{"id":"octreotide","name":"Octreotide","aliases":["Sandostatin","Sandostatin LAR","somatostatin analogue","SMS 201-995"],"url":"https://lyoresearch.com/compounds/octreotide","class":{"id":"endocrine-medicines","name":"Bone and endocrine peptide medicines","url":"https://lyoresearch.com/classes/endocrine-medicines"},"summary":"Octreotide is an eight-amino-acid analogue of somatostatin, the hormone that inhibits growth hormone, insulin, glucagon and most gut hormones. Native somatostatin lasts two minutes; octreotide lasts hours, and a monthly depot lasts a month. It is the standard treatment for acromegaly — growth-hormone excess from a pituitary tumour — and for the flushing and diarrhoea of hormone-secreting neuroendocrine tumours. In the PROMID trial it more than doubled the time before such tumours progressed. It is prescription-only everywhere and, as the drug that suppresses growth hormone, sits at the opposite pole from the secretagogues sold on the grey market.","overall_grade":"A","overall_grade_meaning":"established in humans","human_trials":"PROMID RCT (n=85) + approval programmes + decades of use","regulatory_status":"Approved (Rx)","molecule":{"formula":"C49H66N10O10S2","molecular_weight":"1019.2","cas":"83150-76-9","pubchem_cid":448601,"note":null},"pharmacokinetics":{"basis":"label","route":"Subcutaneous injection (or IV), 2-4 times daily; monthly depot (Sandostatin LAR)","half_life":"About 1.7-1.9 hours","licensed_regimen":"Acromegaly: 50 mcg three times daily initially, maintenance 100-500 mcg three times daily; carcinoid tumours: 100-600 mcg/day in 2-4 divided doses","product":"Sandostatin (immediate-release injection)","source":{"title":"Sandostatin injection prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4e2c9856-1836-49f0-9472-4dbeeb408f39"}},"outcomes":[{"outcome":"Acromegaly (growth hormone and IGF-1 control)","grade":"A","grade_meaning":"established in humans","effect_size":"large","adverse":false,"human_studies":"Approval-grade programmes; many RCTs","evidence":"Normalises IGF-1 in roughly half of patients and shrinks the pituitary tumour in a majority; first-line medical therapy after or instead of surgery.","references":[{"citation":"Octreotide (Sandostatin, Sandostatin LAR) prescribing information and approved indications.","where":"FDA / EMA product information","url":"https://www.accessdata.fda.gov/scripts/cder/daf/"}]},{"outcome":"Carcinoid syndrome symptoms","grade":"A","grade_meaning":"established in humans","effect_size":"large","adverse":false,"human_studies":"Approval-grade","evidence":"Reliable control of flushing and diarrhoea from hormone-secreting neuroendocrine tumours — the 1988 approval indication.","references":[{"citation":"Octreotide (Sandostatin, Sandostatin LAR) prescribing information and approved indications.","where":"FDA / EMA product information","url":"https://www.accessdata.fda.gov/scripts/cder/daf/"}]},{"outcome":"Tumour progression in midgut neuroendocrine tumours","grade":"A","grade_meaning":"established in humans","effect_size":"large","adverse":false,"human_studies":"1 placebo-controlled RCT (n=85)","evidence":"Time to progression rose from 6 to 14.3 months against placebo, in functionally active and inactive tumours alike; survival could not be assessed because too few patients died.","references":[{"citation":"Rinke A, Müller HH, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.","where":"J Clin Oncol, 2009","url":"https://pubmed.ncbi.nlm.nih.gov/19704057/"}],"verbatim":{"text":"Median time to tumor progression in the octreotide LAR and placebo groups was 14.3 and 6 months, respectively (hazard ratio [HR] = 0.34; 95% CI, 0.20 to 0.59; P = .000072).","citation":"Rinke A, Müller HH, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.","url":"https://pubmed.ncbi.nlm.nih.gov/19704057/"}},{"outcome":"Overall survival in neuroendocrine tumours","grade":"B","grade_meaning":"probable, not settled","effect_size":"not measurable","adverse":false,"human_studies":"PROMID (underpowered)","evidence":"A non-significant trend with only 16 deaths at interim; the long-term follow-up remained inconclusive, partly because most placebo patients crossed over.","references":[{"citation":"Rinke A, Müller HH, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.","where":"J Clin Oncol, 2009","url":"https://pubmed.ncbi.nlm.nih.gov/19704057/"}],"verbatim":{"text":"The HR for overall survival was 0.81 (95% CI, 0.30 to 2.18).","citation":"Rinke A, Müller HH, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.","url":"https://pubmed.ncbi.nlm.nih.gov/19704057/"}},{"outcome":"Adverse effects","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":true,"human_studies":"Decades of use","evidence":"Gallstones in a substantial share of long-term users, abdominal cramps and fatty stools, injection-site pain, and disturbed glucose control in either direction.","references":[{"citation":"Octreotide (Sandostatin, Sandostatin LAR) prescribing information and approved indications.","where":"FDA / EMA product information","url":"https://www.accessdata.fda.gov/scripts/cder/daf/"}]}],"regions":[{"region":"European Union","status":"Approved, prescription-only","note":"Authorised in every member state (Sandostatin, LAR) for acromegaly, neuroendocrine tumours and other indications."},{"region":"United States","status":"Approved, prescription-only","note":"FDA-approved since 1988; LAR depot 1998; generics available."},{"region":"United Kingdom","status":"Licensed, prescription-only","note":"Licensed."},{"region":"Australia","status":"Registered, prescription-only","note":"On the ARTG."},{"region":"Canada","status":"Authorised, prescription-only","note":"Health Canada-authorised."},{"region":"Sport (WADA)","status":"Not prohibited","note":"Somatostatin analogues are not on the Prohibited List."}],"faq":[{"q":"What is octreotide used for?","a":"Mainly acromegaly — growth-hormone excess from a pituitary tumour — and the symptoms and growth of hormone-secreting neuroendocrine tumours. Also variceal bleeding, fistulas and dumping syndrome, and as a radiolabelled agent for imaging and therapy."},{"q":"Does it shrink tumours?","a":"It shrinks pituitary tumours in acromegaly in most patients, and in midgut neuroendocrine tumours it mostly stabilises rather than shrinks — time to progression more than doubled in PROMID, with few outright responses."},{"q":"Is it the opposite of the growth-hormone peptides?","a":"In effect, yes. The secretagogues and GHRH analogues push growth hormone up; octreotide is the approved medicine for pushing it down when the body makes too much."}],"references":[{"cite":"Rinke A, Müller HH, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.","where":"J Clin Oncol, 2009","url":"https://pubmed.ncbi.nlm.nih.gov/19704057/","note":"85 patients; interim analysis at 67 progressions."},{"cite":"Octreotide (Sandostatin, Sandostatin LAR) prescribing information and approved indications.","where":"FDA / EMA product information","url":"https://www.accessdata.fda.gov/scripts/cder/daf/","note":"Licensed indications; acromegaly and carcinoid data."}],"last_reviewed":"2026-09-10","literature_searched_to":"2026-09-10","changelog":[{"date":"2026-09-10","note":"Initial publication. Grade A on approval programmes and PROMID."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}