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pirfenidone or nintedanib
Pirfenidone and nintedanib are antifibrotic agents that reduce fibroblast proliferation and collagen deposition to slow lung fibrosis progression.
Pirfenidone and nintedanib are antifibrotic agents that reduce fibroblast proliferation and collagen deposition to slow lung fibrosis progression. Used for Idiopathic pulmonary fibrosis (IPF).
At a glance
| Generic name | pirfenidone or nintedanib |
|---|---|
| Sponsor | Hospices Civils de Lyon |
| Drug class | Antifibrotic agent |
| Target | Pirfenidone: TGF-β pathway; Nintedanib: FGFR, VEGFR, PDGFR tyrosine kinases |
| Modality | Small molecule |
| Therapeutic area | Pulmonary/Respiratory |
| Phase | FDA-approved |
Mechanism of action
Pirfenidone acts as a general antifibrotic by inhibiting TGF-β signaling and reducing inflammatory cytokine production. Nintedanib is a tyrosine kinase inhibitor targeting FGFR, VEGFR, and PDGFR, which are key drivers of fibroblast activation and extracellular matrix deposition. Both drugs slow the decline in lung function in idiopathic pulmonary fibrosis (IPF).
Approved indications
- Idiopathic pulmonary fibrosis (IPF)
Common side effects
- Gastrointestinal disturbances (nausea, diarrhea, vomiting)
- Photosensitivity (pirfenidone)
- Elevated liver enzymes
- Rash
- Abdominal pain
Key clinical trials
- Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD
- Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (PHASE3)
- A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants (PHASE1)
- Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis (PHASE3)
- Management of Progressive Disease in Idiopathic Pulmonary Fibrosis (PHASE4)
- Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients (PHASE1)
- To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF (PHASE2)
- A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- pirfenidone or nintedanib CI brief — competitive landscape report
- pirfenidone or nintedanib updates RSS · CI watch RSS
- Hospices Civils de Lyon portfolio CI