> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/insulin-degludec-80983e6b-a368-4816-829f-a75712c22435 > Record changed: 2026-10-13 # Insulin degludec Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107869) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107869) First approval year 2013 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107869) ## Development status **First approval year** 2013 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107869) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107869) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107869) **Drug name** Insulin degludec Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107869) ### Brand names (8) - ins tresiba - Ins tresiba - insulin degludec component of ryzodeg 70 30 - Insulin degludec component of ryzodeg 70/30 - insulin degludec component of xultophy 100 3 6 - Insulin degludec component of xultophy 100/3.6 - tresiba - Tresiba ### Other names (36) - (1A-21A),(1B-29B)-INSULIN (HUMAN), 29B-(N6-(N-(15-CARBOXY-1-OXOPENTADECYL)-L-.GAMMA.-GLUTAMYL)-L-LYSINE)- - 1a 21a 1b 29b insulin human 29b n6 n 15 carboxy 1 oxopentadecyl l gamma glutamyl l lysine - insulin degludec - Insulin degludec - Insulin Degludec - Insulin Degludec - IV - Insulin Degludec (U-100) - INSULIN DEGLUDEC \[EMA EPAR\] - insulin degludec \[INN\] - INSULIN DEGLUDEC \[JAN\] - INSULIN DEGLUDEC \[ORANGE BOOK\] - INSULIN DEGLUDEC \[USAN\] - Insulin degludec \[WHO-DD\] - insulin degludec ema epar - Insulin degludec injection - Insulin Degludec Injection - Insulin Degludec Injection (Tresiba®) - insulin degludec inn - insulin degludec jan - insulin degludec orange book - insulin degludec usan - insulin degludec who dd - insulina degludec - Insulina degludec - insuline degludec And 11 more, listed on the interactive page. ## Identifiers **ATC classification codes** - A10AE06 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107869) **CAS registry numbers** - 844439-96-9 **ChEMBL ID** CHEMBL2107869 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107869) **PubChem compound IDs** - 118984462 **RxNorm IDs (RxCUI)** - 1670007 **FDA ingredient codes (UNII)** - 54Q18076QB ## Regulatory information ### United States **Applicant** NOVO **Approval date** 25 Sept 2015 **Application number** BLA203314 ### European Union **Status** Authorised **Status date** 20 Jan 2013 **Authorisation date** 20 Jan 2013 **Approved indications** Treatment of diabetes mellitus in adults. **Product number** EMEA/H/C/002498 **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 European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/tresiba) ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only ## Pharmacology ### Drug classification #### Administration routes - Parenteral ### 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** 3 **Condition identifier** MONDO:0005147 **Subject identifier** D003922 - **Condition** Diabetes Mellitus, Type 2 **Highest recorded phase** 3 **Condition identifier** MONDO:0005148 **Subject identifier** D003924 ### Open Targets indications (15) - **Condition identifier** EFO\_0000400 - **Condition identifier** HP\_0001297 - **Condition identifier** HP\_0001394 **Highest recorded phase** 3 - **Condition identifier** HP\_0001943 **Highest recorded phase** 3 - **Condition identifier** HP\_0003074 - **Condition identifier** MONDO\_0005015 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005068 - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005148 - **Condition identifier** MONDO\_0005148 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005154 - **Condition identifier** MONDO\_0005240 - **Condition identifier** MONDO\_0005252 - **Condition identifier** MONDO\_0005328 - **Condition identifier** MONDO\_0012819 **Highest recorded phase** 1 ### Reported adverse events (36) - **Event** abdominal transposition **Reports** 12 **Reporting signal score** 67.325 - **Event** blood glucose decreased **Reports** 189 **Reporting signal score** 503.257 - **Event** blood glucose fluctuation **Reports** 41 **Reporting signal score** 96.4104 - **Event** blood glucose increased **Reports** 269 **Reporting signal score** 452.279 - **Event** cardiogenic shock **Reports** 50 **Reporting signal score** 87.4235 - **Event** congenital cardiovascular anomaly **Reports** 12 **Reporting signal score** 45.6815 - **Event** diabetes mellitus inadequate control **Reports** 121 **Reporting signal score** 293.549 - **Event** diabetic ketoacidosis **Reports** 162 **Reporting signal score** 315.493 - **Event** diabetic metabolic decompensation **Reports** 21 **Reporting signal score** 58.3724 - **Event** diabetic neuropathy **Reports** 34 **Reporting signal score** 88.4283 - **Event** diabetic retinopathy **Reports** 25 **Reporting signal score** 63.8057 - **Event** fatigue **Reports** 49 **Reporting signal score** 55.0645 - **Event** foetal disorder **Reports** 19 **Reporting signal score** 59.0698 - **Event** glycosylated haemoglobin increased **Reports** 97 **Reporting signal score** 209.237 - **Event** heart sounds **Reports** 6 **Reporting signal score** 33.542 - **Event** hyperglycaemia **Reports** 153 **Reporting