Novo Nordisk NVO announced plans to advance amycretin, for weight management, into late-stage development. Amycretin is being developed for subcutaneous and oral administration.

Shares of this Denmark-based company gained 2.95% on June 12, following the announcement.

Oral amycretin is a novel, unimolecular co-agonist of both GLP-1 and amylin receptors being developed by Novo Nordisk to provide an efficacious and convenient treatment for obesity and type 2 diabetes in adults.

NVO decided to advance the candidate into phase III based on feedback received from regulatory authorities following end-of-phase II interactions for subcutaneous and oral amycretin in weight management.

A phase I study evaluated the single-ascending dose and multiple-ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.

A phase Ib/IIa study investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in people with overweight or obesity. The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks.

The phase III program on amycretin is planned to be initiated during the first quarter of 2026.

NVO Focuses on Next Generation Drugs for Obesity

Buoyed by the stupendous success of its blockbuster semaglutide products, Wegovy (obesity) and Ozempic (diabetes), NVO is now developing several next-generation candidates in its pipeline, especially targeting the lucrative U.S. market.

CagriSema, a fixed-dose combination of a long-acting amylin analogue and Wegovy, is the most advanced candidate in Novo Nordisk’s obesity pipeline.

Novo Nordisk will present full results from the phase III REDEFINE 1 and 2 studies on CagriSema shortly.

Management stated that the REDEFINE 1 and 2 studies will provide insights into the transformational potential of CagriSema.

The FDA accepted Novo Nordisk’s regulatory application, seeking the approval of oral semaglutide 25 mg for obesity, for review. A final decision from the regulatory body is expected around the turn of the year.

NVO Stock Under Pressure

Year to date, Novo Nordisk’s shares have lost 4.7% against the industry’s growth of 2.9%.

Image Source: Zacks Investment Research

The stock price was under pressure at the start of the year due to recent market challenges. Stiff competition in the obesity market from its arch-rival, Eli Lilly LLY, along with pipeline and regulatory setbacks, weighed on the share price. We note that NVO’s semaglutide drugs have only been off the FDA’s supply shortage list since February 2025.