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Pirfenidone Oral Product
Pirfenidone Oral Product is a Antifibrotic Small molecule drug developed by Capital Medical University. It is currently in Phase 3 development for Idiopathic pulmonary fibrosis. Also known as: Kitoscell.
Pirfenidone is an antifibrotic agent that inhibits the production of transforming growth factor-beta (TGF-β), a key cytokine involved in fibrosis.
Pirfenidone is an antifibrotic agent that inhibits the production of transforming growth factor-beta (TGF-β), a key cytokine involved in fibrosis. Used for Idiopathic pulmonary fibrosis.
At a glance
| Generic name | Pirfenidone Oral Product |
|---|---|
| Also known as | Kitoscell |
| Sponsor | Capital Medical University |
| Drug class | Antifibrotic |
| Target | TGF-β receptor |
| Modality | Small molecule |
| Therapeutic area | Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Pirfenidone works by binding to the TGF-β receptor, preventing the activation of downstream signaling pathways that lead to fibrosis. This results in the inhibition of fibroblast proliferation and the reduction of extracellular matrix deposition. Additionally, pirfenidone has been shown to have anti-inflammatory and antioxidant properties.
Approved indications
- Idiopathic pulmonary fibrosis
Common side effects
- Fatigue
- Dyspnea
- Nausea
- Diarrhea
Key clinical trials
- Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis (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)
- A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood (PHASE1)
- A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants (PHASE1)
- Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer (PHASE1, PHASE2)
- Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Under Fasting and Fed Conditions (PHASE1)
- Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects (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 Oral Product CI brief — competitive landscape report
- Pirfenidone Oral Product updates RSS · CI watch RSS
- Capital Medical University portfolio CI
Frequently asked questions about Pirfenidone Oral Product
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Related
- Drug class: All Antifibrotic drugs
- Target: All drugs targeting TGF-β receptor
- Manufacturer: Capital Medical University — full pipeline
- Therapeutic area: All drugs in Pulmonology
- Indication: Drugs for Idiopathic pulmonary fibrosis
- Also known as: Kitoscell