Uterine Fibroids

Women's Health
4
Pipeline Programs
3
Companies
12
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
1
0
0
2
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

AbbVie
ORILISSAApproved
elagolix
AbbVie
oral2018

Competitive Landscape

3 companies ranked by most advanced pipeline stage

AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
ElagolixPhase 41 trial
Active Trials
NCT03886220Completed82Est. Apr 2021
Takeda
TakedaTOKYO, Japan
1 program
1
LeuprorelinPhase 25 trials
Active Trials
NCT03555578Recruiting1,890Est. Apr 2026
NCT03209518Completed312Est. Oct 2018
NCT02655237Completed281Est. Sep 2017
+2 more trials
Bayer
BayerLEVERKUSEN, Germany
1 program
1
VilaprisanPhase 11 trial
Active Trials
NCT03411980Completed26Est. Feb 2019

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AbbVieElagolix
TakedaLeuprorelin
TakedaLeuprorelin
TakedaLeuprorelin
TakedaLeuprorelin
TakedaLeuprorelin
TakedaLeuprorelin
BayerVilaprisan
TakedaLeuprorelin
TakedaLeuprorelin
TakedaLeuprorelin
TakedaLeuprorelin

Clinical Trials (12)

Total enrollment: 18,116 patients across 12 trials

A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Start: Apr 2019Est. completion: Apr 202182 patients
Phase 4Completed

A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

Start: Mar 2016Est. completion: Sep 2017281 patients
Phase 3Completed

A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer

Start: Jun 2013Est. completion: Nov 2016116 patients
Phase 3Completed

A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

Start: Mar 2012Est. completion: Dec 2013397 patients
Phase 2Completed

Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

Start: Oct 2011Est. completion: Aug 2013487 patients
Phase 2Completed

A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.

Start: Jun 2006Est. completion: Jul 200780 patients
Phase 2Completed

Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c

Start: Dec 1996Est. completion: Dec 2008341 patients
Phase 2Completed

Pharmacokinetics and Safety of Vilaprisan in Renal Impairment

Start: Feb 2018Est. completion: Feb 201926 patients
Phase 1Completed

Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"

Start: Nov 2017Est. completion: Apr 20261,890 patients
N/ARecruiting

Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"

Start: Mar 2016Est. completion: Oct 2018312 patients
N/ACompleted

Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"

Start: Sep 2011Est. completion: Mar 20152,816 patients
N/ACompleted

Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"

Start: Oct 2005Est. completion: Dec 201011,288 patients
N/ACompleted

Related Jobs in Women's Health

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 actively recruiting trials targeting 18,116 patients
3 companies competing in this space