Asset profile

N-803

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Bladder Cancer

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

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Competitive landscape

2 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 2 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
N-803: this drugApprovedSmall moleculeIL-15 superagonist
NKTR-255Phase 2Biologic (subtype unspecified)IL-15 receptor
IDE397Phase 1/2Small moleculeMAT2A
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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(22 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (3)
November 2026 (1)
Phase 2Bladder CancerNot yet recruiting
Est. primary completion 2026-11 · NCT06829823 · CT.gov ↗
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December 2026 (2)
Phase 2Stage II Squamous Cell Carcinoma of the Head and Neck, Stage III Squamous Cell Carcinoma of the Head and Neck …Recruiting
Est. primary completion 2026-12-01 · NCT06161545 · CT.gov ↗
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Phase 1/2Endometrial Cancer, Cancer of Endometrium, Carcinoma of Endometrium, Endometrial CarcinomaRecruiting
Est. primary completion 2026-12-31 · NCT06253494 · CT.gov ↗
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2027 (9)
March 2027 (1)
Phase 2Long COVID, Long COVID Syndrome, Long Covid 19Recruiting
Est. primary completion 2027-03 · NCT07123727 · CT.gov ↗
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May 2027 (1)
Phase 2Platinum-resistant Ovarian CancerRecruiting
Est. primary completion 2027-05 · NCT06710288 · CT.gov ↗
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June 2027 (2)
Phase 2Adenocarcinoma, Prostate Cancer, Neoplasms, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic TypeNot yet recruiting
Est. primary completion 2027-06-15 · NCT07574541 · CT.gov ↗
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Phase 2/3Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8 …Active not recruiting
Est. primary completion 2027-06-30 · NCT05096663 · CT.gov ↗
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July 2027 (1)
Phase 2Colorectal Carcinoma, Colorectal Neoplasm, Lynch SyndromeActive not recruiting
Est. primary completion 2027-07-01 · NCT05419011 · CT.gov ↗
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August 2027 (1)
Phase 2Sepsis, Septic Shock, Lymphopenia, Immunosuppression, Critical IllnessNot yet recruiting
Est. primary completion 2027-08-03 · NCT07578558 · CT.gov ↗
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October 2027 (1)
Phase 1/2Metastatic Colorectal CancerRecruiting
Est. primary completion 2027-10-31 · NCT06149481 · CT.gov ↗
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December 2027 (2)
Phase 2HIVEnrolling by invitation
Est. primary completion 2027-12 · NCT07145164 · CT.gov ↗
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Phase 2Relapsed B-Cell Non-Hodgkin LymphomaNot yet recruiting
Est. primary completion 2027-12 · NCT07477366 · CT.gov ↗
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2028 (3)
January 2028 (1)
Phase 1Bladder CancerNot yet recruiting
Est. primary completion 2028-01 · NCT07217496 · CT.gov ↗
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February 2028 (1)
Phase 2Neuroblastoma RecurrentRecruiting
Est. primary completion 2028-02-01 · NCT07085338 · CT.gov ↗
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September 2028 (1)
Phase 3NSCLC Stage IVRecruiting
Est. primary completion 2028-09 · NCT06745908 · CT.gov ↗
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2029 (4)
January 2029 (1)
Phase 2Recurrent Prostate Cancer, Prostate CancerRecruiting
Est. primary completion 2029-01-30 · NCT07686380 · CT.gov ↗
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April 2029 (1)
Phase 1Prostate Cancer, Metastatic Prostate CancerNot yet recruiting
Est. primary completion 2029-04-14 · NCT07756593 · CT.gov ↗
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August 2029 (1)
Phase 2Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Urothelial Carcinoma, Head and Neck Squamous Cell Carcinoma, Merkel Cell Carcinoma …Active not recruiting
Est. primary completion 2029-08-31 · NCT03228667 · CT.gov ↗
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December 2029 (1)
Phase 2GlioblastomaActive not recruiting
Est. primary completion 2029-12-31 · NCT06061809 · CT.gov ↗
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2030 (2)
September 2030 (1)
Phase 1Myxoid Liposarcoma, Round Cell Liposarcoma, Synovial SarcomaRecruiting
Est. primary completion 2030-09-02 · NCT07261657 · CT.gov ↗
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December 2030 (1)
Phase 2HPV-Positive Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Head and Neck CancerNot yet recruiting
Est. primary completion 2030-12-31 · NCT07628062 · CT.gov ↗
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2032 (1)
July 2032 (1)
Phase 1/2Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer RecurrentRecruiting
Est. primary completion 2032-07-31 · NCT07355205 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (5)
Phase 2/3 (2)
Phase 2 (27)
Phase 1/2 (13)
Phase 1 (16)
Appears in other studies (4)