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.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• Baseline phase 3 → approval rate +58.3pp
  Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

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

• 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

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

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).

Related

• 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