Ulipristal acetate

Phase 2Small molecule

Ulipristal acetate is a small molecule that works as a Progesterone Receptor Modulator.[2] It is being investigated across 3 indications, with its most advanced program in Phase 2.[1]

Ulipristal acetate is one of 53 small molecule programs targeting Infertility. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

InfertilityActive, not recruiting

ProgesteroneUnknown status

ScreeningRecruiting

InfertilityPreclinical

Active, not recruiting

ProgesteronePreclinical

Unknown status

ScreeningPhase 2

Recruiting

Competition

Competitive Landscape

49 competitors in Infertility

#DrugCompanyPhaseTrials

Femara

Novartis

Approved

4 2

Glucophage

EMD Serono

Approved

4 3

Bayer Aspirin

Nolvadex

Danocrine

Lupron

Sun Pharmaceutical Industries, Inc.

Estrace

Prometrium

2 9

Xylocaine

MMEDRx USA, Inc.

Approved

1 10

Clomid

EMD Serono

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Not yet recruiting

Contraception

NCT06727734

Phase 2Recruiting

Screening

NCT07434128

ApprovedRecruiting

Contraceptive Usage

NCT05674513

Clinical

Trials by Indication[1]

Contraception6 trials

Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Not yet recruiting·TThe University of Hong Kong·Phase 3·NCT06727734·980 enrolled

Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg

Terminated·KKimberly Myer·Phase 4·NCT03537768·532 enrolled

Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy

Completed·NNorthwestern University··NCT05285605·75 enrolled

Show 3 more trials

Ulipristal Emergency Contraception Used Before or After Ovulation

Completed·TThe University of Hong Kong··NCT02517463·700 enrolled

Levonorgestrel Intrauterine System For Emergency Contraception

Completed·PPlanned Parenthood of the St. Louis Region and Southwest Missouri·N/A·NCT01539720·274 enrolled

On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility

Completed·SStanford University·Phase 1·NCT03354117·12 enrolled

Uterine Fibroid3 trials

Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids (LISA)

Terminated·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau··NCT04004884·30 enrolled

Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00290251·72 enrolled

Ulipristal Acetate in Symptomatic Uterine Fibroid

Terminated·MMỹ Đức Hospital·Phase 4·NCT04132349·25 enrolled

Leiomyoma3 trials

Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

Unknown status·UUniversity Magna Graecia·Phase 4·NCT02361905·42 enrolled

A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

Completed· AbbVie logo

AbbVie·Phase 3·NCT02147158·432 enrolled

A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Completed· AbbVie logo

AbbVie·Phase 3·NCT02147197·157 enrolled

Lip2 trials

Ulipristal Acetate 10 mg and Asisted Reproduction

Terminated·IInstituto Valenciano de Infertilidad, IVI VALENCIA·Phase 3·NCT02425878·2 enrolled

Ulipristal Use in Chinese Population

Terminated·QQueen Mary Hospital, Hong Kong·Phase 4·NCT02825719·31 enrolled

Uterine leiomyoma2 trials

Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

Withdrawn·WWatson Pharmaceuticals·Phase 3·NCT01553123

Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma

Unknown status·UUniversity Magna Graecia·Phase 4·NCT02361879·146 enrolled

24 more indications

Progesterone1 trial

Ulipristal Acetate on Progesterone Levels and Glycodelin-A Endometrial Pattern

Unknown status·PPrograma de Asistencia Reproductiva de Rosario·N/A·NCT01391845·16 enrolled

Breast Cancer1 trial

Breast Cancer - Anti-Progestin Prevention Study 1

Completed·MManchester University NHS Foundation Trust·Phase 2·NCT02408770·24 enrolled

Recurrent1 trial

Intervention to End Recurrent Unscheduled Bleeding Trial

Completed·WWashington University School of Medicine·Phase 3·NCT03118297·65 enrolled

