Deupirfenidone (LYT-100) is an orally bioavailable deuterated form of the antifibrotic agent pirfenidone under clinical investigation. It has anti-inflammatory and anti-fibrotic activity and is being studied for pulmonary fibrosis-related disease contexts. The therapy remains investigational.
Deupirfenidone, a deuterated form of pirfenidone, is set to be tested in a phase 3 trial this year after successful phase 2b results. The FDA and European Commission have granted orphan drug designation to support its late-stage development.
PureTech Health announced that deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for idiopathic pulmonary fibrosis, with a Phase 3 trial planned for the first half of 2026.
PureTech Health's deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for treating idiopathic pulmonary fibrosis, a rare and fatal lung disease. Phase 2b trial results showed superior efficacy compared to existing therapies.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07456800 |
PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects |
COMPLETED | PHASE1 |
| NCT07284602 |
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF) |
NOT_YET_RECRUITING | PHASE3 |
| NCT05321420 |
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) |
ACTIVE_NOT_RECRUITING | PHASE2 |
