Islatravir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | IDVYNSO | — | 2026-04-20 | fda.gov ↗ |
Trials 28 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT07086079 | Sep → Dec 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06811246 | Feb → Jul 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06719570 | Jan → Mar 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06619678 | Jan → Jun 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT04515641 | Nov 2020 → Sep 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT04568603 | Oct 2020 → Jul 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT04303156 | Jun → Oct 2020 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02217904 | Sep 2015 → May 2017 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06891066 | Apr 2025 → Aug 2027 expected | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05115838 | Jan 2024 → Oct 2025 | HIV infectious disease | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT05130086 | Oct 2022 → Mar 2024 | HIV infectious disease | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT05052996 | Oct 2021 → Dec 2023 overdue | HIV infectious disease | Gilead Sciences | 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 | NCT04295772 | Nov 2020 → Dec 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT04003103 | Sep 2019 → Mar 2022 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT03272347 | Nov 2017 → Mar 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07266831 | Dec 2025 → Mar 2029 expected | HIV infectious disease | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT06630286 | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06630299 | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05766501 | Mar 2023 → Oct 2025 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05705349 | Mar 2023 → Oct 2025 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05631093 | Feb 2023 → Oct 2024 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05630755 | Feb 2023 → Oct 2024 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04776252 | Sep 2021 → May 2029 expected | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04652700 | Mar 2021 → Aug 2023 | — | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT04644029 | Feb 2021 → Jul 2023 | HIV infectious disease | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT04223778 | Feb 2020 → Sep 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT04223791 | Feb 2020 → Aug 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-21 | Gilead Sciences | Investigational Once-Weekly Oral HIV Treatment Regimen of Islatravir and Lenacapavir Maintained Virological Suppression in Adults With HIV Who Switched Antiretroviral Therapy gilead.com ↗ |
| 2026-06-08 | Gilead Sciences | Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment gilead.com ↗ |
| 2024-10-19 | Gilead Sciences | Gilead and Merck Announce Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48 gilead.com ↗ |
| 2024-03-06 | Gilead Sciences | Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24 gilead.com ↗ |
| 2021-10-26 | Gilead Sciences | Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppressed Adults gilead.com ↗ |
| 2021-03-15 | Gilead Sciences | Gilead and Merck Announce Agreement to Jointly Develop and Commercialize Long-Acting, Investigational Treatment Combinations of Lenacapavir and Islatravir in HIV gilead.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Islatravir | “The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing...” NCT06630286 ↗25“received either doravirine (100 mg) and islatravir (0·25 mg) or bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) orally once daily.” PMID 41763226 ↗ Feb 2026 “The goal of this study is to learn what happens to doravirine (DOR) and islatravir (ISL) in a healthy lactating female's body over time.” NCT07086079 ↗ “Once-weekly oral islatravir plus lenacapavir (ISL+LEN) has the potential to address adherence challenges with daily HIV-1 treatment.” PMID 41429026 ↗ Dec 2025 “Single tablet combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.” NCT05631093 ↗ “Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1)” NCT04295772 ↗ “FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks” NCT04776252 ↗ “FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily” NCT05766501 ↗ “oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP)” NCT04652700 ↗ “doravirine (100 mg) and islatravir (0·75 mg)” NCT04223791 ↗ “Group 1: Doravirine/Islatravir (DOR/ISL)” NCT04223778 ↗ “islatravir/lenacapavir (ISL/LEN) regimen” NCT06630299 ↗ “Doravirine/Islatravir” NCT05630755 ↗ |
| Known as | ISL | “Islatravir (also known as ISL and MK-8591) is a unique nucleoside reverse transcriptase translocation inhibitor in clinical development for treatment of people with HIV-1 infection.” PMID 31911147 ↗ Jan 202010“The goal of this study is to learn what happens to doravirine (DOR) and islatravir (ISL) in a healthy lactating female's body over time.” NCT07086079 ↗ “Once-weekly oral islatravir plus lenacapavir (ISL+LEN) has the potential to address adherence challenges with daily HIV-1 treatment.” PMID 41429026 ↗ Dec 2025 “Islatravir (ISL) is a nucleoside reverse transcriptase translocation inhibitor in development for the treatment of HIV-1 infection.” PMID 40042304 ↗ Mar 2025 “Single tablet combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.” NCT05631093 ↗ “FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily” NCT05766501 ↗ “oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP)” NCT04652700 ↗ “Group 1: Doravirine/Islatravir (DOR/ISL)” NCT04223778 ↗ “islatravir/lenacapavir (ISL/LEN) regimen” NCT06630299 ↗ |
| Known as | Islatravir anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL517231 ↗ |
| Known as | ISLATRAVIR HYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL517231 ↗ |
| Known as | Islatravir monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL517231 ↗ |
| Known as | MK-8591 | ChEMBL registry synonym — accepted as the source's own label CHEMBL517231 ↗ |
| Known as | MK-8591 MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL517231 ↗ |
| Action | Inhibit | “a unique nucleoside reverse transcriptase translocation inhibitor” PMID 31911147 ↗ Jan 2020 |
| Modality | Other / unclassified | “a unique nucleoside reverse transcriptase translocation inhibitor” PMID 31911147 ↗ Jan 2020 |
| Route | Oral | “receiving a single oral dose of islatravir” PMID 31911147 ↗ Jan 2020 |