MYFEMBREE (estradiol)
Myfembree is a combination of relugolix (a GnRH receptor antagonist), estradiol (an estrogen), and norethindrone acetate (a progestin). It is indicated for premenopausal women to manage heavy menstrual bleeding associated with uterine fibroids and moderate to severe pain associated with endometriosis. Due to the risk of continued, potentially irreversible bone loss, use of this medication is limited to a total duration of 24 months.
How MYFEMBREE Works
Relugolix competitively blocks GnRH receptors in the pituitary gland, reducing the release of LH and FSH. This leads to decreased production of ovarian estrogen and progesterone, which reduces fibroid-related bleeding and endometriosis pain. To mitigate the side effects of low estrogen, the medication includes estradiol to maintain bone mineral density and norethindrone acetate to protect the uterine lining from the potential adverse effects of unopposed estrogen.
Details
- Status
- Prescription
- First Approved
- 2021-05-26
- Patent Cliff
- 2042
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
MYFEMBREE Approval History
What MYFEMBREE Treats
3 indicationsMYFEMBREE is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heavy Menstrual Bleeding
- Uterine Leiomyoma
- Endometriosis
MYFEMBREE Boxed Warning
THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS Estrogen and progestin combinations, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism (PE), deep vein thrombosis (DVT), stroke and myocardial infarction (MI), especially in women at increased risk for these events [see Warnings and Precautions ( 5.1 )]. MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for...
WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS Estrogen and progestin combinations, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism (PE), deep vein thrombosis (DVT), stroke and myocardial infarction (MI), especially in women at increased risk for these events [see Warnings and Precautions ( 5.1 )]. MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension [see Contraindications ( 4 )]. WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS See full prescribing information for complete boxed warning Estrogen and progestin combinations, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events. ( 5.1 ) MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension. ( 4 )
MYFEMBREE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MYFEMBREE
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
65 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07455903 | 2025-GAR-001 | Ph 2 | recruiting | Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT |
| NCT04423211 | EA8191 NCI-2020-02686, EA8191 | Ph 3 | recruiting | Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging |
| NCT05716516 ESTHER | STUDY02001740 NCI-2023-05453 | Ph 2 | recruiting | STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER) |
| NCT05050084 | NRG-GU010 NCI-2021-08760, NRG-GU010 | Ph 3 | active not recruiting | Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial |
| NCT05053152 | NRG-GU011 NCI-2021-09164, NRG-GU011 | Ph 2 | active not recruiting | Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study |
| NCT04513717 | NRG-GU009 NCI-2020-04705, NRG-GU009 | Ph 3 | active not recruiting | Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial |
| NCT04523207 results posted | CR108875 56021927PCR2041 | Ph 2 | completed | A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases |
| NCT06378866 DIVINE | MC230502 R01CA286127, 23-012176 | Ph 2 | recruiting | Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial |
| NCT06005610 GETITRIgHT results posted | A5403 38806 | Ph 2 | terminated | Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy |
| NCT07025369 | MC240503 NCI-2025-03965, 25-002008 | Ph 2 | recruiting | Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial |
| NCT05457972 | STUDY20220578 | Ph 4 | recruiting | Postpartum Vaginal Estrogen for Breastfeeding Patients |
| NCT06330805 | OSU-23069 NCI-2024-00705 | Ph 2 | recruiting | Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer |
| NCT06463457 | 24-217 | Ph 2 | active not recruiting | Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) |
| NCT06650579 | STUDY00007557 P30CA138292, NCI-2024-07761 | Ph 3 | recruiting | REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial |
| NCT05320406 REVELUTION results posted | STUDY00003654 NCI-2022-00117, STUDY00003654 | Ph 2 | active not recruiting | RElugolix VErsus LeUprolide Cardiac Trial |
| NCT06631521 | IIR-US-00295 2077841 | Ph 1 | recruiting | Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer |
| NCT06671548 | QLG1079-301 | Ph 3 | recruiting | Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT04192266 results posted | HSC-MS-23-0497 R33MH111907 | Ph 3 | completed | Estrogen and Fear in PTSD |
