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Ulipristal Acetate - open label
Ulipristal acetate is a selective progesterone receptor modulator that acts as an antagonist to progesterone.
Ulipristal acetate is a selective progesterone receptor modulator that acts as an antagonist to progesterone. Used for Emergency contraception, Treatment of moderate to severe symptoms of uterine fibroids.
At a glance
| Generic name | Ulipristal Acetate - open label |
|---|---|
| Also known as | PGL4001 |
| Sponsor | PregLem SA |
| Drug class | Selective progesterone receptor modulator |
| Target | Progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Reproductive health |
| Phase | Phase 3 |
Mechanism of action
By binding to the progesterone receptor, ulipristal acetate inhibits the action of progesterone, which is essential for the growth and maintenance of the endometrium. This mechanism of action is thought to be responsible for its contraceptive effects. Additionally, ulipristal acetate has been shown to have antiproliferative effects on endometrial cells, which may contribute to its contraceptive efficacy.
Approved indications
- Emergency contraception
- Treatment of moderate to severe symptoms of uterine fibroids
Common side effects
- Nausea
- Headache
- Dysmenorrhea
- Vaginal bleeding
Key clinical trials
- Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive (PHASE2)
- A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions (PHASE3)
- Safety and Efficacy of CDB-2914 for Emergency Contraception (PHASE3)
- Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned (PHASE1)
- Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female Subjects (PHASE1)
- A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet (PHASE1)
- Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids (PHASE2)
- PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ulipristal Acetate - open label CI brief — competitive landscape report
- Ulipristal Acetate - open label updates RSS · CI watch RSS
- PregLem SA portfolio CI