Is Leniolisib approved by the US FDA?

Drugs@FDA lists 1 application product line for Leniolisib, including JOENJA (Prescription).

Is Leniolisib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Leniolisib: Joenja.

Are there safety signals or safety updates for Leniolisib?

US FDA: 1 entry (latest 2026-09-11).

Active substance

Leniolisib

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
JOENJA	EQ 70MG BASE; EQ 40MG BASE; EQ 50MG BASE	tablet · oral	PHARMING	Prescription	24 Mar 2023

EMA European Union — centrally authorised medicines

Joenja Pharming Technologies B.V. · Authorised · authorised 21 May 2026 · ATC L03AX22

Therapeutic indication (EMA)

Joenja is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.

Safety signals and safety-related labeling changes

US FDA 11 Sep 2026 JOENJA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for leniolisib →

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.