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Jatenzo FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 6, 2019.

FDA Approved: Yes (First approved March 27, 2019)
Brand name: Jatenzo
Generic name: testosterone undecanoate
Dosage form: Capsules
Company: Clarus Therapeutics, Inc.
Treatment for: Hypogonadism, Male

Jatenzo (testosterone undecanoate) is an oral testosterone replacement therapy for the treatment of low testosterone in hypogonadal men.

  • Jatenzo capsules are taken twice daily with food.
  • The Jatenzo product label contains a boxed warning stating that the drug can cause blood pressure to rise, increasing the risk of heart attack, stroke and cardiovascular death. Healthcare providers should consider a patient’s individual heart disease risks and ensure that blood pressure is adequately controlled before prescribing Jatenzo; they should also periodically monitor patient blood pressure during treatment.
  • Common adverse reactions include polycythemia, diarrhea, dyspepsia, eructation, peripheral edema, nausea, increased hematocrit, headache, prostatomegaly, and hypertension.

Development timeline for Jatenzo

Mar 27, 2019Approval FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism
Jun 26, 2017Clarus Re-submits Jatenzo NDA Following Positive Results of inTUne Trial
Jan 13, 2014Clarus Therapeutics Submits New Drug Application for Rextoro (formerly CLR-610) for the treatment of Low Testosterone

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.