Octreotide

Identity

What the cited literature examines

Octreotide is a synthetic octapeptide analogue of somatostatin. The Drugs@FDA register returned approved applications under this generic name; those products are recorded in the regulatory status field and are not what this page describes. A 1996 New England Journal of Medicine review carries the name as its title, and a 1993 European Journal of Nuclear Medicine paper reports somatostatin receptor scintigraphy with radiolabelled octreotide in a large patient series.

The retrieved clinical records are in neuroendocrine tumours: the 2009 Journal of Clinical Oncology PROMID placebo-controlled study of the long-acting repeatable formulation on tumour growth, 2008 and 2011 papers on everolimus combined with octreotide LAR, and 2021 Lancet Oncology and 2024 Lancet trials of lutetium-177 dotatate with long-acting octreotide against high-dose octreotide. Imaging records include a 2007 Journal of Nuclear Medicine paper on gallium-68 DOTA-TOC PET and a 2001 comparison of lutetium-labelled octreotate with indium-labelled octreotide. A 2000 Annals of Surgery paper examines prophylactic use after pancreaticoduodenectomy and a 1999 Hepatology paper reports its use with midodrine in type 1 hepatorenal syndrome.

Reported mechanism

A somatostatin receptor agonist octapeptide; the retrieved records use its receptor binding both for secretory inhibition and, radiolabelled, for receptor imaging and radionuclide therapy.

Stated in the titles of the cited 1996 New England Journal of Medicine and 1993 European Journal of Nuclear Medicine papers.

Targets named in the cited records: somatostatin receptor subtype 2.

FDA application register

A query of the FDA Drugs@FDA application register on 2026-10-09 returned 17 application record(s) for this compound name (including ANDA216589, ANDA076330, ANDA203765, ANDA217860, NDA019667, marketed as OCTREOTIDE ACETATE, SANDOSTATIN). Material supplied as a research chemical is not the subject of those applications and is not an FDA-approved product.^[2]

Scope statement: this records the result of a single automated query against the openFDA drugsfda endpoint on the stated date. It is not legal advice and is not a jurisdiction-by-jurisdiction legality assessment.

Retrieved 2026-10-09.

Amounts reported in the cited literature

Unknown. No retrieved record in this dataset states an amount, so none is shown. Where an amount is recorded it is what a named study reported administering in its own stated model, in the past tense, and is not a protocol.

No study-reported dose was taken from a source read in v1. Literature-reported values are only recorded where the retrieved citation metadata states the figure.

Adverse effects reported in the cited literature

Unknown. No retrieved record in this dataset reports an adverse effect for this compound, so no row is shown. Absence of a row records the absence of a retrieved report, nothing more.

No adverse-effect row was taken from a source read in v1. Rows are only recorded with the study model named and the reporting citation attached.

Other names

Octreotide appears under these other names in the cited records or in common usage. Each one resolves to this page rather than to a separate page of its own.

• octreotide acetate
• SMS 201-995
• Sandostatin

Where this page sits

Research records

Cited research records for Octreotide, each with its identifier, the publication type it is indexed as, and the study model stated by its assigned subject headings.

Compounds indexed next to it

• Somatostatin — Endocrine and immune signalling peptides
• Tesamorelin — GHRH analogues

Class page: Endocrine and immune signalling peptides. Full index: all indexed compounds.

Questions this page answers

What does the cited literature examine for Octreotide?

Octreotide is a synthetic octapeptide analogue of somatostatin. The Drugs@FDA register returned approved applications under this generic name; those products are recorded in the regulatory status field and are not what this page describes.

Which class is Octreotide indexed under?

Octreotide is indexed under Endocrine and immune signalling peptides. This class groups peptides whose retrieved literature concerns endocrine or immune signalling outside the growth hormone axis.

What does the FDA application register show for Octreotide?

A query of the FDA Drugs@FDA application register on 2026-10-09 returned 17 application record(s) for this compound name (including ANDA216589, ANDA076330, ANDA203765, ANDA217860, NDA019667, marketed as OCTREOTIDE ACETATE, SANDOSTATIN). Material supplied as a research chemical is not the subject of those applications and is not an FDA-approved product.

Sources

1. PubChem Compound Summary for CID 448601, Octreotide. PubChem, National Library of Medicine (2026). pubchem:448601
2. Drugs@FDA application register query for this compound, 17 application(s) returned: ANDA216589, ANDA076330, ANDA203765, ANDA217860, NDA019667. U.S. Food and Drug Administration, openFDA drugsfda endpoint (2026). fda:octreotide
3. Octreotide. The New England journal of medicine (1996). pmid:8532003
4. Somatostatin receptor scintigraphy with [111In-DTPA-D-Phe1]- and [123I-Tyr3]-octreotide: the Rotterdam experience with more than 1000 patients. European journal of nuclear medicine (1993). pmid:8404961
5. 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. Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2009). pmid:19704057
6. Efficacy of RAD001 (everolimus) and octreotide LAR in advanced low- to intermediate-grade neuroendocrine tumors: results of a phase II study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2008). pmid:18779618
7. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet (London, England) (2011). pmid:22119496
8. ¹⁷⁷Lu-Dotatate plus long-acting octreotide versus high‑dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial. The Lancet. Oncology (2021). pmid:34793718
9. [¹⁷⁷Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. Lancet (London, England) (2024). pmid:38851203
10. 68Ga-DOTA-Tyr3-octreotide PET in neuroendocrine tumors: comparison with somatostatin receptor scintigraphy and CT. Journal of nuclear medicine : official publication, Society of Nuclear Medicine (2007). pmid:17401086
11. [177Lu-DOTAOTyr3]octreotate: comparison with [111In-DTPAo]octreotide in patients. European journal of nuclear medicine (2001). pmid:11585290
12. Does prophylactic octreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo-controlled trial. Annals of surgery (2000). pmid:10973392
13. Reversal of type 1 hepatorenal syndrome with the administration of midodrine and octreotide. Hepatology (Baltimore, Md.) (1999). pmid:10347109