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

What is octreotide?

Octreotide is a man-made peptide of eight amino acids, built to copy somatostatin ¹. Somatostatin is a hormone the body makes to switch off other hormones, among them growth hormone, insulin and glucagon ¹. The natural hormone's half-life in blood, the time for half of it to clear, is one to three minutes; octreotide's is 1.7 to 1.9 hours ¹.

Novartis sells it in the United States as Sandostatin ². It is a prescription drug for acromegaly and for the symptoms of two hormone-secreting tumors, carcinoid tumors and VIPomas ¹, and it is not a wellness, weight or performance peptide.

Is octreotide FDA-approved?

Yes. Octreotide is approved by FDA as the prescription medicine Sandostatin, with initial U.S. approval in 1988 ¹. FDA's Drugs@FDA record, the public register of approved drug applications, shows Novartis's NDA 019667 approved on October 21, 1988, with products in marketing status "Prescription" ². An NDA is a new drug application, the file a company submits for approval ².

The injection's label names three uses ¹. In acromegaly it is approved "to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C)" ¹. That use is for patients who have had an inadequate response to three treatments, or cannot be treated with them ¹. The three are surgery, pituitary irradiation (radiation to the pituitary gland) and bromocriptine, a drug, at maximally tolerated doses ¹.

In metastatic carcinoid tumors, tumors of hormone-making cells that have spread, it is approved "for treatment of severe diarrhea and flushing episodes" ¹. In VIPomas, tumors that secrete vasoactive intestinal peptide, it is approved for "the profuse watery diarrhea" they cause ¹.

Across the three uses, the label adds a limitation ¹. Improvement in clinical signs and symptoms, or reduction in tumor size or growth, "were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects" ¹. The label carries no boxed warning ¹. The injection's label was last revised in July 2024 ¹.

Three more products carry the same active ingredient, each approved under its own application ³, ⁴, ⁵. Sandostatin LAR Depot, NDA 021008, approved November 25, 1998, is a long-acting injection into the buttock muscle for the same three uses ³, ⁹. Its label limits it to patients "who have responded to and tolerated" the injection ⁹. Mycapssa, NDA 208232, approved June 26, 2020, is an oral capsule "for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide" ⁴, ¹⁰.

Bynfezia Pen, NDA 213224, approved September 27, 2024, is a prefilled pen for injection under the skin ⁵. Drugs@FDA also lists 23 abbreviated applications, the route for generic copies, with octreotide acetate as the active ingredient ¹¹. Each of the four applications has products in marketing status "Prescription," so the route to any of them is a licensed clinician's prescription ², ³, ⁴, ⁵. None of the labels lists an indication for weight, obesity or body composition ¹, ⁹, ¹⁰.

See the FDA status of every peptide, updated weekly.

How does octreotide work?

Octreotide acts like somatostatin on the body's somatostatin receptors ¹. The label calls it "an even more potent inhibitor of GH, glucagon, and insulin than somatostatin" ¹. It also reduces the release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin and pancreatic polypeptide, hormones of the gut, and lowers blood flow to the abdominal organs ¹.

Those actions explain its approved uses ¹. Growth hormone and IGF-1 fall in acromegaly, and so does the gut hormone output behind the diarrhea and flushing of carcinoid tumors and VIPomas ¹. Single doses also reduce the gallbladder's contraction and bile flow, which is the mechanism behind its gallstone warning ¹. It suppresses thyroid-stimulating hormone as well ¹. That description is the label's own, drawn from studies in patients and healthy volunteers ¹.

The weight studies tested a different idea: that octreotide's suppression of insulin might help people whose insulin runs high lose weight ⁷, ⁸. That hypothesis was tested in small groups, and the label makes no such claim ¹, ⁷, ⁸.

What does the research show?

The evidence for octreotide's approved uses is at the top tier ², ⁹. That rests on FDA approval since 1988 and the depot's trials in patients already controlled on the injection ², ⁹. The weight studies sit lower on the scale: small trials, with mixed results ⁷, ⁸.

