Is Deucravacitinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Deucravacitinib, including Sotyktu (6 mg, Film-coated tablet, SAR 3777.35).

Is Deucravacitinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Deucravacitinib, including SOTYKTU (Prescription).

Is Deucravacitinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Deucravacitinib: Sotyktu.

Are there safety signals or safety updates for Deucravacitinib?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-09-03).

Active substance

Deucravacitinib

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Sotyktu	6 mg	Film-coated tablet · Oral use	30 Bottle	SAR 3777.35	NCE · Prescription	BRISTOL-MYERS SQUIBB	Valid

Indications — CHI Daman Drug Formulary

PSORIASIS

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

Product	Strength	Form · route	Applicant	Status	First approved
SOTYKTU	6MG	tablet · oral	BRISTOL	Prescription	9 Sep 2022

EMA European Union — centrally authorised medicines

Sotyktu Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 24 Mar 2023 · ATC L04AF07

Therapeutic indication (EMA)

Plaque psoriasis Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Sotyktu, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SOTYKTU	02533030	6 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA

Safety signals and safety-related labeling changes

EMA PRAC 3 Sep 2026 PRAC signal: Pemphigoid
Action for MAH: update of the product information: No
US FDA 30 Jun 2026 SOTYKTU — 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 deucravacitinib →

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.