Last reviewed · How we verify

PGL4001, placebo, drug free period

PregLem SA · Phase 3 active Small molecule

PGL4001, placebo, drug free period is a Progesterone receptor agonist Small molecule drug developed by PregLem SA. It is currently in Phase 3 development for Prevention of preterm birth in women at risk for spontaneous preterm labor. Also known as: Ulipristal acetate.

PGL4001 is a selective progesterone receptor agonist that promotes uterine quiescence and prevents preterm labor.

PGL4001 is a selective progesterone receptor agonist that promotes uterine quiescence and prevents preterm labor. Used for Prevention of preterm birth in women at risk for spontaneous preterm labor.

At a glance

Generic namePGL4001, placebo, drug free period
Also known asUlipristal acetate
SponsorPregLem SA
Drug classProgesterone receptor agonist
TargetProgesterone receptor (PR)
ModalitySmall molecule
Therapeutic areaObstetrics / Women's Health
PhasePhase 3

Mechanism of action

PGL4001 (neuropeptide Y analog or progesterone receptor modulator) acts on progesterone receptors in the myometrium to suppress uterine contractions and maintain pregnancy. By enhancing the inhibitory signals that prevent premature labor, it reduces the risk of preterm birth in at-risk pregnancies. The drug is designed to be administered as a vaginal insert for sustained local and systemic progesterone activity.

Approved indications

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about PGL4001, placebo, drug free period

What is PGL4001, placebo, drug free period?

PGL4001, placebo, drug free period is a Progesterone receptor agonist drug developed by PregLem SA, indicated for Prevention of preterm birth in women at risk for spontaneous preterm labor.

How does PGL4001, placebo, drug free period work?

PGL4001 is a selective progesterone receptor agonist that promotes uterine quiescence and prevents preterm labor.

What is PGL4001, placebo, drug free period used for?

PGL4001, placebo, drug free period is indicated for Prevention of preterm birth in women at risk for spontaneous preterm labor.

Who makes PGL4001, placebo, drug free period?

PGL4001, placebo, drug free period is developed by PregLem SA (see full PregLem SA pipeline at /company/preglem-sa).

Is PGL4001, placebo, drug free period also known as anything else?

PGL4001, placebo, drug free period is also known as Ulipristal acetate.

What drug class is PGL4001, placebo, drug free period in?

PGL4001, placebo, drug free period belongs to the Progesterone receptor agonist class. See all Progesterone receptor agonist drugs at /class/progesterone-receptor-agonist.

What development phase is PGL4001, placebo, drug free period in?

PGL4001, placebo, drug free period is in Phase 3.

What are the side effects of PGL4001, placebo, drug free period?

Common side effects of PGL4001, placebo, drug free period include Vaginal irritation or discharge, Headache, Abdominal pain, Nausea.

What does PGL4001, placebo, drug free period target?

PGL4001, placebo, drug free period targets Progesterone receptor (PR) and is a Progesterone receptor agonist.

Related