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Drospirenone/estetrol - Mithra Pharmaceuticals

Drug Profile

Drospirenone/estetrol - Mithra Pharmaceuticals

Alternative Names: DRSP/E4; E4/DRSP; Estelle; Estetrol/Drospirenone; FSN-013; Lydisilka; Nextstellis; PeriNesta™

Latest Information Update: 31 May 2021

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At a glance

  • Originator Estetra S.A.
  • Developer Fuji Pharmaceutical; Libbs Farmaceutica; Mayne Pharma Group; Mithra Pharmaceuticals; Searchlight Pharma
  • Class Androstenes; Anti-inflammatories; Anti-ischaemics; Antiandrogens; Antimigraines; Antineoplastics; Antirheumatics; Cardiovascular therapies; Gonadal steroid hormones; Hormonal replacements; Oral contraceptives; Progesterone congeners; Small molecules
  • Mechanism of Action Estrogen receptor agonists; Hormone replacements; Mineralocorticoid receptor antagonists; Progesterone receptor agonists; Testosterone congener inhibitors
  • Orphan Drug Status

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

  • New Molecular Entity Yes
  • Available For Licensing Yes - Pregnancy

Highest Development Phases

  • Registered Pregnancy

Most Recent Events

  • 27 May 2021 Drospirenone/estetrol receives US FDA marketing exclusivity for five years
  • 21 May 2021 Registered for Pregnancy (Prevention) in Norway, Liechtenstein, Iceland, European Union (PO)
  • 30 Apr 2021 Efficacy data from a phase III E4 FREEDOM clinical trials in Pregnancy presented at the American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting (ACOG-2021)
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