Carnyx targets 2027 IND filing for oral sleep candidate CNYX-005

About one in three U.S. adults sleeps less than the seven hours a night that the Centers for Disease Control and Prevention recommends, a share that held steady from 2013 to 2022. Commonly used sleep medications also raise safety concerns, particularly for older adults. In a Seattle study that followed 3,434 adults aged 65 and older for an average of 7.3 years, people with the heaviest cumulative use of strong anticholinergic drugs, a class that includes the first-generation antihistamines in many over-the-counter sleep aids, had a 54% higher risk of dementia. A Quebec study associated more than 180 prescribed daily doses of benzodiazepines with 84% higher odds of Alzheimer’s disease. In addition, the American Geriatrics Society’s Beers Criteria advise against benzodiazepines and “Z-drugs” such as zolpidem for older adults because of falls, fractures and delirium.

The popular eight-hour sleep target doesn’t encompass the concept of sleep architecture, which describes the stages of sleep and how people cycle through them during the night. Deep NREM sleep is associated with memory consolidation, and researchers are investigating how sleep physiology influences the clearance of metabolic waste, including beta-amyloid, from the brain.

Carnyx Therapeutics, a preclinical-stage drug developer in Indianapolis, is aiming to make sleep architecture a priority. On Oct. 27, it announced that its oral sleep candidate, CNYX-005, had entered IND-enabling development, involving the safety, toxicology and dosing studies that precede an Investigational New Drug (IND) application to the FDA and potential first-in-human testing. Carnyx aims to file the IND at the end of the third quarter or early in the fourth quarter of 2027, the company told R&D World over email.

In aged rats, CNYX-005 increased total sleep time by about 1.5 to 2 hours compared with controls, primarily through increased NREM sleep, Carnyx reported Oct. 14. The company measured the rats’ sleep with implanted electrodes that record the brain’s electrical activity (EEG). “Our objective is not simply to induce sleep, but to investigate whether we can support restorative sleep physiology,” Chief Executive Patrick Gunning said when the company released the data. The findings establish an increase in total NREM sleep, while the extent to which deeper slow-wave sleep contributed to that increase remains unclear.

Gunning, a medicinal chemist who holds professorships at the University of Glasgow and the University of Toronto, has built drug companies before. He co-founded Janpix, a cancer-drug startup that in 2021 became one of 10 companies the investor Medicxi combined to launch Centessa Pharmaceuticals. Centessa later centered its pipeline on orexin receptor 2 agonists for narcolepsy and other disorders of excessive sleepiness, and Eli Lilly completed its purchase of Centessa in June 2026, paying about $6.3 billion upfront plus up to about $1.5 billion more tied to FDA approvals. Chris Brearley, whose hiring as chief medical officer Carnyx announced Oct. 14, has spent more than 30 years in early drug development, including senior roles at Pfizer, Amgen and Serono. Carnyx lists $12 million raised to date and a second program, CNYX-001, an eye drop for retinitis pigmentosa, an inherited disease that destroys the retina’s light-sensing cells.

If CNYX-005 works in people, it would compete with drugs that act on other targets. Benzodiazepines and Z-drugs enhance GABA-mediated inhibition in the brain. In April 2019, the FDA announced a boxed warning for the Z-drugs eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien) after rare but serious injuries, some fatal, during sleepwalking, sleep driving and other complex sleep behaviors. Orexin receptor antagonists block a wake-promoting brain signal. The FDA approved Merck’s Belsomra (suvorexant) in 2014, Eisai’s Dayvigo (lemborexant) in 2019 and Idorsia’s Quviviq (daridorexant) in 2022, and Johnson & Johnson is testing seltorexant, which blocks only the orexin-2 receptor, in phase 3 trials in depression with insomnia symptoms.

An earlier drug developed to deepen slow-wave sleep, Merck and Lundbeck’s gaboxadol, increased slow-wave sleep in trials before the partners ended its phase 3 program in 2007.

CNYX-005 grew out of research involving Epitalon, a synthetic four-amino-acid peptide that has drawn interest in longevity and biohacking circles for its proposed effects on aging and sleep. Carnyx has yet to publicly disclose CNYX-005’s molecular target or its chemical relationship to Epitalon, according to the company’s Nov. 6 response to questions from R&D World.

The FDA placed Epitalon in Category 2 of its compounding lists, for substances that may pose significant safety risks, in September 2023 and removed it from that category in April 2026. FDA staff subsequently recommended against adding it to the list of bulk drug substances eligible for compounding under Section 503A, citing gaps in impurity data and potential immunogenicity risks. On July 24, the agency’s Pharmacy Compounding Advisory Committee voted 7-4, with one abstention, to recommend its inclusion. The vote is advisory, and FDA rulemaking would be required to add Epitalon to the 503A list. “There’s a fundamental difference between a compound generating hype in consumer wellness communities and a distinct therapeutic candidate like CNYX-005, which is undergoing the formal drug development process,” Gunning said in the company’s Oct. 27 announcement.

The next phase of development will characterize CNYX-005’s safety, tolerability, toxicology, pharmacokinetics, exposure and dose-selection parameters ahead of the company’s planned fall 2027 IND filing. Subsequent human studies would begin to test whether the longer NREM sleep observed in aged rats translates into improvements in human sleep.