Drugs / GSK3810109A
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03538626 | Jun 2018 → Aug 2022 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04871113 | Jun 2021 → Oct 2022 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-02-25 | ViiV Healthcare | Results ViiV HEALTHCARE REPORTS POSITIVE 12-MONTH DATA SHOWING INVESTIGATIONAL BNAB LOTIVIBART (N6LS) MAINTAINS HIGH LEVELS OF VIRAL SUPPRESSION IN LONG-ACTING HIV TREATMENT REGIMEN viivhealthcare.com ↗
94% of adults on stable therapy maintained viral suppression with intravenous lotivibart dosed every four months in combination with long-acting cabotegravir |
| 2025-10-09 | ViiV Healthcare | Results ViiV Healthcare showcases breadth of clInIcal and real-world evIdence at EACS and IDWeek 2025 viivhealthcare.com ↗
Safety and Tolerability of N6LS Administered Intravenously or Subcutaneously: Promising Results From Part 1 of the EMBRACE Study |
| 2025-03-12 | ViiV Healthcare | Results ViiV HEALTHCARE’S INVESTIGATIONAL BROADLY NEUTRALISING ANTIBODY - N6LS - SUCCESSFULLY MAINTAINS VIRAL SUPPRESSION IN LONG-ACTING TREATMENT OF HIV viivhealthcare.com ↗
The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. |
| 2025-03-09 | ViiV Healthcare | Results ViiV HEALTHCARE CONTINUES TO DELIVER LONG-ACTING INJECTABLE HIV INNOVATION WITH LATE-BREAKING DATA AND REAL-WORLD INSIGHTS ACROSS PIPELINE AND PORTFOLIO AT CROI 2025 viivhealthcare.com ↗
A new phase IIb study with VH3810109 (VH109), an investigational, broadly neutralising antibody (bNAb) offers efficacy and safety findings of the bNAb (subcutaneous and IV administration) in combination with CAB LA. |
| 2022-10-25 | GlaxoSmithKline | Results ViiV Healthcare presents positive proof-of-concept findings for N6LS, an investigational, broadly neutralising antibody (bNAb) offering a potential new approach for the treatment of HIV gsk.com ↗
The study showed that a single infusion of N6LS demonstrated strong antiviral efficacy at both doses while also being well-tolerated by study participants. |
| 2022-10-25 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS POSITIVE PROOF-OF-CONCEPT FINDINGS FOR N6LS, AN INVESTIGATIONAL, BROADLY NEUTRALISING ANTIBODY (BNAB) OFFERING A POTENTIAL NEW APPROACH FOR THE TREATMENT OF HIV viivhealthcare.com ↗
The study showed that a single infusion of N6LS demonstrated strong antiviral efficacy at both doses while also being well-tolerated by study participants. |
All press releases naming this drug 6 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GSK3810109A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04871113 ↗ |
| Known as | N6LS | “N6LS (VRC-HIVMAB091-00-AB) is a human monoclonal antibody targeted to the HIV-1 CD4 binding site.” NCT03538626 ↗ |
| Known as | VRC-HIVMAB091-00-AB | “N6LS (VRC-HIVMAB091-00-AB) is a human monoclonal antibody targeted to the HIV-1 CD4 binding site.” NCT03538626 ↗ |
| Modality | Monoclonal antibody | “N6LS is a human monoclonal antibody.” NCT03538626 ↗ |
| Route | Intravenous | “It was given into a vein in the arm (intravenously, IV) or as an injection underneath the skin (subcutaneously, SC).” NCT03538626 ↗ |
| Route | Subcutaneous | “It was given into a vein in the arm (intravenously, IV) or as an injection underneath the skin (subcutaneously, SC).” NCT03538626 ↗ |