Drug Profile
Islatravir - Merck Sharp & Dohme
Alternative Names: 4-ethynyl-2-fluoro-2-deoxyadenosine; EFdA; MK-8519; MK-8591; MK-8591-eluting implant; MK-8591DLatest Information Update: 13 Mar 2024
Price :
$50
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At a glance
- Originator Merck Sharp & Dohme
- Developer Gilead Sciences; Merck Sharp & Dohme
- Class Alkynes; Antiretrovirals; Fluorinated hydrocarbons; Purine nucleosides; Small molecules
- Mechanism of Action Nucleoside reverse transcriptase inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III HIV-1 infections
- Phase I HIV infections
- Discontinued HIV-2 infections
Most Recent Events
- 03 Mar 2024 Efficacy and adverse events data from a phase II trial in HIV-1 infections released by Gilead Sciences at the 31st Conference on Retroviruses and Opportunistic Infections 2024 (CROI-2024)
- 27 Apr 2023 Merck Sharp & Dohme reinitiates enrolment in a phase III MK-8591A-019 trial in HIV-1 infections (In adolescents, In adults, In children, In the elderly, Treatment-experienced) in France, UK, Portugal, Denmark, the US, Germany, South Korea, Russia, Ukraine, Spain, South Africa, Peru, Japan, Italy, Colombia, Chile, Canada and Australia, as US FDA places full clinical hold on the trials (NCT04233216) (EudraCT2019-000588-26)
- 08 Mar 2023 Discontinued - Clinical-Phase-Unknown for HIV infections (Prevention) in USA (SC)