Pirfenidone

Phase 3

Roche Holding AG (RHHBY)

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Lung Diseases, Interstitial

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Drug Information

Target Indication

Lung Diseases, Interstitial

Clinical Trial

NCT03099187

Last updated: 3/6/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMA1/10/2023

Pirfenidone Viatris

Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

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EMA6/20/2022

Pirfenidone axunio (previously Pirfenidone AET)

Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

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EMA2/28/2011

Esbriet

Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.

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Drug Science

Mechanism of action & safety profile

Developer

RHHBY

Roche Holding AG

Biotechnology•Europe•NYSE

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