somatostatin analogue

Octreotide

US: FDA-approvedEU: AuthorisedUK: AuthorisedCA: AuthorisedAU: RegisteredCH: AuthorisedBR: RegistadoRS: AuthorisedSG: RegisteredTR: Ruhsatli

Answer

Octreotide is authorised or registered in the US, the EU, the UK, Canada, Australia, Switzerland, Brazil, Serbia, Singapore and Turkey: 10 of the 10 registers read. Highest trial phase: Phase 4 (after approval). It has 344 registered trials, 50 of them running. Brand names on the FDA label register: Octreotide Acetate, Bynfezia Pen, Sandostatin and Mycapssa.

RegulatorTrial register10 regulators' registers, read 2026-09-03 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03

Not medical, legal or regulatory advice.

Registered trials344Trial register ClinicalTrials.gov and EU CTIS
Running now50Trial register recruiting, active or enrolling
Results posted49Trial register with results on the register
Stopped early15.1%Trial register all peptides: 10%

344 trials by status

Trial register
Running 50Completed 192Stopped early 52Status unknown 31Other or not stated 19

ClinicalTrials.gov and EU CTIS · read 2026-10-03 · 49 trials have posted results

Trials first submitted per year

Trial register

ClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 2026 is not complete. 224 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).

Status by jurisdiction

World map
Authorised or registeredNot on the register, or withdrawnNot read yet, or status unknown
WhereStatusRegisterRead
United StatesFDA-approvedFDA, openfda2026-10-03
European UnionAuthorisedEMA, ema2026-10-03
United KingdomAuthorisedMHRA, uk-mhra2026-10-03
CanadaAuthorisedHealth Canada, ca-dpd2026-10-03
AustraliaRegisteredTGA, au-artg2026-10-03
SwitzerlandAuthorisedSwissmedic, ch-swissmedic2026-10-03
BrazilRegistadoANVISA, br-anvisa2026-10-03
SerbiaAuthorisedALIMS, rs-alims2026-09-03
SingaporeRegisteredHSA, sg-hsa2026-09-03
TurkeyRuhsatliTITCK, tr-titck2026-09-03

An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.

Side effects

Trial register
5 placebo-controlled trials · 442 people on Octreotide · grey is placebo
Diarrhoea46.2% 31.7%
Oedema peripheral34.9% 19.6%
Asthenia33.3% 20.9%
Nausea30.8% 21.2%
Fatigue29.8% 27.7%
ClinicalTrials.gov posted results · read 2026-10-03All side effects

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REGISTERED TRIALS

Newest 10 of 344 trials

All 344 trials
NCT02019706
Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
currently recruiting participants · register updated 2026-10-02
NCT00569127
Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, Hig
running, but no longer enrolling · register updated 2026-10-01
NCT07583563
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
currently recruiting participants · register updated 2026-09-25
2024-516616-24-00
A Phase 3 randomized 3-arm trial (double-blind Debio 4126, placebo control, and open-label Debio 4126), to assess the efficacy and
no status recorded · register updated 2026-09-23
2023-507443-10-00
A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of Lutathera in patients with Grade 2 a
no status recorded · register updated 2026-09-18
2024-519667-18-00
Preventing postoperative complications in patients undergoing high-risk pancreatoduodenectomy with a bundle approach including hyd
no status recorded · register updated 2026-09-17
NCT06878664
Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
currently recruiting participants · register updated 2026-09-16
NCT07663318
A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Eff
completed · register updated 2026-09-16
NCT06784752
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
currently recruiting participants · register updated 2026-09-11
NCT07814651
A Clinical Trial to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Octreotide Long-acting Injection in Patie
completed · register updated 2026-09-11

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