signal score** 267.286 - **Event** hypoglycaemia **Reports** 884 **Reporting signal score** 2,784.43 - **Event** hypoglycaemia neonatal **Reports** 37 **Reporting signal score** 112.796 - **Event** hypoglycaemic coma **Reports** 44 **Reporting signal score** 117.332 - **Event** hypoglycaemic seizure **Reports** 10 **Reporting signal score** 33.062 - **Event** hypoglycaemic unconsciousness **Reports** 28 **Reporting signal score** 91.1622 - **Event** impaired gastric emptying **Reports** 35 **Reporting signal score** 73.248 - **Event** ketoacidosis **Reports** 32 **Reporting signal score** 56.3168 - **Event** lactic acidosis **Reports** 74 **Reporting signal score** 76.0347 - **Event** low birth weight baby **Reports** 86 **Reporting signal score** 206.718 And 11 more, listed on the interactive page. ### Trial references (144) - NCT00611884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00611884) - NCT00613951 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00613951) - NCT00614055 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00614055) - NCT00842361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00842361) - NCT00972283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00972283) - NCT00982644 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00982644) - NCT01006291 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01006291) - NCT01009580 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01009580) - NCT01043510 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01043510) - NCT01045447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01045447) - NCT01045707 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01045707) - NCT01046110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01046110) - NCT01059799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01059799) - NCT01059812 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01059812) - NCT01068665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01068665) - NCT01068678 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01068678) - NCT01076647 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01076647) - NCT01134224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01134224) - NCT01135992 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01135992) - NCT01154881 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01154881) - NCT01272193 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01272193) - NCT01326026 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01326026) - NCT01336023 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01336023) - NCT01364428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01364428) - NCT01365507 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01365507) And 119 more, listed on the interactive page. ## Dosing **Dose** 10-50 units **Route** Subcutaneous **How often** Once daily ### Conditions of use (5) - Do not administer intravenously or by infusion pump - Do not dilute or mix with other insulin - Inject into thigh, upper arm, or abdomen - Rotate injection sites - Take with or without food ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Sequence **Type** Protein **Sequence** FVNQHLCGSHLVEALYLVCGERGFFYTPL - **Component** Light chain **Type** Protein **Sequence** GIVEQCCTSICSLYQLENYCN ## National Drug Codes - 0169-2550 - 0169-2660 - 0169-2662 - 0169-2911 - 73070-400 - 73070-403 - 73070-503 - 50090-3491 - 50090-7094 - 50090-7175 - 50090-7176 ## Related records ### Trials (203) - A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin - A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin - A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus - A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin - A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification - A Canadian Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus - A Clinical Study Comparing the Pharmacokinetics and Pharmacodynamic Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection (Tresiba®) in Healthy Subjects - A Clinical Study of GZR33 and GZR101 in Healthy Subjects - A Clinical Study of Insulin Degludec Injection in Subjects With Type 2 Diabetes - A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 in Subjects With Type 2 Diabetes - A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms - A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus - A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus - A Comparison Between Two Formulations of NN5401 in Healthy Subjects - A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs - A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India - A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes - A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus - A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males - A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin ### Approved for (1) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) ### In development for (2) - Type 1 diabetes mellitus Phase 3 - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Phase 3 ### 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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