Drug Profile
Drospirenone/estetrol - Mithra Pharmaceuticals
Alternative Names: ALYSSA; Drovelis; DRSP/E4; E4/DRSP; Estelle; Estetrol/Drospirenone; FSN-013; Lydisilka; Nextstellis; PeriNesta™Latest Information Update: 07 Dec 2023
Price :
$50
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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
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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
- Marketed Pregnancy
- Preregistration Dysmenorrhoea
- Phase III Endometriosis
- Discontinued Hot flashes; Vasomotor symptoms
Most Recent Events
- 04 Dec 2023 Mithra Pharmaceuticals signs a binding Heads of Terms agreement with Gedeon Richter to develop and commercialize ESTELLE® and DONESTA® in China
- 24 Nov 2023 Estetra completes a phase III trial for Pregnancy (Prevention, In adolescents) in Estonia, Finland, Georgia, Latvia, Poland, and Sweden (PO) (NCT04792385) (EudraCT2019-003002-27)
- 03 Nov 2023 Mayne Pharma receives additional patent protection ,, for Drospirenone/estetrol in the US