Clinical Trials
Developing the Next Generation of Therapies to Combat Viral Infections
At Aicuris, our commitment to pioneering therapies in infectious disease drives us to push the boundaries of medical innovation. Our clinical trials are at the core of our mission to develop transformative treatments for patients affected by serious viral infections, including those for which current treatment options are limited or ineffective.
Each study is meticulously designed to assess the safety and efficacy of our novel therapies, with a primary focus on addressing unmet needs in immunocompromised and vulnerable patient populations. Through rigorous clinical research and global collaboration, we aim to bring new solutions to market that can improve quality of life and deliver lasting impact in the fight against infections.
Explore our ongoing and upcoming trials to learn more about our progress in delivering next-generation antiviral therapies.
Ongoing Clinical Trials
AIC468
Single and multiple dose escalation trial in healthy subjects to determine the safety, tolerability, and pharmacokinetics
Single and multiple dose escalation trial in healthy subjects to determine the safety, tolerability, and pharmacokinetics
Indication:
BKV-associated nephropathy
Identifier:
Target Patient Population:
Location:
Germany
The Phase 1 study seeks to assess the safety and tolerability of AIC468, to characterize the dose-dependent adverse event profile. Additionally, the trial will assess the pharmacokinetics (PK) of AIC468 after single and multiple administrations and after single and multiple doses.
Pritelivir
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)
Indication
Acyclovir-resistant or acyclovir-refractory HSV infection
Identifier
Target Patient Population
Location
Argentina, Australia, Belgium, Canada, France, Georgia, Germany, Greece, Israel, Italy, Mexico, Switzerland, United Kingdom, United States
Pritelivir is currently investigated in a Phase 3, randomized, open-label, multicenter comparative study to evaluate the efficacy and safety of pritelivir in the treatment of acyclovir-resistant mucocutaneous HSV (herpes simplex virus) infections in immunocompromised patients
Status
In July 2025, the study was fully recruited. Pritelivir met its primary Phase 3 endpoint and demonstrated statistically significant superiority in lesion healing compared to standard of care.
Early Access to pritelivir oral tablets for immunocompromised patients with refractory HSV infections
Aicuris supports expanded access requests for the treatment of eligible patients outside of the Phase 3 clinical trial and …