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: 05 Oct 2016

Price : $50

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.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Hypogonadism

Most Recent Events

  • 29 Sep 2016 Clarus Therapeutics plans a phase II pharmacokinetics trial for Hypogonadism in USA (PO) (NCT02921386)
  • 15 Jun 2016 Clarus Therapeutics completes enrolment in the phase III inTUne trial for Hypogonadism in USA (NCT02722278)
  • 17 May 2016 Clarus Therapeutics receives complete response letter from the US FDA for testosterone undecanoate in Hypogonadism before May 2016
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