Phase IB Trial of Relugolix and Enzalutamide as Neoadjuvant/ Adjuvant to Local-regional Treatment in Patients With High-risk Locally Advanced Prostate CAncer (RENAPCA)

The goal of this clinical trial is to test how effective and safe it is to use a combination of two medications, relugolix and enzalutamide, in patients with advanced prostate cancer. We want to see if this combination can help improve the chances of curing the cancer and make the patients live longer without the cancer getting worse.
The main questions we want to answer in this study are:
Can using relugolix and enzalutamide together help increase the chances of curing high-risk advanced prostate cancer?
Does this combination treatment help patients live longer without their cancer getting worse?
Participants in this study will be asked to take relugolix and enzalutamide as part of their cancer treatment. They will also undergo Radiation Therapy or prostatectomy, which are standard treatments for this type of cancer.

Start Date01 Aug 2024

Sponsor / Collaborator

University of Oklahoma

NCT06463457 / Not yet recruitingPhase 2IIT

Comeback From Long coursE ADT With RElugolix and Darolutamide in Hormone-sensitive Prostate Cancer (CLEARED)

This research study is being done to determine the rate of testosterone recovery after completing two years of treatment with the combination of relugolix and darolutamide as well as to assess the safety of the drugs when administered in combination.
The names of the drugs in this study are:
Relugolix (a type of gonadotropin-releasing hormone receptor antagonist)
Darolutamide (a type of androgen receptor antagonist)

Start Date01 Aug 2024

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+4]

NCT06462014 / Not yet recruitingNot Applicable

Description of Relugolix Use in Patients With Prostate Cancer: An Analysis of National Veterans Affairs Health Care Network Data

The purpose of this real-world study is the learn about the demographics and clinical characteristics of patients with prostate cancer who initiated relugolix

Start Date28 Jun 2024

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Relugolix

100 Translational Medicine associated with Relugolix

100 Patents (Medical) associated with Relugolix

115

Literatures (Medical) associated with Relugolix

01 Feb 2024·British journal of clinical pharmacology

Considerations on implementation of the newest treatment for symptomatic uterine fibroids: Oral GnRH antagonists

Review

Author: Mol, Ben Willem J ; Huirne, Judith A F ; Bet, Pierre M ; Clark, T Justin ; de Lange, Maria E ; Semmler, Annika ; Hehenkamp, Wouter J K

Abstract:

Novel gonadotrophin releasing hormone (GnRH) antagonist treatments have recently been developed in combination with hormonal add‐back therapy, as an oral treatment option for women suffering from uterine fibroids. Registration trials assessing the GnRH antagonist combination preparations with relugolix, elagolix and linzagolix have assessed treatment efficacy for fibroid‐related heavy menstrual blood loss in comparison to placebo. Marketing authorization has been granted by several agencies including those in Europe, the United Kingdom and the United States. While the registration trials report a robust effect on the reduction of heavy menstrual blood loss and improvement in quality of life scores, reticence is advised before widespread prescription. In this review, we demonstrate limitations in the trial data, namely a lack of generalizability due to the restricted study population, the lack of transparency in the distribution of disease‐level characteristics limiting the predictability of treatment success in the real‐world diverse population, and the absence of any comparison to current alternative treatment methods. Importantly, no clinically meaningful volume reductions were found with GnRH antagonist combination preparations, and long‐term safety data, particularly concerning modest but stable bone mineral density decline, need further addressing. Symptoms related to uterine fibroids adversely affect many women's quality of life and effective medical treatments are lacking. However, despite the urgent need for conservative treatments, it is vitally important that novel drugs, like combination oral GnRH antagonists, undergo sufficiently rigorous evaluation of safety, effectiveness and cost‐effectiveness in a representative population and are compared with alternative treatment methods before introduction into mainstream clinical practice.

01 Feb 2024·American journal of obstetrics and gynecology

Relugolix combination therapy in Black/African American women with symptomatic uterine fibroids: LIBERTY Long-Term Extension study

Article

Author: Schulmann, Thierry ; Stewart, Elizabeth A ; Marsh, Erica E ; Proehl, Sarah ; Lukes, Andrea S ; Zhu, Emily ; Madueke-Laveaux, O Sandra ; Al-Hendy, Ayman

BACKGROUND:

In the LIBERTY Long-Term Extension study, once-daily relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) substantially improved uterine fibroid-associated heavy menstrual bleeding throughout the 52-week treatment period in the overall study population.

