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Home/Compounds/Octreotide
OtherFDA approvedRx required

Octreotide

Also known as: Sandostatin · Mycapssa · Bynfezia
Brands: Sandostatin · Sandostatin LAR · Mycapssa · Bynfezia Pen

Synthetic octapeptide somatostatin analog approved for acromegaly, carcinoid syndrome, and VIPomas.

A
Grade A
Multiple human RCTs
Human studies29
PubMed citations30
Routesubcutaneous, intramuscular, oral
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

Cyclic octapeptide analog of somatostatin. Binds SSTR2 and SSTR5 to suppress GH, glucagon, insulin, and various GI hormones.

Evidence summary

29
Human studies
30
PubMed citations
25
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
subcutaneousintramuscularoral

Side effects & safety

From the FDA label
Source
blurred visionconstipationdiarrheadizzinessfatigueheadachehypoglycemianauseapancreatitispruritusvomiting

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for acromegaly, carcinoid syndrome, VIPomas (Sandostatin, Sandostatin LAR, Mycapssa, Bynfezia)

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT05884255Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.Recruiting · Phase 3 · Advanced Gastroenteropancreatic Neuroendocrine Tumor · n=220NCT07534371Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort StudyActive Not Recruiting · Neuroendocrine Tumors · n=500NCT02019706Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing SyndromeRecruiting · Phase 2 · ACTH · n=80NCT06784752A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients Newly Diagnosed With Grade 1 and Grade 2 (Ki-67 <10%) Advanced GEP-NET With High Disease Burden (NETTER-3)Recruiting · Phase 3 · Somatostatin Receptor Positive (SSTR+) · n=240NCT05153772A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in Subjects With Somatostatin Receptor Expressing Neuroendocrine TumorsActive Not Recruiting · Phase 2 · Neuroendocrine Tumors · n=69NCT00569127Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid PatientsActive Not Recruiting · Phase 3 · Colorectal Neuroendocrine Tumor G1 · n=427NCT07403604Human Models of Selective Insulin Resistance: Diazoxide, Part IRecruiting · Phase 1 · Hyperinsulinemia · n=25NCT05749289Application of Al18F-octreotide PET/CT in Tumors With Positive SSTR ExpressionRecruiting · Phase 2 · SSTR Positive Tumors · n=400NCT03049189A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)Active Not Recruiting · Phase 3 · Neuroendocrine Tumors · n=324NCT05477576Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA TherapyRecruiting · Phase 3 · GEP-NET · n=338NCT06930625A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin AnalogsRecruiting · Phase 3 · Acromegaly · n=119NCT07255248Hoffa's Fat Pad Impingement (HFPI): Saline Injection Verus Ultrasound Guided Cortisone Injection: A Randomized Trial in Adolescent Female AthletesRecruiting · Phase 4 · Hoffa's Fat Pad Impingement · n=62

Showing 12 of 25 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 37211679Fan M, Huang Y et al. · Octreotide and Octreotide-derived delivery systems.Journal of drug targeting (2026)HumanPMID 37755395Daniel CP, Wagner MJ et al. · Acromegaly: Pathophysiological Considerations and Treatment Options Including the Evolving Role of Oral Somatostatin Analogs.Pathophysiology : the official journal of the International Society for Pathophysiology (2026)HumanPMID 32252406Allott L, Dubash S et al. · [18F]FET-&#x3b2;AG-TOCA: The Design, Evaluation and Clinical Translation of a Fluorinated Octreotide.Cancers (2025)HumanPMID 41126983Wang K, Auernhammer CJ et al. · Paltusotine versus octreotide: different effects on radioligand uptake in neuroendocrine tumours.Endocrine oncology (Bristol, England) (2025)HumanPMID 38812667Uygur MM, Villanova M et al. · Clinical Pharmacology of Oral Octreotide Capsules for the Treatment of Acromegaly.TouchREVIEWS in endocrinology (2024)HumanPMID 38258058Asano D, Takakusa H et al. · Oral Absorption of Middle-to-Large Molecules and Its Improvement, with a Focus on New Modality Drugs.Pharmaceutics (2024)HumanPMID 39570708Bahri N, Crook C et al. · Casting a Wide NET: When Is the Optimal Time for 177Lu-Dotatate Treatment?Oncology (Williston Park, N.Y.) (2024)HumanPMID 37434648George J, Ramage J et al. · The role of serotonin inhibition within the treatment of carcinoid syndrome.Endocrine oncology (Bristol, England) (2023)HumanPMID 36559036Kim JC, Park EJ et al. · Gastrointestinal Permeation Enhancers for the Development of Oral Peptide Pharmaceuticals.Pharmaceuticals (Basel, Switzerland) (2022)HumanPMID 34215997Beig A, Feng L et al. · Development and characterization of composition-equivalent formulations to the Sandostatin LAR&#xae; by the solvent evaporation method.Drug delivery and translational research (2022)PMID 32901908Bolanowski M, Zgliczy&#x144;ski W et al. · Therapeutic effect of presurgical treatment with longacting octreotide (Sandostatin&#xae; LAR&#xae;) in patients with acromegaly.Endokrynologia Polska (2021)HumanPMID 32151353O'Dorisio TM, Harris AG et al. · Evolution of Neuroendocrine Tumor Therapy.Surgical oncology clinics of North America (2021)HumanPMID 31815783Mohanty A · Peptide-based therapy in portal hypertension.Current opinion in endocrinology, diabetes, and obesity (2020)HumanPMID 31398712Lamberts SWJ, Hofland LJ · ANNIVERSARY REVIEW: Octreotide, 40 years later.European journal of endocrinology (2019)HumanPMID 28864614Fani M, Nicolas GP et al. · Somatostatin Receptor Antagonists for Imaging and Therapy.Journal of nuclear medicine : official publication, Society of Nuclear Medicine (2017)HumanPMID 28526153Borna RM, Jahr JS et al. · Pharmacology of Octreotide: Clinical Implications for Anesthesiologists and Associated Risks.Anesthesiology clinics (2017)HumanPMID 28923213Enzler T, Fojo T · Long-acting somatostatin analogues in the treatment of unresectable/metastatic neuroendocrine tumors.Seminars in oncology (2017)HumanPMID 25427548Chalkia MT, Stefanoyiannis AP et al. · Patient-specific dosimetry in peptide receptor radionuclide therapy: a clinical review.Australasian physical &amp; engineering sciences in medicine (2015)HumanPMID 22237390van Vliet EI, Teunissen JJ et al. · Treatment of gastroenteropancreatic neuroendocrine tumors with peptide receptor radionuclide therapy.Neuroendocrinology (2014)HumanPMID 23046209Glatstein M, Scolnik D et al. · Octreotide for the treatment of sulfonylurea poisoning.Clinical toxicology (Philadelphia, Pa.) (2012)Human

Showing 20 of 30 papers. View all on PubMed →