long-acting insulin analogue

Insulin degludec

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

Answer

Insulin degludec 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 255 registered trials, 17 of them running. Brand names on the FDA label register: Xultophy 100/3.6, Tresiba and Insulin Degludec.

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 trials255Trial register ClinicalTrials.gov and EU CTIS
Running now17Trial register recruiting, active or enrolling
Results posted95Trial register with results on the register
Stopped early2.7%Trial register all peptides: 10%

255 trials by status

Trial register
Running 17Completed 206Stopped early 7Status unknown 20Other or not stated 5

ClinicalTrials.gov and EU CTIS · read 2026-10-03 · 95 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. 127 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.

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REGISTERED TRIALS

Newest 10 of 255 trials

All 255 trials
NCT07630233
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in H
currently recruiting participants · register updated 2026-09-15
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
NCT04760626
A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2
completed · register updated 2026-08-11
NCT06238778
Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
completed · register updated 2026-07-31
NCT07652528
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
not yet recruiting participants · register updated 2026-07-22
NCT07215312
A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin
running, but no longer enrolling · register updated 2026-07-13
NCT07527078
Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes
currently recruiting participants · register updated 2026-07-01
NCT04795531
A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in Peo
completed · register updated 2026-06-12
NCT06288412
A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fas
completed · register updated 2026-06-08
NCT07599891
Comparing the Safety and Efficacy of Insulin GLARGINE and DEGLUDEC in Glucocorticoid Induced HYPERGLYCEMIA in Hospitalized Patient
completed · register updated 2026-05-20

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