PureTech Announces Orphan Drug Designations for Deupirfenidone in Idiopathic Pulmonary Fibrosis

Deupirfenidone (LYT-100) granted Orphan Drug Designation by FDA and European Commission for rare, fatal lung disease

Published on Feb. 25, 2026

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PureTech Health plc announced that the U.S. Food and Drug Administration (FDA) and European Commission have granted Orphan Drug Designation to deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF), a rare, progressive, and fatal lung disease. Deupirfenidone is being advanced by Celea Therapeutics, a Founded Entity established by PureTech.

Why it matters

Orphan Drug Designation is intended to support the development of therapies for rare diseases with high unmet medical needs. Currently, only a minority of IPF patients have ever been treated with approved therapies due to the tradeoff between modest efficacy and tolerability challenges. Deupirfenidone has the potential to redefine treatment expectations for IPF patients.

The details

In the global Phase 2b ELEVATE IPF trial, deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from an ongoing open-label extension study suggest this effect may be sustained through at least 52 weeks.

  • PureTech's Founded Entity, Celea Therapeutics, intends to finalize financing in the first half of 2026 to support the initiation of the Phase 3 SURPASS-IPF trial in the first half of 2026.

The players

PureTech Health plc

A hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value.

Celea Therapeutics

A wholly-owned subsidiary of PureTech Health plc that is dedicated to advancing transformative treatments for people with serious respiratory diseases.

Robert Lyne

Chief Executive Officer of PureTech Health.

Sven Dethlefs

Chief Executive Officer of Celea Therapeutics.

U.S. Food and Drug Administration (FDA)

The regulatory agency that granted Orphan Drug Designation to deupirfenidone for the treatment of idiopathic pulmonary fibrosis.

European Commission

The regulatory body that granted Orphan Drug Designation to deupirfenidone for the treatment of idiopathic pulmonary fibrosis.

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What they’re saying

“Orphan Drug Designation from both the FDA and European Commission underscores the urgent need for more effective therapies for people living with IPF.”

— Robert Lyne, Chief Executive Officer of PureTech Health (PureTech Health)

“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.”

— Sven Dethlefs, Chief Executive Officer of Celea Therapeutics (PureTech Health)

What’s next

Celea Therapeutics intends to finalize financing in the first half of 2026 to support the initiation of the Phase 3 SURPASS-IPF trial in the first half of 2026.

The takeaway

Deupirfenidone's Orphan Drug Designations from the FDA and European Commission highlight the significant unmet need for more effective and well-tolerated treatments for idiopathic pulmonary fibrosis, a rare and fatal lung disease. The promising Phase 2b data suggest deupirfenidone has the potential to redefine treatment expectations for this underserved patient population.