patients to lanreotide or placebo every 28 days for 96 weeks ³. All had advanced, nonfunctioning neuroendocrine tumors of grade 1 or 2, the slower-growing grades, that were well or moderately differentiated, meaning the cells still resembled normal ones ³. The tumors were somatostatin receptor-positive, carrying the receptor the drug binds ³. They had started in the pancreas, the midgut (the small bowel) or the hindgut (the lower bowel), or at an unknown site ³.

Nonfunctioning means the tumor caused no hormone symptoms ¹. Most patients, 96 percent, had shown no tumor progression in the three to six months before randomization ³.

The primary end point was progression-free survival ³. The median was not reached on lanreotide: fewer than half of the 101 patients had progressed or died by the trial's end ³. In the 103 on placebo it was 18.0 months ³.

That is a hazard ratio for progression or death of 0.47, with a 95 percent confidence interval of 0.30 to 0.73 ³. A hazard ratio of 0.47 means the risk of progression or death at any point was about half that on placebo. The confidence interval is the range within which the true figure most likely lies.

At 24 months, 65.1 percent on lanreotide were alive without progression, against 33.0 percent on placebo ³. There were no significant differences in quality of life or overall survival ³. Ipsen funded the trial ³.

FDA's review of the 2014 supplement names its trial, Study 726, as CLARINET, and the label calls it Study 3 ¹², ¹. Progression or death occurred in 32 of 101 (31.7 percent) on lanreotide and 60 of 103 (58.3 percent) on placebo ¹. The paper gives the placebo median as 18.0 months; FDA's label and review give 16.6 months, from the analysis submitted to FDA ³, ¹, ¹². The arms differed at the start in one respect the label notes ¹. Tumor filled more than a quarter of the liver in 39 percent on lanreotide and 27 percent on placebo ¹.

Studied in people with carcinoid syndrome: Study 4 was a 16-week, double-blind, placebo-controlled trial of 115 patients with neuroendocrine tumors and a history of flushing or diarrhea ¹. It randomized 59 to lanreotide and 56 to placebo ¹. Both arms could inject short-acting octreotide as rescue medicine when symptoms broke through ¹.

The primary outcome was the share of days on which a patient used rescue medicine ¹. It was 34 percent of days on lanreotide and 49 percent on placebo, a difference the label gives as p=0.02, a test of how unlikely chance is to explain it ¹. Daily diarrhea and flushing counts were numerically lower on lanreotide but "not statistically significantly different via hierarchical testing," outcomes tested in a fixed order ¹.

No source on this page reports a trial of lanreotide for weight, body composition, muscle, aging or athletic performance, as of November 10, 2026 ¹, ³, ¹¹. The CLARINET abstract reports progression and survival, not whether tumors shrank ³.

What are the side effects?

Gut effects and gallstones lead. In the label's pool of 416 acromegaly patients from seven studies, 86 percent reported an adverse reaction ¹. Diarrhea was reported by 37 percent, abdominal pain by 19 percent, nausea by 11 percent, and constipation, flatulence, vomiting and loose stools by 6 to 8 percent each ¹. In the four-week placebo-controlled phase of Study 1, 26 of 83 (31 percent) on lanreotide had diarrhea, against none of the 25 on placebo ¹. Diarrhea, abdominal pain and flatulence became more common as the dose rose ¹.

One percent stopped treatment because of gut reactions, and pancreatitis, inflammation of the pancreas, was reported in less than 1 percent ¹. Gallstones or gallbladder sludge were reported in 20 percent of the 416 ¹. Among 167 patients given routine gallbladder ultrasound, 17 percent had stones at the start and 12 percent developed new ones ¹. Injection site pain was reported by 4 percent and an injection site mass by 2 percent, and 5 percent developed a hardened area at the site ¹.

Blood sugar disturbances, high or low, were reported by 14 percent of the 332 acromegaly patients the label counts for that reaction ¹. They were judged related to the drug in 7 percent ¹. Sinus bradycardia, a slow heartbeat, occurred in 3 percent of the pooled patients and 7 percent of those in Studies 1 and 2 ¹. Hypertension occurred in 5 percent and anemia in 3 percent ¹.

In the tumor trial, 88 percent on lanreotide and 90 percent on placebo had an adverse reaction; lanreotide patients' median exposure was 22 months ¹. More common on lanreotide were abdominal pain (34 against 24 percent), musculoskeletal pain (19 against 13) and vomiting (19 against 9) ¹. Headache (16 against 11) and injection site reactions (15 against 7) were too ¹. So were high blood sugar (14 against 5 percent), hypertension (14 against 5) and gallstones (14 against 7) ¹. Five percent stopped for adverse reactions, against 3 percent on placebo ¹.

In the carcinoid trial, headache (12 against 5 percent), dizziness (7 against 0) and muscle spasm (5 against 0) stood out by week 16 ¹. Antibodies to lanreotide, the immune system's reaction to the drug, developed in 10 percent of tumor patients by 96 weeks ¹.

The label carries no boxed warning ¹. Its one contraindication, a reason it gives not to use the drug, is a "history of a hypersensitivity to lanreotide" ¹. It adds that "allergic reactions (including angioedema and anaphylaxis) have been reported" ¹. Angioedema is swelling under the skin, and anaphylaxis a severe allergic reaction.

Its warnings cover five things ¹. Gallstones: the drug "may reduce gallbladder motility and lead to gallstone formation" ¹. Post-marketing reports, those made after approval, include gallbladder inflammation (cholecystitis), bile-duct infection (cholangitis) and pancreatitis, some "requiring cholecystectomy," removal of the gallbladder ¹.

Blood sugar: lanreotide "inhibits the secretion of insulin and glucagon," so patients "may experience hypoglycemia or hyperglycemia" ¹. Heart: "decrease in heart rate may occur" ¹. In the tumor trial, among patients whose heart rate started at 60 or above, a rate below 60 developed in 23 percent on lanreotide against 16 percent on placebo ¹. Thyroid: in acromegaly patients, "slight decreases in thyroid function have been seen," though "clinical hypothyroidism," an underactive thyroid with symptoms, "is rare (less than 1%)" ¹. And, added in July 2024, steatorrhea and fat malabsorption: fatty stools, stool discoloration, loose stools, bloating and weight loss that may signal pancreatic exocrine insufficiency, a shortfall of digestive enzymes ¹.

Post-marketing reports also include injection site abscess, alongside the gallbladder, allergic and fat-malabsorption reactions above ¹. The label says the drug "may reduce fertility in females of reproductive potential," from rat studies, and that human pregnancy data "are not sufficient to determine a drug-associated risk" ¹. It tells clinicians to advise women not to breastfeed during treatment and for six months after the last dose ¹. Safety and effectiveness in children "have not been established" ¹.

In sport

WADA's 2026 Prohibited List does not name lanreotide or somatostatin analogs ¹³. WADA, the World Anti-Doping Agency, lists growth hormone, its analogs and its releasing factors under section S2.2 and insulins and insulin-mimetics under S4.4.2; neither names lanreotide or somatostatin analogs ¹³.

What JumpstartMD offers

JumpstartMD does not prescribe lanreotide. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.