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Details:
MK-8591 (islatravir) is a non-nucleoside reverse transcriptase translocation inhibitor, which is being investigated in phase 2 for HIV-1 infection, in combination with lenacapavir.
Lead Product(s): Islatravir,Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2024
Details:
MK-8591A is a combination of islatravir and Doravirine which are being investigated as non-nucleoside reverse transcriptase translocation inhibitor of HIV-1.
Lead Product(s): Islatravir,Doravirine
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591A
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2023
Details:
Phase 2 study evaluating an investigational weekly oral combination treatment regimen of MK-8591 (islatravir) and Gilead Sciences’ lenacapavir to resume with lower dose of islatravir.
Lead Product(s): Islatravir,Doravirine
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Details:
Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment and prevention of HIV-1.
Lead Product(s): Islatravir
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2021
Details:
MK-8591 (Islatravir), is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment and prevention of HIV-1.
Lead Product(s): Islatravir
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
Company temporarily paused enrollment in the Phase 2 clinical study, primary objective of this study is to evaluate the efficacy of oral weekly islatravir in combination with lenacapavir in virologically suppressed people with HIV (PWH) at Week 24.
Lead Product(s): Islatravir,Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591A
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2021
Details:
Islatravir, a nucleoside reverse transcriptase translocation inhibitor, with other antiretroviral agents and for the prevention of HIV-1 as a monotherapy.
Lead Product(s): Islatravir,MK-8507
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2021
Details:
Islatravir is currently being evaluated across a variety of dosing regimens, for both the treatment of HIV-1 in combination with other antiretroviral agents and for the prevention of HIV-1 as a monotherapy.
Lead Product(s): Islatravir,Doravirine
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591A
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2021
Details:
Both islatravir and lenacapavir have long half-lives and have demonstrated activity at low dosages in independent clinical studies, which support the development as an investigational combination regimen with long-acting formulations, both oral and injectable.
Lead Product(s): Islatravir,Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591A
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2021
Details:
Islatravir is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment of people living with HIV-1 infection in combination with Doravirine.
Lead Product(s): Islatravir,Doravirine
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591A
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2021
Details:
The grant will be used to develop a 12-month bioerodible implant for women against HIV infection coupled with birth control. The implant is expected to deliver a constant level of islatravir for HIV prevention and concurrently a consistent low plasma level of levonorgestrel.
Lead Product(s): Islatravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bill & Melinda Gates Foundation
Deal Size: $1.3 million Upfront Cash: Undisclosed
Deal Type: Funding August 09, 2021
Details:
The levels of islatravir in peripheral blood mononuclear cells (PBMCs) also remained above the pre-specified efficacy PK threshold for PrEP at both doses studied (60 mg and 120 mg) eight weeks after the last study dose.
Lead Product(s): Islatravir
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2021
Details:
At 12 weeks, all three doses resulted in mean islatravir triphosphate concentrations above the target PK threshold, the lowest level of islatravir triphosphate projected to have an antiviral effect as monotherapy in humans based on Phase 1 and Phase 2 data.
Lead Product(s): Islatravir
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2021
Details:
Merck will share late-breaking Phase 1 study results evaluating a new prototype subdermal drug-eluting implant for extended administration of islatravir for pre-exposure prophylaxis (PrEP).
Lead Product(s): Islatravir,MK-8507
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2021
Details:
Interim findings demonstrate that once-monthly oral islatravir achieved the pre-specified efficacy PK threshold for PrEP at both of the two doses studied (60 mg and 120 mg).
Lead Product(s): Islatravir
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2021
Details:
The study, IMPOWER 22, will evaluate the efficacy and safety of islatravir -- Merck’s novel investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) under evaluation for both treatment and prevention -- and is anticipated to begin by early 2021.
Lead Product(s): Islatravir
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bill & Melinda Gates Foundation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Funding November 16, 2020
Details:
Week 96 findings demonstrated that the combination of islatravir and doravirine maintained virologic suppression, and the findings were consistent with Week 48 results.
Lead Product(s): Islatravir,Doravirine
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591A
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
Researchers Will Present Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination with Doravirine, and Phase 1/1b Data for MK-8507, an Investigational NNRTI for the Treatment of HIV-1 Infection.
Lead Product(s): Islatravir,Doravirine
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591A
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2020
Details:
The first sub-analysis further characterized the tolerability and safety profile of islatravir in combination with doravirine (100 mg) through Week 48 across the three dose levels studied (0.25, 0.75, 2.25 mg).
Lead Product(s): Islatravir,Doravirine
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
The data presentations also include a post-hoc analysis of weight change from the Phase 3 DRIVE-SHIFT trial evaluating the effect of switching to DELSTRIGO™ as well as an examination from the OPERA cohort of weight changes in people living with HIV.
Lead Product(s): Islatravir,Doravirine
Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591A
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020
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