AiCuris announced that the US FDA accepted its New Drug Application for pritelivir with priority review, setting a decision target in the fourth quarter of 2026. The company also presented new Phase 3 data at ESCMID 2026, including outcomes through 42 days.
Who it’s for
Pritelivir is being reviewed for immunocompromised patients, such as people receiving transplants or cancer treatment, whose HSV infections are refractory: they don’t clear with standard antivirals, sometimes because the virus has become resistant. For these patients, HSV can be severe and options are limited.
The evidence
In the pivotal Phase 3 PRIOH‑1 trial, pritelivir met its primary endpoint for treating refractory HSV, with or without drug resistance. AiCuris submitted its application in the first quarter of 2026.
Why it matters beyond this group
Pritelivir is a helicase-primase inhibitor, the same drug class as the long-acting candidates now in development for genital herpes. An approval would be the first new HSV treatment in more than two decades and an important validation of the whole class.