somatostatin analogue

Lanreotide

US: FDA-approvedEU: Not on the registerUK: AuthorisedCA: AuthorisedAU: RegisteredCH: AuthorisedBR: RegistadoRS: AuthorisedSG: RegisteredTR: Ruhsatli

Answer

Lanreotide is authorised or registered in the US, the UK, Canada, Australia, Switzerland, Brazil, Serbia, Singapore and Turkey: 9 of the 10 registers read. Highest trial phase: Phase 4 (after approval). It has 125 registered trials, 10 of them running. Brand names on the FDA label register: Lanreotide Acetate and Somatuline Depot.

RegulatorTrial register10 regulators' registers, read 2026-08-31 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03

Not medical, legal or regulatory advice.

Registered trials125Trial register ClinicalTrials.gov and EU CTIS
Running now10Trial register recruiting, active or enrolling
Results posted30Trial register with results on the register
Stopped early16.8%Trial register all peptides: 10%

125 trials by status

Trial register
Running 10Completed 72Stopped early 21Status unknown 14Other or not stated 8

ClinicalTrials.gov and EU CTIS · read 2026-10-03 · 30 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. 89 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 UnionNot on the registerEMA, ema2026-08-31
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 · 437 people on Lanreotide · grey is placebo
Diarrhoea19.5% 23.6%
Abdominal pain16.8% 15.9%
Fatigue12.2% 14.6%
Nausea11% 12%
Vomiting10.8% 7.8%
ClinicalTrials.gov posted results · read 2026-10-03All side effects

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REGISTERED TRIALS

Newest 10 of 125 trials

All 125 trials
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
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
2023-509334-19-00
Trial title: Phase 1b/3 global, randomized, controlled, open-label trial comparing treatment with RYZ101 to standard of care (SoC)
no status recorded · register updated 2026-08-31
2023-508723-12-00
A randomized, multi-center, open-label, active-controlled Phase 3 trial to assess the efficacy and safety of octreotide subcutaneo
no status recorded · register updated 2026-08-10
NCT07087054
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
currently recruiting participants · register updated 2026-08-04
NCT05050942
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
running, but no longer enrolling · register updated 2026-07-28
2023-505884-35-00
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with long-acting Somatostatin Analogues – ATSA trial
no status recorded · register updated 2026-06-17
NCT07534371
Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort
running, but no longer enrolling · register updated 2026-04-16
NCT05048901
Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors
currently recruiting participants · register updated 2026-04-09
NCT02127437
Lanreotide In Polycystic Kidney Disease Study
completed · register updated 2026-04-08

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