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Molecule

Nogapendekin alfa inbakicept

Interleukin-15 Receptor Agonist
Available on requestBiologicCold chain
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Nogapendekin alfa inbakicept is an interleukin-15 receptor agonist indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC). It is available as injection for intravesical use. MedsAcross supplies Nogapendekin alfa inbakicept for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Interleukin-15 Receptor Agonist, Interleukin-15 Receptor Agonists
ATC classification
L03AC03 Nogapendekin alfa inbakicept · Interleukins
US FDA first approval
22 April 2024
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravesical
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 7TK323DLA0

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

ANKTIVA, in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC). ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).

Source: US FDA prescribing information

How it works

Nogapendekin alfa inbakicept-pmln is an IL-15 receptor agonist. IL-15 signals through a heterotrimeric receptor that is composed of the common gamma chain (γc) subunit, the beta chain (βc) subunit, and the IL-15-specific alpha subunit, IL-15 receptor α. IL-15 is trans -presented by the IL-15 receptor α to the shared IL-2/IL-15 receptor (βc and γc) on the surface of CD4 + and CD8 + T cells and NK cells. Binding of nogapendekin alfa inbakicept-pmln to its receptor results in proliferation and activation of NK, CD8 +, and memory T cells without proliferation of immuno-suppressive Treg cells. In vivo, intravesicular nogapendekin alfa inbakicept-pmln alone or in combination with BCG showed anti-tumor activity when compared to BCG alone, in a carcinogen-induced model of bladder cancer in immunocompetent rats.

Source: US FDA prescribing information

Dosing overview

For Intravesical Use Only For induction: 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course may be administered if patients have residual carcinoma in situ (CIS) and/or high-grade Ta tumors at month 3. For maintenance: 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19. For patients with no evidence of high-grade disease at month 25 and later, additional maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours. See full Prescribing Information for dilution and administration instructions.

Source: US FDA prescribing information

Warnings and precautions

Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal. Risk of Metastatic Bladder Cancer with Delayed Cystectomy Delaying cystectomy in patients with BCG-unresponsive NMIBC could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting BCG-unresponsive NMIBC. Of the 77 evaluable patients with BCG-unresponsive CIS treated with ANKTIVA with TICE BCG in QUILT-3.032, 10% (n = 8) progressed to muscle invasive (T2 or greater) bladder cancer, including 7 during the treatment period. Three patients had progression determined at the time of cystectomy.

Source: US FDA prescribing information

Side effects

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

Source: US FDA prescribing information

Storage

Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Nogapendekin alfa inbakicept, sorted by availability.

MedicineManufacturerRegisterAvailability
Anktiva 400 mcg/0.4 mL injectionIntravesical Cold chainAltor BioScience, LLC, an indirect wholly-ownedUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 22 April 2024Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Nogapendekin alfa inbakicept available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Nogapendekin alfa inbakicept and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Nogapendekin alfa inbakicept have?

The catalogue lists 1 brand names for Nogapendekin alfa inbakicept, including Anktiva.

Is Nogapendekin alfa inbakicept approved by the US FDA?

Yes. The US FDA first approved Nogapendekin alfa inbakicept on 22 April 2024, according to Drugs@FDA.

Is Nogapendekin alfa inbakicept authorised in the European Union?

Yes. Nogapendekin alfa inbakicept has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Nogapendekin alfa inbakicept need cold chain shipping?

At least one listed presentation of Nogapendekin alfa inbakicept must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Nogapendekin alfa inbakicept in?

Nogapendekin alfa inbakicept is classified under ATC code L03AC03 (Nogapendekin alfa inbakicept).

References

  1. ANKTIVA prescribing information (Altor BioScience, LLC, an indirect wholly-owned). U.S. National Library of Medicine, DailyMed. Retrieved 27 October 2026
  2. Anktiva: European public assessment report (EPAR). European Medicines Agency. Retrieved 12 June 2026

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