API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
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 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:
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:
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