NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
May 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
MOUNJARO (AUTOINJECTOR) (tirzepatide) by Eli Lilly and Company is g-protein-linked receptor interactions [moa]. Approved for glucose-dependent insulinotropic polypeptide receptor agonist [epc]. First approved in 2022.
Drug data last refreshed 19h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MOUNJARO (tirzepatide) is a dual GIP/GLP-1 receptor agonist administered via subcutaneous autoinjector for the treatment of type 2 diabetes. It works by activating G-protein-linked receptors to improve glucose control through insulin secretion and appetite regulation. The autoinjector formulation enhances patient convenience and adherence compared to pen alternatives.
Peak15.3 years to LOE
MOUNJARO is at peak commercial performance with $2.4B in spending; teams are optimizing market penetration and preparing for competitive GLP-1 landscape expansion.
Mechanism of Action
G-Protein-linked Receptor Interactions
Pharmacologic Class:
Glucose-dependent Insulinotropic Polypeptide Receptor Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Tirzepatide for Treatment of CCCA
Started Sep 2026
20 enrolled
Central Centrifugal Cicatricial Alopecia (CCCA)
Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)
Started Sep 2026
20 enrolled
Pouch, IlealPouches, IleoanalBowel Diseases, Inflammatory
Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese
Started Aug 2026
224 enrolled
Obesity and Overweight
Tirzepatide in Idiopathic Intracranial Hypertension Trial
Started Aug 2026
60 enrolled
Idiopathic Intracranial Hypertension (IIH)
Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity
Started Jul 2026
60 enrolled
Heart Failure and Reduced Ejection FractionObesity & OverweightTirzepatide
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.