Clinical Trials

Multiple clinical trials sponsored by AiCuris Anti-infective Cures AG evaluate Pritelivir across Phase 1, Phase 2, and Phase 3 studies, alongside an expanded access treatment protocol. The research encompasses pharmacokinetic evaluations in healthy subjects as well as efficacy trials for herpes simplex virus (HSV) infections, genital herpes, and herpes labialis. Advanced clinical research includes a completed Phase 3 study investigating Pritelivir for acyclovir-resistant HSV infections.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03073967 COMPLETED
HSV Infection
AiCuris Anti-infective Cures AG
 2017-05-08 PHASE3
NCT05671029 COMPLETED
Healthy Subjects
AiCuris Anti-infective Cures AG
 2022-12-04 PHASE1
NCT05513625 COMPLETED
HSV Infection
AiCuris Anti-infective Cures AG
 2020-07-13 PHASE1
NCT02871492 COMPLETED
Herpes Labialis
AiCuris Anti-infective Cures AG
 2016-11-29 PHASE2
NCT01658826 TERMINATED
Genital Herpes
AiCuris Anti-infective Cures AG
 2012-10 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-12)

Check the Pritelivir (BAY 57-1293) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pritelivir functions as a potent inhibitor of the herpes simplex virus helicase-primase complex, blocking essential viral DNA unwinding and RNA primer synthesis required for viral replication. By halting viral genome synthesis, this mechanism suppresses cellular viral propagation of HSV-1 and HSV-2, offering clinical utility in treating herpes labialis, genital herpes, and acyclovir-resistant herpes simplex infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.