Endometriosis

Women's Health
26
Pipeline Programs
21
Companies
50
Clinical Trials
2 recruiting
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
1
12
0
7
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2100%
+ 26 programs with unclassified modality

On Market (3)

Approved therapies currently available

U
ACTIVELLAApproved
estradiol/norethindrone acetate
Unknown Company
Estrogen [EPC]oral1998
Bayer
NATAZIAApproved
estradiol valerate and estradiol valerate/dienogest
Bayer
oral2010
AbbVie
ORILISSAApproved
elagolix
AbbVie
oral2018

Competitive Landscape

15 companies ranked by most advanced pipeline stage

Bayer
BayerLEVERKUSEN, Germany
6 programs
2
2
1
1
VisannePhase 31 trial
BAY1817080Phase 21 trial
NATAZIA(Dienogest)Phase 25 trials
BAY1128688Phase 11 trial
BAY2328065Phase 11 trial
+1 more programs
Active Trials
NCT02434640Completed51Est. Apr 2016
NCT04851483Completed31Est. Feb 2022
NCT04614246Terminated215Est. May 2022
+6 more trials
AbbVie
AbbVieNORTH CHICAGO, IL
3 programs
1
2
1
ElagolixPhase 35 trials
Estradiol/Norethindrone AcetatePhase 31 trial
Leuprorelin Acetate DepotPhase 21 trial
Active Trials
NCT00797225Completed174Est. Feb 2010
NCT04464187Terminated173Est. Jul 2025
NCT04445025Completed30Est. Dec 2024
+4 more trials
Ipsen
IpsenChina - Tianjin
2 programs
1
1
Decapeptyl SR 11.25mgPhase 41 trial
Triptorelin Pamoate PR 3-monthPhase 31 trial
Active Trials
NCT03232281Completed300Est. Nov 2019
NCT00735852Completed31Est. May 2016
Abbott
AbbottABBOTT PARK, IL
4 programs
3
1
elagolixPhase 32 trials
AsoprisnilPhase 21 trial
AsoprisnilPhase 21 trial
NBI-56418Phase 21 trial
Active Trials
NCT00160446Completed130Est. Jul 2001
NCT00160420Completed73Est. Jul 2004
NCT00109512Completed76Est. Jun 2006
+2 more trials
Pfizer
PfizerNEW YORK, NY
1 program
1
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetatePhase 31 trial
Active Trials
NCT06439524Recruiting110Est. Aug 2026
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
1 program
1
ElagolixPhase 31 trial
Active Trials
NCT05648669UnknownEst. Feb 2024
Ferring Pharmaceuticals
Ferring PharmaceuticalsArgentina - Buenos Aires
2 programs
1
Quinagolide 1080 µgPhase 21 trial
DichloroacetateN/A1 trial
Active Trials
NCT04046081Completed30Est. Sep 2021
NCT03749109Completed67Est. Jul 2021
Astellas
AstellasChina - Shenyang
1 program
1
ASP1707Phase 24 trials
Active Trials
NCT02867306Completed10Est. Aug 2016
NCT02175407Completed14Est. Jun 2014
NCT01767090Completed912Est. Jul 2015
+1 more trials
Mereo BioPharma
Mereo BioPharmaUK - London
1 program
1
Active treatment with a high dose of BGS649Phase 2
Teva
TevaIsrael - Petach Tikva
1 program
1
DR-2001aPhase 21 trial
Active Trials
NCT00117481Completed90Est. Dec 2007
Spago Nanomedical
Spago NanomedicalSweden - Lund
1 program
1
SN132DPhase 21 trial
Active Trials
NCT05664828CompletedEst. Sep 2023
Gesynta Pharma
Gesynta PharmaSweden - Stockholm
1 program
1
VipoglanstatPhase 2Small Molecule1 trial
Active Trials
NCT07260669RecruitingEst. Jun 2027
BioGene Therapeutics
1 program
1
LinifanibPhase 1/2Small Molecule1 trial
Active Trials
NCT03481842WithdrawnEst. Oct 2021
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
Non-Interventional Study of Zoladex in EndometriosisN/A1 trial
Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSISN/A1 trial
Active Trials
NCT00938496Completed408Est. Feb 2012
NCT00761683Terminated105
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
Translational Research in Pelvic PainN/A1 trial
Active Trials
NCT04001244Completed787Est. Feb 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
IpsenDecapeptyl SR 11.25mg
Pfizer40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
Qilu PharmaceuticalElagolix
AbbVieElagolix
AbbVieElagolix
AbbVieElagolix
IpsenTriptorelin Pamoate PR 3-month
AbbVieEstradiol/Norethindrone Acetate
AbbVieElagolix
AbbVieElagolix
AbbVieElagolix
AbbVieElagolix
AbbVieElagolix
BayerDienogest
AbbVieElagolix

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 14,295 patients across 50 trials

NCT00735852IpsenDecapeptyl SR 11.25mg

Decapeptyl SR With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women

Start: Dec 2008Est. completion: May 201631 patients
Phase 4Completed
NCT06439524Pfizer40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate

The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial

Start: Aug 2024Est. completion: Aug 2026110 patients
Phase 3Recruiting

A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain

Start: Sep 2022Est. completion: Feb 2024
Phase 3Unknown

Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

Start: Aug 2020Est. completion: Jun 2030800 patients
Phase 3Active Not Recruiting

