PGL4001 (ulipristal) and iron

PregLem SA · Phase 3 active Small molecule

PGL4001 (ulipristal) and iron is a Selective progesterone receptor modulator with iron supplementation Small molecule drug developed by PregLem SA. It is currently in Phase 3 development for Uterine fibroids (leiomyomas) with heavy menstrual bleeding, Iron deficiency anemia secondary to heavy menstrual bleeding. Also known as: Ulipristal acetate.

Ulipristal is a selective progesterone receptor modulator that suppresses ovulation and alters the endometrium, while iron supplementation addresses iron deficiency anemia.

Ulipristal is a selective progesterone receptor modulator that suppresses ovulation and alters the endometrium, while iron supplementation addresses iron deficiency anemia. Used for Uterine fibroids (leiomyomas) with heavy menstrual bleeding, Iron deficiency anemia secondary to heavy menstrual bleeding.

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 (ulipristal) and iron
Also known as	Ulipristal acetate
Sponsor	PregLem SA
Drug class	Selective progesterone receptor modulator with iron supplementation
Target	Progesterone receptor (PR); iron supplementation (non-receptor target)
Modality	Small molecule
Therapeutic area	Gynecology / Women's Health
Phase	Phase 3

Mechanism of action

Ulipristal acetate acts as a selective progesterone receptor agonist/antagonist, disrupting the luteinizing hormone surge necessary for ovulation and modifying endometrial proliferation. The iron component provides supplemental iron to treat or prevent iron deficiency anemia, which may occur secondary to heavy menstrual bleeding. This combination targets both the hormonal and hematologic aspects of conditions like uterine fibroids.

Approved indications

• Uterine fibroids (leiomyomas) with heavy menstrual bleeding
• Iron deficiency anemia secondary to heavy menstrual bleeding

Common side effects

• Headache
• Abdominal pain
• Nausea
• Amenorrhea or oligomenorrhea
• Hot flushes

Key clinical trials

• PGL4001 Versus Placebo in Uterine Myomas (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 (ulipristal) and iron CI brief — competitive landscape report
• PGL4001 (ulipristal) and iron updates RSS · CI watch RSS
• PregLem SA portfolio CI

Frequently asked questions about PGL4001 (ulipristal) and iron

What is PGL4001 (ulipristal) and iron?

PGL4001 (ulipristal) and iron is a Selective progesterone receptor modulator with iron supplementation drug developed by PregLem SA, indicated for Uterine fibroids (leiomyomas) with heavy menstrual bleeding, Iron deficiency anemia secondary to heavy menstrual bleeding.

How does PGL4001 (ulipristal) and iron work?

Ulipristal is a selective progesterone receptor modulator that suppresses ovulation and alters the endometrium, while iron supplementation addresses iron deficiency anemia.

What is PGL4001 (ulipristal) and iron used for?

PGL4001 (ulipristal) and iron is indicated for Uterine fibroids (leiomyomas) with heavy menstrual bleeding, Iron deficiency anemia secondary to heavy menstrual bleeding.

Who makes PGL4001 (ulipristal) and iron?

PGL4001 (ulipristal) and iron is developed by PregLem SA (see full PregLem SA pipeline at /company/preglem-sa).

Is PGL4001 (ulipristal) and iron also known as anything else?

PGL4001 (ulipristal) and iron is also known as Ulipristal acetate.

What drug class is PGL4001 (ulipristal) and iron in?

PGL4001 (ulipristal) and iron belongs to the Selective progesterone receptor modulator with iron supplementation class. See all Selective progesterone receptor modulator with iron supplementation drugs at /class/selective-progesterone-receptor-modulator-with-iron-supplementation.

What development phase is PGL4001 (ulipristal) and iron in?

PGL4001 (ulipristal) and iron is in Phase 3.

What are the side effects of PGL4001 (ulipristal) and iron?

Common side effects of PGL4001 (ulipristal) and iron include Headache, Abdominal pain, Nausea, Amenorrhea or oligomenorrhea, Hot flushes.

What does PGL4001 (ulipristal) and iron target?

PGL4001 (ulipristal) and iron targets Progesterone receptor (PR); iron supplementation (non-receptor target) and is a Selective progesterone receptor modulator with iron supplementation.

Related

• Drug class: All Selective progesterone receptor modulator with iron supplementation drugs
• Target: All drugs targeting Progesterone receptor (PR); iron supplementation (non-receptor target)
• Manufacturer: PregLem SA — full pipeline
• Therapeutic area: All drugs in Gynecology / Women's Health
• Indication: Drugs for Uterine fibroids (leiomyomas) with heavy menstrual bleeding
• Indication: Drugs for Iron deficiency anemia secondary to heavy menstrual bleeding
• Also known as: Ulipristal acetate