← All compounds · evidence tier first, by design
| Use | E1 | E2 | E3 | E4 | E5 | E6 | E7 | E8 |
|---|---|---|---|---|---|---|---|---|
| E2 Acromegaly (biochemical control) | E2 | |||||||
| E2 Metastatic midgut neuroendocrine tumours (tumour growth control) | E2 | |||||||
| E3 Carcinoid syndrome (diarrhoea and flushing) | E3 | |||||||
| E3 Acute oesophageal variceal bleeding (off-label) | E3 |
Octreotide
Cyclic octapeptide analogue of somatostatin: D-Phe-Cys-Phe-D-Trp-Lys-Thr-Cys-Thr-ol, disulfide bridge Cys2-Cys7; contains D-amino acids and a C-terminal threoninol, so no standard one-letter sequence is given.
Non-standard residues or modifications: no plain one-letter sequence
Also: Octreotide acetate · Codes: SMS 201-995 · Brands: Sandostatin, Sandostatin LAR, Mycapssa
A synthetic eight-residue cyclic analogue of the hormone somatostatin, with a longer half-life than the native hormone. It is an approved prescription drug in the United States and Canada in short-acting and long-acting injectable forms, and in the United States as an oral delayed-release capsule. Labelled uses centre on acromegaly and on symptoms of carcinoid and other hormone-secreting neuroendocrine tumours.
- US A approved
- EU ? not verified
- UK ? not verified
- CA A approved
- AU ? not verified
- JP ? not verified
- CN ? not verified
01Regulatory status, by jurisdiction
| Jurisdiction | Status | Detail and primary source |
|---|---|---|
| US | Approved | Sandostatin (NDA 019667, Novartis) is listed in Drugs@FDA with an original approval as a new molecular entity on 21 October 1988. Long-acting (Sandostatin LAR, NDA 021008, 1998) and oral delayed-release (Mycapssa, NDA 208232, 2020) forms are separately listed.“10/21/1988 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY”Drugs@FDA: FDA-Approved Drugs - NDA 019667 (Sandostatin) · retrieved 2026-10-10 |
| EU | Withdrawn / discontinued | This entry covers only the centrally authorised oral capsule (Mycapssa, EMEA/H/C/005826), authorised 2 December 2022 and withdrawn on 26 February 2025 at the holder's request for commercial reasons. Injectable octreotide products in the EU are nationally authorised and were not verified from a regulator page for this record, so the EU class is left unset.“On 26 February 2025, the European Commission withdrew the marketing authorisation for Mycapssa (octreotide) in the European Union (EU).”Mycapssa | European Medicines Agency (EMA) · retrieved 2026-10-10 |
| CA | Approved | Health Canada Drug Product Database lists Sandostatin (Novartis Pharmaceuticals Canada Inc) with current status Marketed.“Current status: Marketed Current status date: 1998-04-15 Original market date: See footnote 1 1989-12-31 Product name: SANDOSTATIN”Drug Product Database: Product information - SANDOSTATIN · retrieved 2026-10-10 |
| UK AU JP CN | Not yet verified from a primary source. No status is shown rather than an unsourced one. | |
Sport (WADA): Not prohibited. Not named on the Prohibited List. As an approved medicine it also falls outside class S0, which covers only substances without current regulatory approval: “Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use” WADA source
02What the human evidence shows
Acromegaly (biochemical control)
Injectable octreotide has been used in acromegaly since the late 1980s, largely on the basis of uncontrolled and open-label studies. The oral capsule was tested in a randomised, double-blind, placebo-controlled withdrawal trial (OPTIMAL, 56 participants) in people already controlled on injectable somatostatin analogues, and in an open-label randomised non-inferiority trial against injectables (MPOWERED). One adequately designed placebo-controlled RCT is cited here; the outcome is a biochemical marker (IGF-I), not tumour or survival outcomes.
