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Nerandomilast
Clinical data
Trade namesJascayd
Other namesBI-1015550, BI 1015550
AHFS/Drugs.comMultum Consumer Information
MedlinePlusa625107
License data
Drug classPhosphodiesterase-4 inhibitor
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
Chemical and physical data
FormulaC20H25ClN6O2S
Molar mass448.97 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]

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

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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

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

History

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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

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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

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Nerandomilast is the international nonproprietary name.[11]

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

References

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  1. ^ a b c d e f "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. ^ a b c d e f g h "FDA Approves Drug to Treat Chronic, Progressive Lung Disease". U.S. Food and Drug Administration (Press release). 19 December 2025. Retrieved 20 December 2025. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ a b c d e "FDA approves drug to treat idiopathic pulmonary fibrosis". U.S. Food and Drug Administration (FDA) (Press release). 7 October 2025. Retrieved 20 December 2025. Public Domain 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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  • Clinical trial number NCT05321069 for "A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)" at ClinicalTrials.gov
  • Clinical trial number NCT04419506 for "A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)" at ClinicalTrials.gov
  • Clinical trial number NCT05321082 for "A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)" at ClinicalTrials.gov