GLP-1 receptor agonist

Lixisenatide

US: FDA-approvedEU: AuthorisedUK: Not on the registerCA: AuthorisedAU: Status unknownCH: AuthorisedBR: RegistadoRS: AuthorisedSG: RegisteredTR: Ruhsatli

Answer

Lixisenatide is authorised or registered in the US, the EU, Canada, Switzerland, Brazil, Serbia, Singapore and Turkey: 8 of the 10 registers read. No trial states a phase. It has 75 registered trials, 6 of them running. Brand names on the FDA label register: Soliqua 100/33.

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

Not medical, legal or regulatory advice.

Registered trials75Trial register ClinicalTrials.gov
Running now6Trial register recruiting, active or enrolling
Results posted27Trial register with results on the register
Stopped early8%Trial register all peptides: 10%

75 trials by status

Trial register
Running 6Completed 58Stopped early 6Status unknown 5

ClinicalTrials.gov · read 2026-10-03 · 27 trials have posted results

Trials first submitted per year

Trial register

ClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 39 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 KingdomNot on the registerMHRA, uk-mhra2026-09-03
CanadaAuthorisedHealth Canada, ca-dpd2026-10-03
AustraliaStatus unknownTGA, au-artgnot read
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
11 placebo-controlled trials · 7,147 people on Lixisenatide · grey is placebo
Nausea24.8% 6.5%
Hypoglycaemia18.4% 16.4%
Vomiting10.3% 2.6%
Diarrhoea10.1% 8.1%
Headache9.6% 6.8%
ClinicalTrials.gov posted results · read 2026-10-03All side effects

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REGISTERED TRIALS

Newest 10 of 75 trials

All 75 trials
NCT05220917
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
running, but no longer enrolling · register updated 2026-08-13
NCT06716424
A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus
completed · register updated 2026-07-10
NCT07307235
Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes
currently recruiting participants · register updated 2026-07-07
NCT06671587
iGlarLixi CGM Study in Chinese T2D Individuals After OADs
currently recruiting participants · register updated 2026-03-17
NCT07173712
Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes
not yet recruiting participants · register updated 2026-02-06
NCT03439943
Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease
completed · register updated 2025-11-28
NCT05413369
iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
completed · register updated 2025-09-24
NCT07188545
Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic
running, but no longer enrolling · register updated 2025-09-23
NCT07117240
Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes
enrolling by invitation only · register updated 2025-09-19
NCT05114590
Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type
completed · register updated 2025-09-09

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