PureTech Health, a hub-and-spoke biotherapeutics company, announced on February 19th, 2026, that both FDA and the European Commission granted Orphan Drug Designation to deupirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF). Deupirfenidone is currently being advanced by Celea Therapeutics, a wholly-owned subsidiary of PureTech founded to lead deupirfenidone’s late-stage development and potential commercialization, and is expected to initiate a Phase III clinical trial in the first half of 2026, according to a company press release.

Results from the Phase IIb ELEVATE trial found that participants given deupirfenidone 825 mg three times a day (TID) experienced a slower rate of lung function decline at 26 weeks versus those given either pirfenidone 801 mg TID or placebo. 90% of participants who completed the trial enrolled in the open-label extension, and those who continued treatment with deupirfenidone 825 mg TID experienced an overall lung function decline similar to the expected natural decline in lung function in healthy older adults over that time, according to the release.

“Orphan Drug Designation from both the FDA and European Commission underscores the urgent need for more effective therapies for people living with IPF,” said Robert Lyne, CEO, PureTech Health, in the release. “Critically, only a minority of patients with this progressive and fatal disease have ever been treated with currently approved therapies, largely due to the tradeoff between tolerability challenges and modest efficacy. We believe deupirfenidone represents a potentially transformative option for this underserved population and is a compelling example of how PureTech’s model can advance differentiated medicines toward meaningful patient impact.”

“The Phase 2b data for deupirfenidone suggest a new benchmark for efficacy in IPF, with slowing of lung function decline to a level that more closely mirrors healthy aging, without compromising tolerability,” said Sven Dethlefs, PhD, CEO, Celea Therapeutics, in the release. “Orphan Drug Designation further validates both the seriousness of this disease and the importance of advancing our program, which we believe has the potential to redefine treatment expectations for patients living with IPF.”