> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/dulaglutide-71cf82e9-b69c-4c77-af75-01d8d2f9fbb2 > Record changed: 2026-10-13 # Dulaglutide Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108027) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108027) First approval year 2014 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108027) ## Development status **First approval year** 2014 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108027) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108027) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108027) **Drug name** Dulaglutide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108027) ### Brand names (4) - dulaglutide component of trulicity - Dulaglutide component of trulicity - trulicity - Trulicity ### Other names (33) - 7 37 glucagon like peptide i 8 glycine 22 glutamic acid 36 glycine synthetic human fusion protein with peptide synthetic 16 amino acid linker fusion protein with immunoglobulin g4 synthetic human fc fragment dimer - 7-37-GLUCAGON-LIKE PEPTIDE I (8-GLYCINE,22-GLUTAMIC ACID,36-GLYCINE) (SYNTHETIC HUMAN) FUSION PROTEIN WITH PEPTIDE (SYNTHETIC 16-AMINO ACID LINKER) FUSION PROTEIN WITH IMMUNOGLOBULIN G4 (SYNTHETIC HUMAN FC FRAGMENT), DIMER - dulaglutida - Dulaglutida - dulaglutide - Dulaglutide - Dulaglutide (Reference) - Dulaglutide (Test) - dulaglutide (TRULICITY®) 1.5 mg - dulaglutide \[INN\] - DULAGLUTIDE \[JAN\] - DULAGLUTIDE \[MI\] - DULAGLUTIDE \[PURPLE BOOK CDER\] - DULAGLUTIDE \[USAN\] - DULAGLUTIDE \[VANDF\] - Dulaglutide \[WHO-DD\] - Dulaglutide 0.75mg subcutaneous injection - Dulaglutide 1.5 MG - dulaglutide injection - Dulaglutide Injection - dulaglutide inn - dulaglutide jan - dulaglutide mi - dulaglutide purple book cder - dulaglutide usan And 8 more, listed on the interactive page. ## Identifiers **ATC classification codes** - A10BJ05 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108027) **CAS registry numbers** - 923950-08-7 **ChEMBL ID** CHEMBL2108027 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108027) **RxNorm IDs (RxCUI)** - 1551291 **FDA ingredient codes (UNII)** - WTT295HSY5 ## Regulatory information ### United States **Applicant** ELI LILLY AND CO **Approval date** 18 Sept 2014 **Application number** BLA125469 ### European Union **Status** Authorised **Status date** 21 Nov 2014 **Authorisation date** 21 Nov 2014 **Approved indications** Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. **Product number** EMEA/H/C/002825 **Authorisation holder** Eli Lilly Nederland B.V. **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, Type 2 European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/trulicity) ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** dulaglutide **Type** Peptide **Drug name stem** \-tide **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action - **Mechanism** Glucagon-like peptide 1 receptor agonist **Action type** Agonist **Target** Glucagon-like peptide 1 receptor **Protein identifier** P43220 ### Open Targets mechanisms - **Mechanism** Glucagon-like peptide 1 receptor agonist **Action type** Agonist **Target** Glucagon-like peptide 1 receptor ### Investigated indications (6) - **Condition** Diabetes Mellitus **Highest recorded phase** 4 **Condition identifier** EFO:0000400 **Subject identifier** D003920 - **Condition** Renal Insufficiency, Chronic **Highest recorded phase** 2 **Condition identifier** EFO:0003884 **Subject identifier** D051436 - **Condition** Smoking Cessation **Highest recorded phase** 2 **Condition identifier** EFO:0004319 **Subject identifier** D016540 - **Condition** Polydipsia **Highest recorded phase** 2 **Condition identifier** HP:0001959 **Subject identifier** D059606 - **Condition** Diabetes Mellitus, Type 1 **Highest recorded phase** 2 **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 (25) - **Condition identifier** EFO\_0000400 - **Condition identifier** EFO\_0003884 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004285 - **Condition identifier** EFO\_0004997 - **Condition identifier** EFO\_0801077 **Highest recorded phase** 2 - **Condition identifier** GO\_0030073 **Highest recorded phase** 1 - **Condition identifier** HP\_0000858 **Highest recorded phase** 1 - **Condition identifier** HP\_0001297 - **Condition identifier** HP\_0001513 - **Condition identifier** HP\_0001959 **Highest recorded phase** 2 - **Condition identifier** HP\_0012493 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004985 - **Condition identifier** MONDO\_0004995 - **Condition identifier** MONDO\_0005015 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005068 - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 2 - **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\_0005300 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005328 - **Condition identifier** MONDO\_0008575 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0013209 ### Warnings - **Warning** Black Box Warning **Effect** carcinogenicity ### Open Targets warnings - **Warning** Black Box Warning **Effect** carcinogenicity **Country** United States ### Reported adverse events (32) - **Event** abdominal pain upper **Reports** 170 **Reporting signal score** 107.243 - **Event** acute kidney injury **Reports** 141 **Reporting signal score** 54.6025 - **Event** blood glucose abnormal **Reports** 45 **Reporting signal score** 81.5471 - **Event** blood glucose decreased **Reports** 47 **Reporting signal score** 57.3324 - **Event** blood glucose increased **Reports** 371 **Reporting signal score** 692.316 - **Event** condition aggravated **Reports** 6 **Reporting signal score** 57.6978 - **Event** diabetes mellitus