Also known as: Esbriet
Pirfenidone is an antifibrotic TGF-beta synthesis inhibitor used in idiopathic pulmonary fibrosis. It is marketed under the brand name Esbriet and used as prescription therapy in the United States. The FDA first approved Esbriet on October 15, 2014.
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.
DelveInsight releases three separate pipeline reports covering metastatic prostate cancer (80+ companies, 85+ drugs), iPSC-derived NK cells (12+ companies, 15+ drugs), and interstitial lung diseases (120+ companies, 120+ drugs), highlighting recent regulatory approvals, trial launches, and emerging therapies.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07588646 |
Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects |
COMPLETED | PHASE1 |
| NCT07454291 |
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants |
RECRUITING | PHASE1 |
| NCT07082842 |
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF |
RECRUITING | PHASE3 |
| NCT07015398 |
A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants |
COMPLETED | PHASE1 |
| NCT06928272 |
Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study |
RECRUITING | PHASE3 |
| NCT06485635 |
Real-life-persistence to Antifibrotic Treatments |
COMPLETED | |
| NCT06484153 |
Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT06253117 |
Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis. |
RECRUITING | PHASE2 |
| NCT06241560 |
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood |
RECRUITING | PHASE2 |
| NCT06224790 |
Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy |
COMPLETED | PHASE4 |
