Kye Pharmaceuticals signs licensing and distribution agreement with Neurim for SLENYTO® in Canada
Wednesday, January 14, 2026
Kye Pharmaceuticals, a Canadian specialty pharmaceutical company, has entered into a licensing and distribution agreement with Neurim Pharmaceuticals for SLENYTO® (extended-release melatonin) in Canada.
SLENYTO® is the first and only prescription extended-release melatonin developed specifically to treat insomnia in children and adolescents with Autism Spectrum Disorder (ASD) and/or Smith-Magenis Syndrome (SMS). The product received marketing authorisation from Health Canada in September 2025. It is already approved in several international markets, including Germany, France and the UK, and addresses sleep disturbances, a common and significant condition in children with ASD and SMS.
Under the agreement, Kye Pharmaceuticals will manage regulatory activities, commercialisation and distribution of SLENYTO® in the Canadian market.
The partnership supports Kye’s focus on providing specialised therapies for patients with unmet medical needs. Sleep disorders, particularly insomnia, place a considerable burden on children with autism and their families, and SLENYTO® offers a prescription-grade, child-appropriate extended-release treatment designed for this specific patient group.
SLENYTO® was developed by Neurim Pharmaceuticals using its proprietary extended-release melatonin technology and expertise in circadian rhythm and sleep disorders. The collaboration aims to expand access to a targeted paediatric treatment for insomnia and improve care for children with neurodevelopmental conditions in Canada.
Source: prnewswire.com
