Cynata Therapeutics (ASX:CYP) has been notified by the World Health Organization that the name Pixenstrocel has been selected as the proposed International Nonproprietary Name (INN) for its Cymerus iPSC-derived mesenchymal stem cells.
The proposed INN is expected to appear in the WHO Drug Information List 136 of Proposed INN early in 2027, followed by a four-month comment period, with final confirmation anticipated around May 2027.
Cynata says the INN will describe the active agent used in its products, while existing product codes will remain in use.
The company currently identifies its final products with codes including CYP-001 for intravenous infusion, CYP-004 for intra-articular injection, and CYP-006TK for topical wound dressing, and says trade names will be chosen in due course and used alongside the INN.
Nuket Desem, Cynata’s Director of Regulatory and Scientific Affairs, said, "As we await the results of the Australian Phase 3 trial of CYP-004 in osteoarthritis and the multinational Phase 2 trial of CYP-001 in acute graft versus host disease, in parallel we are pursuing a number of important activities to progress towards our ultimate goal of seeking regulatory approval to market our products. Selection of an INN is one of these important activities, and we look forward to the final confirmation from the WHO next year."