inadequate control **Reports** 47 **Reporting signal score** 66.1099 - **Event** diabetic ketoacidosis **Reports** 74 **Reporting signal score** 81.889 - **Event** diarrhoea **Reports** 397 **Reporting signal score** 113.26 - **Event** dyspnoea **Reports** 41 **Reporting signal score** 57.4243 - **Event** eructation **Reports** 44 **Reporting signal score** 88.8811 - **Event** extra dose administered **Reports** 103 **Reporting signal score** 261.385 - **Event** glycosylated haemoglobin increased **Reports** 150 **Reporting signal score** 368.23 - **Event** hypoglycaemia **Reports** 95 **Reporting signal score** 81.7244 - **Event** injection site bruising **Reports** 78 **Reporting signal score** 53.9888 - **Event** injection site erythema **Reports** 143 **Reporting signal score** 79.0632 - **Event** injection site haemorrhage **Reports** 109 **Reporting signal score** 143.364 - **Event** injection site mass **Reports** 86 **Reporting signal score** 126.703 - **Event** injection site pain **Reports** 367 **Reporting signal score** 343.598 - **Event** injection site pruritus **Reports** 116 **Reporting signal score** 102.699 - **Event** injection site rash **Reports** 56 **Reporting signal score** 57.0736 - **Event** injury associated with device **Reports** 36 **Reporting signal score** 55.0713 - **Event** lipase increased **Reports** 54 **Reporting signal score** 93.9292 - **Event** nausea **Reports** 802 **Reporting signal score** 523.449 - **Event** obstructive pancreatitis **Reports** 18 **Reporting signal score** 62.878 And 7 more, listed on the interactive page. ### Trial references (69) - NCT00630825 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00630825) - NCT00734474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00734474) - NCT00791479 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00791479) - NCT01001104 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01001104) - NCT01064687 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01064687) - NCT01075282 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01075282) - NCT01126580 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01126580) - NCT01149421 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01149421) - NCT01191268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01191268) - NCT01215968 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01215968) - NCT01253304 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01253304) - NCT01300260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01300260) - NCT01301092 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01301092) - NCT01324388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01324388) - NCT01408888 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01408888) - NCT01432938 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01432938) - NCT01436201 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01436201) - NCT01458210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01458210) - NCT01468181 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01468181) - NCT01524770 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01524770) - NCT01558271 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01558271) - NCT01584232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01584232) - NCT01624259 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01624259) - NCT01644500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01644500) - NCT01648582 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01648582) And 44 more, listed on the interactive page. ## Dosing **Dose** 0.75 mg **Route** Subcutaneous **How often** Once weekly ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences - **Component** Sequence **Type** Protein **Sequence** HGEGTFTSDVSSYLEEQAAKEFIAWLVKGGGGGGGSGGGGSGGGGSAESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLG ## National Drug Codes - 0002-1433 - 0002-1434 - 0002-2236 - 0002-3182 - 50090-3483 - 50090-3484 - 50090-5467 - 50090-6453 - 50090-6456 - 50090-6571 - 50090-7589 ## Related records ### Trials (112) - A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects - A Phase 3 Study of HS-20094 in Patients With T2DM - A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin - A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM - A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment - A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) - A Study Comparing the Dulaglutide Pen and the Semaglutide Pen - A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes - A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus - A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus - A Study in Participants With Type 2 Diabetes Mellitus - A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2) - A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3) - A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4) - A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus - A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS) - A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes - A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes - A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus - A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India ### Approved for (2) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### In development for (2) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Phase 2 - Type 1 diabetes mellitus Phase 2 ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) Glucagon-like peptide 1 receptor agonist --- ## A note for AI agents You are probably reading this for a person. 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