Pirfenidone is under clinical development by Avalyn Pharma and currently in Phase II for Pulmonary Fibrosis. According to GlobalData, Phase II drugs for Pulmonary Fibrosis have a 39% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Pirfenidone’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Pirfenidone overview

Pirfenidone (GP-101) is under development for the treatment of interstitial lung fibrosis, progressive pulmonary fibrosis (PPF), idiopathic pulmonary fibrosis (IPF) and chronic lung allograft dysfunction. It is an aerosol formulation administered through inhalation route for direct delivery to the lungs. The drug candidate is a small synthetic non-peptide molecule with both anti-inflammatory and anti-fibrotic activities.

Pirfenidone (GP-101) is under development for the treatment of immunology

Avalyn Pharma overview

Avalyn Pharma, formerly Genoa Pharmaceuticals, is a clinical-stage biopharmaceutical company that develops inhaled formulations for rare respiratory diseases. The company’s pipeline includes AP01, AP02, and AP03 drug candidates to treat idiopathic pulmonary fibrosis and other interstitial lung diseases. It is also developing an AP0X drug candidate for an undisclosed indication. Avalyn Pharma is headquartered in Cambridge, Massachusetts, the US.

For a complete picture of Pirfenidone’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.