OBJECTIVE:

Black or African American women typically experience a greater extent of disease and symptom burden of uterine fibroids vs other racial groups and have traditionally been underrepresented in clinical trials. This secondary analysis aimed to assess the efficacy and safety of relugolix combination therapy in the subgroup population of Black or African American women with uterine fibroids in the LIBERTY Long-Term Extension study.

STUDY DESIGN:

Black or African American premenopausal women (aged 18-50 years) with uterine fibroids and heavy menstrual bleeding who completed the 24-week randomized, placebo-controlled, double-blind LIBERTY 1 (identifier: NCT03049735) or LIBERTY 2 (identifier: NCT03103087) trials were eligible to enroll in the 28-week LIBERTY Long-Term Extension study (identifier: NCT03412890), in which all women received once-daily, open-label relugolix combination therapy. The primary endpoint of this subanalysis was the proportion of Black or African American treatment responders: women who achieved a menstrual blood loss volume of <80 mL and at least a 50% reduction in menstrual blood loss volume from the pivotal study baseline to the last 35 days of treatment by pivotal study randomized treatment group. The secondary outcomes included rates of amenorrhea and changes in symptom burden and quality of life.

RESULTS:

Overall, 241 of 477 women (50.5%) enrolled in the LIBERTY Long-Term Extension study self-identified as Black or African American. In Black or African American women receiving continuous relugolix combination therapy for up to 52 weeks, 58 of 70 women (82.9%; 95% confidence interval, 72.0%-90.8%) met the treatment responder criteria for reduction in heavy menstrual bleeding (primary endpoint). A substantial reduction in menstrual blood loss volume from the pivotal study baseline to week 52 was demonstrated (least squares mean percentage change: 85.0%); 64.3% of women achieved amenorrhea; 59.1% of women with anemia at the pivotal study baseline achieved a substantial improvement (>2 g/dL) in hemoglobin levels; and decreased symptom severity and distress because of uterine fibroid-associated symptoms and improvements in health-related quality of life through 52 weeks were demonstrated. The most frequently reported adverse events during the cumulative 52-week treatment period were hot flush (12.9%), headache (5.7%), and hypertension (5.7%). Bone mineral density was preserved through 52 weeks.

CONCLUSION:

Once-daily relugolix combination therapy improved uterine fibroid-associated heavy menstrual bleeding in most Black or African American women who participated in the LIBERTY Long-Term Extension study. The safety and efficacy profile of relugolix combination therapy in Black or African American women was consistent with previously published results from the overall study population through 52 weeks. Findings from this subanalysis will assist shared decision-making by helping providers and Black or African American women understand the efficacy and safety of relugolix combination therapy as a pharmacologic option for the management of uterine fibroid-associated symptoms.

01 May 2024·Anti-cancer agents in medicinal chemistry

An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021)

Review

Author: Gupta, Ghanshyam Das ; Jain, Ankit ; Vishakha, S ; Verma, Sant Kumar ; Navneesh, N ; Patel, Preeti ; Kurmi, Balak Das

Abstract::

New drugs being established in the market every year produce specified structures for selective biological targeting. With medicinal insights into molecular recognition, these begot molecules open new rooms for designing potential new drug molecules. In this review, we report the compilation and analysis of a total of 56 drugs including 33 organic small molecules (Mobocertinib, Infigratinib, Sotorasib, Trilaciclib, Umbralisib, Tepotinib, Relugolix, Pralsetinib, Decitabine, Ripretinib, Selpercatinib, Capmatinib, Pemigatinib, Tucatinib, Selumetinib, Tazemetostat, Avapritinib, Zanubrutinib, Entrectinib, Pexidartinib, Darolutamide, Selinexor, Alpelisib, Erdafitinib, Gilteritinib, Larotrectinib, Glasdegib, Lorlatinib, Talazoparib, Dacomitinib, Duvelisib, Ivosidenib, Apalutamide), 6 metal complexes (Edotreotide Gallium Ga-68, fluoroestradiol F-18, Cu 64 dotatate, Gallium 68 PSMA-11, Piflufolastat F-18, 177Lu (lutetium)), 16 macromolecules as monoclonal antibody conjugates (Brentuximabvedotin, Amivantamab-vmjw, Loncastuximabtesirine, Dostarlimab, Margetuximab, Naxitamab, Belantamabmafodotin, Tafasitamab, Inebilizumab, SacituzumabGovitecan, Isatuximab, Trastuzumab, Enfortumabvedotin, Polatuzumab, Cemiplimab, Mogamulizumab) and 1 peptide enzyme (Erwiniachrysanthemi-derived asparaginase) approved by the U.S. FDA between 2018 to 2021. These drugs act as anticancer agents against various cancer types, especially non-small cell lung, lymphoma, breast, prostate, multiple myeloma, neuroendocrine tumor, cervical, bladder, cholangiocarcinoma, myeloid leukemia, gastrointestinal, neuroblastoma, thyroid, epithelioid and cutaneous squamous cell carcinoma. The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.

