At a glance
- Octreotide is an FDA-approved drug, marketed as Sandostatin, Octreotide, Mycapssa, Bynfezia (first approval: October 21, 1988).
- PubMed lists 10,266 publications mentioning it, including 511 randomized controlled trials and 1,164 animal-only studies.
- ClinicalTrials.gov lists 327 registered studies testing it (49 active).
- FDA's adverse event system (FAERS) holds 35,429 reports mentioning it; 27,840 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA019667 | SANDOSTATIN | Approved, marketed | October 21, 1988 | NOVARTIS |
| NDA021008 | SANDOSTATIN LAR | Approved, marketed | November 25, 1998 | NOVARTIS |
| ANDA076313 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | Approved, marketed | March 28, 2005 | WEST-WARD PHARMS INT |
| ANDA076330 | OCTREOTIDE ACETATE | Approved, marketed | April 8, 2005 | WEST-WARD PHARMS INT |
| ANDA075957 | OCTREOTIDE ACETATE | Approved, marketed | October 3, 2005 | MEITHEAL |
| ANDA075959 | OCTREOTIDE ACETATE | Approved, marketed | November 21, 2005 | MEITHEAL |
| ANDA077450 | OCTREOTIDE ACETATE | Approved, marketed | February 10, 2006 | FRESENIUS KABI USA |
| ANDA077457 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | Approved, marketed | February 10, 2006 | FRESENIUS KABI USA |
| ANDA077372 | OCTREOTIDE ACETATE | Approved, discontinued | August 14, 2007 | SUN PHARM INDS |
| ANDA077373 | OCTREOTIDE ACETATE | Approved, discontinued | August 14, 2007 | SUN PHARM INDS |
| ANDA077329 | OCTREOTIDE ACETATE | Approved, discontinued | March 4, 2008 | SUN PHARM INDS |
| ANDA077330 | OCTREOTIDE ACETATE | Approved, discontinued | March 4, 2008 | SUN PHARM INDS |
| ANDA077331 | OCTREOTIDE ACETATE | Approved, discontinued | March 4, 2008 | SUN PHARM INDS |
| ANDA079198 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | Approved, marketed | February 10, 2011 | MYLAN INSTITUTIONAL |
| ANDA090985 | OCTREOTIDE ACETATE PRESERVATIVE FREE | Approved, discontinued | May 11, 2011 | WOCKHARDT USA |
| ANDA090986 | OCTREOTIDE ACETATE | Approved, discontinued | May 11, 2011 | WOCKHARDT USA |
| ANDA090834 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | Approved, marketed | November 12, 2013 | SAGENT PHARMS INC |
| ANDA091041 | OCTREOTIDE ACETATE | Approved, marketed | November 12, 2013 | SAGENT PHARMS INC |
| ANDA203765 | OCTREOTIDE ACETATE | Approved, marketed | September 7, 2018 | HERITAGE |
| ANDA204669 | OCTREOTIDE ACETATE | Approved, marketed | December 27, 2018 | HERITAGE |
| NDA208232 | MYCAPSSA | Approved, marketed | June 26, 2020 | CHIESI |
| ANDA216807 | OCTREOTIDE ACETATE | Approved, marketed | June 13, 2023 | GLAND |
| ANDA216839 | OCTREOTIDE ACETATE | Approved, marketed | June 22, 2023 | GLAND |
| ANDA210317 | OCTREOTIDE ACETATE | Approved, marketed | December 5, 2023 | TEVA PHARMS USA INC |
| ANDA217860 | OCTREOTIDE ACETATE | Approved, discontinued | May 2, 2024 | QUAGEN |
| NDA213224 | BYNFEZIA PEN | Approved, marketed | September 27, 2024 | SUN PHARM |
| ANDA216589 | OCTREOTIDE ACETATE | Approved, marketed | December 12, 2025 | MYLAN LABS LTD |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Lanreotide for the prevention of postoperative pancreatic fistula (S2408): study protocol for a multicenter randomized controlled trial.
- Case Report: Beyond the initial diagnosis: a case of Wilson's disease presenting as acute decompensated cirrhosis.
- Adjunctive gabexate mesylate with octreotide and clinical outcomes in older adults with acute pancreatitis: a retrospective study.
- Octreotide-modified pH-responsive nanocomposites for ultrasound imaging-guided chemo-photothermal therapy of prostate cancer.
- Mineralocorticoid receptor signaling reduces somatostatin expression in developing sensory neurons and drives neonatal pain after early-life stress.
- Cervical Chylous Fistula After Lymphadenectomy for Differentiated Thyroid Carcinoma: Anatomy, Risk Factors, and Management Strategies-A Narrative Review.
- Mechanistic Basis of Octreotide Therapy in Neonatal Postoperative Chylothorax: A Translational Case Report.
- Oxalate Nephropathy in a patient with Neuroendocrine tumor receiving Long-acting Octreotide.
- Fat graft-reinforced repair of refractory cervical chyle leak after neck dissection.
- Diet-induced obesity enhances the glycaemic response to glucagon in male C57BL/6J mice.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 327
- Active
- 49
- With posted results
- 67
Conditions studied
Show 40 more studies
All 327 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 35,429
- Serious
- 27,840
- With death outcome
- 7,671
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- Sandostatin
- Octreotide Acetate
- OCTREOTIDE ACETATE
- Sandostatin LAR Depot
- Mycapssa
- Mycapssa
- OCTREOTIDE ACETATE
- BYNFEZIA Pen
- Octreotide Acetate
- OCTREOTIDE ACETATE
- Octreotide Acetate
- Octreotide Acetate
- Octreotide Acetate
- Octreotide Acetate
- Octreotide
- Octreotide
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.