Is Duvelisib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Duvelisib.

Is Duvelisib approved by the US FDA?

Drugs@FDA lists 1 application product line for Duvelisib, including COPIKTRA (Prescription).

Is Duvelisib authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Duvelisib.

Are there safety signals or safety updates for Duvelisib?

US FDA: 1 entry (latest 2024-07-26).

Active substance

Duvelisib

SFDA 2
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Copiktra	25 mg	Capsule, hard · Oral use	56 Blister	SAR 22428.00	NCE · Prescription	GENZYME EUROPE B.V.	Withdrawn by MAH · Not Marketed
Copiktra	15 mg	Capsule, hard · Oral use	56 Blister	SAR 22428.00	NCE · Prescription	GENZYME EUROPE B.V.	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
COPIKTRA	15MG; 25MG	capsule · oral	SECURA	Prescription	24 Sep 2018

EMA European Union — centrally authorised medicines

Copiktra Secura Bio Limited · Withdrawn · authorised 19 May 2021 · ATC L01EM04

Therapeutic indication (EMA)

Copiktra monotherapy is indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies. Follicular lymphoma (FL) that is refractory to at least two prior systemic therapies.

Safety signals and safety-related labeling changes

US FDA 26 Jul 2024 COPIKTRA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for duvelisib →

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.