Tenax Therapeutics, Inc., a pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases, announced the successful completion of its comparative pharmacokinetic study of TNX-201, for the treatment of pulmonary arterial hypertension (“PAH”).
Tenax Therapeutics’ efforts to optimize its formulation of imatinib mesylate, TNX-201, have culminated in a modified release tablet that effectively minimizes gastric release while preserving bioavailability. The pharmacokinetic data from this trial showed that TNX-201 significantly exceeded Tenax’ relative bioavailability threshold (area under the curve (AUC)) when compared to reference Gleevec® tablets. These pharmacokinetic results are consistent with earlier in vitro dissolution data that indicated the formulation should limit gastric release while optimizing intestinal absorption.
Based on these pharmacokinetic findings, Tenax Therapeutics and its formulation partner are now manufacturing TNX-201 at the target scale for both the Phase 3 trial and future market demand.