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OCT 16 2026
UPCOMING · 77 DAYS TO PDUFA

Aicuris Anti-infective Cures AG pritelivir

for acyclovir-resistant mucocutaneous herpes simplex virus infections in immunocompromised adults

NDA · Priority Review

About

Pritelivir is an antiviral drug that blocks the action of a key protein the herpes simplex virus needs to copy itself and spread. For immunocompromised individuals, who are vulnerable to infections that resist standard treatments, this direct mechanism could provide a needed alternative when other therapies fail.

Pivotal trial

PRIOH-1 Phase 3 completed NCT03073967

Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once w...

Source: ClinicalTrials.gov

Also in development