Drug Profile


Alternative Names: 4-Hydroxytamoxifen; 4-Hydroxytamoxifen (afimoxifene) gel; 4-Hydroxytamoxifen gel; 4-OH tamoxifen; 4-OHT; TamoGel

Latest Information Update: 02 Sep 2017

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At a glance

  • Originator Besins International
  • Developer Atossa Genetics; Besins Healthcare; BHR Pharma
  • Class Antineoplastics; Hydroxytestosterones; Non-opioid analgesics
  • Mechanism of Action Estrogen receptor antagonists; Selective estrogen receptor modulators
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Hyperplasia
  • Phase II Breast cancer
  • No development reported Breast pain; Gynaecomastia
  • Discontinued Keloids

Most Recent Events

  • 21 Aug 2017 Phase-III clinical trials in Hyperplasia in USA (Topical) (NCT03199963)
  • 03 Jul 2017 BHR Pharma plans a phase III trial for Hyperplasia (NCT03199963)
  • 31 May 2017 National Cancer Institute initiates enrolment in a phase IIb trial for Breast cancer in USA (Topical) (NCT02993159)
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