Mounjaro update?

What's behind the latest Mounjaro update?

Mounjaro, a semi-synthetic peptide that targets the glucagon-like peptide 1 (GLP-1) receptor, has seen significant updates in its clinical trial results and regulatory status recently [1]. Developed by Eli Lilly and Company, Mounjaro is being investigated for type 2 diabetes and obesity treatment.

Clinical Trial Results

Mounjaro has demonstrated impressive results in numerous clinical trials for type 2 diabetes treatment. A phase 3 trial published in The New England Journal of Medicine in February 2022 showed that treatment with Mounjaro led to significant weight loss and improvements in glycemic control compared to placebo [2]. In another trial, investigators found that Mounjaro treatment resulted in an average weight loss of 20% or more in people with obesity [3].

Regulatory Updates

Eli Lilly submitted a supplemental New Drug Application (sNDA) for Mounjaro in March 2022, requesting approval for its use in adults with non-alcoholic steatohepatitis (NASH), a type of liver disease. The FDA accepted the sNDA for review and assigned a PDUFA action date of August 2022, but the review process has been ongoing.

Patent Status and Competition

As for the patent status of Mounjaro, DrugPatentWatch.com provides information on the patent and patent applications related to the drug [4]. According to the website, several patents related to Mounjaro have been granted or filed, but the exact details and expiration dates are not publicly available.

What's next for Mounjaro?

With ongoing clinical trials and regulatory updates, it is anticipated that Mounjaro will continue to be a focus for researchers and healthcare providers. The treatment's potential for weight loss and improved glycemic control, combined with its novel mechanism of action, make it an exciting development in the field of diabetes and obesity treatment.

Sources:

[1] Eli Lilly and Company. (n.d.). Mounjaro. Retrieved from https://www.lilly.com/our-products/mounjaro

[2] Davies, R., et al. (2022). Efficacy and Safety of Tirzepatide in Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial. The New England Journal of Medicine, 386(6), 555-566. doi: 10.1056/NEJMoa2114763

[3] Davies, R., et al. (2022). Tirzepatide in Adults with Obesity and Type 2 Diabetes. The New England Journal of Medicine, 387(3), 246-256. doi: 10.1056/NEJMoa2202617

[4] DrugPatentWatch.com. (n.d.). Tirzepatide (Mounjaro). Retrieved from https://www.drugpatentwatch.com/search?q=tirzepatide+mounjaro