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Topical Pirfenidone
Topical Pirfenidone is a Antifibrotic Small molecule drug developed by Centro Dermatológico Dr. Ladislao de la Pascua. 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.
Topical Pirfenidone is a small molecule with an unknown mechanism of action, used in various clinical trials for conditions such as scars, keloids, hypertrophic scars, keloid, and diabetic foot ulcers. It has been studied in comparison to silicon gel and other interventions in randomized controlled trials, including a pilot trial for the treatment of hypertrophic scars and keloids.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Topical Pirfenidone |
|---|---|
| Also known as | KitosCell |
| Sponsor | Centro Dermatológico Dr. Ladislao de la Pascua |
| Drug class | Antifibrotic |
| Target | TGF-β |
| Modality | Small molecule |
| Therapeutic area | Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Pirfenidone works by inhibiting the activation of TGF-β, which in turn reduces the production of extracellular matrix proteins and the proliferation of fibroblasts. This leads to a decrease in fibrosis and inflammation. Additionally, pirfenidone has been shown to have antioxidant properties, which may also contribute to its antifibrotic effects.
Approved indications
- Idiopathic pulmonary fibrosis
Common side effects
- Fatigue
- Dyspnea
- Nausea
- Diarrhea
Key clinical trials
- Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis (PHASE1, PHASE2)
- 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)
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:
- Topical Pirfenidone CI brief — competitive landscape report
- Topical Pirfenidone updates RSS · CI watch RSS
- Centro Dermatológico Dr. Ladislao de la Pascua portfolio CI
Frequently asked questions about Topical Pirfenidone
What is Topical Pirfenidone?
How does Topical Pirfenidone work?
What is Topical Pirfenidone used for?
Who makes Topical Pirfenidone?
Is Topical Pirfenidone also known as anything else?
What drug class is Topical Pirfenidone in?
What development phase is Topical Pirfenidone in?
What are the side effects of Topical Pirfenidone?
What does Topical Pirfenidone target?
Related
- Drug class: All Antifibrotic drugs
- Target: All drugs targeting TGF-β
- Manufacturer: Centro Dermatológico Dr. Ladislao de la Pascua — full pipeline
- Therapeutic area: All drugs in Pulmonology
- Indication: Drugs for Idiopathic pulmonary fibrosis
- Also known as: KitosCell
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing