Drug

Nerandomilast

As of the edition of 20 October 2026, Nerandomilast is a small molecule: marketed, first approved in 2025 (US); acts on PDE4B; US protection ends in 2032.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2026
Kind
Small molecule
Brand name
Jascayd
First approved
7 October 2025 (US)
Approvals on record
4 in 2 regions
Holder of the most recent approval
Boehringer Ingelheim
Registered trials
37, 0 stopped early
Disease areas
Lungs and airways; Skin and connective tissue; Bones, joints and muscles; Digestive system; Nervous system; Pregnancy and women's health

US protection

US protection ends in 2032.

The last listed US exclusivity ends in 2032. The application that gives this date is held by Boehringer Ingelheim.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

10 listings count towards this date. The exact date and each listing are in the product.

See the exact date and the 10 listings behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Nerandomilast.

Target

GeneProteinUniProt
PDE4B3',5'-cyclic-AMP phosphodiesterase 4BQ07343

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1010
Phase 1232300
Phase 23210
Phase 39270
Phase 41010
All trials37

Who has held its approvals

CompanyRoleYears
Boehringer IngelheimOriginator and Lead sponsor of trials2012 to now