At a glance
- Originator Gynetics
- Developer Gynetics; Shire
- Class Hormonal replacements; Norpregnanes; Oral contraceptives; Small molecules
- Mechanism of Action Progesterone receptor agonists
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
On Fast track
Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.
- New Molecular Entity No
Highest Development Phases
- Registered Contraception
Most Recent Events
- 15 Mar 2016 Biomarkers information updated
- 26 Jun 2000 Registered for Contraception in Canada (PO)
- 26 Jun 2000 Registered for Contraception in USA (PO)