INDIANAPOLIS – October 28, 2026 -- Carnyx Therapeutics has advanced its lead oral sleep candidate, CNYX-005, into Investigational New Drug (IND)-enabling development, bringing the preclinical asset closer to potential first-in-human studies.
Aged-rat data show 1.5 to 2 hours of added sleep
In recently reported preclinical findings, CNYX-005 increased total sleep time by roughly 1.5 to 2 hours versus controls in aged rats. The gain was driven primarily by increased non-rapid eye movement (NREM) sleep. Chief Medical Officer Chris Brearley said existing treatments are limited by safety, tolerability and long-term use concerns, which he cited as the case for additional options.
IND-enabling program targets safety, toxicology and dose selection
The program will characterize CNYX-005's safety, tolerability, toxicology, pharmacokinetics, exposure profile and dose selection parameters. These data are intended to support an IND submission and first-in-human clinical studies.
Epitalon origins put Carnyx in a regulatory spotlight
CNYX-005 originated from research involving Epitalon, a peptide popular in longevity and biohacking circles for its proposed effects on aging and sleep. The U.S. Food and Drug Administration (FDA) has noted that compounded Epitalon lacks sufficient human safety data. CEO Patrick Gunning drew a line between consumer-wellness hype and a candidate in formal development, saying the process is designed to "establish how a candidate behaves in the body."
Sleep-drug market forecast to reach $44.08 billion by 2032
IndustryARC projects the global sleep-disorder treatment drugs market will double from 2025 to 2032, reaching US$44.08 billion. Carnyx is also developing CNYX-001 for retinitis pigmentosa, though the source gives no development timeline for either program.