In a significant setback to its obesity drug development efforts, Pfizer announced Monday it is discontinuing work on its experimental weight loss medication danuglipron after discovering a potential case of liver damage in one of its clinical trial participants.
The pharmaceutical giant’s decision represents its second withdrawal from the oral obesity drug market since 2023, further complicating its attempts to establish a foothold in the rapidly growing weight loss medication sector. The company’s chief scientific officer, Chris Boshoff, expressed disappointment while reaffirming Pfizer’s commitment to advancing other promising therapeutic programs.
The obesity drug market, which generated $13 billion in sales last year, has become increasingly competitive as pharmaceutical companies race to develop oral alternatives to existing injectable treatments. Market leaders Eli Lilly and Novo Nordisk currently maintain their dominance, with both companies advancing oral medications through Phase 3 clinical trials.
Danuglipron’s development journey has been marked by challenges. Earlier testing of a twice-daily version revealed significant side effects, prompting Pfizer to pursue a once-daily formulation which they believed would show improved results. CEO Albert Bourla had previously expressed optimism about potentially becoming the second company, after Lilly, to bring an obesity pill to market.
While the frequency of liver enzyme elevations observed during danuglipron’s testing was comparable to other obesity medications, Pfizer cited the combination of clinical trial data, the potential liver damage case, and recent regulatory feedback as factors in their decision to halt development.
Despite this setback, Pfizer maintains other obesity treatments in its pipeline. These include a Phase 2 drug targeting the GIP gut hormone and a Phase 1 GLP-1 medication being developed in partnership with Nxera Pharma. The company is also exploring additional obesity drug candidates through its collaboration with Flagship Pioneering.
The announcement triggered speculation among Wall Street analysts about Pfizer’s potential pursuit of acquisitions to bolster its obesity drug portfolio, particularly if its pipeline candidates share structural similarities with danuglipron. The news sparked increased investor interest in companies developing weight loss treatments, with shares of Viking Therapeutics, Altimmune, Structure Therapeutics, and Metsera all seeing gains in Monday trading.
These companies represent various stages of obesity drug development: Viking has both injectable and oral treatments in advanced testing; Altimmune has shown promising Phase 2 results for a dual-acting therapy; Structure Therapeutics reported positive Phase 2 data last year; and Metsera successfully raised $275 million in a January IPO following encouraging results from its long-acting GLP-1 injection development program.
The news reflects the broader challenges faced by pharmaceutical companies attempting to develop safe and effective oral weight loss medications, even as demand for obesity treatments continues to grow. The withdrawal of danuglipron further consolidates the current market advantage held by established players Eli Lilly and Novo Nordisk, while highlighting the significant hurdles new entrants face in bringing oral obesity medications to market.
This development underscores the complexity of obesity drug
development and the careful balance companies must strike between therapeutic effectiveness and patient safety. As the obesity treatment landscape continues to evolve, pharmaceutical companies remain focused on developing innovative solutions while navigating regulatory requirements and addressing safety concerns.
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