Pfizer announced on Friday that it would stop developing the twice-daily version of its experimental weight loss pill.
- While most common adverse events were mild and gastrointestinal in nature consistent with the mechanism, high rates were observed; no new safety signals were observed
- High discontinuation rates, greater than 50%, were seen across all doses compared to approximately 40% with placebo
- Ongoing pharmacokinetic study of once-daily formulation of danuglipron will continue, the outcome of which will inform a path forward
The drugmaker observed high rates of adverse side effects, with up to 73% experiencing nausea, up to 47% vomiting and up to 25% experiencing diarrhea.
“At this time, twice-daily danuglipron formulation will not advance into Phase 3 studies,” the company said.
But Pfizer said it still plans to release data on a once-a-day version of the drug in the first half of 2024. “We believe an improved once-daily formulation of danuglipron could play an important role in the obesity treatment paradigm, and we will focus our efforts on gathering the data to understand its potential profile,” said Mikael Dolsten, MD., PhD., Chief Scientific Officer & President, Pfizer Research and Development. “Results from ongoing and future studies of the once-daily danuglipron modified release formulation will inform a potential path forward with an aim to improve the tolerability profile and optimize both study design and execution.”
Shares of Pfizer fell 4% in premarket trading Friday after it announced the trial results. However, given the potential size of this market, Pfizer will likely continue their research and trials well into the future.