Studied in people with acromegaly: the depot's label reports three trials in patients already controlled on the injection ⁹. Two enrolled 101 patients in total and a third enrolled 151 ⁹. Among 88 patients who received all 27 to 28 monthly injections in the first two, 83 percent kept mean growth hormone below 5 ng/mL ⁹. On the injection, before the switch, 78 percent of the same patients had kept it there ⁹.

In the third trial, 97 percent of the 122 patients who received all 12 injections did, and 67 percent had a normal IGF-1 ⁹. Two open-label studies, in which patients and clinicians knew the treatment, enrolled 143 previously untreated patients ⁹. They found a median tumor volume reduction of 20.6 percent and 24.5 percent at 24 weeks ⁹.

Studied in people with carcinoid syndrome: a six-month trial enrolled 93 patients already responsive to the injection, 67 randomized to the depot and 26 continuing the injection ⁹. The label says mean daily stool frequency "was as well controlled on SANDOSTATIN LAR DEPOT as on Sandostatin Injection," and mean daily flushing episodes "were similar" on both ⁹. About 50 to 70 percent of those who completed the trial on the depot needed supplemental injections at some point to control symptoms ⁹.

Studied in people against placebo for tumor growth: the PROMID trial was published online in August 2009 ⁶. Its planned interim analysis covered 85 treatment-naive patients, people not previously treated, randomized to monthly octreotide LAR or a placebo, an inactive copy ⁶. All had well-differentiated metastatic midgut neuroendocrine tumors: tumors of hormone-producing cells in the small-bowel region, spread beyond it, whose cells still resemble normal ones ⁶. At the planned interim analysis, a look at the data before the trial's end, there had been 67 progressions and 16 deaths ⁶.

Median time to tumor progression was 14.3 months on octreotide LAR and 6 months on placebo ⁶. That is a hazard ratio of 0.34, with a 95 percent confidence interval of 0.20 to 0.59; a ratio below 1 means progression came later on the drug ⁶.

At six months, 66.7 percent on octreotide LAR had stable disease, against 37.2 percent on placebo ⁶. Seven deaths occurred on octreotide LAR and nine on placebo, and the authors said the survival analysis "was not confirmatory" because of the low number of deaths ⁶. The depot's label still says its effect on tumor size, growth and spread in carcinoid syndrome and VIPomas "has not been determined" ⁹.

Studied in people for weight, with mixed results. Hypothalamic obesity is weight gain after damage to the hypothalamus, the brain region that governs appetite and energy, in children treated for brain tumors or with cranial irradiation ⁷. A randomized, double-blind, placebo-controlled trial, in which neither patients nor clinicians knew who had the drug, was published in June 2003 ⁷.

It gave 18 such children daily octreotide injections or placebo for six months ⁷. Weight rose by 1.6 kilograms on octreotide and by 9.1 on placebo, and BMI, body mass index, fell by 0.2 against a rise of 2.2 ⁷. The authors called the drug "safe and well tolerated" in that group ⁷.

The larger trial did not repeat the result. The injection's label reports "a single randomized, double-blind, placebo-controlled, 6 month pharmacokinetics study in 60 pediatric patients age 6 to 17 years with hypothalamic obesity resulting from cranial insult," given the depot or saline monthly ¹. BMI rose 0.1 kg/m² on octreotide and 0.0 on saline, and the label states: "Efficacy was not demonstrated" ¹. Diarrhea occurred in 11 of the 30 treated, and new gallstones in 33 percent, a higher rate than in the adult indications ¹.

Studied in adults with obesity: a multicenter, randomized, double-blind, placebo-controlled trial was published in February 2006 ⁸. It enrolled 172 adults with a BMI of 30 to 65 and evidence of insulin hypersecretion, the body making more insulin than normal ⁸. After six months, the two higher-dose arms had lost weight that was statistically significant against their own starting weight; the abstract reports no test against placebo for that change ⁸.

