Drug Profile

GS 5366

Alternative Names: ABI-5366; GS-5366

Latest Information Update: 14 Apr 2026

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At a glance

Originator Assembly Biosciences
Class Antivirals; Small molecules
Mechanism of Action DNA helicase-primase 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
Available For Licensing Yes

Highest Development Phases

Phase I Herpes simplex virus type 2 infections

Most Recent Events

03 Feb 2026 Assembly Biosciences completes a phase I trial in Herpes simplex virus type 2 infections in Australia (PO) (NCT06385327)
09 Dec 2025 Adverse events and efficacy data from a phase Ia/Ib trial in Herpes simplex virus type 2 infections released by Assembly Biosciences
10 Oct 2025 Assembly Biosciences plans phase-II trial for Herpes simplex virus type 2 infection in mid-2026

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