Hikma Pharmaceuticals and Marius Pharmaceuticals announce licensing agreement for KYZATREX® (testosterone undecanoate) CIII capsules in Canada
Raleigh, NC and London, UK, 5 May 2026 –Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Canada Limited (Hikma) and Marius Pharmaceuticals (Marius) today announced a licensing agreement for the commercialization and distribution of KYZATREX® (testosterone undecanoate) CIII capsules in Canada. Under the terms of the agreement, Hikma will license KYZATREX® from Marius and will be responsible for the regulatory filings, commercialization, and distribution of KYZATREX® in Canada. KYZATREX® is an oral prescription drug indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism). Please see full indication statement in the Product Monograph once authorized at https://pdf.hres.ca/dpd_pm/00082355.PDF.
“Hikma is a market leader in providing Canadian patients with high-quality injectable hormone medicines and we are excited to partner with Marius following regulatory authorization,” said Mike Armstrong, Hikma’s Canada Country Director.
“We are pleased to partner with Hikma to bring KYZATREX® to the Canadian market,” said Amit Shah, COO of Marius Pharmaceuticals. “Through Hikma’s commercial infrastructure and experience working with the Canadian healthcare system, the company expects to support access to KYZATREX® for the Canadian market, subject to regulatory authorization.”
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KYZATREX® has associated risks. Healthcare professionals should consult the Canadian Product Monograph once available.
KYZATREX® is a registered trademark of Marius Pharmaceuticals
About Hikma:
Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com
Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB/stable S&P and BBB/stable Fitch)
About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal
EVP, Strategic Planning and Global Affairs
+44 (0)20 7399 2760/ +44 7776 477050
Steven Weiss
US Communications +1 732 788 8279
Marius Pharmaceuticals
Lilly Washburn
Senior Manager, Marketing & Communications lilly@mariuspharma.com