> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/insulin-glargine-8aa23d8d-fb05-42b5-b490-2e4b67136155 > Record changed: 2026-10-13 # Insulin glargine Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201497) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201497) First approval year 2000 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201497) ## Development status **First approval year** 2000 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201497) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201497) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201497) **Drug name** Insulin glargine Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201497) ### Brand names (32) - abasaglar - Abasaglar - Abasaglar (previously abasria) - abasaglar kwikpen - Abasaglar kwikpen - abasaglar previously abasria - basaglar - Basaglar - ins lantus - Ins lantus - ins lantus opticlik - Ins lantus opticlik - ins lantus optiset - Ins lantus optiset - ins lantus solostar - Ins lantus solostar - insulin glargine component of basaglar - Insulin glargine component of basaglar - insulin glargine component of soliqua 100 33 - Insulin glargine component of soliqua 100/33 - lantus - Lantus - lusduna - Lusduna - semglee And 7 more, listed on the interactive page. ### Other names (148) - albiglutide insulin glargine - basaglar component insulin glargine - BASAGLAR COMPONENT INSULIN GLARGINE - basalin - Basalin - basalog - Basalog - galactus - Galactus - Gla-100 (insulin glargine) - glargin - Glargin - glargine - Glargine - glaricon - Glaricon - hoe 71gt - HOE 71GT - hoe 901 - HOE 901 - HOE-71GT - HOE-901 - hoe901 - HOE901 - INSULIN (A20A-GLYCINE,B30A-ARGININE,B30B-ARGININE) (HUMAN) And 123 more, listed on the interactive page. ## Identifiers **ATC classification codes** - A10AE04 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201497) **CAS registry numbers** - 160337-95-1 **ChEMBL ID** CHEMBL1201497 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201497) **PubChem compound IDs** - 118984454 **FDA ingredient codes (UNII)** - 2ZM8CX04RZ ### RxNorm IDs (RxCUI) (2) - 274783 - 2589006 ## Regulatory information ### United States **Applicant** SANOFI AVENTIS US **Approval date** 20 Apr 2000 **Application number** BLA021081 ### European Union **Status** Authorised **Status date** 9 Jun 2000 **Authorisation date** 9 Jun 2000 **Approved indications** Treatment of diabetes mellitus in adults, adolescents and children aged two years and above **Product number** EMEA/H/C/000284 **Authorisation holder** sanofi-aventis Deutschland GmbH **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 3 **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/lantus) ### Other regulatory facts **Patents** 0 **Designations** 0 **Earliest recorded loss of exclusivity** 15 Nov 2022 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** insulin glargine **Type** Peptide **Approval recorded by Guide to Pharmacology** Yes #### 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 (14) - **Condition** Diabetes Mellitus **Highest recorded phase** 4 **Condition identifier** EFO:0000400 **Subject identifier** D003920 - **Condition** Hypertension **Highest recorded phase** 3 **Condition identifier** EFO:0000537 **Subject identifier** D006973 - **Condition** Leukemia **Highest recorded phase** 3 **Condition identifier** EFO:0000565 **Subject identifier** D007938 - **Condition** Lymphoma **Highest recorded phase** 3 **Condition identifier** EFO:0000574 **Subject identifier** D008223 - **Condition** Coronary Disease **Highest recorded phase** 3 **Condition identifier** EFO:0001645 **Subject identifier** D003327 - **Condition** Diabetic Retinopathy **Highest recorded phase** 0.5 **Condition identifier** EFO:0003770 **Subject identifier** D003930 - **Condition** Atherosclerosis **Highest recorded phase** 3 **Condition identifier** EFO:0003914 **Subject identifier** D050197 - **Condition** Myocardial Infarction **Highest recorded phase** 3 **Condition identifier** EFO:0008583 **Subject identifier** D009203 - **Condition** Prediabetic State **Highest recorded phase** 3 **Condition identifier** EFO:1001121 **Subject identifier** D011236 - **Condition** Hyperglycemia **Highest recorded phase** 3 **Condition identifier** HP:0003074 **Subject identifier** D006943 - **Condition** Hypercholesterolemia **Highest recorded phase** 3 **Condition identifier** HP:0003124 **Subject identifier** D006937 - **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 - **Condition** Cystic Fibrosis **Highest recorded phase** 3 **Condition identifier** MONDO:0009061 **Subject identifier** D003550 ### Open Targets indications (35) - **Condition identifier** EFO\_0000400 - **Condition identifier** EFO\_0000565 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000574 **Highest recorded phase** 3 - **Condition identifier** EFO\_0001068 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003770 - **Condition identifier** EFO\_0003884 - **Condition identifier** EFO\_0008583 **Highest recorded phase** 3 - **Condition identifier** EFO\_0008585 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001121 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001923 **Highest recorded phase** 3 - **Condition identifier** HP\_0001297 - **Condition identifier** HP\_0001943 **Highest recorded phase** 3 - **Condition identifier** HP\_0003074 **Highest recorded phase** 3 - **Condition identifier** HP\_0040270 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0000873 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0004967 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0004995 - **Condition identifier** MONDO\_0005015 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005068 - **Condition identifier** MONDO\_0005136 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005147 - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005148 - **Condition identifier** MONDO\_0005148 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005154 And 10 more, listed on the interactive page. ### Reported adverse events (20) - **Event** blood glucose abnormal **Reports** 262 **Reporting signal score** 539.886 - **Event** blood glucose decreased **Reports** 792 **Reporting signal score** 1,954.08 - **Event** blood glucose fluctuation **Reports** 230 **Reporting signal score** 561.897 - **Event** blood glucose increased **Reports** 2,482 **Reporting signal score** 5,624.23 - **Event** device operational issue **Reports** 244 **Reporting signal score** 999.568 - **Event** diabetes mellitus