Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma 
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  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Review, Journal:  Relugolix/Estradiol/Norethisterone Acetate: A Review in Endometriosis-Associated Pain. (Pubmed Central) -  Apr 9, 2024   
    Relugolix combination therapy was generally well tolerated and BMD loss over time was minimal. With the convenience of a once daily oral dosing regimen, relugolix combination therapy is a valuable addition to the options currently available for the management of endometriosis-associated pain.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Trial completion date, Trial primary completion date, Combination therapy:  SERENE: Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy (clinicaltrials.gov) -  Mar 6, 2024   
    P3,  N=1020, Active, not recruiting, 
    With the convenience of a once daily oral dosing regimen, relugolix combination therapy is a valuable addition to the options currently available for the management of endometriosis-associated pain. Trial completion date: Apr 2025 --> Feb 2026 | Trial primary completion date: Apr 2024 --> Feb 2025
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy:  MYFEMBREE (clinicaltrials.gov) -  Jan 1, 2024   
    P=N/A,  N=530, Not yet recruiting, 
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Journal, Combination therapy:  LIBERTY Randomized Withdrawal Study: Relugolix Combination Therapy for Heavy Menstrual Bleeding Associated With Uterine Fibroids. (Pubmed Central) -  Nov 27, 2023   
    Most women had return of heavy menstrual bleeding and associated symptoms after treatment cessation, which improved upon retreatment with relugolix combination therapy. Relugolix combination therapy was well tolerated, the adverse event profile remained consistent, and the mean bone mineral density was generally preserved through 2 years of treatment.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Journal, Combination therapy:  A Randomized Open-Label Study of Relugolix (Pubmed Central) -  Jul 31, 2023   
    P1
    Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Sep 2023 Relugolix 40 mg in combination with E2 1 mg and NETA 0.5 mg provided systemic E2 concentrations within a range expected to minimize the risk of undesirable effects of hypoestrogenism associated with the administration of relugolix alone.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Trial completion:  SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain (clinicaltrials.gov) -  Jul 20, 2023   
    P3,  N=802, Completed, 
    Relugolix 40 mg in combination with E2 1 mg and NETA 0.5 mg provided systemic E2 concentrations within a range expected to minimize the risk of undesirable effects of hypoestrogenism associated with the administration of relugolix alone. Active, not recruiting --> Completed
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Journal, Combination therapy:  Development of relugolix combination therapy as a medical treatment option for women with uterine fibroids or endometriosis. (Pubmed Central) -  May 24, 2023   
    In women, the reduction in follicle-stimulating hormone concentrations prevents natural follicular development, suppressing ovarian production of estrogen, and together with reductions in LH concentrations, prevent ovulation, corpus luteum formation, and, thereby, the production of progesterone (P)...The clinical development of relugolix incorporated the addition of a 1 mg dose of E2 and a 0.5-mg dose of norethindrone acetate (NETA) to achieve systemic E2 concentrations that remain in a therapeutic range while mitigating the risk for bone mineral density loss and vasomotor symptoms, enabling the longer-term treatment and reducing the impact of symptoms on quality of life, and potentially delaying or preventing the need for surgery...Relugolix 120 mg (ORGOVYX) was developed by Myovant Sciences and is approved in the United States, EU, and UK as the first and only oral androgen-deprivation therapy for the treatment of advanced prostate cancer. This review is focused on the development of relugolix and relugolix-CT in women's health indications.
  • ||||||||||  Journal:  Oral Gonadotropin-Releasing Hormone Antagonists for the Treatment of Uterine Leiomyomas. (Pubmed Central) -  May 1, 2023   
    The efficacy of these agents appears to be robust over a wide spectrum of clinical presentations, demonstrating that worse disease parameters at baseline do not appear to inhibit efficacy. Across clinical trials, participants largely reflected the population of individuals affected by uterine leiomyomas.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Trial initiation date, Combination therapy:  MYFEMBREE (clinicaltrials.gov) -  Mar 28, 2023   
    P=N/A,  N=530, Not yet recruiting, 
    Across clinical trials, participants largely reflected the population of individuals affected by uterine leiomyomas. Initiation date: Feb 2023 --> Jun 2023
  • ||||||||||  Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer, norethindrone / Generic mfg.
