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Drug

Pirfenidone

Approved · EMA
Emerging researchLate-stage development

Also known as Esbriet, Pirfenidona.

RxNorm1592254ChEMBLCHEMBL1256391UNIID7NLD2JX7U
1
Research papers
17
Active clinical trials
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Open-label, Single-group Trial to Evaluate the Effect of Pirfenidone on the Pharmacokinetics of a Single Oral Dose of BI 1015550

Clinical trial2026-08-04Primary completion · ClinicalTrials.gov

A Randomized Phase 1b/2 Clinical Trial Evaluating Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

Clinical trial2026-07-22Primary completion · ClinicalTrials.gov

Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)

Clinical trial2026-07-08Results expected Q1 2027 · ClinicalTrials.gov

A Phase I Evaluation of the Safety and Tolerability of Pirfenidone in Idiopathic Subglottic Stenosis

Clinical trial2026-06-17Results expected Q4 2027 · ClinicalTrials.gov

Pirfenidone to Prevent Fibrosis in ARDS. A Randomized Controlled Trial - PIONEER

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants

Clinical trial2026-05-15Results expected Q4 2026 · ClinicalTrials.gov

Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Clinical trial2026-05-13Results expected Q1 2027 · ClinicalTrials.gov

Approval: Pirfenidone Viatris (EMA)

Regulatory2023-01-10EMA

Approval: Pirfenidone axunio (previously Pirfenidone AET) (EMA)

Regulatory2022-06-20EMA

Drug Safety Update: Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing

Regulatory2020-11-16MHRA

Phase II trial of pirfenidone in children and young adults with neurofibromatosis type 1 and progressive plexiform neurofibromas.

Research2014-04-22Pediatric blood & cancer

Approval: Esbriet (EMA)

Regulatory2011-02-28EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pirfenidone
Aliases & brands
EsbrietPirfenidona
RxNorm CUI
1592254
ChEMBL ID
CHEMBL1256391
UNII
D7NLD2JX7U
Regulatory jurisdictions
emamhra

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2011-02-28
Latest approval
2023-01-10
Authorities
EMA · MHRA
Total events
4
emaEuropean Medicines Agency· 3 events
2023-01-10Approval
Approval: Pirfenidone Viatris (EMA)

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

Evidence ↗
2022-06-20Approval
Approval: Pirfenidone axunio (previously Pirfenidone AET) (EMA)

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

Evidence ↗
2011-02-28Approval
Approval: Esbriet (EMA)

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

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2020-11-16Safety communicationSafety
Drug Safety Update: Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

99 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
99
registered trials across all phases
LATEST COMPLETION 2025
17
Active studies
15
Recruiting
33
Late-stage (III+)
59
Completed
23
Discontinued
PHASE DISTRIBUTIONn = 99
Phase 121Phase 1 / 26Phase 239Phase 2 / 34Phase 315Phase 410Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Single-center, Randomized, Double-blind, Controlled Study Comparing the Efficacy and Safety of Pirfenidone Versus Placebo in the Treatment of Takayasu Arteritis on the Basis of Conventional Immunosuppressive Therapy

Not yet recruitingPH IVShanghai Zhongshan Hospitaln=922030

Efficacy, Safety, Immune Function of Pirfenidone in the Treatment of Connetive Tissue Disease -Related Interstitial Lung Disease(CTD-LID)

Unknown statusPH IVQilu Hospital of Shandong Universityn=1202025

Efficacy, Safety and Predictive Indicators of Immunosuppressant Combined With Pirfenidone in the Treatment of Connective Tissue Disease-related Interstitial Lung Disease (CTD-ILD)

Unknown statusPH IVQilu Hospital of Shandong Universityn=2002025

Effectiveness & Safety of Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy: A Randomized Controlled Trial

CompletedPH IVSidrah Lodhin=602025

A Study of the Efficacy and Safety of Pirfenidone vs. Nintedanib in the Treatment of Fibrotic Lung Disease After Coronavirus Disease-19 Pneumonia

Unknown statusPH IVPost Graduate Institute of Medical Education and Research, Chandigarhn=482022

Recent completions

Trials that read out recently, adding to the completed evidence base.

Exploring the Fibrosis-Modulating Potential of Metformin and Pirfenidone in Oral Submucous Fibrosis: Molecular Mechanisms to Clinical Applications

CompletedPH I/IIZiauddin Universityn=452025

A Phase 1, Two-Part, Open-Label Drug-Drug Interaction Study to Evaluate the Steady State Pharmacokinetics and Safety Following Co-Administration of Nalbuphine Extended-Release Tablets (NAL ER), and Pirfenidone or Nintedanib in Healthy Adult Subjects

CompletedPH ITrevi Therapeuticsn=1322025

Effectiveness & Safety of Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy: A Randomized Controlled Trial

CompletedPH IVSidrah Lodhin=602025

A Phase I/Ib Trial of Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC

CompletedPH IH. Lee Moffitt Cancer Center and Research Instituten=482024

Pilot Study of Kitoscell LP (pirfenidone LP) Vs Collagen-polyvinylpyrrolidone As Treatment and Protection in Patients with Moderate to Severe COVID-19

CompletedPH II/IIIMaterno-Perinatal Hospital of the State of Mexicon=362024

A Randomized, Open-Label, Two-Period, Double-Crossover Comparative Study on the Pharmacokinetics of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Chinese Subjects Under Fed Conditions

CompletedPH IOverseas Pharmaceuticals, Ltd.n=122024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Pediatric blood & cancer1
Leading researchers
  • Babovic-Vuksanovic D1
  • Balis FM1
  • Blaney SM1
  • Cohen B1
  • Dombi E1
  • Fox E1
  • Goldman S1
  • Goodspeed W1
Leading institutions
free-text, unnormalised
  • National Cancer Institute1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.