News (Medical) associated with Relugolix

05 Mar 2024

·firstwordpharma.com

Sumitomo’s US arm trims more jobs amid restructuring blitz

After axing around 500 positions at its US unit in July last year, Sumitomo Pharma announced another round of layoffs – this time slashing approximately 400 jobs, primarily in sales and marketing, as it intensifies efforts to restructure the subsidiary.The company cited the “current severe business environment” and the failure to achieve projected sales targets for three of its key products - Orgovyx (relugolix), Myfembree (relugolix/estradiol/norethisterone acetate), and Gemtesa (vibegron). Sumitomo recently revised down estimates for the drugs, with North American sales of Orgovyx in the current fiscal year seen reaching $290 million, down from an earlier prediction of $396 million.Meanwhile, annual revenue from Gemtesa in North America is now seen at $260 million, cut from previous guidance of $362 million, with Myfembree set to bring in $70 million, slashed from a prior forecast of $192 million. Jefferies analysts called the cuts to the outlook “bigger-than-expected,” noting that it is “increasingly unlikely” that the company will meet the targets of its “ambitious-looking medium term plan.”Sumitomo has also seen a significant revenue dip due to US patent expiry for the schizophrenia therapy Latuda (lurasidone). Sales of the product in North American plunged 97% in the third quarter of the current fiscal year to $5 million.Assets that the drugmaker hoped would replace lost revenue from Latuda have also stumbled in development. Last year, a pair of Phase III studies investigating the Otsuka-partnered schizophrenia candidate ulotaront failed to meet their primary endpoints. Sumitomo said recently that the development strategy for the drug in this indication continues to be discussed with Otsuka.

Phase 3NDAFinancial StatementBiosimilar

23 Oct 2023

·www.biospace.com

Sumitomo Pharma Announces Authorization in Canada of ORGOVYX® (relugolix) for the Treatment of Men with Advanced Prostate Cancer

– ORGOVYX is the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist Approved for Advanced Prostate Cancer in Canada – MISSISSAUGA, Ontario, Oct. 23, 2023 /PRNewswire/ -- Sumitomo Pharma Canada, Inc., announced today that Health Canada has approved ORGOVYX® (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available for prescription in Canada in Q1 2024. "Roughly 1 in 8 Canadian men will develop prostate cancer in their lifetime, and the ability to suppress testosterone, primarily achieved through androgen deprivation therapy (ADT), is foundational in the treatment of the advanced stages of the disease," said Fred Saad, M.D., FRCS, Professor and Chairman of the Department of Surgery and Director of Genitourinary Oncology at the University of Montreal. "In the HERO study, ORGOVYX demonstrated rapid, sustained, and profound testosterone suppression when compared to leuprolide. ORGOVYX is the first approved ADT in Canada that can be administered orally, and once daily, offering a safe and effective option for advanced prostate cancer patients in the country." "We're pleased that with Health Canada's approval of ORGOVYX, we are helping to expand upon treatment options for Canadian men living with advanced prostate cancer," said Lisa Mullett, General Manager of Sumitomo Pharma Canada, Inc. "We are committed to making ORGOVYX available to patients across Canada early in the new year." The Health Canada approval was based on the results of the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study evaluating the safety and efficacy of ORGOVYX in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous ADT. In the Phase 3 study, ORGOVYX met the primary endpoint and demonstrated superiority in sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks compared to those receiving leuprolide acetate injections, the current standard of care. The most frequent adverse events reported in at least 10% of men in the ORGOVYX group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea. ORGOVYX was previously approved by the U.S. Food and Drug Administration on December 18, 2020 and granted marketing authorization by the European Commission for advanced hormone-sensitive prostate cancer on April 29, 2022. About Advanced Prostate Cancer Prostate cancer is the most common cancer in Canadian men, and, in 2023 an estimated 24,700 men will be diagnosed.1 Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, LHRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued. About ORGOVYX® (relugolix) ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration, the European Commission and Health Canada for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer. About Sumitomo Pharma Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information, please visit and LinkedIn to follow us. The Sumitomo Pharma icon is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. ORGOVYX is a trademark of Sumitomo Pharma Switzerland GmbH. © 2023 Sumitomo Pharma America, Inc. All rights reserved. References Fraser M, Mohammad A. The landscape of prostate cancer research in Canada. doi: 10.1200/JCO.2023.41.6_suppl.394 Journal of Clinical Oncology 41, no. 6_suppl (February 20, 2023) 394-394.

