Nerandomilast

Nerandomilast
Clinical data
Trade namesJascayd
Other namesBI-1015550, BI 1015550
AHFS/Drugs.comMonograph
MedlinePlusa625107
License data
Routes of
administration		By mouth
Drug classPhosphodiesterase-4 inhibitor
ATC code
Legal status
Legal status
Identifiers
  • (5R)-2-[4-(5-chloropyrimidin-2-yl)piperidin-1-yl]-4-{[1-(hydroxymethyl)cyclobutyl]amino}-6,7-dihydro-5H-5λ⁴-thieno[3,2-d]pyrimidin-5-one
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. It is a phosphodiesterase 4 (PDE4) inhibitor. It is taken by mouth.

Common side effects include diarrhea, decreased weight, decreased appetite, and nausea.

Nerandomilast was approved for medical use in the United States in October 2025. The US Food and Drug Administration considers it to be a first-in-class medication.

Medical uses

Nerandomilast is indicated for the treatment of idiopathic pulmonary fibrosis and for the treatment of progressive pulmonary fibrosis.

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

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

Side effects

Side effects include diarrhea, decreased weight, decreased appetite, and nausea.

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.

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. 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.

In July 2026, a phase III trial called VERANDA-SSc (NCT07497087) began testing nerandomilast in adults with systemic sclerosis. Its primary outcome is the time to disease progression or death.

Society and culture

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

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

In May 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Jascayd, intended for the treatment of adults with idiopathic pulmonary fibrosis or adults with progressive pulmonary fibrosis. The applicant for this medicinal product is Boehringer Ingelheim International GmbH. Nerandomilast was authorized for medical use in the European Union in July 2026.

Names

Nerandomilast is the international nonproprietary name.

Nerandomilast is sold under the brand name Jascayd.

References

  1. 1 2 3 4 5 6 "Jascayd- nerandomilast tablet, film coated". DailyMed. 23 October 2025. Retrieved 20 December 2025.
  2. 1 2 3 "Jascayd EPAR". European Medicines Agency (EMA). 22 May 2026. Retrieved 28 May 2026. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. 1 2 "Jascayd PI". Union Register of medicinal products. 16 July 2026. Retrieved 9 September 2026.
  4. ↑ "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.
  5. 1 2 "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information. 38 (1). 2024. hdl:10665/378096.
  6. ↑ 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.
  7. 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. Public Domain This article incorporates text from this source, which is in the public domain.
  8. 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. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ↑ "Novel Drug Approvals for 2025". U.S. Food and Drug Administration (FDA). 8 July 2026. Retrieved 19 July 2026.
  10. ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2025" (PDF). U.S. Food and Drug Administration (FDA). January 2026.
  11. ↑ "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.
  12. ↑ "A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis (VERANDA-SSc)". ClinicalTrials.gov. U.S. National Library of Medicine. Retrieved 25 September 2026.
  13. ↑ Vats A (9 September 2026). "Nerandomilast Philippines: Three Hospitals Listed". The Witfire Elite Pharma News. Retrieved 25 September 2026.
  14. ↑ "Drug Approval Package: Jascayd". U.S. Food and Drug Administration (FDA). 6 November 2025. Retrieved 20 December 2025.
  15. ↑ "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.
  16. ↑ "Nerandomilast Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). Retrieved 22 December 2025.
  17. ↑ "New medicine for two types of pulmonary fibrosis". European Medicines Agency (EMA) (Press release). 22 May 2026. Retrieved 28 May 2026.