Is Mobocertinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Mobocertinib, including EXKIVITY (Discontinued).

Is Mobocertinib authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Mobocertinib.

Are there safety signals or safety updates for Mobocertinib?

US FDA: 1 entry (latest 2023-09-15).

Active substance

Mobocertinib

US FDA 1
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
EXKIVITY	EQ 40MG BASE	capsule · oral	TAKEDA PHARMS USA	Discontinued	15 Sep 2021

EMA European Union — centrally authorised medicines

Exkivity Takeda Pharma A/S · Application withdrawn · ATC L01EB

Therapeutic indication (EMA)

Treatment of adult patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Safety signals and safety-related labeling changes

US FDA 15 Sep 2023 EXKIVITY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for mobocertinib →

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.