Clarus Therapeutics’ Jatenzo (Testosterone Undecanoate Capsules for Oral Use) (CIII) Receives FDA’S Approval for Testosterone Replacement Therapy in Certain Adult Men

 Clarus Therapeutics’ Jatenzo (Testosterone Undecanoate Capsules for Oral Use) (CIII) Receives FDA’S Approval for Testosterone Replacement Therapy in Certain Adult Men

Clarus Therapeutics’ Jatenzo (Testosterone Undecanoate Capsules for Oral Use) (CIII) Receives FDA’S Approval for Testosterone Replacement Therapy in Certain Adult Men

Shots:

  • The approval is based on P-III inTUNE clinical trial assessing Jatenzo vs Axiron in 222 patients in ratio (3:1) for patients with hypogonadal male in adults
  • The study resulted: met 1EP as 87.3% of patients and the lower bound of the 95% confidence interval 81.3% met the FDA targets of ≥ 75% and ≥ 65% respectively, consistent with two earlier P-III data
  • Jatenzo is a softgel oral formulation of testosterone undecanoate for testosterone replacement therapy in certain adults available in three dosage form 158 mg, 198 mg and 237 mg administered twice daily with its expected marketing in H2’19

Click here to read full press release/ article | Ref: Clarus Therapeutics | Image: Twitter

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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