    Clinical, Journal, HEOR, Combination therapy:  Quality of life with relugolix combination therapy for uterine fibroids: LIBERTY randomized trials. (Pubmed Central) -  Feb 27, 2023   
    After 24 weeks of treatment with relugolix combination therapy, women with symptomatic uterine fibroids experienced substantial improvements in health-related quality of life, with all subscales showing improvement, including emotional well-being, physical and social activities, and sexual function. Additionally, women reported significant reductions in overall symptom burden and distress caused by key fibroid-associated symptoms.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    New trial, Combination therapy:  MYFEMBREE (clinicaltrials.gov) -  Feb 22, 2023   
    P=N/A,  N=530, Not yet recruiting, 
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Journal, Combination therapy:  Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas. (Pubmed Central) -  Nov 16, 2022   
    P3
    Improvements in heavy menstrual bleeding and anemia and reduction of uterine leiomyoma-associated symptom burden were sustained through up to 52 weeks of treatment with relugolix combination therapy in women with uterine leiomyomas. No new safety concerns were identified, and BMD was maintained.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Review, Journal:  Relugolix/Estradiol/Norethisterone (Norethindrone) Acetate: A Review in Symptomatic Uterine Fibroids. (Pubmed Central) -  Nov 16, 2022   
    Treatment with this combination for over up to 2 years did not induce a clinically meaningful bone loss in the majority of women. Relugolix/estradiol/norethisterone acetate, with its convenient once-daily administration, is a useful addition to current pharmacological treatment options for premenopausal women with symptomatic uterine fibroids.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, Oriahnn (elagolix/estradiol/norethindrone acetate) / AbbVie, Neurocrine
    Review, Journal:  Efficacy and Safety of Oral GnRH antagonists in Patients with Uterine Fibroids: A Systematic Review. (Pubmed Central) -  Nov 15, 2022   
    These drugs, alone and in combination with estradiol/norethindrone acetate (E2/NETA), showed significantly better efficacy than placebo in improving bleeding, discomfort, uterine/leiomyoma sizes, and quality of life in premenopausal patients with symptomatic uterine fibroids. However, more randomized double blind multicenter clinical trials are needed to confirm these results and to see long-term benefits.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma
    Relugolix Combination Therapy Improves Uterine Fibroid Symptoms Independent of Fibroid Location over 24 Weeks (Gaylord Rockies Resort Hotel & Convention Center - RED ROCK 6/7) -  Oct 6, 2022 - Abstract #AAGL2022AAGL_225;    
    Interventions: Participants were randomized to once-daily Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) or placebo for 24 weeks. Relugolix-CT improved HMB and other UF-associated symptoms through 24 weeks independent of fibroid location.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    RELUGOLIX COMBINATION THERAPY IN NORTH AMERICAN WOMEN WITH ENDOMETRIOSIS-ASSOCIATED PAIN: SPIRIT 1 AND 2 TRIALS (Anaheim Convention Center - Poster Hall in Expo Hall) -  Aug 21, 2022 - Abstract #ASRM2022ASRM_705;    
    Treatment effect of Rel-CT in the NA subgroup was consistent with that seen in the SPIRIT overall population. IMPACT STATEMENT: Consistency of outcomes between NA and overall SPIRIT populations support generalizability of overall results for NA women with endometriosis-associated pain.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Dainippon, Pfizer, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma
    Journal, Combination therapy:  Relugolix Combination Therapy for Uterine Leiomyoma-Associated Pain in the LIBERTY Randomized Trials. (Pubmed Central) -  Jun 15, 2022   
    P3
    Over 24 weeks, relugolix-CT significantly reduced moderate-to-severe uterine leiomyoma-associated pain with a more pronounced effect on menstrual pain. These data support that relugolix-CT had clinically meaningful effects on women's experience of uterine leiomyoma-associated pain.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Pharma, Pfizer, ASKA Pharma, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Trial completion, Trial completion date:  Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids (clinicaltrials.gov) -  Apr 26, 2022   
    P3,  N=229, Completed, 
    These data support that relugolix-CT had clinically meaningful effects on women's experience of uterine leiomyoma-associated pain. Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Nov 2021
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Dainippon, Pfizer, Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
    Bleeding Patterns in Women with Uterine Fibroids Receiving Relugolix Combination Therapy over 1 Year (Hall E) -  Mar 31, 2022 - Abstract #ACOG2022ACOG_144;    
    The majority of women with UF-associated HMB who received relugolix combination therapy for up to 52 weeks achieved amenorrhea. Of the remaining women who had either cyclic or irregular bleeding, approximately half had spotting or light/moderate bleeding that was considered within the normal range for MBL (≤80mL).
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Dainippon, Pfizer, Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
    Relugolix Combination Therapy Improves Uterine Fibroid Symptoms Independent of Fibroid Location (Ballroom 20BC) -  Mar 31, 2022 - Abstract #ACOG2022ACOG_120;    
    INTRODUCTION: In the Phase 3, replicate, institutional review board-approved LIBERTY 1 and 2 studies, relugolix combination therapy (Relugolix CT; once daily relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) improved uterine fibroid (UF)-associated heavy menstrual bleeding (HMB), pain, and quality of life (QoL). Relugolix combination therapy improves HMB and other UF-associated symptoms independent of the location of the largest fibroid.
  • ||||||||||  Myfembree (relugolix/estradiol/norethindrone acetate) / Sumitomo Dainippon, Pfizer, Oriahnn (elagolix/estradiol/norethindrone acetate) / AbbVie, Neurocrine
    Clinical, Journal, Adverse events:  Current approaches to overcome the side effects of GnRH analogs in the treatment of patients with uterine fibroids. (Pubmed Central) -  Mar 23, 2022   
    The results regarding the efficacy of new-generation oral GnRH-antagonists, such as elagolix, relugolix and linzagolix, is promising and offer potential prospect for the future therapy of UFs. However, these antagonists must be combined with hormonal Add-back therapy to minimize the resultant hypoestrogenic side effects such as bone loss.