ANKTIVA (nogapendekin alfa inbakicept-pmln)
ANKTIVA (nogapendekin alfa inbakicept-pmln) is an interleukin-15 (IL-15) receptor agonist indicated for use in combination with Bacillus Calmette-Guérin (BCG). It is approved for the treatment of adult patients with nonmuscle invasive bladder cancer (NMIBC) that is unresponsive to BCG. This therapeutic role specifically addresses patients presenting with carcinoma in situ (CIS), occurring either with or without papillary tumors.
How ANKTIVA Works
ANKTIVA acts as an IL-15 receptor agonist that signals through a heterotrimeric receptor complex to stimulate the immune system. The drug is trans-presented to the shared IL-2/IL-15 receptor located on the surface of natural killer (NK) cells and CD8+ T cells. This interaction leads to the proliferation and activation of these effector cells to enhance anti-tumor activity. This mechanism is designed to activate immune responses without the proliferation of immunosuppressive regulatory T cells.
Details
- Status
- Prescription
- First Approved
- 2024-04-22
- Routes
- INTRAVESICAL
- Dosage Forms
- SOLUTION
ANKTIVA Approval History
What ANKTIVA Treats
2 indicationsANKTIVA is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nonmuscle Invasive Bladder Cancer
- Carcinoma In Situ
ANKTIVA Target & Pathway
ProTarget
ANKTIVA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ANKTIVA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ANKTIVA treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07123727 | COVID-4.019-LONG | Ph 2 | recruiting | A Study to Examine Anktiva for the Treatment of COVID-19. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ANKTIVA FDA Label Details
Indications & Usage
FDA Label (PDF)ANKTIVA is indicated for the treatment of Nonmuscle Invasive Bladder Cancer; Carcinoma In Situ.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.