Eli Lilly has received FDA’s Fast Track designation for tirzepatide for treatment of adults with obesity or who are overweight with weight-related comorbidities.

Tirzepatide is a once-weekly glucose-dependent insulinotropic polypeptide receptor and GLP-1 glucagon-like peptide-1 receptor agonist. The drug activates the two receptors, which decreases  blood glucose levels.

The company plans to begin a rolling submission to the FDA of a New Drug Application (NDA) sometime this year supported by two phase 3 clinical trials.

The drug is FDA-approved as Mounjaro as an adjunct treatment, along with diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. Mounjaro was approved for this indication in May.