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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:
GS-9883 (bictegravir), an HIV type 1 integrase inhibitor in combination with GS-6207 (lenacapavir), a structural capsid protein inhibitor is being evaluated for the treatment of HIV-1-infection.
Lead Product(s): Bictegravir,Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-9883
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2024
Details:
Sunlenca (lenacapavir) is a selective long-acting inhibitor of HIV-1 capsid function which inhibits HIV-1 replication by interfering with multiple essential steps of the viral lifecycle.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca
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 October 18, 2023
Details:
Sunlenca (lenacapavir) is a selective long-acting inhibitor of HIV-1 capsid function which inhibits HIV-1 replication by interfering with multiple essential steps of the viral lifecycle.
Lead Product(s): Lenacapavir,Teropavimab,Zinlirvimab
Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca
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 February 22, 2023
Details:
Sunlenca is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1. Sunlenca works by blocking the HIV-1 virus’ protein shell (the capsid), thereby interfering with multiple essential steps of the viral lifecycle.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2022
Details:
Sunlenca (lenacapavir) is a first-in-class, long-acting HIV capsid inhibitor approved in the United States, the United Kingdom, Canada and the European Union, for the treatment of HIV infection, in combination with other antiretroviral.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2022
Details:
Sunlenca (lenacapavir), is first-in-class capsid inhibitor with multi-stage mechanism of action, offering a new, every six-month treatment option for people with HIV whose virus no longer effectively responds to their current therapy.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2022
Details:
The NDA resubmission contains comprehensive CMC data to support the compatibility of GS-6207 (lenacapavir), first-in-class, investigational long-acting HIV-1 capsid inhibitor with an alternative vial type made from aluminosilicate glass.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
Recommendation is based on week 26 Data from the CAPELLA Trial showing twice-yearly GS-6207 (lenacapavir) achieved high rates of virologic suppression in heavily treatment-experienced people with HIV.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Sunlenca
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, 2022
Details:
GS-6207 (Lenacapavir) is Gilead’s potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Lenacapavir was generally well tolerated in CAPELLA, with no serious adverse events.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
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 May 16, 2022
Details:
In the CRL, the FDA has cited Chemistry Manufacturing and Controls issues relating to the compatibility of GS-6207 (lenacapavir), HIV-1 capsid inhibitor, with the proposed container vial as the reason for their action.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
One-year data from the Capella and Calibrate trials show GS-6207 (lenacapavir) leads to high rates of virologic suppression in heavily treatment-experienced people living with multi-drug resistant HIV and treatment-naïve people living with HIV.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2022
Details:
Lenacapavir is Gilead’s potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. The company remains confident about the future potential of lenacapavir.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 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:
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:
Both cohorts are part of the ongoing maintenance period of the study evaluating the safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen.
Lead Product(s): Lenacapavir,ARV Regimen,Optimized Background Regimen
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2021
Details:
The submission is supported by data from the Phase 2/3 CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen.
Lead Product(s): Lenacapavir,Undiscosed
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2021
Details:
The new interim efficacy results demonstrate that lenacapavir administered subcutaneously every six months maintained high rates of virologic suppression through 26 weeks in a difficult-to-treat patient population with limited therapy options and high unmet medical need.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2021
Details:
Data will include Phase 2/3 CAPELLA trial results evaluating the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multidrug resistant HIV-1 infection.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2021
Details:
88% of the participants receiving lenacapavir experienced at least a 0.5 log10 reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as compared with 17% of those receiving placebo.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2020
Details:
Presentations will highlight new switch data for Biktarvy, as well as real-world findings and patient-reported outcomes from a treatment perspective, and new data on Gilead's first-in-class investigational long-acting injectable lenacapavir.
Lead Product(s): Lenacapavir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
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 September 30, 2020
Details:
Phase 1 trial results supports further evaluation of a six-month dosing interval for a sustained delivery formulation of Gilead’s novel, investigational HIV-1 capsid inhibitor, lenacapavir (GS-6207).
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
Phase 1B study demonstrates the potential of GS-6207 to rapidly reduce viral load after a single subcutaneous injection.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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 11, 2020
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