Phase 3Drug ApprovalClinical Result

19 Oct 2023

·www.prnewswire.com

Sumitomo Pharma and Pfizer in Canada Receive Health Canada Approval for MYFEMBREE®

MISSISSAUGA, ON and KIRKLAND, QC, Oct. 19, 2023 /PRNewswire/ -- Sumitomo Pharma Canada, Inc. and Pfizer Canada today announced that Health Canada has granted a Notice of Compliance (NOC) for MYFEMBREE (Relugolix, estradiol and norethindrone acetate tablets) for the management of moderate to severe pain associated with endometriosis in pre-menopausal women on October 17, 2023. On September 22, 2023, Health Canada also approved MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. This combination therapy oral treatment is taken once daily and provides a new option for women to manage their symptoms related to endometriosis and uterine fibroids. "Health Canada's approval of MYFEMBREE across the uterine fibroid and endometriosis indications marks a significant milestone in our commitment to women's health," said Lisa Mullett, General Manager, Sumitomo Pharma Canada, Inc. "These are multi-faceted and complex chronic conditions, and we are proud to make new treatment options available to women in Canada." "MYFEMBREE's approval is a testament to the shared commitment between our two companies to support women's health," added Andréa Mueller, Primary Care Portfolio Lead at Pfizer Canada. "We are proud to help women manage their health at all stages of their lives." This approval is based on several comprehensive Phase 3 studies, including the LIBERTY 1 and LIBERTY 2 trials for uterine fibroids and the SPIRIT 1 and SPIRIT 2 trials for endometriosis. "Uterine fibroids and endometriosis are very common conditions affecting millions of Canadians. Endometriosis, in particular, can be a very challenging and complex condition to treat, often resulting in years of delay to diagnosis, said Dr. Sony Sukhbir Singh, Professor and Chair of the Department of Obstetrics and Gynecology, at the University of Ottawa. "These conditions can cause debilitating symptoms such as pain and bleeding, impacting daily life and overall well-being for many girls, women and gender diverse individuals." Following this approval Pfizer Canada will lead commercialization efforts of MYFEMBREE in the uterine fibroid and endometriosis indications. In partnership with Sumitomo Pharma in Canada, Pfizer Canada is currently assessing the timeline of availability for MYFEMBREE and are committed to bringing supply of this medicine to Canadians as quickly as possible. About Uterine Fibroids Uterine fibroids are the most common benign tumors in women of reproductive age.1 Uterine fibroids may be underdiagnosed due to several factors. Roughly 50 to 80% of women may have asymptomatic fibroids, meaning they don't experience noticeable symptoms. Additionally, some women with fibroid-related symptoms, such as heavy menstrual bleeding and pain, might not seek medical attention because they consider these issues to be a normal part of their menstrual cycles. Furthermore, healthcare providers may sometimes dismiss these symptoms as normal, contributing to the underestimation of uterine fibroid prevalence in Canadian women. 