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Drug

Nogapendekin alfa inbakicept

Approved · EMA
Late-stage development

Also known as Anktiva, NOGAPENDEKIN ALFA INBAKIC, nogapendekin alfa and inbakicept.

RxNorm2682678
5
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase Ib/II, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN)

Clinical trial2026-07-10Results expected Q3 2032 · ClinicalTrials.gov

A Pilot Trial of N-803 in Patients With Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy

Clinical trial2026-06-15Results expected Q3 2030 · ClinicalTrials.gov

Open-Label, Single-Arm Phase 2 Study Of Nogapendekin Alfa Inbakicept, PD-L1 T-HaNK, And Bevacizumab And Randomized Phase 2B Study Of Nogapendekin Alfa Inbakicept, Bevacizumab, And Tumor Treatment Fields With Or Without PD-L1 T-HaNK In Participants With Recurrent Or Progressive Glioblastoma

Clinical trial2026-06-04Results expected Q4 2030 · ClinicalTrials.gov

Phase 2, Randomized, Open-Label Clinical Trial Evaluating Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care Alone in Critically Ill Adults With Sepsis and Persistent Lymphopenia

Clinical trial2026-05-11Results expected Q3 2027 · ClinicalTrials.gov

Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer

Clinical trial2026-04-29Results expected Q2 2027 · ClinicalTrials.gov

ImmunityBio responds to FDA scrutiny over Anktiva promotional claims with new protocols

Regulatory2026-04-06Regulatory news · Fierce Pharma

Approval: Anktiva (EMA)

Regulatory2026-02-16EMA

Phase Ib Trial Combining N-803 and Pembrolizumab With Shorter Duration of Enfortumab Vedotin in Treatment-Naïve Patients With Metastatic Urothelial Carcinoma

Clinical trial2027-05-30Withdrawn · ClinicalTrials.gov

Phase 3 Randomized, Blinded, Placebo-Controlled Study Evaluating Nogapendekin Alfa Inbakicept and iNKT Cells In Critically Ill Adults With Severe Community-Acquired Pneumonia With or Without Sepsis/Acute Respiratory Distress Syndrome

Clinical trial2029-12-31Withdrawn · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Nogapendekin alfa inbakicept
Aliases & brands
AnktivaNOGAPENDEKIN ALFA INBAKICnogapendekin alfa and inbakicept
RxNorm CUI
2682678
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2026-02-16
Latest approval
2026-02-16
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2026-02-16Approval
Approval: Anktiva (EMA)
Indication: 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… Show full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

7 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
7
registered trials across all phases
5
Active studies
5
Recruiting
1
Late-stage (III+)
2
Discontinued
PHASE DISTRIBUTIONn = 7
Early Phase 11Phase 12Phase 1 / 21Phase 22Phase 31
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.