FDA Approval

Nerandomilast FDA Approval

Published: 09 October 2025 27 views Related Drug: Nerandomilast (Nerandomilast)

Today, the FDA has announced that Nerandomilast, being sold under the brand name Jascayd, has just been approved for the treatment of idiopathic pulmonary fibrosis (IPF), which is very rare, serious and progressive disease with very limited treatment options available. This medication is the first and new therapy, that is receiving approval within the last 10 years.

What is this drug?

Nerandomilast is an oral phosphodiesterase 4 (PDE4) inhibitor that exerts both antifibrotic and immunomodulatory effects. By inhibiting PDE4, nerandomilast reduces the expression of pro-fibrotic growth factors and inflammatory cytokines, which are highly expressed in case of IPF.

The most common adverse reactions reported with nerandomilast were diarrhea, COVID-19, upper respiratory tract infection, depression, decreased weight, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.

 

What is this drug used mainly for?

Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease that affects the tissue surrounding the air sacs, or alveoli, in the lungs. This condition develops when that lung tissue becomes thick and stiff for unknown reasons. Over time, these changes can cause permanent scarring in the lungs, called fibrosis, that makes it progressively more difficult to breathe.

 

References:

  • Research, C. F. D. E. A. (n.d.). FDA approves drug to treat idiopathic pulmonary fibrosis. U.S. Food And Drug Administration. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-idiopathic-pulmonary-fibrosis
  • Mullard, A. (2025). FDA approves PDE4 inhibitor for IPF. Nature Reviews Drug Discovery. https://doi.org/10.1038/d41573-025-00181-0
  • FDA Gives Nod to Nerandomilast for Severe Lung Disease - Medscape - October 09, 2025.