Drugs / VH3810109
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07053384 | Jul 2025 → Jan 2027 expected | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05291520 | Feb 2022 → Apr 2023 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05996471 | Aug 2023 → May 2026 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-02-25 | GlaxoSmithKline | 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 gsk.com ↗
GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,* today announced positive 12-month interim efficacy and tolerability data from the phase IIb EMBRACE study. |
| 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 ↗
VH109 (N6LS) Cutoff for Baseline Phenotypic Sensitivity to VH3810109 (N6LS) Did Not Impact Occurrence of Confirmed Virologic Failure in the Phase 2b EMBRACE Study |
| 2025-03-12 | GlaxoSmithKline | Results ViiV Healthcare’s investigational broadly neutralising antibody - N6LS - successfully maintains viral suppression in long-acting treatment of HIV gsk.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. |
| 2025-03-12 | 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 | GlaxoSmithKline | 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 gsk.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 LA8. |
| 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 9 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VH3810109 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07053384 ↗ |
| Known as | GSK3810109 | “Safety and pharmacokinetics of a single dose of VH3810109 (also known as GSK3810109), administered either subcutaneously (SC) with rHuPH20 or intravenously (IV)” NCT05291520 ↗1“single dose of VH3810109 (also known as GSK3810109), administered either subcutaneously” PMID 40698814 ↗ Jul 2025 |
| Known as | N6LS | “The CD4-binding site antibody VH3810109 (N6LS) demonstrated broad and potent neutralization activity in vitro and robust antiviral activity in people with HIV-1.” PMID 40698814 ↗ Jul 2025 |
| Route | Subcutaneous | “Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.” NCT05291520 ↗ |