A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

Start: Dec 2017Est. completion: Oct 201811 patients
Phase 3Terminated

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Start: Sep 2017Est. completion: Jun 2024478 patients
Phase 3Completed
NCT03232281IpsenTriptorelin Pamoate PR 3-month

Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis

Start: Jul 2017Est. completion: Nov 2019300 patients
Phase 3Completed
NCT03213457AbbVieEstradiol/Norethindrone Acetate

A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain

Start: Jul 2017Est. completion: Dec 2023681 patients
Phase 3Completed

An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start: Sep 2016Est. completion: Mar 2019433 patients
Phase 3Completed

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

Start: Feb 2016Est. completion: Jan 2019378 patients
Phase 3Completed

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Start: Dec 2015Est. completion: Dec 2018413 patients
Phase 3Completed

Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain

Start: May 2014Est. completion: May 2017496 patients
Phase 3Completed

A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Start: Sep 2013Est. completion: Dec 2016815 patients
Phase 3Completed

Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients

Start: Mar 2013Est. completion: Nov 2015250 patients
Phase 3Completed

Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain

Start: Dec 2012Est. completion: Apr 2016506 patients
Phase 3Completed

Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

Start: Oct 2012Est. completion: Dec 2014312 patients
Phase 3Completed

Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects

Start: Jun 2012Est. completion: Nov 2014955 patients
Phase 3Completed

A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Start: May 2012Est. completion: Sep 2015872 patients
Phase 3Completed

Effect on Primary Dysmenorrhea

Start: Apr 2009Est. completion: Nov 2010507 patients
Phase 3Completed

To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

Start: Sep 2008Est. completion: May 2011409 patients
Phase 3Completed

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Start: Feb 2006Est. completion: May 2008231 patients
Phase 3Completed

Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

Start: Jul 2004Est. completion: Mar 2008168 patients
Phase 3Completed

Bleeding Pattern Study

Start: Jun 2003Est. completion: Feb 20051,315 patients
Phase 3Completed

A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis

Start: Oct 2025Est. completion: Jun 2027
Phase 2Recruiting

Efficacy of SN132D in Patients With Suspected Endometriosis

Start: Nov 2022Est. completion: Sep 2023
Phase 2Completed

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb

Start: Jan 2021Est. completion: May 2022215 patients
Phase 2Terminated

Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis

Start: Aug 2019Est. completion: Jul 202167 patients
Phase 2Completed

Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Start: Apr 2013Est. completion: Dec 2015571 patients
Phase 2Completed

A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain

Start: Dec 2012Est. completion: Jul 2015912 patients
Phase 2Completed

Visanne Study to Assess Safety in Adolescents

Start: Mar 2011Est. completion: Jun 2014111 patients
Phase 2Completed

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Start: Oct 2009Est. completion: Sep 2010137 patients
Phase 2Completed
NCT00797225AbbVieLeuprorelin Acetate Depot

Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

Start: Nov 2008Est. completion: Feb 2010174 patients
Phase 2Completed

Valette (Combined Oral Contraceptive SH T04769G and SH D00659AF) Low Ovulation Inhibition

Start: Apr 2007Est. completion: Dec 200760 patients
Phase 2Completed

Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

Start: Dec 2006Est. completion: Nov 2008252 patients
Phase 2Completed

Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain

Start: Jun 2005Est. completion: Dec 200790 patients
Phase 2Completed

Endometriosis Trial: Study of NBI-56418 in Endometriosis

Start: Apr 2005Est. completion: Jun 200676 patients
Phase 2Completed

A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398

Start: Dec 2002Est. completion: Jul 200473 patients
Phase 2Completed

A Study to Evaluate the Safety and Effectiveness of Three Asoprisnil Doses in the Treatment of Women With Endometriosis

Start: May 2000Est. completion: Jul 2001130 patients
Phase 2Completed

Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis

Start: Oct 2021Est. completion: Oct 2021
Phase 1/2Withdrawn

A Trial to Learn What Happens to Different Medicinal Forms of BAY2328065 When They Enter the Body and How Safe They Are in Healthy Male and Female Participants

Start: Apr 2021Est. completion: Feb 202231 patients
Phase 1Completed

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

Start: Sep 2020Est. completion: Dec 202430 patients
Phase 1Completed

Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam

Start: Nov 2017Est. completion: Feb 201968 patients
Phase 1Completed

A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis

Start: Jul 2016Est. completion: Aug 201610 patients
Phase 1Completed

Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women

Start: Apr 2015Est. completion: Apr 201651 patients
Phase 1Completed

A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects

Start: Apr 2014Est. completion: Jun 201414 patients
Phase 1Completed

A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707

Start: Aug 2011Est. completion: Sep 20116 patients
Phase 1Completed

An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females

Start: Jun 2011Est. completion: Nov 2012216 patients
Phase 1Completed

Pharmacodynamic Characterization of Dienogest

Start: Sep 2008Est. completion: Sep 2009102 patients
Phase 1Completed

A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules

Start: Jan 2022Est. completion: Jul 2025173 patients
N/ATerminated

A Study to Gather Information About User Satisfaction in Women in Russia Who Take Estradiol Valerate/Dienogest

Start: Jun 2021Est. completion: Apr 2023255 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

7 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 14,295 patients
21 companies competing in this space