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Islatravir - Merck Sharp & Dohme

Drug Profile

Islatravir - Merck Sharp & Dohme

Alternative Names: 4-ethynyl-2-fluoro-2-deoxyadenosine; EFdA; MK-8519; MK-8591; MK-8591-eluting implant; MK-8591D

Latest Information Update: 13 Mar 2024

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III HIV-1 infections
  • Phase I HIV infections
  • Discontinued HIV-2 infections

Most Recent Events

  • 06 Mar 2024 Efficacy and adverse events data from a phase II trial in HIV-1 infections released by Gilead Sciences
  • 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)
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