The mean differences from the placebo arm in percent weight change were 1.98 and 1.87 percent ⁸. The share losing 5 percent or more of body weight was 7 to 21 percent on octreotide against 11 percent on placebo, a difference that was not statistically significant ⁸. Blood glucose over a glucose tolerance test, a measured sugar drink, ran higher on octreotide than on placebo ⁸. The most common adverse events were diarrhea, headache, gallstones, nausea and abdominal pain ⁸.

A single-blind study, in which patients but not clinicians were kept from knowing the treatment, enrolled 20 women (18 completed) ¹². They had polycystic ovary syndrome, a hormonal condition, and abdominal obesity; all were on a low-calorie diet for seven months, with octreotide or placebo for the last six ¹². The depot "had no additional effect in reducing body fat or improving fat distribution than placebo" ¹². Every weight trial above ran six or seven months, and none enrolled more than 172 people ¹, ⁷, ⁸, ¹². No longer or larger trial was found among this page's sources as of November 10, 2026 ¹, ⁷, ⁸, ¹².

What are the side effects?

Gallbladder problems lead. In clinical trials, "primarily patients with acromegaly or psoriasis" in the label's words, 63 percent of patients developed biliary tract abnormalities ¹. That was 27 percent with gallstones, 24 percent with sludge without stones and 12 percent with bile duct dilatation ¹. Among those treated for 12 months or longer, 52 percent had stones or sludge, while under 2 percent of those treated for a month or less developed gallstones ¹. One patient developed ascending cholangitis, an infection of the bile ducts, and died ¹.

Gut effects are next. Diarrhea, loose stools, nausea and abdominal discomfort were each seen in 34 to 61 percent of acromegalic patients in U.S. studies, and 2.6 percent stopped because of them ¹. The same symptoms were seen in 5 to 10 percent of patients with carcinoid tumors and VIPomas ¹. In acromegalic patients, sinus bradycardia, a slow heartbeat, developed in 25 percent, conduction abnormalities in 10 percent and arrhythmias in 9 percent ¹. High blood sugar occurred in 16 percent and low blood sugar in 3 percent of acromegalic patients, and each in about 1.5 percent of other patients ¹.

Biochemical hypothyroidism occurred in 12 percent of acromegalic patients, and 4 percent needed thyroid replacement ¹. Pain on injection was reported by 7.7 percent, headache by 6 percent and dizziness by 5 percent ¹. Anaphylactoid reactions, severe allergic-type reactions, including anaphylactic shock, "have been reported in several patients" ¹. Post-marketing reports add, in the label's grouping, gallstones, gallbladder inflammation (cholecystitis), bile-duct infection (cholangitis) and pancreatitis, "which have sometimes required cholecystectomy," removal of the gallbladder ¹. They also add intestinal obstruction and pancreatic exocrine insufficiency, a shortfall of digestive enzymes, and thrombocytopenia, a low platelet count ¹.

The label's one contraindication is "Sensitivity to this drug or any of its components" ¹. Its warnings cover cardiac conduction abnormalities, gallstones and their complications, high and low blood sugar, hypothyroidism, steatorrhea and low vitamin B12 ¹. Complete atrioventricular block, a block in the heart's electrical conduction, was reported in patients given it intravenously during surgery ¹. Steatorrhea is fatty stool from poor absorption of dietary fat, and the label says it may come with weight loss ¹.

The label says safety and efficacy in children "have not been demonstrated" ¹. Post-marketing reports in children, most notably under 2 years of age, include hypoxia (low oxygen), necrotizing enterocolitis (a severe bowel disease of infants) and death ¹. Most of those children had serious underlying conditions ¹. The label also tells clinicians to discuss unintended pregnancy with premenopausal women, since treatment of acromegaly "may lead to improved fertility" ¹.

In sport

WADA's 2026 Prohibited List does not name octreotide, and somatostatin analogs are not a listed class ¹³. WADA, the World Anti-Doping Agency, lists growth hormone, its analogs and its releasing factors in section S2.2, and insulins in section S4.4.2 ¹³.

What JumpstartMD offers

JumpstartMD does not prescribe octreotide. 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.