Policy & Regulation
Ceruvia Lifesciences submits IND application to commence NYPRG-101 clinical study
22 June 2022 -

Ceruvia Lifesciences, a US-based neurotransformational medicine biopharmaceutical company, announced on Tuesday that it has submitted an IND application to commence a phase one, single centre, randomised, double blind, placebo controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NYPRG-101 (2-bromo-D-lysergic acid diethylamide) in healthy adult participants.

NYPRG-101 is being developed for the prevention of migraine. It is also referred to in the literature as BOL-148 and is a non-hallucinogenic analogue of LSD, differing by only one atom. It was first synthesized at Sandoz by Albert Hofmann in 1957 and was used as a placebo in early LSD trials. BOL-148 has been administered to over 150 humans (126 healthy volunteers and 28 patients) in clinical and experimental settings since the 1950s, with most of the research occurring prior to 1970. During these early studies, the product was observed to be non-hallucinogenic.

The Phase one single ascending dose (SAD) trial is to be conducted at a single clinical research site in the United States and will assess the safety, tolerability, pharmacokinetics and effects on neurocognitive functioning of healthy adult participants.

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