Pirfenidone is under clinical development by F. Hoffmann-La Roche and currently in the Phase I, Phase II and Pre-Registration in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Pirfenidone’s likelihood of approval (LoA) and phase transition for Asbestosis took place on 30 Jun 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Pirfenidone Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Pirfenidone overview

Pirfenidone (Esbriet, Pirespa) is an immunosuppressant, and antifibrotic agent. It is formulated as hard gelatin capsules, tablets and film-coated tablets for oral route of administration. Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

The drug candidate is under development for the treatment of progressive fibrosing interstitial lung disease, bronchiolitis obliterans, heart failure, asbestosis. It was under development for the treament of pulmonary radiation toxicity, diabetic nephropathy and systemic sclerosis-related interstitial lung disease (SSc-ILD). The drug candidate is administered through oral route. It was also under development for preserved left ventricular ejection fraction (diastolic heart failure) and Hermansky-Pudlak syndrome (HPS) associated interstitial lung disease.

F. Hoffmann-La Roche overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, commercial laboratories, healthcare professionals, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

Quick View Pirfenidone LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Pirfenidone
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Genetic Disorders
  • Immunology
  • Metabolic Disorders
  • Respiratory
  • Toxicology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.