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Pirfenidone Capsules
Pirfenidone Capsules is a Antifibrotic agent Small molecule drug developed by Shanghai Zhongshan Hospital. It is currently FDA-approved for Idiopathic pulmonary fibrosis (IPF). Also known as: F647.
Pirfenidone reduces fibroblast proliferation and collagen production by inhibiting multiple pro-fibrotic cytokines and growth factors.
Pirfenidone reduces fibroblast proliferation and collagen production by inhibiting multiple pro-fibrotic cytokines and growth factors. Used for Idiopathic pulmonary fibrosis (IPF).
At a glance
| Generic name | Pirfenidone Capsules |
|---|---|
| Also known as | F647 |
| Sponsor | Shanghai Zhongshan Hospital |
| Drug class | Antifibrotic agent |
| Target | TGF-β pathway; multiple pro-fibrotic cytokines |
| Modality | Small molecule |
| Therapeutic area | Pulmonology / Respiratory |
| Phase | FDA-approved |
Mechanism of action
Pirfenidone is an antifibrotic agent that suppresses the activity of transforming growth factor-beta (TGF-β) and other fibrogenic mediators, thereby reducing extracellular matrix deposition and fibroblast activation. It works through multiple pathways to inhibit the progression of pulmonary fibrosis by decreasing inflammatory cytokine production and fibroblast differentiation into myofibroblasts.
Approved indications
- Idiopathic pulmonary fibrosis (IPF)
Common side effects
- Gastrointestinal disturbances (nausea, dyspepsia, vomiting)
- Photosensitivity reaction
- Fatigue
- Headache
- Anorexia
Key clinical trials
- A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants (PHASE1)
- PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects (PHASE1)
- Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia (PHASE2, PHASE3)
- Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis (PHASE1, PHASE2)
- Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients (PHASE1)
- Effect of Pirfenidone on TA Fibrosis (PHASE4)
- Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF) (PHASE3)
- Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC (PHASE1)
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 Capsules CI brief — competitive landscape report
- Pirfenidone Capsules updates RSS · CI watch RSS
- Shanghai Zhongshan Hospital portfolio CI
Frequently asked questions about Pirfenidone Capsules
What is Pirfenidone Capsules?
How does Pirfenidone Capsules work?
What is Pirfenidone Capsules used for?
Who makes Pirfenidone Capsules?
Is Pirfenidone Capsules also known as anything else?
What drug class is Pirfenidone Capsules in?
What development phase is Pirfenidone Capsules in?
What are the side effects of Pirfenidone Capsules?
What does Pirfenidone Capsules target?
Related
- Drug class: All Antifibrotic agent drugs
- Target: All drugs targeting TGF-β pathway; multiple pro-fibrotic cytokines
- Manufacturer: Shanghai Zhongshan Hospital — full pipeline
- Therapeutic area: All drugs in Pulmonology / Respiratory
- Indication: Drugs for Idiopathic pulmonary fibrosis (IPF)
- Also known as: F647
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing