Nerandomilast

Last updated

Nerandomilast
Nerandomilast.svg
Clinical data
Trade names Jascayd
Other namesBI-1015550, BI 1015550
AHFS/Drugs.com Multum Consumer Information
MedlinePlus a625107
License data
Drug class Phosphodiesterase-4 inhibitor
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
Chemical and physical data
Formula C20H25ClN6O2S
Molar mass 448.97 g·mol−1
3D model (JSmol)
  • C1CC(C1)(CO)NC2=NC(=NC3=C2[S@](=O)CC3)N4CCC(CC4)C5=NC=C(C=N5)Cl
  • InChI=1S/C20H25ClN6O2S/c21-14-10-22-17(23-11-14)13-2-7-27(8-3-13)19-24-15-4-9-30(29)16(15)18(25-19)26-20(12-28)5-1-6-20/h10-11,13,28H,1-9,12H2,(H,24,25,26)/t30-/m1/s1
  • Key:UHYCLWAANUGUMN-SSEXGKCCSA-N

Nerandomilast, sold under the brand name Jascayd, is a medication used for the treatment of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. [1] It is a phosphodiesterase 4 (PDE4) inhibitor. [1] [4] It is taken by mouth. [1]

Contents

Side effects include diarrhea, decreased weight, decreased appetite, and nausea. [5]

Nerandomilast was approved for medical use in the United States in October 2025. [6]

Medical uses

Nerandomilast is indicated for the treatment of idiopathic pulmonary fibrosis and for the treatment of progressive pulmonary fibrosis. [1] [5] [7]

Idiopathic pulmonary fibrosis affects the tissue surrounding the air sacs, or alveoli, in the lungs. [6] It develops when this lung tissue becomes thick and stiff. [6] Over time, these changes can cause permanent lung scarring (fibrosis) that makes it more difficult to breathe. [6]

Progressive pulmonary fibrosis is a chronic disease characterized by gradual, irreversible scarring of the lungs, which can lead to progressive breathing difficulties. [5] Progressive pulmonary fibrosis is an umbrella term that can describe progressive lung scarring in many interstitial lung diseases. [5]

Side effects

Side effects include diarrhea, decreased weight, decreased appetite, and nausea. [5]

History

The efficacy of nerandomilast for the treatment of idiopathic pulmonary fibrosis was evaluated in two randomized, double-blind, placebo-controlled trials of adults with idiopathic pulmonary fibrosis. [6]

The efficacy of nerandomilast for the treatment of progressive pulmonary fibrosis was demonstrated in FIBRONEER-ILD (NCT05321082), a randomized, double-blind, placebo-controlled study that enrolled 1,178 adults with progressive pulmonary fibrosis. [5] Participants were randomly assigned 1:1:1 to receive twice daily administration of nerandomilast 9 mg, nerandomilast 18 mg, or placebo, for at least 52 weeks. [5]

Society and culture

Nerandomilast was approved for medical use in the United States in October 2025. [8] [9]

The US Food and Drug Administration granted the application for nerandomilast an orphan drug designation for the idiopathic pulmonary fibrosis indication [10] and breakthrough therapy designation for the progressive pulmonary fibrosis indication. [5]

Names

Nerandomilast is the international nonproprietary name. [11]

Nerandomilast is sold under the brand name Jascayd. [1]

References

  1. 1 2 3 4 5 6 "Jascayd- nerandomilast tablet, film coated". DailyMed. 23 October 2025. Retrieved 20 December 2025.
  2. ↑ "Jascayd (nerandomilast tablets), for oral use" (PDF). Boehringer Ingelheim Pharmaceuticals, Inc. U.S. Food and Drug Administration. December 2025.
  3. ↑ "Jascayd (nerandomilast) receives first regulatory approval for progressive pulmonary fibrosis in China" (Press release). Boehringer Ingelheim. 10 December 2025. Retrieved 20 December 2025– via GlobeNewswire.
  4. ↑ Ibrahim M, Piazza GA, Ahsan F (December 2025). "Nerandomilast as the first PDE4B-selective therapy in idiopathic pulmonary fibrosis". Trends in Pharmacological Sciences. doi:10.1016/j.tips.2025.11.006. PMID   41354560.
  5. 1 2 3 4 5 6 7 8 "FDA Approves Drug to Treat Chronic, Progressive Lung Disease". U.S. Food and Drug Administration (Press release). 19 December 2025. Retrieved 20 December 2025.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  6. 1 2 3 4 5 "FDA approves drug to treat idiopathic pulmonary fibrosis". U.S. Food and Drug Administration (FDA) (Press release). 7 October 2025. Retrieved 20 December 2025.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  7. ↑ "U.S. FDA approves Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults" (Press release). Boehringer Ingelheim. 19 December 2025. Retrieved 20 December 2025– via GlobeNewswire.
  8. ↑ "Drug Approval Package: Jascayd". U.S. Food and Drug Administration (FDA). 6 November 2025. Retrieved 20 December 2025.
  9. ↑ "U.S. FDA approves Boehringer's Jascayd (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade". Boehringer Ingelheim (Press release). Retrieved 9 October 2025.
  10. ↑ "Nerandomilast Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). Retrieved 22 December 2025.
  11. ↑ World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information. 38 (1). hdl: 10665/378096 .
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