Tirzepatide
Highest phase reached
Approved
Drug type
Protein
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Tirzepatide
- mounjaro
- Mounjaro
- Mounjaro (autoinjector)
- mounjaro autoinjector
- zepbound
- Zepbound
- Zepbound (autoinjector)
- zepbound autoinjector
- bg 121
- BG-121
- eloralintide and tirzepatide
- ly 3298176
- LY-3298176
- ly3298176
- Ly3298176
- LY3298176
- mounjaro
- Mounjaro
- tirzepatida
- Tirzepatida
- tirzepatide
- Tirzepatide
- TIRZEPATIDE
- Tirzepatide (Flexible titration)
- Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.)
- Tirzepatide (Mounjaro)
- Tirzepatide (Per-label titration)
- Tirzepatide (T.G.)
- Tirzepatide [INN]
- Tirzepatide [JAN]
- Tirzepatide [MI]
- Tirzepatide [WHO-DD]
- Tirzepatide 2.5mg weekly
And 8 more, listed on the interactive page.
- ATC classification codes
- A10BX16
Sources for recorded values
- CAS registry numbers
- 2023788-19-2
- ChEMBL ID
- CHEMBL4297839
- RxNorm IDs (RxCUI)
- 2601723
- FDA ingredient codes (UNII)
- OYN3CCI6QE
- Applicant
- ELI LILLY AND CO
- Approval date
- 13 May 2022
- Application number
- NDA215866
- Status
- Authorised
- Status date
- 15 Sept 2022
- Authorisation date
- 15 Sept 2022
- Approved indications
- Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults, adolescents and children aged 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 the populations studied, see sections 4.4, 4.5 and 5.1. Weight management Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obesity) or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus). For trial results with respect to obstructive sleep apnoea (OSA) and heart failure with preserved ejection fraction (HFpEF), see section 5.1.
- Product number
- EMEA/H/C/005620
- 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
- Obesity
- Overweight
European medicines record
- Patents
- 12
- Designations
- 1
- Earliest recorded loss of exclusivity
- 30 Dec 2041
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- tirzepatide
- Type
- Peptide
- Drug name stem
- -tide
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Agonist
- Action type
- Agonist
- Target
- GLP-1 receptor
- Gene symbol
- GLP1R
- Protein identifier
- P43220
- Median affinity
- 8.37
- Affinity units
- pKi
- Action
- Agonist
- Action type
- Agonist
- Target
- GIP receptor
- Gene symbol
- GIPR
- Protein identifier
- P48546
- Median affinity
- 9.87
- Affinity units
- pKi
- Mechanism
- Gastric inhibitory polypeptide receptor agonist
- Action type
- Agonist
- Target
- Gastric inhibitory polypeptide receptor
- Protein identifier
- P48546
- Mechanism
- Glucagon-like peptide 1 receptor agonist
- Action type
- Agonist
- Target
- Glucagon-like peptide 1 receptor
- Protein identifier
- P43220
- Mechanism
- Gastric inhibitory polypeptide receptor agonist
- Action type
- Agonist
- Target
- Gastric inhibitory polypeptide receptor
- 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
- Obesity
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Obesity, Morbid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001074
- Subject identifier
- D009767
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Overweight
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005935
- Subject identifier
- D050177
- Condition
- Non-alcoholic Fatty Liver Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001249
- Subject identifier
- D065626
- Condition
- Diabetes Mellitus, Type 2
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005148
- Subject identifier
- D003924
- Condition
- Wolfram Syndrome
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0018105
- Subject identifier
- D014929
- Condition identifier
- EFO_0000195
- Condition identifier
- EFO_0000400
- Condition identifier
- EFO_0000537
- Condition identifier
- EFO_0001073
- Condition identifier
- EFO_0001074
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004319
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005935
- Condition identifier
- EFO_0005935
- Highest recorded phase
- 4
- Condition identifier
- EFO_0010702
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000235
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000710
- Condition identifier
- EFO_1001249
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001494
- Highest recorded phase
- 3
- Condition identifier
- HP_0000789
- Highest recorded phase
- 2
- Condition identifier
- HP_0000822
- Highest recorded phase
- 4
- Condition identifier
- HP_0000855
- Highest recorded phase
- 2
- Condition identifier
- HP_0001395
- Highest recorded phase
- 2
- Condition identifier
- HP_0001399
- Highest recorded phase
- 1
- Condition identifier
- HP_0001513
- Highest recorded phase
- 4
- Condition identifier
- HP_0001824
- Condition identifier
- HP_0025502
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002046
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004691
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004790
- Highest recorded phase
- 2
And 31 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- carcinogenicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Country
- United States
- Event
- diabetic ketoacidosis
- Reports
- 4
- Reporting signal score
- 11.4079
- Event
- drug interaction
- Reports
- 6
- Reporting signal score
- 9.21452
- Event
- weight decreased
- Reports
- 6
- Reporting signal score
- 9.75974
- NCT02759107
- NCT03131687
- NCT03311724
- NCT03322631
- NCT03730662
- NCT03861039
- NCT03861052
- NCT03882970
- NCT03951753
- NCT03954834
- NCT03987919
- NCT04039503
- NCT04093752
- NCT04235959
- NCT04255433
- NCT04537923
- NCT05260021
- NCT05433584
- NCT05553093
- NCT05564039
- NCT05706506
- NCT05963022
- NCT06221969
- NCT06246799
- NCT04081337
And 12 more, listed on the interactive page.
- Dose
- 2.5 mg
- Route
- Subcutaneous
- How often
- Once weekly
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Heavy chain
- Type
- Protein
- Sequence
- YX1EGTFTSDYSIX1LDKIAQK1AFVQWLIAGGPSSGAPPPS1
- 0002-0152
- 0002-0243
- 0002-1152
- 0002-1214
- 0002-1243
- 0002-1340
- 0002-1423
- 0002-1457
- 0002-1460
- 0002-1471
- 0002-1484
- 0002-1495
- 0002-1506
- 0002-2002
- 0002-2214
- 0002-2340
- 0002-2423
- 0002-2457
- 0002-2460
- 0002-2471
- 0002-2484
- 0002-2495
- 0002-2506
- 0002-3002
- 0002-3411
And 29 more, listed on the interactive page.
Related records
Trials (217)
- 2024 Tirzepatide-Bariatric Surgery
- A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese
- A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar
- A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
- A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
- A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
- A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
- A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
- A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity
- A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD
- A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants
- A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
- A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices
- A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
- A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
- A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
- A Study of a Weight Loss Intervention in People With Endometrial Cancer
- A Study of BGM0504 in Participants With Obesity
- A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes
- A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants
Approved for (3)
In development for (4)
- Chronic kidney disease Phase 2
- Metabolic dysfunction-associated steatohepatitis Phase 2
- Morbid obesity Phase 2
- Wolfram syndrome Phase 2
Other linked conditions (5)
- Endometrial cancer
- Hidradenitis suppurativa
- Hyperlipidemia
- Hypertensive disorder
- Type 1 diabetes mellitus