ANKTIVA Concentrate for intravesical suspension Ref.[116339] Active ingredients: Nogapendekin alfa

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: ImmunityBio Ireland Limited, 6 th Floor, 2 Grand Canal Square, Dublin 2, Ireland, D02 A342

Product name and form

ANKTIVA 400 microgram concentrate for intravesical suspension.

Pharmaceutical Form

Concentrate for intravesical suspension.

Nogapendekin alfa inbakicept is a clear to slightly opalescent, colourless to slightly yellow solution, pH 7.4.

Qualitative and quantitative composition

One vial (0.4 mL) contains 400 micrograms nogapendekin alfa inbakicept.

Nogapendekin alfa inbakicept is a complex consisting of two nogapendekin alfa bound to inbakicept, produced in Chinese hamster ovary (CHO-K1) cell line by recombinant technology.

For the full list of excipients, see section 6.1.

Active Ingredient

Nogapendekin alfa inbakicept is an IL-15 receptor agonist. Binding of nogapendekin alfa inbakicept to its receptor results in proliferation and activation of NK, CD4+, CD8+, and memory T cells without proliferation of immuno-suppressive Treg cells.

List of Excipients

Disodium phosphate
Potassium dihydrogen phosphate
Sodium chloride
Water for injections
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

0.4 mL solution in a glass vial with a serum stopper (chlorobutyl elastomer with a Flurotec B2-40 coating) and an aluminium alloy seal containing a yellow plastic polypropylene flip-off cap.

Pack size: 1 single-dose vial.

Marketing authorization holder

ImmunityBio Ireland Limited, 6th Floor, 2 Grand Canal Square, Dublin 2, Ireland, D02 A342

Marketing authorization dates and numbers

EU/1/25/2002/001

Drugs

Drug Countries
ANKTIVA United States

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