Ulipristal - HRA Pharma
Alternative Names: CDB-2914; ella; ellaOne; Esmya; Fibristal; HRP 2000; PGL-4001; RTI 3021-12; RU 44675; Ulipristal acetate; UPA; UPA C-IUS; UPA C-ring; UPA-IUS; UPA-UF; UPA-VR; VA-2914Latest Information Update: 10 Feb 2025
At a glance
- Originator HRA Pharma; National Institutes of Health (USA)
- Developer AbbVie; ASKA Pharmaceutical; Gedeon Richter; HRA Pharma; Population Council (USA); PregLem
- Class Antineoplastics; Norpregnadienes; Oral contraceptives; Small molecules
- Mechanism of Action Selective progesterone receptor modulators
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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 - Female genital diseases; Uterine leiomyoma
Highest Development Phases
- Marketed Pregnancy; Uterine leiomyoma
- Discontinued Breast cancer; Endometriosis; Menopausal syndrome
Most Recent Events
- 10 Feb 2025 Planned Prescription Drug User Fee Act (PDUFA) date for Uterine leiomyoma in USA (PO) is 2018-08-31
- 18 Jul 2024 Regulatory submission withdrawn for Uterine leiomyoma in European Union (PO)
- 18 Jul 2024 European commission withdraws marketing approval for Uterine leiomyoma in European Union (PO)