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Drug

Octreotide

Approved · EMA
Emerging researchLate-stage developmentRising momentum
Also known as Bynfezia, Mycapssa, SandoSTATIN, Octreotida+3 more

Bynfezia, Mycapssa, SandoSTATIN, Octreotida, Octrotide, Octreotide Acetate, Octreotidum.

RxNorm7617ChEMBLCHEMBL1680ATCH01CB02UNIIRWM8CCW8GP
3
Research papers
6
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients

Clinical trial2026-05-29Results posted · ClinicalTrials.gov

Role of Hyperinsulinemia in NAFLD: Dexamethasone-Pancreatic Clamp Pilot & Feasibility Study

Clinical trial2026-03-31Withdrawn · ClinicalTrials.gov

Phase 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 Therapy

Clinical trial2026-03-30Results expected Q4 2026 · ClinicalTrials.gov

Human Models of Selective Insulin Resistance: Pancreatic Clamp

Clinical trial2026-02-06Results expected Q4 2028 · ClinicalTrials.gov

Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

Clinical trial2025-10-30Completed · ClinicalTrials.gov

Treatment of Orthostatic Intolerance

Clinical trial2025-10-08Results expected Q4 2029 · ClinicalTrials.gov

Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

Clinical trial2025-10-03Results expected Q4 2027 · ClinicalTrials.gov

Approval: Oczyesa (EMA)

Regulatory2025-06-30EMA

Market withdrawal: Mycapssa (EMA)

Regulatory2025-02-26EMA

A Randomized Trial Evaluating Patient Experience and Preference Between Octreotide Long-Acting Release and Lanreotide for Treatment of Well-Differentiated Neuroendocrine Tumors.

Research2022-06-20JCO oncology practice

Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival.

Research2008-05-01Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Does prophylactic octreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo-controlled trial.

Research2000-09-01Annals of surgery

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Octreotide
Aliases & brands
BynfeziaMycapssaSandoSTATINOctreotidaOctrotideOctreotide AcetateOctreotidum
RxNorm CUI
7617
ChEMBL ID
CHEMBL1680
ATC codes
H01CB02
UNII
RWM8CCW8GP
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-06-30
Latest approval
2025-06-30
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2025-06-30Approval
Approval: Oczyesa (EMA)

Indication: Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Evidence ↗
2025-02-26Market withdrawalMarket
Market withdrawal: Mycapssa (EMA)

Indication: Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

102 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
102
registered trials across all phases
LATEST COMPLETION 2025
6
Active studies
4
Recruiting
51
Late-stage (III+)
67
Completed
29
Discontinued
PHASE DISTRIBUTIONn = 102
Early Phase 12Phase 115Phase 1 / 24Phase 230Phase 2 / 31Phase 320Phase 416Phase N / A14

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Randomized Controlled Trial Protocol Comparing Splenic Artery Ligation Versus Octreotide for Portal Flow Modulation (SCALOP) in Living Donor Liver Transplantation

Not yet recruitingPH IVKing Faisal Specialist Hospital & Research Centern=802030

Comparison of 24-hours Versus 72-hours of Octreotide Infusion Along With Endoscopic Therapy in Preventing Early Rebleed From Esophageal Varices: a Multi-center, Randomized Clinical Study

TerminatedPH IVMedical University of South Carolinan=342024

Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed: A Randomized Controlled Study

Unknown statusPH IVTanta Universityn=1842023

A Pilot Study To Evaluate Patient Experience With the Somatostatin Analogs Octreotide Long Acting Release and Lanreotide During the Treatment of Advanced, Nonfunctional, Well Differentiated Neuroendocrine Tumors

CompletedPH IVMemorial Sloan Kettering Cancer Centern=512023

Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903): A Multicenter, Single-blind, Randomised Controlled Trial

Unknown statusPH IVNanfang Hospital, Southern Medical Universityn=602022

Recent completions

Trials that read out recently, adding to the completed evidence base.

Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

CompletedN/ALahore General Hospitaln=602025

Role of Hyperinsulinemia in Non-Alcoholic Fatty Liver Disease (NAFLD) Pathogenesis: Pancreatic Clamp Pilot & Feasibility Study

CompletedPH IColumbia Universityn=182025

A Phase I Study of Safety and Immunogenicity of Survivin Long Peptide Vaccine (SurVaxM) in Patients With Metastatic Neuroendocrine Tumors (NETs)

CompletedPH IRoswell Park Cancer Instituten=192025

Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer, a Prospective Randomized Open Label Phase II Study - OTIS

CompletedPH IIFredrik Klevebron=202024

Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas.

CompletedPH IIAssistance Publique Hopitaux De Marseillen=202023

A Multicenter, Randomized, Open-label Clinical Trial Assessing the Efficacy of Octreotide in Decreasing Blood and Iron Requirements in Patients With Refractory Anemia Due to Angiodysplasias

CompletedPH IIIRadboud University Medical Centern=622023

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20002022
Major research themes3
Neuroendocrine Tumors1Octreotide1Pancreaticoduodenectomy1
Journals, researchers & institutions
Top journals
  • Annals of surgery1
  • JCO oncology practice1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Calderon C1
  • Cameron JL1
  • Campbell KA1
  • Capanu M1
  • Choti MA1
  • Chou JF1
  • Coleman J1
  • Cruz E1
Leading institutions
free-text, unnormalised
  • Erasmus Medical Center1
  • Johns Hopkins Hospital1
  • Memorial Sloan Kettering Cancer Center1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

lutetium Lu 177 dotatate

Studied across 7 of the same disease areas as Octreotide in the shared literature.

7 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.