Drug Profile


Alternative Names: Donesta; E4

Latest Information Update: 01 Jun 2016

Price : $50

At a glance

  • Originator Pantarhei Bioscience
  • Class Gonadal steroid hormones; Hormonal replacements; Oral contraceptives; Small molecules
  • Mechanism of Action Estrogen receptor beta modulators
  • Orphan Drug Status

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

  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Atrophic vaginitis; Breast cancer; Osteoarthritis; Pregnancy; Vasomotor symptoms
  • Phase I Migraine; Prostate cancer
  • Discontinued Cardiovascular disorders; Multiple sclerosis; Sjogren's syndrome

Most Recent Events

  • 14 Apr 2016 Phase-II clinical trials in Vasomotor symptoms in Poland (PO, Capsule) (EudraCT2015-004018-44)
  • 01 Apr 2016 Estetra completes a phase I trial in Pregnancy prevention (In volunteers) in United Kingdom (PO) (NCT02720224)
  • 18 Mar 2016 Pantarhei Biosciences plans a phase I/II trial for Breast cancer (Late-stage disease, Second-line therapy or greater) in Armenia (NCT02718144)
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