> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/glimepiride-9fa39756-be21-4a6d-999a-bc4b8645f5c9 > Record changed: 2026-10-13 # Glimepiride Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) First approval year 1995 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) ## Development status **First approval year** 1995 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) **Drug name** Glimepiride Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) **Molecular weight** 490.63 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) **Structure (SMILES)** CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N\[C@H\]3CC\[C@H\](C)CC3)cc2)C1=O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) ### Brand names (10) - amaryl - Amaryl - glimepiride - Glimepiride - glimepiride component of avandaryl - Glimepiride component of avandaryl - glimepiride component of duetact - Glimepiride component of duetact - niddaryl - Niddaryl ### Other names (68) - 1 p 2 3 ethyl 4 methyl 2 oxo 3 pyrroline 1 carboxamido ethyl phenyl sulfonyl 3 trans 4 methylcyclohexyl urea - 1-((P-(2-(3-ETHYL-4-METHYL-2-OXO-3-PYRROLINE-1-CARBOXAMIDO)ETHYL)PHENYL)SULFONYL)-3-(TRANS-4-METHYLCYCLOHEXYL)UREA - 1h pyrrole 1 carboxamide 3 ethyl 2 5 dihydro 4 methyl n 2 4 4 methylcyclohexyl amino carbonyl amino sulfonyl phenyl ethyl 2 oxo trans - 1H-PYRROLE-1-CARBOXAMIDE, 3-ETHYL-2,5-DIHYDRO-4-METHYL-N-(2-(4-(((((4-METHYLCYCLOHEXYL)AMINO)CARBONYL)AMINO)SULFONYL)PHENYL)ETHYL)-2-OXO-, TRANS- - 1mg glimepiride - 1mg Glimepiride - 2mg Glimepiride - 3mg Glimepiride - 4mg Glimepiride - Amaryl® - AMARYL® 4 mg Tablets - Amaryl® Tablets 1 mg - duetact component glimepiride - DUETACT COMPONENT GLIMEPIRIDE - glimepirida - Glimepirida - glimepiride - Glimepiride - GLIMEPIRIDE - Glimepiride (double-blind) - Glimepiride (HOE490) - GLIMEPIRIDE (HOE490) - Glimepiride (open-label) - Glimepiride (oral) - Glimepiride (SU) And 43 more, listed on the interactive page. ## Identifiers **ATC classification codes** - A10BB12 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) **CAS registry numbers** - 93479-97-1 **ChEMBL ID** CHEMBL1481 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) **InChIKey** WIGIZIANZCJQQY-RUCARUNLSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1481) **RxNorm IDs (RxCUI)** - 25789 **FDA ingredient codes (UNII)** - 6KY687524K ## Regulatory information ### United States **Applicant** TAKEDA PHARMS USA **Approval date** 28 Jul 2006 **Application number** NDA021925 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** glimepiride **Type** Synthetic organic **Drug name stem** gli- **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (2) - **Mechanism** Sulfonylurea receptor 1, Kir6.2 blocker **Action type** Blocker **Target** Sulfonylurea receptor 1, Kir6.2 **Protein identifier** Q09428 - **Mechanism** Sulfonylurea receptor 1, Kir6.2 blocker **Action type** Blocker **Target** Sulfonylurea receptor 1, Kir6.2 **Protein identifier** Q14654 ### Open Targets mechanisms - **Mechanism** Sulfonylurea receptor 1, Kir6.2 blocker **Action type** Blocker **Target** Sulfonylurea receptor 1, Kir6.2 ### DrugCentral mechanisms (2) - **Action type** Blocker **Gene symbol** ABCC9|KCNJ11 **Protein identifier** O60706|Q14654 **Organism** Homo sapiens **Target development level** Clinical - **Action type** Blocker **Gene symbol** ABCC8|KCNJ11 **Protein identifier** Q09428|Q14654 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (7) - **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** Coronary Disease **Highest recorded phase** 3 **Condition identifier** EFO:0001645 **Subject identifier** D003327 - **Condition** Atherosclerosis **Highest recorded phase** 3 **Condition identifier** EFO:0003914 **Subject identifier** D050197 - **Condition** Hypercholesterolemia **Highest recorded phase** 3 **Condition identifier** HP:0003124 **Subject identifier** D006937 - **Condition** Diabetes Mellitus, Type 2 **Highest recorded phase** 4 **Condition identifier** MONDO:0005148 **Subject identifier** D003924 - **Condition** Diabetes Mellitus, Type 2 **Highest recorded phase** 4 **Condition identifier** Orphanet:552 **Subject identifier** D003924 ### Open Targets indications (22) - **Condition identifier** EFO\_0000400 - **Condition identifier** HP\_0001263 - **Condition identifier** HP\_0001297 - **Condition identifier** HP\_0001943 **Highest recorded phase** 3 - **Condition identifier** HP\_0003074 - **Condition identifier** HP\_0040270 - **Condition identifier** MONDO\_0002525 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0004995 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005003 - **Condition identifier** MONDO\_0005010 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005015 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005027 - **Condition identifier** MONDO\_0005068 - **Condition identifier** MONDO\_0005148 - **Condition identifier** MONDO\_0005148 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005154 - **Condition identifier** MONDO\_0005240 - **Condition identifier** MONDO\_0005252 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005300 - **Condition identifier** MONDO\_0005328 - **Condition identifier** Orphanet\_552 - **Condition identifier** Orphanet\_552 **Highest recorded phase** 2 ### Reported adverse events (26) - **Event** acute kidney injury **Reports** 142 **Reporting signal score** 95.2582 - **Event** altered state of consciousness **Reports** 78 **Reporting signal score** 133.485 - **Event** blood glucose decreased **Reports** 75 **Reporting signal score** 150.768 - **Event** blood glucose increased **Reports** 141 **Reporting signal score** 185.872 - **Event** blood lactic acid **Reports** 19 **Reporting signal score** 96.0339 - **Event** bradypnoea **Reports** 19 **Reporting signal score** 43.7235 - **Event** depressed level of consciousness **Reports** 57 **Reporting signal score** 50.2525 - **Event** diabetes mellitus inadequate control **Reports** 133 **Reporting signal score** 368.887 - **Event** diabetic metabolic decompensation **Reports** 45 **Reporting signal score** 170.47 - **Event** drug interaction **Reports** 120 **Reporting signal score** 43.8768 - **Event** glycosylated haemoglobin increased **Reports** 81 **Reporting signal score** 180.75 - **Event** hyperglycaemia **Reports** 76 **Reporting signal score** 101.598 - **Event** hyperhidrosis **Reports** 85 **Reporting signal score** 50.3581 - **Event** hyperkalaemia **Reports** 72 **Reporting signal score** 80.7592 - **Event** hypoglycaemia **Reports** 1,161 **Reporting