Kye Pharmaceuticals Licenses Zeqmelit for Canada
Mississauga-based Kye gains exclusive Canadian rights to AcuCort's rapidly dissolving dexamethasone oral film.
Updated on Nov. 9, 2026 in Healthcare
Kye Pharmaceuticals has signed an exclusive licence and distribution agreement with AcuCort AB for Zeqmelit in Canada, granting it rights to register, market, distribute and sell the product. Zeqmelit is a rapidly dissolving dexamethasone oral film, and a regulatory submission in Canada is planned for early 2027.
Why it matters
Zeqmelit's water-free film is placed on the tongue and dissolves to deliver dexamethasone through the lining of the mouth, which may help patients who cannot swallow during urgent inflammatory reactions. The deal extends the product's reach beyond its current Nordic markets as Kye expands its Canadian portfolio.
Kye has launched seven innovative prescription products in Canada since 2024, and the Canadian market serves roughly 40 million people. The agreement's upfront payment, milestone payments and royalty rates were not disclosed.
The players
Kye Pharmaceuticals
A Canadian specialty pharmaceutical company headquartered in Mississauga, Ontario, that focuses on launching innovative prescription products and was recognized on the Globe & Mail list of Canada's Top Growing Companies for 2025 and 2026.
AcuCort AB
A Swedish pharmaceutical company listed on the Spotlight Stock Market under ticker ACUC, which developed Zeqmelit and markets it in several Nordic countries.
Health Canada
The federal department responsible for regulating drugs and health products in Canada, whose marketing authorisation is required before Zeqmelit can launch.
The details
The agreement grants Kye exclusive rights to register, market, distribute and sell Zeqmelit in Canada, with compensation structured as an upfront payment, a regulatory milestone, milestone payments and royalties on net sales. AcuCort, which trades on the Spotlight Stock Market under ticker ACUC, already markets Zeqmelit in Sweden, Denmark, Norway and Finland, and holds a separate arrangement with Glenmark Pharmaceuticals for several European markets.
Timeline
November 9, 2026: Kye and AcuCort announced the licence and distribution agreement.
Early 2027: Planned regulatory submission for Zeqmelit in Canada.
2028: Expected launch in Canada, subject to Health Canada marketing authorisation.
Market Landscape
Specialty pharmaceutical companies are increasingly licensing European-developed products for North American distribution rather than building them in-house. Kye's arrangement with AcuCort follows that pattern, positioning Kye to add a differentiated delivery format to its Canadian portfolio.
Canadians who struggle to swallow medication could eventually have access to a dissolving oral film for dexamethasone rather than tablets. Any launch depends on Health Canada approval, which is not expected before 2028.
The takeaway
Products that solve practical administration problems, such as delivery for patients who cannot swallow, can create distinct commercial openings even in established drug categories. Readers tracking Canadian drug access should watch for the Health Canada submission in early 2027.
What happens next
Kye is expected to file for regulatory approval of Zeqmelit with Health Canada in early 2027, with a possible launch in 2028 if authorisation is granted.
Further reading
For more on how drug distribution deals shape the Canadian market, see the Healthcare section.
Source note: This article includes information reported by Simcoe Reformer.
