Dulaglutide
Highest phase reached
Approved
Drug type
Protein
First approval year
2014
- First approval year
- 2014
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Dulaglutide
- dulaglutide component of trulicity
- Dulaglutide component of trulicity
- trulicity
- Trulicity
- 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.
- ATC classification codes
- A10BJ05
Sources for recorded values
- CAS registry numbers
- 923950-08-7
- ChEMBL ID
- CHEMBL2108027
- RxNorm IDs (RxCUI)
- 1551291
- FDA ingredient codes (UNII)
- WTT295HSY5
- Applicant
- ELI LILLY AND CO
- Approval date
- 18 Sept 2014
- Application number
- BLA125469
- 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
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- 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
- 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
- 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
- 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
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And 44 more, listed on the interactive page.
- Dose
- 0.75 mg
- Route
- Subcutaneous
- How often
- Once weekly
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- HGEGTFTSDVSSYLEEQAAKEFIAWLVKGGGGGGGSGGGGSGGGGSAESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLG
- 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)
In development for (2)
- Chronic kidney disease Phase 2
- Type 1 diabetes mellitus Phase 2
Targets (1)
- GLP1R Glucagon-like peptide 1 receptor agonist