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Topical Pirfenidone — Competitive Intelligence Brief

Topical Pirfenidone (Topical Pirfenidone) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antifibrotic. Area: Pulmonology.

phase 3 Antifibrotic TGF-β Pulmonology Small molecule Live · refreshed every 30 min

Target snapshot

Topical Pirfenidone (Topical Pirfenidone) — Centro Dermatológico Dr. Ladislao de la Pascua. Pirfenidone is an antifibrotic agent that inhibits the production of transforming growth factor-beta (TGF-β), a key cytokine involved in fibrosis.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Topical Pirfenidone TARGET Topical Pirfenidone Centro Dermatológico Dr. Ladislao de la Pascua phase 3 Antifibrotic TGF-β
pirfenidone or nintedanib pirfenidone or nintedanib Hospices Civils de Lyon marketed Antifibrotic agent Pirfenidone: TGF-β pathway; Nintedanib: FGFR, VEGFR, PDGFR tyrosine kinases
Luspatercept Injectable Product Luspatercept Injectable Product Sun Yat-sen University marketed Erythroid maturation agent Activin A; TGF-β superfamily ligands
WINREVAIR SOTATERCEPT-CSRK MERCK SHARP DOHME marketed activin A and other TGF-β superfamily ligands
Pirfenidone Capsules Pirfenidone Capsules Shanghai Zhongshan Hospital marketed Antifibrotic agent TGF-β pathway; multiple pro-fibrotic cytokines
Invossa K Inj. Invossa K Inj. Kolon Life Science phase 3 Gene therapy (cell-based) TGF-β1 (transforming growth factor-beta 1)
BAT1706 BAT1706 Bio-Thera Solutions phase 3 Bispecific antibody; PD-1/TGF-β inhibitor PD-1 and TGF-β

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 class)

  1. Beijing Continent Pharmaceutical Co, Ltd. · 1 drug in this class
  2. Capital Medical University · 1 drug in this class
  3. Centro Dermatológico Dr. Ladislao de la Pascua · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Topical Pirfenidone — Competitive Intelligence Brief. https://druglandscape.com/ci/topical-pirfenidone. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing