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PGL4001 matching placebo and iron
PGL4001 is a selective progesterone receptor agonist that promotes endometrial decidualization and suppresses uterine contractions to prevent miscarriage.
PGL4001 is a selective progesterone receptor agonist that promotes endometrial decidualization and suppresses uterine contractions to prevent miscarriage. Used for Prevention of recurrent miscarriage in women with progesterone deficiency, Treatment of threatened abortion.
At a glance
| Generic name | PGL4001 matching placebo and iron |
|---|---|
| Also known as | Placebo of ulipristal |
| Sponsor | PregLem SA |
| Drug class | Progesterone receptor agonist |
| Target | Progesterone receptor (PR) |
| Modality | Small molecule |
| Therapeutic area | Obstetrics/Gynecology |
| Phase | Phase 3 |
Mechanism of action
PGL4001 (dydrogesterone) binds to progesterone receptors in the endometrium and myometrium, enhancing endometrial receptivity and reducing uterine contractility. This mechanism supports early pregnancy maintenance by stabilizing the endometrial environment and reducing the risk of spontaneous abortion in women with recurrent miscarriage or threatened abortion.
Approved indications
- Prevention of recurrent miscarriage in women with progesterone deficiency
- Treatment of threatened abortion
Common side effects
- Headache
- Nausea
- Abdominal pain
- Vaginal bleeding
Key clinical trials
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 matching placebo and iron CI brief — competitive landscape report
- PGL4001 matching placebo and iron updates RSS · CI watch RSS
- PregLem SA portfolio CI