Last reviewed 2026-04-23 · How we verify

PGL4001, progestin

PregLem SA · Phase 3 active Small molecule

PGL4001, progestin is a Progestin (progesterone receptor agonist) Small molecule drug developed by PregLem SA. It is currently in Phase 3 development for Heavy menstrual bleeding, Preterm labor prevention. Also known as: Ulipristal acetate.

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

Generic name	PGL4001, progestin
Also known as	Ulipristal acetate
Sponsor	PregLem SA
Drug class	Progestin (progesterone receptor agonist)
Target	Progesterone receptor (PR)
Modality	Small molecule
Therapeutic area	Gynecology / Women's Health
Phase	Phase 3

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

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

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Frequently asked questions about PGL4001, progestin

What is PGL4001, progestin?

PGL4001, progestin is a Progestin (progesterone receptor agonist) drug developed by PregLem SA, indicated for Heavy menstrual bleeding, Preterm labor prevention.

How does PGL4001, progestin work?

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

What is PGL4001, progestin used for?

PGL4001, progestin is indicated for Heavy menstrual bleeding, Preterm labor prevention.

Who makes PGL4001, progestin?

PGL4001, progestin is developed by PregLem SA (see full PregLem SA pipeline at /company/preglem-sa).

Is PGL4001, progestin also known as anything else?

PGL4001, progestin is also known as Ulipristal acetate.

What drug class is PGL4001, progestin in?

PGL4001, progestin belongs to the Progestin (progesterone receptor agonist) class. See all Progestin (progesterone receptor agonist) drugs at /class/progestin-progesterone-receptor-agonist.

What development phase is PGL4001, progestin in?

PGL4001, progestin is in Phase 3.

What are the side effects of PGL4001, progestin?

Common side effects of PGL4001, progestin include Headache, Abdominal pain, Nausea, Breast tenderness.

What does PGL4001, progestin target?

PGL4001, progestin targets Progesterone receptor (PR) and is a Progestin (progesterone receptor agonist).

Drug class: All Progestin (progesterone receptor agonist) drugs
Target: All drugs targeting Progesterone receptor (PR)
Manufacturer: PregLem SA — full pipeline
Therapeutic area: All drugs in Gynecology / Women's Health
Indication: Drugs for Heavy menstrual bleeding
Indication: Drugs for Preterm labor prevention
Also known as: Ulipristal acetate
Compare: PGL4001, progestin vs similar drugs
Pricing: PGL4001, progestin cost, discount & access