Drugs / N-803
last change Jul 2026 re-read 1 minute ago

N-803

English name Anktiva

Protein / enzyme biologic

Developed for
non-small cell lung carcinoma · acute myeloid leukemia · HIV infectious disease · malignant pancreatic neoplasm · colorectal cancer · head and neck squamous cell carcinoma · myelodysplastic syndrome · cutaneous neuroendocrine carcinoma
+67 more · lymphopenia · infectious disease with sepsis · non-invasive bladder urothelial carcinoma · prostate cancer · urothelial carcinoma · AIDS · castration-resistant prostate carcinoma · chronic myeloid leukemia · hepatocellular carcinoma · indolent B-cell non-Hodgkin lymphoma · long COVID-19 · non-Hodgkin lymphoma · plasma cell myeloma · pneumonia · triple-negative breast carcinoma · acute respiratory distress syndrome · adenocarcinoma · adult acute respiratory distress syndrome · adult T-cell leukemia/lymphoma · B-cell chronic lymphocytic leukemia · B-cell non-Hodgkin lymphoma · breast cancer · cancer · cervical cancer · chordoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · colon carcinoma · COVID-19 · endometrial carcinoma · Ewing sarcoma · fallopian tube cancer · gastric cancer · gastroesophageal cancer · glioblastoma · head and neck cancer · Hodgkins lymphoma · lung cancer · melanoma · metastatic melanoma · metastatic neoplasm · mismatch repair cancer syndrome · myxoid liposarcoma · neuroblastoma · oropharynx squamous cell carcinoma · ovarian cancer · ovarian carcinoma · pancreatic ductal adenocarcinoma · pancreatic neoplasm · peripheral T-cell lymphoma, not otherwise specified · primary cutaneous T-cell lymphoma · primary peritoneal carcinoma · prostate carcinoma · rectum adenocarcinoma · refractory malignant neoplasm · refractory plasma cell neoplasm · renal cell carcinoma · rhabdomyosarcoma · round cell liposarcoma · small cell lung carcinoma · small intestine cancer · squamous cell carcinoma · synovial sarcoma · T-cell prolymphocytic leukemia · thyroid cancer · urinary bladder cancer · uterine adnexa cancer · colorectal neoplasm
Investigated by
ImmunityBio, Inc. · National Cancer Institute (NCI) · Altor BioScience · Masonic Cancer Center, University of Minnesota · University of Minnesota · National Institute of Allergy and Infectious Diseases (NIAID)
+30 more · Washington University School of Medicine · Henry M. Jackson Foundation for the Advancement of Military Medicine · Rockefeller University · American Society of Clinical Oncology · American Society of Hematology · Brenda Cooper, MD · Bristol-Myers Squibb · Dana-Farber Cancer Institute · Eli Lilly and Company · Gabrielle's Angel Foundation · HIV Vaccine Trials Network · Janssen Vaccines & Prevention B.V. · Medical University of South Carolina · Michael Peluso, MD · Miltenyi Biomedicine GmbH · NantCell, Inc. · National Institutes of Health (NIH) · Seth Pollack · St. Jude Children's Research Hospital · Thai Red Cross AIDS Research Centre · The Foundation for Barnes-Jewish Hospital · The Leukemia and Lymphoma Society · The V Foundation for Cancer Research · US Military HIV Research Program · University of Pennsylvania · University of Utah · Vadim S Koshkin · Walter Reed Army Institute of Research (WRAIR) · Weill Medical College of Cornell University · amfAR, The Foundation for AIDS Research

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved · conditional EU (EMA) Anktiva 2026-02-16 europa.eu
Approved US (FDA) ANKTIVA 2024-04-22 fda.gov