| NCT06499870 | NU 24U02 NCI-2024-03934, STU00221219 | Ph 2 | recruiting | Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial |
| NCT03689543 results posted | 180144 18-M-0144 | Ph 2 | completed | Estrogen Receptor Beta and Mood |
| NCT05605964 | MVT-601-056 | Ph 3 | completed | Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate |
| NCT04666129 | MVT-601-049 | Ph 1 | completed | Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer |
| NCT05765500 | 22-599 | Ph 2 | recruiting | RecoverPC: Relugolix vs GnRH Agonist in Quality of Life |
| NCT06253702 | 2023-0548 1R01HL150361-01, EDUC/KINESIOLOGY | Ph 4 | completed | Brain Blood Flow Responses to Stress: Sex Differences |
| NCT02238808 PRESTO | EER001 | Ph 2 | active not recruiting | A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers |
| NCT03751124 results posted | MVT-601-035 2018-001368-43 | Ph 3 | completed | Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT03412890 results posted | MVT-601-3003 2017-003310-74 | Ph 3 | completed | LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT05617820 | 71836003 | Ph 3 | completed | Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy |
| NCT06129851 | STUDY00150674 NCI-2023-09079, STUDY00150674 | Ph 2 | not yet recruiting | Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer |
| NCT03654274 results posted | MVT-601-3103 2017-004066-10 | Ph 3 | completed | SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain |
| NCT04225221 results posted | 19-2343 R21MH121726 | Ph 2 | completed | Neurobiology of Bulimia Nervosa |
| NCT04933240 | HM20021901 | Ph 4 | withdrawn | Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial |
| NCT03103087 results posted | MVT-601-3002 2016-005113-50 | Ph 3 | completed | LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT03049735 results posted | MVT-601-3001 2016-003727-27 | Ph 3 | completed | LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT01923298 results posted | 13-0477-04 EString | Ph 2 | completed | Estradiol Levels in Patients Treated With Estring |
| NCT03085095 HERO results posted | MVT-601-3201 2017-000160-15 | Ph 3 | completed | A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer |
| NCT03493126 results posted | 2018H0006 | Ph 4 | completed | Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function |
| NCT02995694 results posted | 71462901 | Ph 3 | completed | A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis |
| NCT04714554 | MVT-601-054 | Ph 1 | completed | A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men |
| NCT04978688 | MVT-601-1001 | Ph 1 | completed | Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants |
| NCT01441635 results posted | M12-663 | Ph 2 | completed | Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids |
| NCT03204331 | MVT-601-3102 2017-001632-19 | Ph 3 | completed | SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain |
| NCT03204318 | MVT-601-3101 2017-001588-19 | Ph 3 | completed | SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain |
| NCT01895881 EPPA | EPPA - 12101906 | Ph 2 | withdrawn | Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial |
| NCT00997893 RISE results posted | 2009-0052 5R01MH083782-05 | Ph 2 | completed | Research Investigation of Soy and Estrogen |
| NCT03848234 | EST-S-01 | Ph 3 | completed | Estradiol Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder |
| NCT02455453 results posted | 201411005 5R01CA195450-03 | Ph 2 | completed | Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography |
| NCT01083641 results posted | CO09711 H-2009-0172, NCI-2011-00618 | Ph 2 | terminated | Estrogen for Triple Negative Breast Cancer |
| NCT02255175 PEERS results posted | 13-3572 K12HD001441-15, K23MH105569-01A1 | Ph 4 | completed | Perimenopausal Effects of Estradiol on Reward Responsiveness |
| NCT01942668 REPLENISH results posted | TXC12-05 REPLENISH Trial | Ph 3 | completed | A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms |
Showing 50 of 65 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MYFEMBREE FDA Label Details
Indications & Usage
FDA Label (PDF)MYFEMBREE is indicated for the treatment of Heavy Menstrual Bleeding; Uterine Leiomyoma; Endometriosis.
WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS Estrogen and progestin combinations, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism (PE), deep vein thrombosis (DVT), stroke and myocardial infarction (MI), especially in women at inc...
MYFEMBREE Patents & Exclusivity
Patents (8 active)
Exclusivity
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Revenue Insights
- • Quarterly revenue tracking
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Patent Timeline
- • Cliff: 2042
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
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Competitive Landscape
- • 9 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.