Back to discover
Drug

Insulin icodec

Approved · EMA
Emerging researchLate-stage development

Also known as Awiqli, Insulin 287.

RxNorm2740394UNIIP7YU3ED05N
1
Research papers
4
Active clinical trials
1
Regulatory events
Latest activity
beta

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

EFFectiveness of Once-weekly Insulin ICodec Versus Once-daily Basal Insulin Analogues in an Insulin-naïve Type 2 diabEtes Population in Real-world cliNical pracTice- The EFFICIENT Pragmatic Study Effectiveness of Insulin Icodec in Real-world Clinical Practice

Clinical trial2026-08-04Primary completion · ClinicalTrials.gov

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

Clinical trial2026-06-29Results expected Q1 2027 · ClinicalTrials.gov

Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting

Clinical trial2026-06-16Results posted · ClinicalTrials.gov

A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.

Clinical trial2026-06-12Results posted · ClinicalTrials.gov

Protocol Title: A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification Short Title: A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

Clinical trial2026-06-03Results posted · ClinicalTrials.gov

Evaluation of the Pharmacokinetics and Pharmacodynamics of IBI3035 and Awiqli? (Ecoporin Insulin Injection) in a Randomized, Open-label, Single-dose, Two-formulation, Crossover Design in Healthy Male Subjects in China: A Phase I Clinical Trial.

Clinical trial2026-05-15Results expected Q3 2027 · ClinicalTrials.gov

A Study to Evaluate Flash Glucose Monitoring Based Titration of Once-weekly Insulin Icodec in Insulin-naïve Participants With Type 2 Diabetes

Clinical trial2026-04-30Results posted · ClinicalTrials.gov

A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec, Both With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes Treated With Basal Insulin

Clinical trial2025-12-15Results posted · ClinicalTrials.gov

A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen

Clinical trial2025-12-04Results posted · ClinicalTrials.gov

Approval: Awiqli (EMA)

Regulatory2024-05-17EMA

Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial.

Research2021-04-19Diabetes care

Profile

Identifiers & mechanism

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

Canonical name
Insulin icodec
Aliases & brands
AwiqliInsulin 287
RxNorm CUI
2740394
UNII
P7YU3ED05N
Regulatory jurisdictions
ema

Regulatory timeline

1 event

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
2024-05-17
Latest approval
2024-05-17
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-05-17Approval
Approval: Awiqli (EMA)

Indication: Treatment of diabetes mellitus in adults

Evidence ↗

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

Clinical trials

31 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
31
registered trials across all phases
LATEST COMPLETION 2025
4
Active studies
4
Recruiting
13
Late-stage (III+)
27
Completed
PHASE DISTRIBUTIONn = 31
Phase 115Phase 23Phase 312Phase 41

Late-stage studies

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

EFFectiveness of Once-weekly Insulin ICodec Versus Once-daily Basal Insulin Analogues in an Insulin-naïve Type 2 diabEtes Population in Real-world cliNical pracTice- The EFFICIENT Pragmatic Study Effectiveness of Insulin Icodec in Real-world Clinical Practice

RecruitingPH IVNovo Nordisk A/Sn=5862028

A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

RecruitingPH IIINovo Nordisk A/Sn=8772027

A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin

RecruitingPH IIIGan & Lee Pharmaceuticals.n=3002026

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

CompletedPH IIINovo Nordisk A/Sn=4122025

Protocol Title: A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification Short Title: A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

CompletedPH IIINovo Nordisk A/Sn=1482025

Recent completions

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

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

CompletedPH IIINovo Nordisk A/Sn=4122025

Protocol Title: A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification Short Title: A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

CompletedPH IIINovo Nordisk A/Sn=1482025

Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes

CompletedPH INovo Nordisk A/Sn=302025

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.

CompletedPH IIIKey trialNovo Nordisk A/Sn=1,2912024

A Study to Evaluate Flash Glucose Monitoring Based Titration of Once-weekly Insulin Icodec in Insulin-naïve Participants With Type 2 Diabetes

CompletedPH IIINovo Nordisk A/Sn=512024

A Study Investigating the Pharmacokinetic Properties of Insulin Icodec in Children and Adolescents With Type 2 Diabetes

CompletedPH INovo Nordisk A/Sn=182024

Research activity

1 papers

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

Major research themes1
Diabetes Mellitus, Type 21
Journals, researchers & institutions
Top journals
  • Diabetes care1
Leading researchers
  • Bajaj HS1
  • Bergenstal RM1
  • Christoffersen A1
  • Davies MJ1
  • Gowda A1
  • Isendahl J1
  • Lingvay I1
  • Rosenstock J1
Leading institutions
free-text, unnormalised
  • Dallas Diabetes Research Center1
  • Diabetes Research Centre1
  • International Diabetes Center at Park Nicollet1
  • Leadership Sinai Centre for Diabetes1
  • NIHR Leicester Biomedical Research Centre1
  • University of Alberta1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.