Is Nogapendekin alfa inbakicept 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 Nogapendekin alfa inbakicept, including ANKTIVA (1 mg/ml, concentrate for solution for injection, SAR 162442.50).

Is Nogapendekin alfa inbakicept approved by the US FDA?

Drugs@FDA lists 1 application product line for Nogapendekin alfa inbakicept, including ANKTIVA (Prescription).

Is Nogapendekin alfa inbakicept authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nogapendekin alfa inbakicept: Anktiva.

Active substance

Nogapendekin alfa inbakicept

SFDA 2
US FDA 1
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ANKTIVA	1 mg/ml	concentrate for solution for injection · Intravenous, Intravesical	1 Vial	SAR 162442.50	Biological · Prescription	Immunitybio	Valid
ANKTIVA	2 mg/ml	concentrate for solution for injection · Subcutaneous use			Biological · Prescription	Immunitybio	Conditional Approval

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

Product	Strength	Form · route	Applicant	Status	First approved
ANKTIVA	400mcg/0.4 mL	solution · intravesical	ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU	Prescription	22 Apr 2024

EMA European Union — centrally authorised medicines

Anktiva Immunitybio Ireland Limited · Authorised · authorised 16 Feb 2026 · ATC L03AC03

Therapeutic indication (EMA)

Anktiva in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

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.