Trials 95 · started per year

today
US approved 2024
EU approved 2026
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07261657 Apr 2026 → Sep 2030 expected myxoid liposarcoma, round cell liposarcoma, synovial sarcoma Seth Pollack Recruiting No outcome recorded
Phase 122 trials
Phase 1 NCT07488884 Jun 2026 → Jun 2027 expected pancreatic ductal adenocarcinoma ImmunityBio, Inc. Not yet recruiting No outcome recorded
Phase 1 NCT07217496 Feb 2026 → May 2027 urothelial carcinoma Vadim S Koshkin Withdrawn No outcome recorded
Phase 1 NCT07049432 Feb 2026 → Dec 2030 B-cell non-Hodgkin lymphoma University of Utah Withdrawn No outcome recorded
Phase 1 NCT05618925 Aug 2025 → May 2026 overdue non-Hodgkin lymphoma ImmunityBio, Inc. Recruiting No outcome recorded
Phase 1 NCT06040918 Oct 2023 → Sep 2024 ImmunityBio, Inc. Completed No outcome recorded
Phase 1 NCT05769569 Sep 2023 → Jul 2025 HIV infectious disease Henry M. Jackson Foundation for the Advancement of Military Medicine Withdrawn No outcome recorded
Phase 1 NCT05245292 Dec 2022 → Dec 2025 HIV infectious disease Rockefeller University Completed No outcome recorded
Phase 1 NCT04898543 Jun 2021 → May 2026 overdue metastatic neoplasm ImmunityBio, Inc. Active not recruiting No outcome recorded
Phase 1 NCT04340596 May 2021 → Jun 2026 overdue HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Active not recruiting No outcome recorded
Phase 1 NCT04808908 Apr 2021 → Jul 2022 AIDS University of Minnesota Completed No outcome recorded
Phase 1/230 trials
Phase 1/2 NCT05642195 Jul 2026 → Dec 2033 non-small cell lung carcinoma National Cancer Institute (NCI) Suspended No outcome recorded
Phase 1/2 NCT07355205 Jul 2026 → Jul 2032 expected non-small cell lung carcinoma Washington University School of Medicine Recruiting No outcome recorded
Phase 1/2 NCT06253494 May 2024 → Dec 2026 expected endometrial carcinoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1/2 NCT06149481 Mar 2024 → Oct 2027 expected colorectal cancer National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1/2 NCT04247282 Jun 2020 → Aug 2021 head and neck cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT04144335 Jan → Dec 2020 AIDS University of Minnesota Withdrawn No outcome recorded
Phase 1/2 NCT03563157 Sep 2018 → Apr 2019 colorectal cancer ImmunityBio, Inc. Terminated No outcome recorded
Phase 1/2 NCT03647423 Aug 2018 → Aug 2020 chordoma ImmunityBio, Inc. Withdrawn No outcome recorded
Phase 1/2 NCT03169777 Aug 2018 → Jan 2019 colorectal cancer ImmunityBio, Inc. Withdrawn No outcome recorded
Phase 1/2 NCT03586869 Jul 2018 → Apr 2019 malignant pancreatic neoplasm ImmunityBio, Inc. Terminated No outcome recorded
Phase 235 trials
Phase 2 NCT07574541 Jul 2026 → Jun 2027 expected adenocarcinoma, prostate cancer National Cancer Institute (NCI) Not yet recruiting No outcome recorded
Phase 2 NCT07686380 Jul 2026 → Jan 2029 expected prostate carcinoma National Cancer Institute (NCI) Not yet recruiting No outcome recorded
Phase 2 NCT07628062 Jul 2026 → Dec 2030 expected oropharynx squamous cell carcinoma ImmunityBio, Inc. Not yet recruiting No outcome recorded
Phase 2 NCT07578558 Jul 2026 → Aug 2027 expected immunodeficiency disease, infectious disease with sepsis, lymphopenia ImmunityBio, Inc. Not yet recruiting No outcome recorded
Phase 2 NCT07492888 Apr → Nov 2026 adult acute respiratory distress syndrome, infectious disease with sepsis, lymphopenia, pneumonia ImmunityBio, Inc. Withdrawn No outcome recorded
Phase 2 NCT07477366 Apr 2026 → Dec 2027 expected indolent B-cell non-Hodgkin lymphoma ImmunityBio, Inc. Not yet recruiting No outcome recorded
Phase 2 NCT06765902 Dec 2025 → Jan 2031 prostate cancer ImmunityBio, Inc. Withdrawn No outcome recorded
Phase 2 NCT06765954 Dec 2025 → Jan 2031 prostate cancer ImmunityBio, Inc. Withdrawn No outcome recorded
Phase 2 NCT07108036 Nov 2025 → Oct 2026 expected long COVID-19 ImmunityBio, Inc. Recruiting No outcome recorded
Phase 2 NCT07085338 Nov 2025 → Feb 2028 expected neuroblastoma St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03022825 Jun 2017 → Oct 2024 overdue urinary bladder cancer ImmunityBio, Inc. Active not recruiting No outcome recorded
Phase 35 trials
Phase 3 NCT07524257 May 2026 → May 2029 non-small cell lung carcinoma ImmunityBio, Inc. Withdrawn No outcome recorded
Phase 3 NCT07551544 May 2026 → May 2032 non-invasive bladder urothelial carcinoma ImmunityBio, Inc. Withdrawn No outcome recorded
Phase 3 NCT07492875 Apr 2026 → Apr 2029 acute respiratory distress syndrome, immunodeficiency disease, infectious disease with sepsis, lymphopenia +1 ImmunityBio, Inc. Withdrawn No outcome recorded
Phase 3 NCT06745908 Oct 2025 → Sep 2028 expected non-small cell lung carcinoma ImmunityBio, Inc. Recruiting No outcome recorded
Phase 3 NCT03520686 May 2018 → Oct 2025 non-small cell lung carcinoma ImmunityBio, Inc. Terminated No outcome recorded
Phase not stated1 trial
NCT06956547 lymphopenia ImmunityBio, Inc. Available No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/24 trials
Phase 1/2 NCT07410676 Background Feb 2026 → Dec 2028 expected breast cancer, colorectal cancer, cutaneous melanoma, esophageal cancer +9 Essen Biotech Recruiting No outcome recorded
Phase 1/2 NCT04927884 Background Sep 2021 → Sep 2022 triple-negative breast carcinoma ImmunityBio, Inc. Terminated No outcome recorded
Phase 1/2 NCT03387085 Background Mar 2018 → Sep 2020 triple-negative breast carcinoma ImmunityBio, Inc. Terminated No outcome recorded
Phase 1/2 NCT03167177 Background Dec 2017 → Jan 2019 melanoma ImmunityBio, Inc. Withdrawn No outcome recorded
Phase 21 trial
Phase 2 NCT03003728 Background Nov 2019 → Jul 2020 plasma cell myeloma University of Arkansas Withdrawn No outcome recorded

