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Estetrol - Mithra Pharmaceuticals/Pantarhei Bioscience

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Drug Profile

Estetrol - Mithra Pharmaceuticals/Pantarhei Bioscience

Alternative Names: Donesta; E4; Estetrol

Latest Information Update: 05 Mar 2024

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At a glance

  • Originator Pantarhei Bioscience
  • Developer Estetra SPRL; Mithra Pharmaceuticals; Pantarhei Bioscience
  • Class Anti-inflammatories; Anti-ischaemics; Antimigraines; Antineoplastics; Antirheumatics; Cardiovascular therapies; Gonadal steroid hormones; Hormonal replacements; Oral contraceptives; Small molecules
  • Mechanism of Action Estrogen receptor agonists
  • Orphan Drug Status

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

    Yes - Cerebral ischaemia
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Vasomotor symptoms
  • Phase II Atrophic vaginitis; Breast cancer; COVID 2019 infections; Female sexual dysfunction; Osteoarthritis; Pregnancy; Prostate cancer
  • Phase I Cerebral ischaemia
  • Preclinical Wounds
  • No development reported Migraine
  • Discontinued Cardiovascular disorders; Multiple sclerosis; Sjogren's syndrome

Most Recent Events

  • 01 Mar 2024 Estetra completes a phase III E4Comfort Study I trial in Vasomotor symptoms in US, Argentina, Brazil, Romania, Russia, Canada, Czech Republic, United Kingdom, Lithuania, Spain, Hungary, Poland, Slovakia, Italy (PO) (NCT04209543)
  • 29 Jan 2024 Phase-II clinical trials in Female sexual dysfunction in USA (unspecified route) (NCT06308614)
  • 21 Dec 2023 Mithra Pharmaceuticals signs a binding Heads of Terms agreement with Rafa Laboratories to commercialise DONESTA® in Israel and the Palestinian territories
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