Wednesday, July 8, 2026

Drug profile · INN

pirfenidone

pirfenidone (ARX-PIRFENIDONE) is a unknown. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L04) L04AX05
US status approved
Patents linked 0
Pipeline programs 6
News articles 0
Drug details — pirfenidone
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
0
Programs
6
Data quality
0.89

Quick answer

pirfenidone (ARX-PIRFENIDONE) is a unknown. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN pirfenidone
Brand ARX-PIRFENIDONE
Mechanism Unknown
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation CAPSULE
ATC code L04AX05

Mechanism of action

Unknown

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. AP01-007 Phase 2 · Anaxis Pharma · Progressive Pulmonary Fibrosis
  2. Pirfenidone Phase 2 · United Therapeutics Europe · Cardiac Failure
  3. Pirfenidone Solution for Inhalation Phase 2 · Anaxis Pharma · Progressive pulmonary fibrosis [PPF] Idiopathic pulmonary f
  4. Pirfenidone Solution for Inhalation Phase 2 · Anaxis Pharma · Interstitial Lung Diseases (ILD), including but not limited
  5. Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg Phase 1 · BioXcel Therapeutics · Alcohol Use Disorder (AUD)
  6. Pirfenidone Phase 1 · Lakefront Biotherapeutics NV · Healthy

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is pirfenidone?

pirfenidone (ARX-PIRFENIDONE) is a unknown. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for pirfenidone?

ARX-PIRFENIDONE is a marketed brand name for pirfenidone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of pirfenidone?

pirfenidone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.