Press releases naming this drug 8 releases

DateIssuerRelease
2026-07-29 ImmunityBio, Inc. ImmunityBio Receives United Arab Emirates (UAE) Marketing Authorization for ANKTIVA® Across BCG-Unresponsive Non-Muscle Invasive Bladder Cancer for CIS and Papillary Disease and Metastatic Non-Small Cell Lung Cancer immunitybio.com
2026-05-22 ImmunityBio, Inc. ImmunityBio Presents Health Economic Analysis at ISPOR 2026 Showing ANKTIVA® Plus BCG Delivers Lower Cost per Sustained Complete Response Versus TAR-200 in BCG-Unresponsive NMIBC CIS immunitybio.com
2026-05-19 ImmunityBio, Inc. ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027 immunitybio.com
2026-05-18 ImmunityBio, Inc. ImmunityBio Announces Comprehensive U.S. Patents Covering Combination of ANKTIVA with BCG for Cancer Treatment, with Terms Through 2035 immunitybio.com
2026-04-21 ImmunityBio, Inc. ImmunityBio Announces ANKTIVA® Is Now Available in Saudi Arabia for Bladder and Lung Cancer Patients; Market Entry Achieved Within Two Months of MENA Partnership immunitybio.com
2026-03-26 ImmunityBio, Inc. ImmunityBio Confirms Statistical Power in Pivotal Randomized BCG-Naïve NMIBC Trial to Detect Clinically Meaningful Differences Between ANKTIVA® Plus BCG Versus BCG Alone; Supplemental BLA Submission on Track for 2026 immunitybio.com
2026-03-20 ImmunityBio, Inc. ImmunityBio Announces Approval in Macau SAR, China for ANKTIVA® in BCG-Unresponsive NMIBC with CIS ± Papillary Tumors immunitybio.com
2026-03-17 ImmunityBio, Inc. ImmunityBio Announces NCCN® Clinical Practice Guidelines in Oncology Have Been Updated to Include ANKTIVA® Plus BCG for Patients With BCG-Unresponsive NMIBC With Papillary-Only Disease immunitybio.com

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 106 sources stand behind the page.

