A UPLC-MS/MS assay for the quantification of the novel viral helicase-primase drug candidate adibelivir (IM-250) in human specimen

  • J Chromatogr B Analyt Technol Biomed Life Sci. 2026 May 1:1275:124995. doi: 10.1016/j.jchromb.2026.124995.
Cindy Bay  1 ,  Mariano Bergamino  1 ,  Max Sauter  1 ,  David Czock  1 ,  Christian Gege  2 ,  Antje Blank  1 ,  Gerald Kleymann  2 ,  Jürgen Burhenne  3
Affiliations
  • 1. Heidelberg University, Medical Faculty Heidelberg/Heidelberg University Hospital, Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany.
  • 2. Innovative Molecules GmbH, Lipowsky Str. 10, 81373 Munich, Germany.
  • 3. Heidelberg University, Medical Faculty Heidelberg/Heidelberg University Hospital, Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany. Electronic address: [email protected].
PMID: 41780214 DOI: 10.1016/j.jchromb.2026.124995
Abstract

Adibelivir (IM-250) is a novel helicase-primase inhibitor under development for the treatment of herpes simplex virus infections. A sensitive ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) assay was established for the quantification of adibelivir in human plasma and urine samples of a first-in-human clinical trial using a deuterated internal standard. This assay was validated based on the pertinent ICH M10 guideline for the linear range of 1-1000 ng/mL. The method fulfilled all criteria with a high inter-run accuracy of 100.0-101.4% and inter-run precision of 2.96-10.5%. The feasibility of the assay was shown for two healthy individuals by evaluating their pharmacokinetics of adibelivir. Additionally, the assay was adapted for the quantification of adibelivir in urine with a lowered calibration range of 0.1-100 ng/mL. The present work provides a fully validated assay for pharmacokinetic analyses of adibelivir in clinical development, e.g. in its first-in-human phase I trial (EudraCT 2022-003679-40).

Keywords
Adibelivir; Helicase-primase inhibitor; IM-250; Quantification; UPLC-MS/MS; Validation.
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