Ulipristal acetate is a selective progesterone receptor modulator (SPRM) used for two primary indications:
1. As an emergency contraceptive (single-dose, within 120 hours of unprotected sex)
2. For the treatment of uterine fibroids in premenopausal women (in repeated 3-month courses)
Ulipristal acts by inhibiting or delaying ovulation and modulating endometrial activity. In fibroid treatment, it reduces fibroid size and controls bleeding by antagonizing progesterone receptors in uterine tissues.
Indications include:
∙ Emergency contraception (marketed as Ella® or EllaOne®)
∙ Uterine fibroids (marketed as Esmya® in some regions)
Parent: Ulipristal Acetate
Parent: Ulipristal
Ulipristal is synthesized via multi-step steroidal chemistry, and impurities may result from starting materials, intermediates, or degradation. As it is administered both orally and occasionally over multiple cycles, impurity levels must adhere to ICH Q3A/B and pharmacopeial guidelines.
Process-Related Impurities
Degradation Impurities
Elemental Impurities
Analytical Techniques for Impurity Detection
Ulipristal binds to progesterone receptors and modulates their activity. It acts as an antagonist in the endometrium and ovaries, inhibiting ovulation and suppressing fibroid growth.
Emergency contraceptive use is limited to occasional doses only, not as regular contraception. For fibroids, repeated courses are allowed but with monitoring for liver function and endometrial health.
Store at room temperature, protected from light and moisture. Keep in original packaging until use.
