JASCAYD

Launch

nerandomilast

NDAORALTABLETPriority Review
Approved
Oct 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
8

Mechanism of Action

4 (PDE4) with at least nine-fold preferential inhibition of the PDE4B isoenzyme over PDE4A, PDE4C, and PDE4D based on in vitro data. PDE4 hydrolyzes and inactivates cyclic adenosine monophosphate (cAMP). Nerandomilast exerts both antifibrotic and immunomodulatory effects as PDE4B inhibition…

Clinical Trials (5)

NCT07366034Phase 3Not Yet Recruiting

A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease

Started Jul 2026
35 enrolled
Fibrosing Interstitial Lung Disease
NCT07201922Phase 3Recruiting

A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

Started Feb 2026
80 enrolled
Familial Pulmonary FibrosisInterstitial Lung AbnormalitiesInterstitial Lung Diseases
NCT06806592Phase 3Recruiting

A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases

Started Sep 2025
400 enrolled
Interstitial Lung DiseasesSystemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases
NCT07081932Phase 1Completed

A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood

Started Aug 2025
16 enrolled
Healthy
NCT07100964Phase 1Completed

A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood

Started Aug 2025
16 enrolled
Healthy

Loss of Exclusivity

LOE Date
Oct 22, 2038
153 months away
Patent Expiry
Oct 22, 2038
Exclusivity Expiry
Oct 7, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
8754073
Nov 26, 2029
SubstanceProduct
U-4298
8609670
Aug 23, 2032
Substance
9802954
Feb 19, 2034
U-4298
11406638
Oct 22, 2038
U-4297
11813266
Oct 22, 2038
U-4292