FDA green­lights Mar­ius' oral hy­pog­o­nadism pill; VBL Ther­a­peu­tics makes cuts to its work­force

The FDA has ap­proved Mar­ius’ testos­terone re­place­ment treat­ment for adult males with hy­pog­o­nadism, or testos­terone de­fi­cien­cy.

The oral drug, to be mar­ket­ed as Kyza­trex, will be avail­able at three dif­fer­ent dos­es — 100, 150 and 200mg — and the pill would be tak­en twice dai­ly. The drug was ap­proved on the back of a Phase III pro­gram with 155 males with hy­pog­o­nadism. Of the men who got Kyza­trex, 88% had an av­er­age testos­terone lev­el with­in a nor­mal range by the three-month mark.

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