Drugs / Vesatolimod
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT05458102 | Aug 2022 → May 2023 | HIV infectious disease | Gilead Sciences | Terminated | No outcome recorded |
| Phase 1 | NCT03060447 | May 2017 → Feb 2020 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02858401 | Jan 2015 → Feb 2019 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01590641 | Apr 2012 → Sep 2013 | hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01590654 | Apr 2012 → Nov 2013 | hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01591668 | Mar → Dec 2012 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06071767 | Apr 2024 → Apr 2028 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Suspended | No outcome recorded Stop: Enrollment |
| Phase 24 trials · 2 missed | ||||||
| Phase 2 | NCT05281510 | Jun 2022 → Jan 2025 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT04364035 | Feb 2020 → Oct 2022 | HIV infectious disease | Aelix Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02579382 | Nov 2015 → Jan 2017 | chronic hepatitis B virus infection | Gilead Sciences | Completed | Missed primary |
| Phase 2 | NCT02166047 | Jun 2014 → May 2016 | chronic hepatitis B virus infection | Gilead Sciences | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-03-12 | Gilead Sciences | Results Gilead Presents New HIV Treatment and Cure Research Data at CROI 2025, Including an Investigational Long-Acting, Twice-Yearly Therapy Option gilead.com ↗
Results presented at CROI showed the treatment combination was generally well-tolerated with no treatment-related serious adverse events (TEAEs) reported. |
| 2023-02-14 | Gilead Sciences | Results Gilead Demonstrates Transformative Potential Impact Of Antiviral Innovation at CROI 2023 gilead.com ↗
Vesatolimod pharmacodynamic response is associated with time to HIV rebound |
| 2020-03-10 | Gilead Sciences | Results Treatment With Gilead’s Vesatolimod Is Evaluated for Safety and Virologic and Immunologic Response Versus Placebo in Phase 1B HIV Functional Cure Study gilead.com ↗
These findings mark the first clinical data showing TLR7 stimulation by vesatolimod is associated with a modestly increased time to viral rebound compared to placebo, as well as enhanced immune function and decreased levels of intact HIV DNA. |
| 2019-07-23 | Gilead Sciences | Results Gilead Announces Latest Data in Ongoing HIV Cure Research Program gilead.com ↗
The Phase 1 and preclinical study results demonstrate that the TLR7 agonists vesatolimod (GS-9620) and GS-986 can induce immune activation and follow earlier preclinical research suggesting that TLR7 agonists can potentially lead to viral remission, as part of combination regimens. |
| 2019-07-18 | Gilead Sciences | Results Gilead to Present New Data on HIV Prevention, Treatment and Cure Research at IAS 2019 gilead.com ↗
Vesatolimod (GS-9620) is Safe and Pharmacodynamically Active in HIV-Infected Individuals |
| 2018-03-04 | Gilead Sciences | Results Gilead Announces Data from New Preclinical Study Evaluating a Combination of an Investigational TLR7 Agonist and an Investigational HIV Envelope Targeting Antibody in SHIV-Infected, Virally Suppressed Monkeys gilead.com ↗
Data from the study conducted in simian-human immunodeficiency virus (SHIV)-infected rhesus monkeys on suppressive antiretroviral therapy (ART) demonstrated that a combination treatment of GS-9620 and PGT121 resulted in a subset of animals maintaining viral suppression after ART discontinuation. |
| 2016-02-24 | Gilead Sciences | Results Gilead Announces Data From New Preclinical Study Evaluating an Investigational TLR7 Agonist in SIV-Infected Monkeys gilead.com ↗
Data from the study conducted in simian immunodeficiency virus (SIV)-infected virally suppressed rhesus macaques on antiretroviral therapy (ART) demonstrate that TLR7 agonist treatment induced transient plasma SIV RNA blips and reduced SIV DNA. |
All press releases naming this drug 7 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vesatolimod | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05281510 ↗ |
| Known as | GS-9620 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04364035 ↗ |
| Known as | VES | “VRC07523LS + CAP256V2LS + Vesatolimod (VES)” NCT05281510 ↗1“Vesatolimod (VES)” NCT06071767 ↗ |
| Action | Activate | “GS-9620 is a potent oral agonist of toll-like receptor 7” PMID 25105516 ↗ Aug 2014 |
| Modality | Small molecule | — CHEMBL2424780 ↗ |
| Route | Oral | “GS-9620 is a potent oral agonist of toll-like receptor 7” PMID 25105516 ↗ Aug 2014 |
| Target | TLR7 | “Treatment with vesatolimod, an investigational, oral, toll-like receptor 7 (TLR7) agonist, leads to sustained viral remission in some non-human primates when combined with...” PMID 33043969 ↗ Jun 2021 |