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Lenacapavir

Generic Name
Lenacapavir
Brand Names
Sunlenca
Drug Type
Small Molecule
Chemical Formula
C39H32ClF10N7O5S2
CAS Number
2189684-44-2
Unique Ingredient Identifier
A9A0O6FB4H
Background

HIV/AIDS remains an area of concern despite the introduction of numerous successful therapies, mainly due to the emergence of multidrug resistance and patient difficulty in adhering to treatment regimens. Lenacapavir is a first-in-class capsid inhibitor that demonstrates picomolar HIV-1 inhibition as a monotherapy in vitro, little to no cross-resistance with existing antiretroviral agents, and extended pharmacokinetics with subcutaneous dosing.

Lenacapavir was first globally approved on August 22, 2022 by the European Commission to treat adults with multi-drug resistant HIV infection. On December 22, 2022, it was also approved by the FDA.

Indication

Lenacapavir, in combination with other antiretroviral(s), is indicated for the treatment of multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults who are experiencing a failure of their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Associated Conditions
Multidrug resistant HIV-1 infection
Associated Therapies
-

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

Phase 2
Recruiting
Conditions
HIV-1-infection
Interventions
Drug: Lenacapavir
Drug: BIC/LEN FDC
First Posted Date
2024-08-01
Last Posted Date
2025-01-09
Lead Sponsor
Gilead Sciences
Target Recruit Count
75
Registration Number
NCT06532656
Locations
🇺🇸

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

🇮🇹

IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali, Roma, Italy

🇿🇦

Be Part Yoluntu, Cape Town, South Africa

and more 8 locations
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