- [1] A higher proportion of participants on oral octreotide than on placebo kept IGF-I within the target range in a randomised withdrawal trial in adults with acromegaly
Registered-study counts: ClinicalTrials.gov intervention search “octreotide”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Metastatic midgut neuroendocrine tumours (tumour growth control)
The PROMID trial randomised 85 treatment-naive patients with metastatic well-differentiated midgut neuroendocrine tumours to long-acting octreotide or placebo and reported a longer time to tumour progression with octreotide. No overall survival benefit was established in the primary report. This indication is not part of the US label wording for octreotide.
- [2] Longer time to tumour progression with long-acting octreotide than with placebo in patients with metastatic midgut neuroendocrine tumours
Registered-study counts: ClinicalTrials.gov intervention search “octreotide”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Carcinoid syndrome (diarrhoea and flushing)
The cited randomised trial compared long-acting and short-acting octreotide formulations in malignant carcinoid syndrome rather than octreotide against placebo; it was small and partly open-label. Symptom control with the two formulations was reported as similar. Placebo-controlled evidence for symptom relief with octreotide itself was not identified in this review.
- [3] Long-acting and short-acting octreotide formulations gave comparable control of diarrhoea and flushing in patients with malignant carcinoid syndrome
Registered-study counts: ClinicalTrials.gov intervention search “octreotide carcinoid”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Acute oesophageal variceal bleeding (off-label)
n/c: not counted here; see the cited review.
Octreotide is used off-label in acute variceal bleeding. A Cochrane systematic review of randomised trials of somatostatin analogues (somatostatin and octreotide) found no reduction in mortality and only a small effect on the need for transfusion, with trial quality and results varying. The number of octreotide-specific RCTs is not stated here because the review pooled both agents.
- [4] Systematic review of randomised trials found no mortality reduction with somatostatin analogues in acute variceal bleeding
Registered-study counts: ClinicalTrials.gov intervention search “octreotide variceal”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Key registered trials
| NCT | Title (as registered) | Phase | Status |
|---|---|---|---|
| NCT03252353 | Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly | 3 | Unknown |
| NCT02685709 | Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly | 3 | Completed |
| NCT00171873 | Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut | 3 | Completed |
03Safety signals
- Gallbladder and biliary stone formation [5]
Gallstones and gallbladder sludge are a labelled warning for somatostatin analogues; a case of intrahepatic stones during octreotide therapy for acromegaly has been reported.
04What is unknown
- Whether octreotide improves overall survival in metastatic midgut neuroendocrine tumours has not been shown in the cited placebo-controlled trial
- Placebo-controlled evidence for symptom relief in carcinoid syndrome with octreotide itself was not identified; the cited trial compared two octreotide formulations
- Octreotide-specific effect estimates in acute variceal bleeding are not separable from somatostatin in the cited pooled review
- Status in the UK, Australia, Japan and China was not verified from regulator sources for this record
05Product quality
No independent purity results have been published for this compound yet. The purity programme will publish full methods and vendor-named results, passes and failures, once its protocol has had legal review.
06Citations
- Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide (2020). doi:10.1210/clinem/dgaa526
- 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 (2009). doi:10.1200/JCO.2009.22.8510
- Octreotide Acetate Long-Acting Formulation Versus Open-Label Subcutaneous Octreotide Acetate in Malignant Carcinoid Syndrome (1999). doi:10.1200/JCO.1999.17.2.600
- Somatostatin analogues for acute bleeding oesophageal varices (2008). doi:10.1002/14651858.CD000193.pub3
- Hepatolithiasis (Intrahepatic Stone) During Octreotide Therapy for Acromegaly: A Case Report. doi:10.1023/a:1012880113759
Every DOI is resolved against Crossref and every NCT number against ClinicalTrials.gov, title for title, before publication. Regulatory sources are cited inline above with a verbatim quote and retrieval date.
07Mechanism
Octreotide binds somatostatin receptors, mainly subtypes 2 and 5, and in human studies lowers secretion of growth hormone, IGF-I and several gastrointestinal and pancreatic hormones.
Mechanism is placed last on purpose: a plausible mechanism is not evidence that a compound works in people.
Reviewed by OSMF research team (AI-assisted, source-verified) on 2026-10-10. Found an error? It goes in the corrections log: report it.