Drugs / Pritelivir
Pritelivir
also known as
AIC316 · AIC-090093 · AIC005 · AIC090016 · BAY 57-1293 · BAY 60-6616 · PRITELIVIR MESYLATE · Pritelivir mesylate anhydrous · +2 more
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05671029 | Dec 2022 → May 2023 | — | AiCuris Anti-infective Cures AG | Completed | No outcome recorded |
| Phase 1 | NCT05513625 | Jul → Oct 2020 | herpes simplex infectious disease | AiCuris Anti-infective Cures AG | Completed | No outcome recorded |
| Phase 23 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT02871492 | Nov 2016 → Sep 2017 | herpes labialis | AiCuris Anti-infective Cures AG | Completed | Missed primary |
| Phase 2 | NCT01658826 | Oct 2012 → May 2013 | genital herpes | AiCuris Anti-infective Cures AG | Terminated | Met primary |
| Phase 2 | NCT01047540 | Mar → Dec 2010 | genital herpes simplex type 2 infectious disorder | AiCuris Anti-infective Cures AG | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03073967 | May 2017 → Aug 2025 | herpes simplex infectious disease | AiCuris Anti-infective Cures AG | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT05844436 | — | — | AiCuris Anti-infective Cures AG | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-04-16 | AiCuris Anti-infective Cures AG | Regulatory Aicuris Receives FDA Priority Review for Pritelivir NDA and Presents New Phase 3 Data at ESCMID 2026 aicuris.com ↗
Aicuris Anti-infective Cures AG (“Aicuris”) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) filed for pritelivir. |
| 2026-02-25 | AiCuris Anti-infective Cures AG | Results Pritelivir Demonstrates Superior Efficacy in People Living with HIV with Refractory HSV in Phase 3 PRIOH-1 aicuris.com ↗ |
| 2026-02-05 | AiCuris Anti-infective Cures AG | Results Aicuris Presents Positive Phase 3 Data for Pritelivir in Immunocompromised Patients with Refractory Herpes Simplex Virus at TANDEM aicuris.com ↗
Pritelivir achieved a clinically meaningful and statistically significant superiority in lesion healing of 62.7% compared to 34.0% for ICT, with an adjusted treatment difference of 28.4% (p = 0.0047). |
| 2025-10-20 | AiCuris Anti-infective Cures AG | Results Aicuris Presents Positive Phase 2 Results for Pritelivir and Favorable Phase 1 Safety Data for AIC468 at ID Week 2025 aicuris.com ↗
Results from pritelivir Phase 2 study demonstrate a favorable safety profile and a numerically higher lesion healing rate vs. foscarnet |
| 2025-10-16 | AiCuris Anti-infective Cures AG | Results Aicuris Announces Pritelivir Met Primary Endpoint in Immunocompromised Herpes Simplex Virus-infected Patients in Phase 3 Pivotal Trial aicuris.com ↗
Pritelivir demonstrated clinically meaningful and highly statistically significant superiority (p=0.0047) in lesion healing up to 28 days of treatment, compared with standard-of-care (SoC) treatments in refractory Herpes Simplex Virus (HSV) infected immunocompromised patients |
All press releases naming this drug 7 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pritelivir | “A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of "AIC316 (Pritelivir)" 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV...” NCT01658826 ↗ |
| Known as | AIC-090093 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4069597 ↗ |
| Known as | AIC005 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4069597 ↗ |
| Known as | AIC090016 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4069597 ↗ |
| Known as | AIC316 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01047540 ↗ |
| Known as | BAY 57-1293 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4069597 ↗ |
| Known as | BAY 60-6616 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4069597 ↗ |
| Known as | PRITELIVIR MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4069597 ↗ |
| Known as | Pritelivir mesylate anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL4069597 ↗ |
| Known as | Pritelivir methanesulfonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4069597 ↗ |
| Known as | PTV | “To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV.” NCT05513625 ↗ |
| Modality | Small molecule | — CHEMBL4069597 ↗ |
| Route | Oral | “Pritelivir oral tablet as single daily doses of 100 mg” NCT03073967 ↗ |