Is Voclosporin approved by the US FDA?

Drugs@FDA lists 1 application product line for Voclosporin, including LUPKYNIS (Prescription).

Is Voclosporin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Voclosporin: Lupkynis.

Are there safety signals or safety updates for Voclosporin?

US FDA: 1 entry (latest 2025-10-08).

Active substance

Voclosporin

US FDA 1
EMA 2
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
LUPKYNIS	7.9MG	capsule · oral	AURINIA	Prescription	22 Jan 2021

EMA European Union — centrally authorised medicines

Lupkynis Otsuka Pharmaceutical Netherlands B.V. · Authorised · authorised 15 Sep 2022 · ATC L04AD03

Therapeutic indication (EMA)

Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).

Luveniq Lux Biosciences GmbH · Application withdrawn · ATC L04AD03

Therapeutic indication (EMA)

treatment of non-infectious uveitis

Safety signals and safety-related labeling changes

US FDA 8 Oct 2025 LUPKYNIS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for voclosporin →

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.