Is Nerandomilast approved by the US FDA?

Drugs@FDA lists 2 application product lines for Nerandomilast, including JASCAYD (Prescription); JASCAYD (Prescription).

Is Nerandomilast authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nerandomilast: Jascayd.

Are there safety signals or safety updates for Nerandomilast?

US FDA: 1 entry (latest 2026-08-14).

Active substance

Nerandomilast

US FDA 2
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
JASCAYD	9MG; 18MG	tablet · oral	BOEHRINGER INGELHEIM	Prescription	7 Oct 2025
JASCAYD	9MG; 18MG	tablet · oral	BOEHRINGER INGELHEIM	Prescription	19 Dec 2025

EMA European Union — centrally authorised medicines

Jascayd Boehringer Ingelheim International GmbH · Authorised · authorised 15 Jul 2026 · ATC L04AA61

Therapeutic indication (EMA)

Jascayd is indicated for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF). Jascayd is indicated for the treatment of adult patients with Progressive Pulmonary Fibrosis (PPF).

Safety signals and safety-related labeling changes

US FDA 14 Aug 2026 JASCAYD — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for nerandomilast →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.