Abortion1 trial

Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

Completed·—·Phase 4·NCT04989400·24 enrolled

Efficacy1 trial

Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days

Completed·PPremier Research·Phase 2·NCT01953679·180 enrolled

Breast1 trial

Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation

Completed·—·Phase 1·NCT02922127·29 enrolled

Endometrial1 trial

A Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women

Unknown status·PPopulation Council·Phase 1/2·NCT02451826·19 enrolled

Bleeding1 trial

Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena

Unknown status·UUniversity of Campinas, Brazil·Phase 4·NCT03186586·32 enrolled

IVF Outcome1 trial

IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure

Unknown status·SSheba Medical Center·Phase 4·NCT02601196·20 enrolled

GnRH Analog1 trial

Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

Unknown status·UUniversity Magna Graecia·Phase 4·NCT02357563·110 enrolled

Menopausal Women1 trial

Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

Unknown status·UUniversity of Cagliari·Phase 4·NCT02440750·50 enrolled

MPA1 trial

Impact of Combined Hormonal Contraceptives on UPA

Completed·OOregon Health and Science University·Phase 4·NCT02577601·36 enrolled

Adenomyosis1 trial

Adenomyosis and Ulipristal Acetate

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT02587000·26 enrolled

PrEP1 trial

Ulipristal Acetate for Cervical Preparation

Completed·SStanford University·Phase 1·NCT03802149·13 enrolled

Safety and Efficacy1 trial

Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive

Withdrawn·PPremier Research·Phase 2·NCT03296098

Impaired Renal Function1 trial

Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female Subjects

Completed· AbbVie logo

AbbVie·Phase 1·NCT02634437·19 enrolled

Women1 trial

Impact of Esmya on Fertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques

Completed·AASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO··NCT03349190·127 enrolled

Surgery1 trial

Esmya Versus Surgery Before IVF/ICSI

Active, not recruiting·UUniversitair Ziekenhuis Brussel··NCT04028986·40 enrolled

Pregnancy1 trial

Ulipristal Acetate for Use in Early Pregnancy Loss

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT05216952·3 enrolled

Ovarian Function1 trial

Ovarian Function With ENG Implant and UPA Use

Completed·UUniversity of Utah·Phase 1·NCT04291001·40 enrolled

Dysmenorrhea1 trial

Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis

Withdrawn·VVanderbilt University Medical Center·Phase 4·NCT03325868

Ovarian Reserve1 trial

The Effect of Ulipristal Acetate (UPA) on Women Ovarian Reserve

Unknown status·UUniversity Magna Graecia·Phase 4·NCT02361892·73 enrolled

Screening1 trial

Progesterone Receptor Modulator Mammogram Pretreatment for Premenopausal People With a History of Dense Breast Tissue

Recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT07434128·26 enrolled

Contraceptive Usage1 trial

Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Recruiting·OOregon Health and Science University·Approved·NCT05674513·140 enrolled

Sources

References

[1]
ClinicalTrials.gov — 40 trial records for Ulipristal acetate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ulipristal acetate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ulipristal acetate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Progesterone Receptor Modulator[2]
Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: AbbVie

Ulipristal acetate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Contraception6 trials

Uterine Fibroid3 trials

Leiomyoma3 trials

Lip2 trials

Uterine leiomyoma2 trials

Progesterone1 trial

Breast Cancer1 trial

Recurrent1 trial

Abortion1 trial

Efficacy1 trial

Breast1 trial

Endometrial1 trial

Bleeding1 trial

IVF Outcome1 trial

GnRH Analog1 trial

Menopausal Women1 trial

MPA1 trial

Adenomyosis1 trial

PrEP1 trial

Safety and Efficacy1 trial

Impaired Renal Function1 trial

Women1 trial

Surgery1 trial

Pregnancy1 trial

Ovarian Function1 trial

Dysmenorrhea1 trial

Ovarian Reserve1 trial

Screening1 trial

Contraceptive Usage1 trial

References

Drug Info

Quick Facts

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