FieldValueCited text
Known as N-803 N-803 is an interleukin 15 (IL-15)/interleukin 15 receptor (IL-15R) alpha super agonist complex that can enhance both natural killer (NK) cell and T cell anti-tumor activity...” NCT04247282
51

“a single infusion of haploidentical related donor NK cells was given plus either IL-2 or N-803 (an IL-15 superagonist)” PMID 38207119 May 2024

“plus an IL-15 superagonist complex, N-803, dosed at 6 mcg/kg, subcutaneously (SC) at week 1” NCT05245292

N-803 subcutaneously (SubQ) administered on day 1 of each 21-day cycle” NCT07049432

“Nogapendekin alfa inbakicept (NAI, also known as N-803, ANKTIVA):” NCT03520686

“Given nogapendekin alfa inbakicept (N-803) SC” NCT05419011

“Nogapendekin Alfa Inbakicept (N803)” NCT07488884

NCT04340596

NCT03228667

NCT04385849

NCT02138734

NCT06040918

NCT05007769

NCT02384954

NCT06149481

NCT05245292

NCT06829823

NCT03022825

NCT03853317

NCT04847466

NCT06745908

NCT06253494

NCT06765954

NCT03387085

NCT03493945

NCT04390399

NCT07085338

NCT06710288

NCT05769569

NCT02465957

NCT05642195

NCT06765902

NCT04927884

NCT03387111

NCT07686380

NCT07108036

NCT04808908

NCT04144335

NCT07145164

NCT06161545

NCT07477366

NCT04505501

NCT05445882

NCT06061809

NCT02099539

NCT03563170

NCT04898543

NCT07049432

NCT04491955

NCT02989844

NCT04290546

NCT07574541

Known as also known as IL-15N72D:IL-15RαSu/IgG1 Fc complex]), ALT-803 also known as IL-15N72D:IL-15RαSu/IgG1 Fc complex]), ALT-803NCT03853317
Known as ALT-803 “A combination of agents will be administered to subjects in this study: Aldoxorubicin Hydrochloride HCI, ALT-803, ETBX-051, ETBX-061, GI-6301, haNK, avelumab, cetuximab,...” NCT03647423
34

“nogapendekin alfa inbakicept (also known as ALT-803; recombinant human superagonist interleukin-15 (IL-15) complex” NCT05618925

“N-803 formerly known as Alt-803NCT02989844

“N-803, also known as ALT-803NCT04491955

NCT03050216

NCT03169790

NCT03365661

NCT02782546

NCT03563144

NCT01885897

NCT03554109

NCT03167177

NCT02523469

NCT03167164

NCT03574649

NCT03169738

NCT03136406

NCT03169764

NCT03003728

NCT03387098

NCT02559674

NCT03054909

NCT03586869

NCT03169777

NCT03381586

NCT01946789

NCT03329248

NCT01898793

NCT03563157

NCT02890758

NCT03197584

NCT02191098

NCT03127098

NCT03175666

NCT03197571

Known as ANKTIVA “This is a summary of two studies that looked at the safety and effectiveness of a potential new treatment, N-803 (Anktiva), in combination with a standard treatment bacillus...” PMID 38953850 Jul 2024
4

“Nogapendekin alfa inbakicept (NAI, also known as N-803, ANKTIVA):” NCT03520686

“N-803 (Anktiva)” NCT04491955

NCT07123727

NCT07551544

Known as IL-15 “N-803 is also known as Interleukin-15 or "IL-15", a powerful and long lasting protein that can affect the immune system by stimulating immune cells such as CD8+ T cells and...” NCT07145164
6

