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Heavy Menstrual Bleeding

3
Pipeline Programs
11
Companies
9
Clinical Trials
5 recruiting
1
Approved Products

Pipeline by Development Stage

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

On Market (1)

Approved therapies currently available

AbbVie
ORILISSAApproved
elagolix
AbbVie
oral2018
4M Part D

Competitive Landscape

10 companies ranked by most advanced pipeline stage

AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
1
ElagolixPhase 31 trial
Active Trials
NCT03271489Completed478Est. Jun 2024
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
Levonorgestrel IUSPhase 41 trial
Active Trials
NCT03317795Completed18Est. Dec 2020
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
2 programs
Levonorgestrel Intrauterine SystemN/A1 trial
Sparrow LinkN/A1 trial
Active Trials
NCT05916469Recruiting300Est. Jun 2029
NCT07326722Recruiting80Est. Aug 2027
SPARK Biopharma
SPARK BiopharmaKorea - Seoul
2 programs
Sparrow LinkN/A
Volta SystemN/A1 trial
Active Trials
NCT06814028Completed40Est. Sep 2025
Spark Biomedical
Spark BiomedicalTX - Dallas
2 programs
Sparrow LinkN/A
Volta SystemN/A
Channel Medsystems
Channel MedsystemsCA - Berkeley
1 program
CereneN/A
Channel Therapeutics
Channel TherapeuticsNJ - North Brunswick
1 program
CereneN/A1 trial
Active Trials
NCT05922657Recruiting300Est. Dec 2027
Medtronic
MedtronicNJ - Phillipsburg
1 program
Hysteroscopic myomectomy with TruclearN/A1 trial
Active Trials
NCT02934789Completed69Est. May 2018
Rejoni
RejoniMA - Bedford
1 program
Juveena Hydrogel SystemN/A1 trial
Active Trials
NCT06634719Recruiting7Est. Jun 2026
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
1 program
RelugolixPHASE_31 trial
Active Trials
NCT06671548Recruiting120Est. Jan 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Human BioSciencesLevonorgestrel IUS
Qilu PharmaceuticalRelugolix
AbbVieElagolix
Oregon TherapeuticsSparrow Link
Oregon TherapeuticsLevonorgestrel Intrauterine System
SPARK BiopharmaVolta System
RejoniJuveena Hydrogel System
Channel TherapeuticsCerene
MedtronicHysteroscopic myomectomy with Truclear

Clinical Trials (9)

Total enrollment: 1,412 patients across 9 trials

Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

Start: Nov 2017Est. completion: Dec 202018 patients
Phase 4Completed

Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start: Jan 2024Est. completion: Jan 2027120 patients
Phase 3Recruiting

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

Delivering tAN to Reduce HMB: The LUNA Study

Start: Mar 2026Est. completion: Aug 202780 patients
N/ARecruiting
NCT05916469Oregon TherapeuticsLevonorgestrel Intrauterine System

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Start: Sep 2025Est. completion: Jun 2029300 patients
N/ARecruiting

Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial

Start: Feb 2025Est. completion: Sep 202540 patients
N/ACompleted
NCT06634719RejoniJuveena Hydrogel System

Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)

Start: Feb 2025Est. completion: Jun 20267 patients
N/ARecruiting

A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device

Start: Jun 2023Est. completion: Dec 2027300 patients
N/ARecruiting
NCT02934789MedtronicHysteroscopic myomectomy with Truclear

Effectiveness of Truclear on Patient Quality of Life

Start: Sep 2014Est. completion: May 201869 patients
N/ACompleted

Phase Legend

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

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
5 actively recruiting trials targeting 1,412 patients
11 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.