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PGL4001
PGL4001 is a selective progesterone receptor modulator that acts as a progesterone agonist to reduce uterine contractions and bleeding.
PGL4001 is a selective progesterone receptor modulator that acts as a progesterone agonist to reduce uterine contractions and bleeding. Used for Heavy menstrual bleeding, Uterine fibroids (leiomyomas).
At a glance
| Generic name | PGL4001 |
|---|---|
| Also known as | Ulipristal acetate |
| Sponsor | PregLem SA |
| Drug class | Selective progesterone receptor modulator (SPRM) |
| Target | Progesterone receptor (PR) |
| Modality | Small molecule |
| Therapeutic area | Gynecology / Women's Health |
| Phase | Phase 3 |
Mechanism of action
PGL4001 (ulipristal acetate) selectively binds to progesterone receptors in the uterus, modulating endometrial and myometrial function. By acting as a progesterone receptor agonist, it reduces abnormal uterine bleeding and suppresses uterine contractions, making it effective for managing heavy menstrual bleeding and potentially other gynecological conditions related to progesterone signaling.
Approved indications
- Heavy menstrual bleeding
- Uterine fibroids (leiomyomas)
Common side effects
- Headache
- Abdominal pain
- Nausea
- Amenorrhea
- Hot flushes
Key clinical trials
- Mammogram Pretreatment With Ulipristal Acetate (PHASE2)
- PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PHASE3)
- PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PHASE3)
- PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study) (PHASE3)
- PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PHASE3)
- PGL4001 Versus GnRH-agonist in Uterine Myomas (PHASE3)
- PGL4001 Versus Placebo in Uterine Myomas (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:
- PGL4001 CI brief — competitive landscape report
- PGL4001 updates RSS · CI watch RSS
- PregLem SA portfolio CI