signal score** 4,365.68 - **Event** hypoglycaemic coma **Reports** 157 **Reporting signal score** 658.437 - **Event** hypoglycaemic encephalopathy **Reports** 39 **Reporting signal score** 194.438 - **Event** lactic acidosis **Reports** 132 **Reporting signal score** 235.884 - **Event** loss of consciousness **Reports** 124 **Reporting signal score** 96.8587 - **Event** neuroglycopenia **Reports** 11 **Reporting signal score** 57.5223 - **Event** oliguria **Reports** 25 **Reporting signal score** 45.0757 - **Event** pancreatitis acute **Reports** 57 **Reporting signal score** 68.3645 - **Event** postprandial hypoglycaemia **Reports** 10 **Reporting signal score** 48.4708 - **Event** renal failure acute **Reports** 75 **Reporting signal score** 58.0238 - **Event** renal impairment **Reports** 106 **Reporting signal score** 97.004 And 1 more, listed on the interactive page. ### Trial references (155) - NCT00000620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000620) - NCT00032487 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00032487) - NCT00044447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00044447) - NCT00099944 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00099944) - NCT00106340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00106340) - NCT00131664 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00131664) - NCT00151697 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00151697) - NCT00294723 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00294723) - NCT00309608 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00309608) - NCT00318422 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00318422) - NCT00318461 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00318461) - NCT00318656 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00318656) - NCT00331851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00331851) - NCT00343980 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00343980) - NCT00347100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00347100) - NCT00353691 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00353691) - NCT00359762 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00359762) - NCT00360698 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00360698) - NCT00427154 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00427154) - NCT00437554 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00437554) - NCT00449605 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00449605) - NCT00469092 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00469092) - NCT00469586 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00469586) - NCT00474838 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00474838) - NCT00562172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00562172) And 130 more, listed on the interactive page. ## Dosing **Dose** 1-2mg, up to 8mg **Route** Oral **How often** Once daily ### Conditions of use (3) - Administer with breakfast or first meal of the day - Dose increases no more frequently than every 1 to 2 weeks - Use conservative titration in at-risk patients (elderly, renal impairment) ## Chemical properties **Hydrogen bond acceptors** 5 **Hydrogen bond donors** 3 **Polar surface area** 124.68 **Calculated partition coefficient (ALogP)** 3.07 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 7 **Heavy atoms** 34 **Molecular formula** C24H34N4O5S **Natural product** Yes ## National Drug Codes - 0615-8332 - 0615-8333 - 0615-8334 - 16571-773 - 16571-774 - 16571-775 - 16729-001 - 16729-002 - 16729-003 - 42571-100 - 42571-101 - 42571-102 - 42571-103 - 42571-104 - 42571-105 - 43063-121 - 43063-122 - 43063-587 - 43063-630 - 43063-697 - 43063-698 - 43063-699 - 43063-946 - 43547-394 - 43547-395 And 82 more, listed on the interactive page. ## Biological measurements ### Observed measurements #### Oral bioavailability **Median** 100 **Mean** 100 **Minimum** 100 **Maximum** 100 **Unit** % **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - F ## Related records ### Trials (363) - 24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes - 3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) - A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone - A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes - A Comparison of Atorvastatin and Glimepiride Fixed Dose Combination and Atorvastatin and Glimepiride Loose Combination in the Treatment of Patients With Type 2 Diabetes Mellitus - A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM) - A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes - A Long-term Trial to Compare the Effects of Liraglutide and Sulphonylurea (Glimepiride) Both in Combination With Metformin on Clinical, Endothelial and Image Markers of Cardiovascular Risk in Patients With Type 2 Diabetes - A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies - A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab - A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia - A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis - A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graft-versus-Host Disease After Haploidentical Stem Cell Transplantation in Children - A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate - A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA - A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) - A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus - A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD - A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253) - A Study in Healthy Volunteers Investigating How Quickly and to What Extent BAY1817080 is Taken up, Distributed, Broken Down and Eliminated From the Body, as Well as the Difference Between 2 Different Types of Tablets of BAY1817080 and the Difference Between Oral Dose and Dose in the Vein ### Approved for (3) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) - Maturity-onset diabetes of the young - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### In development for (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 - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) Phase 3 ### Targets (2) - [ABCC8](https://trialight.com/data/target/abcc8-d5b12ce5-01cf-50d6-9a80-43fb995d8808.md) Sulfonylurea receptor 1, Kir6.2 blocker - [KCNJ11](https://trialight.com/data/target/kcnj11-0c4c8434-214d-5b32-815c-56501b745a8a.md) Sulfonylurea receptor 1, Kir6.2 blocker --- ## A note for AI agents You are probably reading this for a person. 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