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Nerandomilast: First Approval.

Michael B Brown1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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Summary
This summary is machine-generated.

Nerandomilast is a new oral treatment for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It is a selective phosphodiesterase 4B inhibitor that has received recent approvals in the USA and China.

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Area of Science:

  • Pharmacology
  • Pulmonology
  • Drug Development

Background:

  • Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are chronic lung diseases with limited treatment options.
  • Phosphodiesterase 4B (PDE4B) is a potential therapeutic target for fibrotic lung diseases.
  • Nerandomilast is an oral selective PDE4B inhibitor developed for treating lung fibrosis.

Purpose of the Study:

  • To summarize the key milestones in the development of nerandomilast.
  • To highlight the regulatory approvals for nerandomilast in treating IPF and PPF.

Main Methods:

  • Review of development history and clinical trial data.
  • Analysis of regulatory submission and approval timelines.

Main Results:

  • Nerandomilast received its first approval in the USA on October 7, 2025, for adult IPF.
  • Subsequent approvals in China (October 22, 2025) for IPF and in China and the USA (December 2025) for PPF were obtained.
  • Ongoing global filings and Phase II/III trials indicate continued development.

Conclusions:

  • Nerandomilast represents a significant advancement in the treatment of IPF and PPF.
  • The drug's development milestones and approvals mark a new therapeutic option for patients with fibrotic lung diseases.
  • Further clinical trials and global filings are expected to expand access to this novel treatment.