“Drug: Interleukin-15 (IL-15) Low-dose IL-15 given after NK cell infusion to support NK cell survival dose used in NK protocols: 6 MIU per dose” NCT07410676

NCT01385423

NCT01369888

NCT02689453

NCT02395822

NCT00528489

Known as IL-15N72D:IL-15RαSu/IgG1 Fc complex “recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D:IL-15RαSu/IgG1 Fc complex\]” NCT03574649
1

“also known as IL15N72D:IL-15RαSu/IgG1 Fc complex” NCT03169738

Known as Interleukin-15 “N-803 is also known as Interleukin-15 or "IL-15", a powerful and long lasting protein that can affect the immune system by stimulating immune cells such as CD8+ T cells and...” NCT07145164
1

“Drug: Interleukin-15 (IL-15) Low-dose IL-15 given after NK cell infusion to support NK cell survival dose used in NK protocols: 6 MIU per dose” NCT07410676

Known as NAI “Nogapendekin alfa inbakicept (NAI, also known as N-803, ANKTIVA):” NCT03520686
6

“IL-15 receptor superagonist nogapendekin-alfa-inbakicept (NAI)” PMID 42238576 May 2026

“neoadjuvant therapy of nogapendekin alfa inbakicept (NAI) SC” NCT07488884

“nogapendekin alfa inbakicept (NAI) plus chemoimmunotherapy” NCT07524257

“Nogapendekin Alfa Inbakicept (NAI)” NCT07628062

“Nogapendekin alfa inbakicept (NAI)” NCT07578558

“Nogapendekin alfa inbakicept (NAI)” NCT07492875

Known as nogapendekin alfa inbakicept “N-803 (Nogapendekin Alfa Inbakicept): A soluble complex consisting of a modified human interleukin-15 (IL-15) variant bound to a human IL-15 receptor alpha subunit/human...” NCT06765902
14

“N-803 (nogapendekin alfa inbakicept): A soluble complex of an IL-15 variant bound to a human IL-15 receptor alpha subunit/human IgG1 Fc fusion protein.” NCT06765954

nogapendekin alfa inbakicept (also known as ALT-803; recombinant human superagonist interleukin-15 (IL-15) complex” NCT05618925

Nogapendekin alfa inbakicept (NAI, also known as N-803, ANKTIVA):” NCT03520686

“Given nogapendekin alfa inbakicept (N-803) SC” NCT05419011

NCT07578558

NCT07492875

NCT07261657

NCT07628062

NCT07492888

NCT07488884

NCT07217496

NCT06956547

NCT07524257

NCT07355205

Known as recombinant human IL-15 “To evaluate whether IL-15 potentiates ADCC in humans, we conducted a phase 1 single-center study of recombinant human IL-15 and alemtuzumab in patients with CD52-positive...” PMID 35475910 Feb 2023
Known as recombinant human interleukin-15 “Our initial effort with intravenous bolus recombinant human interleukin-15 (rhIL-15) was limited by postinfusional reactions.” PMID 33883258 Apr 2021
Known as rhIL-15 “Forty-two patients received either intravenous (IV) (NCT01385423) or subcutaneous (SC) (NCT02395822) recombinant human IL-15 (rhIL-15) after lymphodepleting chemotherapy and...” PMID 31266741 Jul 2019
2

“Our initial effort with intravenous bolus recombinant human interleukin-15 (rhIL-15) was limited by postinfusional reactions.” PMID 33883258 Apr 2021

“Intravenous Recombinant Human IL-15 (rhIL-15)” NCT01385423

Action Activate “Preclinical studies with both HIV and SIV suggest that the drug has potential to reduce virus reservoirs by activating virus from latency and enhancing effector function.” PMID 35102335 Jan 2022
Modality Protein / enzyme biologic “recombinant human IL-15” NCT01369888
Route Other “Group 1 will receive an injection of PENNVAX-B combined with 0.8 mg IL-15 in each deltoid or placebo.” NCT00528489