2,3,4,5 About Endometriosis Endometriosis is a chronic disease characterized by growth of endometrial-like tissue outside the uterus.6 This growth of endometriotic tissue relies on estrogen, a hormone crucial for regulating the female reproductive system.7 Endometriosis mainly affects women of reproductive age, occurring between their first menstrual period and menopause, when estrogen levels decline.8 In Canada, 7.0% of women aged 18-48 have endometriosis, with an average diagnosis age of 27.9. Most Canadian women experience symptoms before diagnosis with an average delay of 5.4 years in diagnosis.9 Symptoms include menstrual pain, pelvic pain, and pain during sex, with 60% reporting moderate to severe pain. 6,9,10 Endometriosis can impact fertility, quality of life, and work productivity.11 About MYFEMBREE® MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) has received a dual indication approval, making it the first Health Canada-approved oral treatment to manage uterine fibroids and endometriosis. MYFEMBREE was approved by the U.S. Food and Drug Administration for the treatment of heavy menstrual bleeding associated with uterine fibroids in May 2021 and for the management of moderate to severe pain associated with endometriosis in August 2022. About Sumitomo Pharma Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information, please visit or follow us on LinkedIn. About Pfizer Canada Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world's best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube. 1 BMC Public Health, Global, regional, and national time trends in incidence, prevalence, years lived with disability for uterine fibroids, 1990–2019: an age-period-cohort analysis for the global burden of disease 2019 study, , Accessed August 22, 2023 2 Laberge PY, Vilos GA, Vilos AG, Janiszewski PM. Burden of symptomatic uterine fibroids in Canadian women: a cohort study. Curr Med Res Opin. 2016;32(1):165-75. doi:10.1185/03007995.2015.1107534 3 Bukulmez O, Doody KJ. Clinical features of myomas. Obstet Gynecol Clin North Am. Mar 2006;33(1):69-84. doi:10.1016/j.ogc.2005.12.002 4 Stovall DW. Clinical symptomatology of uterine leiomyomas. Clin Obstet Gynecol. Jun 2001;44(2):364-71. doi:10.1097/00003081-200106000-00022 5 Zimmermann A, Bernuit D, Gerlinger C, Schaefers M, Geppert K. Prevalence, symptoms and management of uterine fibroids: an international internet-based survey of 21,746 women. BMC Women's Health. Mar 26 2012;12:6. 6 Zondervan, K.T., et al., Endometriosis. Nat Rev Dis Primers, 2018. 4(1): p. 9. 7 Ahn, S.H., et al., Pathophysiology and immune dysfunction in endometriosis. BioMed research international, 2015. 2015. 8 Stratton, P. and K.J. Berkley, Chronic pelvic pain and endometriosis: translational evidence of the relationship and implications. Hum Reprod Update, 2011. 17(3): p. 327-46. 9 Singh, S., et al., Prevalence, symptomatic burden, and diagnosis of endometriosis in Canada: cross-sectional survey of 30 000 women. Journal of Obstetrics and Gynaecology Canada, 2020. 42(7): p. 829-838. 10 Becker, K., et al., Real world data on symptomology and diagnostic approaches of 27,840 women living with endometriosis. Scientific Reports, 2021. 11(1): p. 1-9. 11 Macer, M.L. and H.S. Taylor, Endometriosis and infertility: a review of the pathogenesis and treatment of endometriosis-associated infertility. Obstetrics and Gynecology Clinics, 2012. 39(4): p. 535-549. SOURCE Sumitomo Pharma America

