Testosterone undecanoate - Clarus Therapeutics

Drug Profile

Testosterone undecanoate - Clarus Therapeutics

Alternative Names: CLR-610; Jatenzo; Oral TU - Clarus; OriTex™; Rextoro; TE - Clarus Therapeutics; Testosterone prodrug; TU

Latest Information Update: 12 Nov 2018

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At a glance

  • Originator Clarus Therapeutics
  • Class Anabolic steroids; Androstenols; Hormonal replacements; Small molecules; Testosterone congeners
  • Mechanism of Action Testosterone replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Hypogonadism

Most Recent Events

  • 17 Mar 2018 Updated efficacy, adverse events and pharmacokinetics data from the phase III inTUne trial in Hypogonadism presented at the the 100th Annual Meeting of the Endocrine Society (ENDO-2018).
  • 16 Jan 2018 The Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of US FDA votes against benefit/risk profile of testosterone undecanoate for Hypogonadism
  • 26 Jun 2017 Clarus Therapeutics re-submits NDA with the US FDA for Hypogonadism
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