Drugs / Ulonivirine
Ulonivirine
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT05093972 | Jan → Jun 2027 expected | liver disorder | Merck Sharp & Dohme LLC | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07595263 | Aug 2026 → Jan 2027 expected | — | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT07530289 | Apr → May 2026 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT07305831 | Jan → Apr 2026 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT07334886 | Sep → Nov 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06619678 | Jan → Jun 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02174159 | Sep 2014 → Jul 2015 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06891066 | Apr 2025 → Aug 2027 expected | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04564547 | Mar 2021 → Jan 2025 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07266831 | Dec 2025 → Feb 2029 expected | HIV infectious disease | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Merck Sharp & Dohme LLC | Results Investigational Once-Weekly Oral HIV Treatment Regimen Of Islatravir And Lenacapavir Maintained Virological Suppression In Adults With HIV Who Switched Antiretroviral Therapy msd.com ↗
The data provide strong evidence for the potential of ISL/LEN to be the first and only once-weekly oral HIV treatment option for adults with virologic suppression on a stable antiretroviral regimen. |
| 2021-11-18 | Merck Sharp & Dohme LLC | Results Merck Provides Update on Phase 2 Clinical Trial of Once-Weekly Investigational Combination of MK-8507 and Islatravir for the Treatment of People Living with HIV-1 merck.com ↗
Decreases in total lymphocyte and CD4+ T-cell counts were observed in study participants randomized to receive ISL+MK-8507. |
| 2021-07-12 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of New Data from Broad HIV Program at IAS 2021 merck.com ↗
No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir. |
| 2020-10-08 | Merck Sharp & Dohme LLC | Results Merck Announces Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination With Doravirine in Adults With HIV-1 Infection merck.com ↗
Company Also Presenting Phase 1/1b Results for MK-8507, a New Investigational Once-Weekly Oral HIV Agent |
| 2020-10-01 | Merck Sharp & Dohme LLC | Results Merck to Present New Data from the Company’s Diverse HIV Portfolio and Pipeline at HIV Glasgow 2020 merck.com ↗
Single doses of MK-8507, a novel HIV-1 NNRTI, reduced HIV viral load for at least a week. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Merck Sharp & Dohme LLC | Investigational Once-Weekly Oral HIV Treatment Regimen Of Islatravir And Lenacapavir Maintained Virological Suppression In Adults With HIV Who Switched Antiretroviral Therapy msd.com ↗ |
| 2021-11-18 | Merck Sharp & Dohme LLC | Merck Provides Update on Phase 2 Clinical Trial of Once-Weekly Investigational Combination of MK-8507 and Islatravir for the Treatment of People Living with HIV-1 merck.com ↗ |
| 2021-07-12 | Merck Sharp & Dohme LLC | Merck Announces Presentation of New Data from Broad HIV Program at IAS 2021 merck.com ↗ |
| 2020-10-08 | Merck Sharp & Dohme LLC | Merck Announces Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination With Doravirine in Adults With HIV-1 Infection merck.com ↗ |
| 2020-10-01 | Merck Sharp & Dohme LLC | Merck to Present New Data from the Company’s Diverse HIV Portfolio and Pipeline at HIV Glasgow 2020 merck.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ulonivirine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04564547 ↗ |
| Known as | [14C]Ulonivirine | “A Study of [14C]Ulonivirine ([14C]MK-8507) in Healthy Adults (MK-8507-006)” NCT07334886 ↗ |
| Known as | MK-8507 | “A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018)” NCT07530289 ↗ |
| Known as | ULO | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06891066 ↗ |
| Known as | Ulonivirina | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095253 ↗ |
| Modality | Small molecule | — CHEMBL5095253 ↗ |
| Route | Oral | “Ulonivirine tablet taken by mouth.” NCT04564547 ↗ |