Drug ApprovalPhase 3

100 Deals associated with Relugolix

External Link

KEGG	Wiki	ATC	Drug Bank
D10888	Relugolix	L01XX	DB11853

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Prostate Carcinoma	CA	Sumitomo Pharma Co., Ltd.	23 Oct 2023
Castration-Resistant Prostatic Cancer	EU	Accord Healthcare SLU	29 Apr 2022
Castration-Resistant Prostatic Cancer	IS	Accord Healthcare SLU	29 Apr 2022
Castration-Resistant Prostatic Cancer	LI	Accord Healthcare SLU	29 Apr 2022
Castration-Resistant Prostatic Cancer	NO	Accord Healthcare SLU	29 Apr 2022
Endometriosis	JP	ASKA Pharmaceutical Co., Ltd.	24 Dec 2021
Prostatic Cancer	US	Sumitomo Pharma Co., Ltd.	18 Dec 2020
Leiomyoma	JP	ASKA Pharmaceutical Co., Ltd.	08 Jan 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Menorrhagia	Phase 3	US	Myovant Sciences GmbH	26 Apr 2017
Menorrhagia	Phase 3	BR	Myovant Sciences GmbH	26 Apr 2017
Menorrhagia	Phase 3	IT	Myovant Sciences GmbH	26 Apr 2017
Menorrhagia	Phase 3	PL	Myovant Sciences GmbH	26 Apr 2017
Menorrhagia	Phase 3	ZA	Myovant Sciences GmbH	26 Apr 2017
Menorrhagia	Phase 3	GB	Myovant Sciences GmbH	26 Apr 2017
Uterine Fibroids	Phase 3	US	Myovant Sciences GmbH	26 Apr 2017
Uterine Fibroids	Phase 3	BR	Myovant Sciences GmbH	26 Apr 2017
Uterine Fibroids	Phase 3	IT	Myovant Sciences GmbH	26 Apr 2017
Uterine Fibroids	Phase 3	PL	Myovant Sciences GmbH	26 Apr 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05467176 (OPTYX study, ASCO2024)	Not Applicable	Usher Syndromes PSA \| testosterone \| distant metastases	394	Relugolix monotherapy	dneaynhgqh(wdhaixwdak) = amejhppero jnokvoetmk (skybayurfp, 238.5) View more	-	24 May 2024
ASCO2024	Not Applicable	-	267	Relugolix	mqfagyxfho(okjoqsilks) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment rxeingmelv (icxqjosnrz )	-	24 May 2024
NCT03412890 (CTgov)	Phase 3	Menorrhagia \| Uterine Fibroids	477	Relugolix+E2/NETA (Relugolix Plus E2/NETA (Group A))	tjykawwclk(kmilbgmqdg) = dtlokwnswi lwuoswdgor (tfpsjldalv, tnxqiwxqxz - tjfpcabddt) View more	-	09 May 2024
				Relugolix+E2/NETA (Relugolix Plus Delayed E2/NETA (Group B))	tjykawwclk(kmilbgmqdg) = eykjckjivy lwuoswdgor (tfpsjldalv, slveualsro - kcygdmgcjk) View more
AUA2024	Not Applicable	Advanced Prostate Carcinoma	-	Leuprolide	acbnmndxro(ikaqrtrniv) = kebwvgbemh gsrjtbvtkx (xtoxgcynof )	-	01 May 2024
				Relugolix	acbnmndxro(ikaqrtrniv) = rfmxuowubp gsrjtbvtkx (xtoxgcynof )
HERO study (ASCO_GU2024)	Not Applicable	Advanced Prostate Carcinoma	152	Relugolix	wxjqexgbng(meyzpatimm) = Three pts (2%) had a major adverse cardiovascular event, including one sudden death, one with congestive heart failure, and one with myocardial infarction. Two pts (1%) reported grade 3 fatigue. G3 LFT elevations recorded in 2 pts (1%). No clinical signals of DDI reported. wzdvqweifo (jjasjcgcsc )	Positive	25 Jan 2024
NCT03654274 (Pubmed)	Phase 3	Pain \| Endometriosis	1,261	Relugolix CT	enfwdsfezu(dftjoawqxl) = ihnpvisoyv cspwzitjot (pfhyzvpymi )	-	18 Jan 2024
NCT03654274 (CTgov)	Phase 3	Pain \| Endometriosis	802	Relugolix+E2/NETA (Relugolix Plus E2/NETA (Group A))	uydbbjbsik(tktlbsejtf) = ghnnswvohc neumoqgrii (jonotjthbd, yveikyhugg - janfinremg) View more	-	20 Jul 2023
				Relugolix+E2/NETA (Relugolix Plus Delayed E2/NETA (Group B))	uydbbjbsik(tktlbsejtf) = djrmbtprdh neumoqgrii (jonotjthbd, wlwbmxhyab - cdernyktws) View more
NCT04523207 (Apa-RP, ASCO2023) Manual	Phase 2	Localized Prostate Carcinoma Maintenance	12	Apalutamide+Relugolix	wqebkwpgtm(gdvqawtpis) = nicoknkzej jhbzpwuxgi (gdeehlrego ) View more	Positive	31 May 2023
NCT03085095 (HERO, ESMO_ASIA2022) Manual	Phase 3	Advanced Prostate Carcinoma	297	relugolix (Asian men)	hwkydrpsal(yltpkgerfv) = yozwbmfgjd ibpvdlqqsc (czwxssipto, 93.3 - 98.8) View more	Positive	02 Dec 2022
				leuprolide (Asian men)	hwkydrpsal(yltpkgerfv) = sikymchllv ibpvdlqqsc (czwxssipto, 81.2 - 93.8) View more
NCT03204318 \| NCT03204331 (SPIRIT 1 and 2, Pubmed \| Lancet)	Phase 3	Pain	-	Relugolix combination therapy	xnynxohrqn(jbqibisaxy) = pikcnwstwr wisovtgsrd (qnjlvereit )	Positive	18 Jun 2022
				Placebo	xnynxohrqn(jbqibisaxy) = rfrefpofbb wisovtgsrd (qnjlvereit )

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