PGL4001, progestin, drug free period

PregLem SA · Phase 3 active Small molecule

PGL4001, progestin, drug free period is a Progestin / Selective Progesterone Receptor Modulator Small molecule drug developed by PregLem SA. It is currently in Phase 3 development for Hormonal contraception with scheduled menstrual cycling. Also known as: Ulipristal acetate.

PGL4001 is a selective progesterone receptor modulator that provides contraceptive and menstrual regulation effects through progestin activity with a structured drug-free period.

PGL4001 is a selective progesterone receptor modulator that provides contraceptive and menstrual regulation effects through progestin activity with a structured drug-free period. Used for Hormonal contraception with scheduled menstrual cycling.

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, drug free period
Also known as	Ulipristal acetate
Sponsor	PregLem SA
Drug class	Progestin / Selective Progesterone Receptor Modulator
Target	Progesterone receptor
Modality	Small molecule
Therapeutic area	Contraception / Women's Health
Phase	Phase 3

Mechanism of action

PGL4001 acts as a progestin to suppress ovulation and alter endometrial conditions, preventing pregnancy. The drug-free period design allows for scheduled withdrawal bleeding, mimicking natural menstrual cycles while maintaining contraceptive efficacy. This approach combines hormonal contraception with a defined monthly cycle pattern.

Approved indications

• Hormonal contraception with scheduled menstrual cycling

Common side effects

• Headache
• Nausea
• Breast tenderness
• Irregular bleeding patterns

Key clinical trials

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

Frequently asked questions about PGL4001, progestin, drug free period

What is PGL4001, progestin, drug free period?

PGL4001, progestin, drug free period is a Progestin / Selective Progesterone Receptor Modulator drug developed by PregLem SA, indicated for Hormonal contraception with scheduled menstrual cycling.

How does PGL4001, progestin, drug free period work?

PGL4001 is a selective progesterone receptor modulator that provides contraceptive and menstrual regulation effects through progestin activity with a structured drug-free period.

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

PGL4001, progestin, drug free period is indicated for Hormonal contraception with scheduled menstrual cycling.

Who makes PGL4001, progestin, drug free period?

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

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

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

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

PGL4001, progestin, drug free period belongs to the Progestin / Selective Progesterone Receptor Modulator class. See all Progestin / Selective Progesterone Receptor Modulator drugs at /class/progestin-selective-progesterone-receptor-modulator.

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

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

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

Common side effects of PGL4001, progestin, drug free period include Headache, Nausea, Breast tenderness, Irregular bleeding patterns.

What does PGL4001, progestin, drug free period target?

PGL4001, progestin, drug free period targets Progesterone receptor and is a Progestin / Selective Progesterone Receptor Modulator.

Related

• Drug class: All Progestin / Selective Progesterone Receptor Modulator drugs
• Target: All drugs targeting Progesterone receptor
• Manufacturer: PregLem SA — full pipeline
• Therapeutic area: All drugs in Contraception / Women's Health
• Indication: Drugs for Hormonal contraception with scheduled menstrual cycling
• Also known as: Ulipristal acetate