Drugs / VRC07-523LS
last change Jun 2026 re-read 2 minutes ago

VRC07-523LS

also known as VRC-HIVMAB075-00-AB · TMB-380

Monoclonal antibody

Developed for
HIV infectious disease · AIDS · acquired immunodeficiency
Investigated by
National Institute of Allergy and Infectious Diseases (NIAID) · Department of Health and Human Services · Henry M. Jackson Foundation for the Advancement of Military Medicine · National Institutes of Health (NIH) · US Military HIV Research Program · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
+28 more · International AIDS Vaccine Initiative · National Institute of Mental Health (NIMH) · Rockefeller University · TaiMed Biologics Inc. · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Beth Israel Deaconess Medical Center · Boris Juelg, MD PhD · Dale and Betty Bumpers Vaccine Research Center (VRC) · David Ho · GeoVax, Inc. · Gilead Sciences · HIV Prevention Trials Network · HIV Vaccine Trials Network · Harvard School of Public Health (HSPH) · Ichor Medical Systems Incorporated · ImmunityBio, Inc. · Janssen Pharmaceuticals · Janssen Vaccines & Prevention B.V. · Mologen AG · Monogram Biosciences · Orlando Immunology Clinic · Ragon Institute of MGH, MIT and Harvard · University of California, San Francisco · University of Minnesota · University of North Carolina, Chapel Hill · University of Texas Health, Houston AIDS Research Team (HART) · ViiV Healthcare · amfAR, The Foundation for AIDS Research

Trials 29 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 118 trials
Phase 1 NCT06987318 Dec 2026 → Aug 2027 expected HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Not yet recruiting No outcome recorded
Phase 1 NCT07390955 Mar 2026 → Aug 2027 expected HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 1 NCT06517693 Jan 2026 → Dec 2027 expected National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 1 NCT06484335 Mar 2025 → Aug 2027 expected HIV infectious disease Henry M. Jackson Foundation for the Advancement of Military Medicine Recruiting No outcome recorded
Phase 1 NCT05890963 Nov 2023 → Apr 2026 overdue HIV infectious disease David Ho Active not recruiting 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 NCT05184452 Nov 2021 → Jul 2023 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed 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 NCT04212091 Nov 2020 → Jan 2023 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT03928821 Jul 2019 → Mar 2021 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/26 trials
Phase 1/2 NCT06508749 Nov 2024 → Sep 2027 expected HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 1/2 NCT05275998 Jul 2022 → Nov 2024 HIV infectious disease TaiMed Biologics Inc. Completed No outcome recorded
Phase 1/2 NCT04983030 Apr 2022 → Feb 2026 AIDS, acquired immunodeficiency Boris Juelg, MD PhD Completed No outcome recorded
Phase 1/2 NCT04357821 Aug 2020 → Jun 2026 overdue HIV infectious disease University of California, San Francisco Active not recruiting No outcome recorded
Phase 1/2 NCT04144335 Jan → Dec 2020 AIDS University of Minnesota Withdrawn No outcome recorded
Phase 1/2 NCT02140255 Jan 2015 → Jan 2028 expected HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 25 trials
Phase 2 NCT07215468 Dec 2025 → Aug 2027 expected HIV infectious disease TaiMed Biologics Inc. Active not recruiting No outcome recorded
Phase 2 NCT06812494 Mar 2025 → Jan 2027 expected HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 2 NCT05719441 Aug 2024 → Apr 2028 expected National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 2 NCT05281510 Jun 2022 → Jan 2025 HIV infectious disease Gilead Sciences Completed No outcome recorded
Phase 2 NCT03739996 Dec 2019 → Apr 2024 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT07655141 Comparator Jan 2027 → Jul 2029 expected HIV infectious disease Hospital Universitario 12 de Octubre Not yet recruiting No outcome recorded
Phase 1/2 NCT03721510 Comparator Dec 2018 → Oct 2021 HIV infectious disease International AIDS Vaccine Initiative Completed No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 32 sources stand behind the page.

FieldValueCited text
Known as VRC-07-523LS “the Broadly Neutralizing Antibodies VRC07-523LS and PGT121 Plus or Minus haNK Cells for Reduction of HIV Reservoirs” NCT04144335
28

“single dose of two bNAbs (VRC07-523LS and 10-1074, which target CD4 binding site and V3 loop, respectively)” NCT04357821

“TMB-380, aka VRC-07-523LS is a monoclonal antibody that binds to HIV.” NCT05275998

“VRC07-523LS” NCT07215468

NCT07655141

NCT03928821

NCT05184452

NCT03721510

NCT04983030

NCT06508749

NCT06812494

NCT03739996

NCT03803605

NCT05769569

NCT04340596

NCT03735849

NCT05890963

NCT03565315

NCT02256631

NCT02140255

NCT05281510

NCT04212091

NCT07390955

NCT06517693

NCT06987318

NCT05719441

NCT03387150

NCT06484335

NCT03205917

Known as TMB-380 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07215468
1

NCT05275998

Known as VRC-HIVMAB075-00-AB “A Phase I Safety and Pharmacokinetics Study to Evaluate a Human Monoclonal Antibody (MAB) VRC-HIVMAB095-00-AB (10E8VLS) Administered Alone or Concurrently with MAB...” NCT03565315
4

“VRC07-523LS (VRC-HIVMAB075-00-AB) is a recombinant human immunoglobulin G1 (IgG1) broadly neutralizing monoclonal antibody (bNAb) directed against the HIV-1 CD4 binding site” NCT06484335

VRC-HIVMAB075-00-AB (VRC07-523LS) is a human monoclonal antibody (mAb) that targets the HIV-1 CD4 binding site.” NCT04983030

NCT03015181

NCT02840474

Action Inhibit “VRC07-523LS administration significantly decreased VL in 8 out of 9 participants, with an average decline of 1.7 ± 0.8 log10 copies/mL within 14 days after administration.” PMID 39989458 Feb 2025
Modality Monoclonal antibody “VRC01, VRC01LS, and VRC07-523LS are anti-HIV neutralizing monoclonal antibodies” NCT02256631
Route Subcutaneous “40 mg/kg administered subcutaneously” NCT02140255