E8001 / Eisai - LARVOL DELTA

Quantification of PEG2000-DMG and TS-202, an ionic lipid, in rabbit plasma by LC-MS/MS: Application to complement C5 siRNA lipid nanoparticles. (PubMed, J Pharm Biomed Anal) - "A simple and robust assay was developed for the quantification of PEG2000-DMG and TS-202, key components of the lipid nanoparticle (LNP) formulation of E8001-LNP, which encapsulates small-interfering RNA targeting complement C5, in rabbit plasma...Detection was performed using selected reaction monitoring in positive ion mode, with mass transitions of m/z 780.8 → 698.9 for PEG2000-DMG and m/z 650.5 → 126.3 for TS-202...Application to a toxicokinetic study in rabbits revealed that PEG2000-DMG was eliminated much faster than TS-202. The incurred sample reanalysis further confirmed the assay reproducibility."

Journal • Preclinical

A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Eisai Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion

A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Eisai Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Eisai Co., Ltd. | Trial completion date: Sep 2022 ➔ Sep 2023 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date