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A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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Trial Profile

A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2025

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At a glance

  • Drugs Nerandomilast (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms FIBRONEER™-IPF
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 22 Oct 2025 According to a Boehringer Ingelheim media release, regulatory submissions for nerandomilast in IPF are also under review in Japan and the EU, with filings in other geographies to follow.
  • 22 Oct 2025 According to a Boehringer Ingelheim media release, based on data from this study, JASCAYD(nerandomilast) has been approved in China by China's National Medical Products Administration (NMPA) as an oral treatment option for idiopathic pulmonary fibrosis (IPF) in adult patients.
  • 09 Oct 2025 According to a Boehringer Ingelheim media release, based on data from two clinical trials: FIBRONEER-IPF (NCT05321069) and Trial 2 (NCT04419506), JASCAYD(nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment option for idiopathic pulmonary fibrosis (IPF) in adult patients

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