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pirfenidone 8% gel
pirfenidone 8% gel is a Antifibrotic agent Small molecule drug developed by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.. It is currently in Phase 3 development for Localized skin fibrosis and scleroderma (topical indication in phase 3). Also known as: kitoscell.
Pirfenidone reduces skin fibrosis and inflammation by inhibiting fibroblast proliferation and transforming growth factor-beta (TGF-β) signaling.
Pirfenidone reduces skin fibrosis and inflammation by inhibiting fibroblast proliferation and transforming growth factor-beta (TGF-β) signaling. Used for Localized skin fibrosis and scleroderma (topical indication in phase 3).
At a glance
| Generic name | pirfenidone 8% gel |
|---|---|
| Also known as | kitoscell |
| Sponsor | Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. |
| Drug class | Antifibrotic agent |
| Target | TGF-β signaling pathway; fibroblast proliferation |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Pirfenidone is an antifibrotic agent that suppresses the production of extracellular matrix proteins and pro-inflammatory cytokines, particularly by blocking TGF-β-mediated fibroblast activation. When formulated as a topical gel, it targets dermal fibrosis and inflammatory skin conditions at the site of application, reducing collagen deposition and tissue remodeling.
Approved indications
- Localized skin fibrosis and scleroderma (topical indication in phase 3)
Common side effects
- Application site irritation
- Erythema
- Pruritus
Key clinical trials
- Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids (PHASE3)
- Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars (PHASE3)
- Effect of Topic Pirfenidone in Diabetic Ulcers (PHASE3)
- Efficacy of Pirfenidone Plus MODD in Diabetic Foot Ulcers (PHASE1, PHASE2)
- Pirfenidone, an Antifibrotic and Antiinflammatory Drug (PHASE2)
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 8% gel CI brief — competitive landscape report
- pirfenidone 8% gel updates RSS · CI watch RSS
- Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. portfolio CI
Frequently asked questions about pirfenidone 8% gel
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Related
- Drug class: All Antifibrotic agent drugs
- Target: All drugs targeting TGF-β signaling pathway; fibroblast proliferation
- Manufacturer: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Localized skin fibrosis and scleroderma (topical indication in phase 3)
- Also known as: kitoscell
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