Last reviewed 2026-04-23 · How we verify

PGL4001, progestin

PGL4001 is a selective progesterone receptor agonist that mimics the action of the natural hormone progesterone to modulate uterine contractility and endometrial function.

PGL4001 is a selective progesterone receptor agonist that mimics the action of the natural hormone progesterone to modulate uterine contractility and endometrial function. Used for Heavy menstrual bleeding, Preterm labor prevention.

At a glance

Mechanism of action

As a progestin, PGL4001 binds to progesterone receptors in the uterus and endometrium, suppressing myometrial contractions and promoting endometrial changes that support pregnancy maintenance or prevent abnormal uterine bleeding. This mechanism allows it to address conditions where progesterone deficiency or receptor dysfunction contributes to pathology, such as heavy menstrual bleeding or preterm labor prevention.

Approved indications

• Heavy menstrual bleeding
• Preterm labor prevention

Common side effects

• Headache
• Abdominal pain
• Nausea
• Breast tenderness

Key clinical trials

• 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)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• PGL4001, progestin CI brief — competitive landscape report
• PGL4001, progestin updates RSS · CI watch RSS
• PregLem SA portfolio CI