inadequate control **Reports** 622 **Reporting signal score** 1,513.27 - **Event** diabetic ketoacidosis **Reports** 686 **Reporting signal score** 1,213.52 - **Event** diabetic metabolic decompensation **Reports** 123 **Reporting signal score** 358.485 - **Event** diabetic retinopathy **Reports** 129 **Reporting signal score** 330.594 - **Event** gait inability **Reports** 146 **Reporting signal score** 205.178 - **Event** glycosylated haemoglobin increased **Reports** 500 **Reporting signal score** 1,083.26 - **Event** hyperglycaemia **Reports** 751 **Reporting signal score** 1,284.13 - **Event** hypoglycaemia **Reports** 3,628 **Reporting signal score** 10,568.7 - **Event** hypoglycaemia neonatal **Reports** 111 **Reporting signal score** 280.581 - **Event** hypoglycaemic coma **Reports** 339 **Reporting signal score** 1,041.42 - **Event** hypoglycaemic unconsciousness **Reports** 151 **Reporting signal score** 499.832 - **Event** ketoacidosis **Reports** 159 **Reporting signal score** 275.816 - **Event** premature baby **Reports** 390 **Reporting signal score** 423.127 - **Event** wrong drug administered **Reports** 126 **Reporting signal score** 214.559 - **Event** wrong technique in device usage process **Reports** 109 **Reporting signal score** 219.446 ### Trial references (343) - NCT00000620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000620) - NCT00069784 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00069784) - NCT00082381 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00082381) - NCT00097084 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00097084) - NCT00097500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00097500) - NCT00097877 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00097877) - NCT00099619 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00099619) - NCT00106366 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00106366) - NCT00110370 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00110370) - NCT00135057 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00135057) - NCT00135096 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00135096) - NCT00147745 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00147745) - NCT00151697 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00151697) - NCT00174642 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00174642) - NCT00174668 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00174668) - NCT00174681 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00174681) - NCT00174824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00174824) - NCT00184613 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00184613) - NCT00184626 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00184626) - NCT00191178 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191178) - NCT00191464 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191464) - NCT00258804 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00258804) - NCT00268645 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00268645) - NCT00272064 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00272064) - NCT00272077 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00272077) And 318 more, listed on the interactive page. ## Dosing **Dose** 0.2 units/kg or up to 10 units **Route** Subcutaneous **How often** Once daily ### Conditions of use (5) - Administer into abdomen, thigh, or deltoid - Do not dilute or mix with other insulin or solutions - Do not inject into lipodystrophy or lipodystrophy sites - Rotate injection sites within the same region - Use with caution in patients with visual impairment ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Sequence **Type** Protein **Sequence** FVNQHLCGSHLVEALYLVCGERGFFYTPKTRR - **Component** Sequence **Type** Protein **Sequence** GIVEQCCTSICSLYQLENYCG ## National Drug Codes - 0002-7715 - 0002-8980 - 0024-5761 - 0024-5869 - 0024-5871 - 0088-2219 - 0088-2220 - 0955-2900 - 0955-3900 - 72572-422 - 72572-424 - 83257-011 - 83257-012 - 83257-014 - 83257-015 - 87682-090 - 50090-0876 - 50090-1398 - 50090-2193 - 50090-4068 - 50090-4177 - 50090-6439 ## Pharmacologic actions - Hypolipidemic Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000960.html) - Hypoglycemic Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D007004.html) ## Related records ### Trials (1,136) - 18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes - 20 Week Bridging Study in Type II DM - 24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine - 24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine - 32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus - 5 Versus 10 Units of Insulin in Hyperkalemia Management - 6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes - A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM) - 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 2-Month Safety Follow-Up Trial - A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin - A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine - 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 Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period - A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine - 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 Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus ### 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) ### In development for (11) - [Acute myocardial infarction](https://trialight.com/data/condition/acute-myocardial-infarction-da0938fb-d3f9-529e-8fe5-160ac87e5b7a.md) Phase 3 - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) Phase 3 - [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) Phase 3 - [Cystic fibrosis](https://trialight.com/data/condition/cystic-fibrosis-6f9870eb-6ebc-5bec-a50b-34b0b323a7c3.md) Phase 3 - [Diabetic retinopathy](https://trialight.com/data/condition/diabetic-retinopathy-3213cb12-9e5d-5ef7-827d-b64b152d71f9.md) Early phase 1 - Hyperglycemia Phase 3 - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) Phase 3 - [Leukemia](https://trialight.com/data/condition/leukemia-519aefcd-8521-5941-851b-5b77ca925ca5.md) Phase 3 - [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) Phase 3 - [Malaria](https://trialight.com/data/condition/malaria-54828cac-9b96-5833-93e2-e012d4505853.md) Phase 3 - Prediabetes syndrome Phase 3 ### Other linked conditions (1) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.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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