Tirzepatide is under clinical development by Eli Lilly and Co and currently in Phase II for Metabolic Dysfunction-Associated Steatohepatitis (MASH). According to GlobalData, Phase II drugs for Metabolic Dysfunction-Associated Steatohepatitis (MASH) does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Tirzepatide LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tirzepatide overview

Tirzepatide (Mounjaro, Zepbound) is a 39-amino-acid modified peptide based on the GIP sequence acts as hypoglycemic agent, it is formulated as solution for subcutaneous route of administration. Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Mounjaro was indicated for weight management, including weight loss and weight maintenance, as an adjunct to a reduced-calorie diet and increased physical activity in adults with an initial Body Mass Index (BMI).

Tirzepatide is under development for the treatment of type 2 diabetes, heart failure with preserved ejection fraction (diastolic heart failure), obstructive sleep apnea, chronic kidney disease and non-alcoholic steatohepatitis (NASH). It is administered subcutaneously as a solution. The drug candidate is a new biological entity (NBE) which acts by targeting glucagon like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP).

Eli Lilly and Co overview

Eli Lilly and Co (Lilly) is a healthcare company that is engaged in the discovery, development, and marketing of human healthcare products. The company offers medicines for cardiovascular conditions, diabetes, endocrinology, cancer, neurological problems, autoimmune disorders, men’s health, and musculoskeletal problems. The company distributes its pharmaceutical health products through independent wholesale distributors. Lilly conducts research and development activities to discover and deliver innovative medicines. It also promotes products through sales representatives and marketing agreements with other pharmaceutical companies. The company also offers its products in North America, South America, Europe, the Middle East, Africa and Asia-Pacific. Lilly is headquartered in Indianapolis, Indiana, the US.

For a complete picture of Tirzepatide’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.