No Fridge Required for Nitisinone Tablets Approved in Canada

CYCLE Pharmaceuticals is pleased to announce that CYCLE’s Nitisinone Tablets have been approved by Health Canada for the treatment of Hereditary Tyrosinemia type 1 (HT-1). This is the first Nitisinone product to be approved anywhere in the world that can be stored at room temperature ‑ refrigeration is not required. CYCLE’s Nitisinone Tablets are also proven to be effective when taken with or without food.

Nitisinone is used to treat HT-1 alongside dietary restrictions and is a lifelong drug treatment.

HT-1 is a rare metabolic disease with at least 1,000 patients worldwide.  The prevalence of HT-1 is high in Quebec with approximately 100 people affected. For this reason, CYCLE Pharmaceuticals targeted Canada for its first Nitisinone Tablets approval, working alongside Health Canada to reach HT-1 patients as quickly as possible.

“Nitisinone is a life-long twice-a-day treatment for HT-1 patients.  CYCLE has worked with physicians and patient groups to reduce the impact that this treatment has on their daily lives. It has taken us more than 4 years to develop a Nitisinone Tablet that meets patients’ needs, ensuring the same medical treatment. We are keen to see patients fully benefitting from the new characteristics our product brings, and are looking forward to working with patients, caregivers and physicians to continue to improve the support for the HT-1 community.” said Antonio Benedetti, CEO, CYCLE Pharmaceuticals.

Available in three strengths, 2 mg, 5 mg and 10 mg, Nitisinone Tablets are manufactured and packaged in Switzerland.

For further information on Nitisinone Tablets, please visit

About Cycle Pharmaceuticals

Cycle Pharmaceuticals is a Cambridge-based pharmaceutical company that optimises and increases access to existing pharmaceuticals. Specifically, Cycle focuses on three areas of pharmaceutical development:

  • Improving orphan drugs, which treat the under-served rare disease patient community;
  • Reinstating drug products that have been previously marketed;
  • Working with our academic and other partners to extend pharmaceuticals to new medical areas where there is clear unmet need.

For further information, please visit