Leiomyoma

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Boston ScientificCA - Valencia

1 program

Uterine Fibroid EmbolizationPhase 41 trial

Active Trials

NCT00628901Completed60Est. Jan 2011

AbbottABBOTT PARK, IL

5 programs

AsoprisnilPhase 31 trial

AsoprisnilPhase 21 trial

Active Trials

NCT00156182Completed38Est. Dec 2001

NCT00160459Completed129Est. Jul 2001

NCT00160381Completed432Est. Jan 2005

+2 more trials

Human BioSciencesWV - Martinsburg

3 programs

MifepristonePhase 31 trial

CDB-2914Phase 21 trial

Establishment of Fibroid Tissue BankN/A1 trial

Active Trials

NCT00710346Terminated43Est. Sep 2016

NCT00044876Completed56Est. Oct 2015

NCT00133705Completed70Est. Jun 2010

AbbVieNORTH CHICAGO, IL

2 programs

Ulipristal acetatePhase 31 trial

Active Trials

NCT02147197Completed157Est. Mar 2016

NCT02147158Completed432Est. Nov 2016

BayerLEVERKUSEN, Germany

5 programs

BAY1002670Phase 21 trial

VilaprisanPhase 21 trial

BAY1002670Phase 11 trial

VilaprisanPhase 11 trial

Vilaprisan, BAY1002670Phase 11 trial

Active Trials

NCT01816815Completed73Est. Jan 2013

NCT03092999Completed36Est. Jul 2017

NCT03342859Terminated10Est. Jan 2020

+2 more trials

Terumo MedicalGermany - Leverkusen

1 program

Uterine fibroid embolization BeadBlock™Phase 11 trial

Active Trials

NCT00361036Completed44Est. Mar 2010

GynesonicsCA - Redwood City

2 programs

VizAblate SystemN/A1 trial

Active Trials

NCT01539187Terminated6Est. Jun 2014

NCT01226290Terminated51Est. Mar 2014

InsightecFL - Miami

1 program

ExAblate 2000N/A1 trial

Active Trials

NCT00131365Completed9Est. Feb 2009

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

Boston ScientificUterine Fibroid Embolization

AbbVieUlipristal acetate

AbbottAsoprisnil

Human BioSciencesMifepristone

AbbottAsoprisnil

BayerVilaprisan

BayerBAY1002670

Human BioSciencesCDB-2914

AbbottAsoprisnil

BayerVilaprisan, BAY1002670

BayerVilaprisan

BayerBAY1002670

Showing 15 of 20 trials with date data

Clinical Trials (20)

Total enrollment: 3,073 patients across 20 trials

NCT00628901 Boston ScientificUterine Fibroid Embolization

A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

Start: Jan 2006Est. completion: Jan 201160 patients

Phase 4Completed

NCT02147197 AbbVieUlipristal acetate

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

Start: Mar 2014Est. completion: Mar 2016157 patients

Phase 3Completed

NCT02147158 AbbVieUlipristal acetate

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

Start: Jan 2014Est. completion: Nov 2016432 patients

Phase 3Completed

NCT00156195 AbbottAsoprisnil

Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

Start: Sep 2003Est. completion: Jan 2007523 patients

Phase 3Completed

NCT00133705 Human BioSciencesMifepristone

Trial of Mifepristone for Fibroids

Start: Jul 2003Est. completion: Jun 201070 patients

Phase 3Completed

NCT00160381 AbbottAsoprisnil

A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

Start: Sep 2002Est. completion: Jan 2005432 patients

Phase 3Completed

NCT00152269 AbbottAsoprisnil

Treatment of Uterine Fibroids With Asoprisnil(J867)

Start: Jul 2002Est. completion: Jan 2005475 patients

Phase 3Completed

NCT02465814 BayerVilaprisan

Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

Start: Jun 2015Est. completion: Oct 2016120 patients

Phase 2Completed

NCT02131662 BayerBAY1002670

Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap

Start: May 2014Est. completion: May 2016309 patients

Phase 2Completed

NCT00044876 Human BioSciencesCDB-2914

Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist

Start: Sep 2002Est. completion: Oct 201556 patients

Phase 2Completed

NCT00156182 AbbottAsoprisnil

A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

Start: Apr 2001Est. completion: Dec 200138 patients

Phase 2Completed

NCT00160459 AbbottAsoprisnil

A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

Start: May 2000Est. completion: Jul 2001129 patients

Phase 2Completed

NCT03342859 BayerVilaprisan, BAY1002670

Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned

Start: Nov 2017Est. completion: Jan 202010 patients

Phase 1Terminated

NCT03092999 BayerVilaprisan

Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)

Start: Mar 2017Est. completion: Jul 201736 patients

Phase 1Completed

NCT01816815 BayerBAY1002670

Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670

Start: Nov 2011Est. completion: Jan 201373 patients

Phase 1Completed

NCT00361036 Terumo MedicalUterine fibroid embolization BeadBlock™

Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent

Start: Aug 2006Est. completion: Mar 201044 patients

Phase 1Completed

NCT01539187 GynesonicsVizAblate System

Fibroid Ablation Study - Large Fibroids

Start: Jun 2012Est. completion: Jun 20146 patients

N/ATerminated

NCT01226290 GynesonicsVizAblate System

Fibroid Ablation Study

Start: Jan 2011Est. completion: Mar 201451 patients

N/ATerminated

NCT00710346 Human BioSciencesEstablishment of Fibroid Tissue Bank

Establishment of Fibroid Tissue Bank

Start: Jun 2008Est. completion: Sep 201643 patients

N/ATerminated

NCT00131365 InsightecExAblate 2000

Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids

Start: Jan 2006Est. completion: Feb 20099 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

6 late-stage (Phase 3) programs, potential near-term approvals

9 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.