> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/insulin-icodec-fa77ad93-ab76-47ee-8df1-57e5650af79a > Record changed: 2026-10-13 # Insulin icodec Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594581) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594581) First approval year 2024 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594581) ## Development status **First approval year** 2024 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594581) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594581) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594581) **Drug name** Insulin icodec Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594581) ### Brand names (6) - awiqli - Awiqli - insulin icodec component of nn1535 icosema - Insulin icodec component of nn1535 icosema - insulin icodec component of nn1535 laisema - Insulin icodec component of nn1535 laisema ### Other names (28) - insulin 287 - Insulin 287 - insulin icodec - Insulin icodec - Insulin Icodec - insulin icodec \[INN\] - INSULIN ICODEC \[USAN\] - Insulin icodec \[WHO-DD\] - insulin icodec abae - Insulin icodec Injection - Insulin Icodec Injection - insulin icodec inn - insulin icodec usan - insulin icodec who dd - Insulin Icodec-ABAE - long acting insulin 287 - Long-acting-insulin-287 - nn1436 - NN1436 - nn1535 icosema component insulin icodec - NN1535 ICOSEMA COMPONENT INSULIN ICODEC - nn1535 laisema component insulin icodec - NN1535 LAISEMA COMPONENT INSULIN ICODEC - nnc0148 0287 - Nnc0148-0287 And 3 more, listed on the interactive page. ## Identifiers **ATC classification codes** - A10AE07 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594581) **CAS registry numbers** - 1188379-43-2 **ChEMBL ID** CHEMBL4594581 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594581) **RxNorm IDs (RxCUI)** - 2740394 **FDA ingredient codes (UNII)** - P7YU3ED05N ## Regulatory information ### United States **Applicant** NOVO NORDISK INC **Approval date** 26 Mar 2026 **Application number** BLA761326 ### European Union **Status** Authorised **Status date** 17 May 2024 **Authorisation date** 17 May 2024 **Approved indications** Treatment of diabetes mellitus in adults **Product number** EMEA/H/C/005978 **Authorisation holder** Novo Nordisk A/S **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Diabetes Mellitus - Diabetes Mellitus, Type 2 European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/awiqli) ### Other regulatory facts **First in class** No **Orphan designation** No ## Pharmacology ### Mechanisms of action - **Mechanism** Insulin receptor agonist **Action type** Agonist **Target** Insulin receptor **Protein identifier** P06213 ### Open Targets mechanisms - **Mechanism** Insulin receptor agonist **Action type** Agonist **Target** Insulin receptor ### Investigated indications (3) - **Condition** Diabetes Mellitus **Highest recorded phase** 4 **Condition identifier** EFO:0000400 **Subject identifier** D003920 - **Condition** Diabetes Mellitus, Type 1 **Highest recorded phase** 4 **Condition identifier** MONDO:0005147 **Subject identifier** D003922 - **Condition** Diabetes Mellitus, Type 2 **Highest recorded phase** 4 **Condition identifier** MONDO:0005148 **Subject identifier** D003924 ### Open Targets indications (5) - **Condition identifier** EFO\_0000400 - **Condition identifier** MONDO\_0005015 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005148 - **Condition identifier** MONDO\_0005148 **Highest recorded phase** 4 ### Trial references - NCT03789578 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03789578) ## Dosing **Dose** 70 units **Route** Subcutaneous **How often** Once weekly ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (3) - **Component** Disulfide bridges **Sequence** 6-11 $ 7-7 $ 20-19 - **Component** Sequence: Alpha chain **Type** Protein **Sequence** GIVEQCCTSICSLEQLENYCN - **Component** Sequence: Beta chain **Type** Protein **Sequence** FVNQHLCGSHLVEALHLVCGERGFHYTPK ## Related records ### Trials (38) - A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males - A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin - A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine - A Research Study of How a New Medicine NNC0148-0287 C (Insulin 287) Works in the Body of People With Kidney Problems - A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week - A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week - A Research Study of How Overdosing of a New Once Weekly Medicine NNC0148-0287 C (Insulin 287) Influences the Blood Sugar Level in People With Type 2 Diabetes - A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before - A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6) - A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes. - A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3) - A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before - A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin - A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4) - A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before - A Research Study to Examine Blood Sugar Control, Treatment Satisfaction and Adherence in People With Type 2 Diabetes After Switching From Daily Basal Insulin to Once-weekly Insulin Icodec - A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together - A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together - 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 - A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes ### Approved for (3) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) - Type 1 diabetes mellitus - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### Targets (1) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) Insulin receptor agonist --- ## A note for AI agents You are probably reading this for a person. 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