USA — Pharmaceutical giant Pfizer has abandoned the development of the twice-daily version of its oral weight-loss drug danuglipron.

This decision follows a mid-stage trial that experienced elevated dropout rates attributed to side effects, particularly nausea and vomiting.

Although the drug met the primary goal of weight reduction, Pfizer’s pivot represents a setback to its ambitions of establishing an early presence in the rapidly expanding weight-loss drug market, anticipated to be valued at US$100 billion by the end of the decade.

Danuglipron, belonging to the same class of diabetes and obesity treatments as Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro, will now exclusively undergo development as a once-daily, modified-release version.

Pfizer’s CEO, Albert Bourla, had previously expressed high hopes for the product, envisioning the potential for an obesity pill to become a US$10-billion-a-year product for the company.

The trial results indicated that patients on the twice-daily version experienced weight loss ranging from 6.9% to 11.7% at 32 weeks, compared to a weight gain of 1.4% for those on the placebo.

However, the trial also revealed a notable downside, with high discontinuation rates exceeding 50% across all doses, compared to approximately 40% in the placebo group.

Adverse events, particularly nausea (up to 73%), vomiting (up to 47%), and diarrhea (up to 25%), contributed to the decision to discontinue the twice-daily version.

Despite this setback, Pfizer is redirecting its focus to a once-daily, modified-release version of danuglipron.

The company is actively gathering data to understand the potential profile of this formulation, with results expected in the first half of 2024.

This shift underscores Pfizer’s commitment to navigating the challenges in the weight-loss drug market, which is becoming increasingly competitive.

Pfizer’s foray into weight-loss drugs is seen as a strategic move to counterbalance waning demand for its COVID-19 vaccine and treatment products.

The once-daily version of danuglipron is now pivotal to Pfizer’s strategy, as CEO Albert Bourla believes that a successful weight loss pill could eventually contribute significantly to the company’s revenue.

The competition in the weight loss drug space is intensifying, with Eli Lilly and Novo Nordisk racing to develop more convenient pill versions of their blockbuster weight loss and diabetes injections.

Pfizer aims to release phase two trial data on the once-a-day version of danuglipron in early 2024, providing additional insights that will inform its path forward in the evolving weight-loss drug market.

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