Tenax Nears 230-Patient Phase III Enrollment, Second Global Trial Kicks Off
Tenax Therapeutics is completing enrollment in its first 230-patient Phase III levosimendan trial across North America, expects finish in H1 and report data in H2. The company launched a second Phase III in Q4 with two-year recruitment and cites open-label oral data showing >20% BNP reduction and six-minute walk gains.
1. Enrollment Progress and Timeline
Tenax Therapeutics is finalizing enrollment in its first Phase III levosimendan trial, randomizing 230 patients across the U.S. and Canada and expecting to complete recruitment in H1 with data reported in H2.
2. Global Second Phase III Trial
The company initiated a second global Phase III study in Q4 with a two-year recruitment period, mirroring inclusion criteria of the U.S.-Canada trial to ensure a well-powered comparison.
3. Open-Label Oral Results
Open-label oral data from the extension showed more than 20% reductions in BNP levels, improvements in six-minute walk distance and favorable pharmacokinetics with high patient adherence at 3 mg dosing.
4. Market Size and Mechanism
Tenax targets an addressable market of roughly 2 million PH-HFpEF patients in the U.S. and Europe, leveraging levosimendan’s vasodilatory effects to reduce preload and wedge pressure in this symptomatic population.