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Drospirenone/estetrol - Mithra Pharmaceuticals

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Drug Profile

Drospirenone/estetrol - Mithra Pharmaceuticals

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

Latest Information Update: 27 Dec 2024

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At a glance

  • Originator Estetra S.A.
  • Developer Estetra SPRL; Fuji Pharmaceutical; Gedeon Richter; Libbs Farmaceutica; Lotus Pharmaceuticals; 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.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes - Pregnancy

Highest Development Phases

  • Marketed Pregnancy
  • Registered Dysmenorrhoea
  • Phase III Endometriosis
  • Discontinued Hot flashes; Vasomotor symptoms

Most Recent Events

  • 24 Sep 2024 Registered for Dysmenorrhoea in Japan (PO)
  • 03 Jun 2024 Searchlight Pharma has been acquired by Apotex
  • 13 May 2024 Mithra Pharmaceuticals receives two patent protections for Drospirenone/estetrol in the US

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