pirfenidone 8% gel — Competitive Intelligence Brief

pirfenidone 8% gel (pirfenidone 8% gel) competitive landscape: 3 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antifibrotic agent. Area: Dermatology.

phase 3 Antifibrotic agent TGF-β signaling pathway; fibroblast proliferation Dermatology Small molecule

Target snapshot

pirfenidone 8% gel (pirfenidone 8% gel) — Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.. Pirfenidone reduces skin fibrosis and inflammation by inhibiting fibroblast proliferation and transforming growth factor-beta (TGF-β) signaling.

Comparator set (3 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
pirfenidone 8% gel TARGET	pirfenidone 8% gel	Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.	phase 3	Antifibrotic agent	TGF-β signaling pathway; fibroblast proliferation
Pirfenidone Capsules	Pirfenidone Capsules	Shanghai Zhongshan Hospital	marketed	Antifibrotic agent	TGF-β pathway; multiple pro-fibrotic cytokines
pirfenidone or nintedanib	pirfenidone or nintedanib	Hospices Civils de Lyon	marketed	Antifibrotic agent	Pirfenidone: TGF-β pathway; Nintedanib: FGFR, VEGFR, PDGFR tyrosine kinases
COL-1620	COL-1620	Merck KGaA, Darmstadt, Germany	phase 3	Antifibrotic agent

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antifibrotic agent class)

1. Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. · 1 drug in this class
2. Hospices Civils de Lyon · 1 drug in this class
3. Merck KGaA, Darmstadt, Germany · 1 drug in this class
4. Shanghai Zhongshan Hospital · 1 drug in this class