Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)

The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).

Start Date29 Jul 2026

Sponsor / Collaborator

Baptist Health South Florida, Inc.

[+1]

CTRI/2026/05/110587

/ Not yet recruitingPhase 4

A prospective open label single-arm multicentre Phase IV study to assess efficacy and safety of Relugolix 120 mg tablet in adult patients with advanced prostate cancer - NIL

Start Date29 May 2026

Sponsor / Collaborator

Zydus Lifesciences Ltd.

CTR20261607

/ TerminatedNot Applicable

瑞卢戈利片在健康受试者中的单剂量、随机、开放、交叉、两制剂、餐后人体生物等效性试验

[Translation] A single-dose, randomized, open-label, crossover, two-formulation, postprandial human bioequivalence study of relugoli tablets in healthy subjects.

考察参比制剂与受试制剂在健康人体内的生物等效性和安全性。

[Translation]

The bioequivalence and safety of the reference formulation and the test formulation in healthy human subjects were investigated.

Start Date11 May 2026

Sponsor / Collaborator

Hangzhou Minsheng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Relugolix

100 Translational Medicine associated with Relugolix

100 Patents (Medical) associated with Relugolix

243

Literatures (Medical) associated with Relugolix

31 Dec 2026·GYNECOLOGICAL ENDOCRINOLOGY

Relugolix combination therapy in symptomatic adenomyosis and uterine fibroids: a case series

Article

Author: Angioni, Stefano ; Chilà, Caterina ; Di Michele, Stefano ; Saponara, Stefania ; Muzii, Ludovico ; D'Alterio, Maurizio Nicola ; Vignali, Michele ; Maiorana, Antonio

OBJECTIVE:

To evaluate the clinical efficacy and safety of a once-daily oral fixed-dose combination of relugolix 40 mg, estradiol 1 mg, and norethisterone acetate 0.5 mg in women with symptomatic adenomyosis coexisting with uterine fibroids.

METHODS:

This case series included six women with uterine fibroids and concomitant adenomyosis, diagnosed by transvaginal ultrasound according to MUSA criteria. All patients received continuous treatment for 12 months. Clinical outcomes included changes in dysmenorrhea and pelvic pain assessed by the Visual Analogue Scale (VAS), menstrual blood loss evaluated through the Pictorial Blood Assessment Chart (PBAC), and hemoglobin levels. Ultrasonographic assessment measured uterine volume and adenomyosis-related features before and after treatment.

RESULTS:

All patients achieved complete resolution of dysmenorrhea and chronic pelvic pain, with VAS scores reduced to zero. Menstrual bleeding ceased in all cases (PBAC = 0), and hemoglobin levels improved after 12 months. Ultrasound examination demonstrated a reduction in uterine volume ranging from 8.6% to 58.3%, along with partial regression of direct adenomyotic features. No adverse events or treatment discontinuations were reported during follow-up.

CONCLUSIONS:

Relugolix/estradiol/norethisterone acetate combination therapy was effective, well-tolerated, and associated with consistent clinical and sonographic improvement in women with adenomyosis and coexisting fibroids. Future larger-scale, controlled studies with extended follow-up are warranted to validate these findings.

24 Jul 2026·EXPERT OPINION ON PHARMACOTHERAPY

GnRH antagonists for the treatment of fibroids and adenomyosis, current evidence and future perspectives

Review

Author: Ottonello, Silvia ; Vellone, Valerio Gaetano ; Perrone, Umberto ; Barra, Fabio ; Gazzo, Irene ; Rosato, Francesco Paolo ; Ferrero, Simone ; Olcese, Francesca

INTRODUCTION:

Uterine fibroids and adenomyosis are common estrogen- and progesterone-dependent disorders associated with heavy menstrual bleeding, pelvic pain, anemia, and impaired quality of life. Although surgery remains widely used, there is an increasing demand for effective uterus-preserving medical therapies. Oral gonadotropin-releasing hormone (GnRH) antagonists have recently emerged as a novel therapeutic option, allowing rapid, reversible, and dose-dependent suppression of ovarian steroidogenesis.

AREAS COVERED:

This narrative, based on a targeted PubMed/MEDLINE literature search and review of major guideline documents published up to May 2026, summarizes the pharmacological properties, mechanisms of action, and clinical evidence regarding GnRH antagonists (elagolix, relugolix and linzagolix) in uterine fibroids and adenomyosis. Evidence from randomized controlled, extension studies, and emerging literature was critically reviewed, focusing on control of heavy menstrual bleeding, pain reduction, quality of life, safety, and the role of add-back therapy.

EXPERT OPINION:

GnRH antagonists represent a major advance in the medical treatment of uterine fibroids and are highly effective in controlling heavy menstrual bleeding. Their role in adenomyosis appears promising, although evidence remains limited. These agents should currently be considered suppressive rather than curative therapies, as symptoms often recur after discontinuation. Long-term integration into individualized treatment strategies will require further safety and comparative effectiveness data.

04 Jul 2026·EUROPEAN JOURNAL OF CONTRACEPTION AND REPRODUCTIVE HEALTH CARE

Perimenopausal hot flashes do not depend on crude circulating oestradiol levels: further evidences from women treated with oral GnRH antagonists combination therapy for symptomatic fibroids

Article

Author: Barretta, Marta ; La Marca, Antonio ; Iaccheri, Mattia ; Versailles, Jacques Berthold Evens ; Grandi, Giovanni

PURPOSE:

Some perimenopausal women treated for fibroid-related bleeding may already experience hot flashes.

MATERIALS AND METHODS:

In this pilot case series, we evaluated the effect of relugolix combination therapy (relugolix 40 mg + oestradiol 1 mg + norethisterone acetate 0.5 mg) on hot flashes and endocrine parameters in seven perimenopausal women.

RESULTS:

All women reported a marked improvement (visual analogue scale: 8.6 ± 1.0) of hot flashes, while treatment significantly suppressed FSH (p = 0.004), LH (p = 0.002) and oestradiol (p = 0.002) serum levels.

CONCLUSIONS:

These preliminary findings indicate that hot flashes improvement may not depend on crude circulating oestradiol levels in perimenopausal women, but probably on their stabilisation with the oral GnRH antagonist addition.

110

News (Medical) associated with Relugolix

04 Aug 2026

·www.fiercepharma.com

Pfizer unveils additional $2.5B in planned cost savings through 2029

Pfizer will reduce its costs by $2.5 billion in another round of cutbacks, which will kick in next year and run through 2029. The New York company unveiled the plan in its second-quarter earnings report (PDF). The savings effort comes amid a quarter in which Pfizer topped expectations with a 3% revenue increase to $15 billion. The company raised its 2026 sales guidance at the midpoint by $500 million to a range of $60.5 billion to $62.5 billion. The additional cutbacks bring Pfizer’s total cost-savings target (PDF) to $9.7 billion through 2029. Of the new $2.5 billion effort, $1.5 billion is earmarked for optimizing the company’s manufacturing operations, with the remaining $1 billion added to Pfizer’s “cost realignment program.” In total, the cost realignment plan is designed to save the company $6.7 billion through the end of 2029. Pfizer is churning $500 million of the cost savings into R&D investment this year, it added. The manufacturing optimization effort is “focused on network structure changes, product portfolio enhancements and additional operational efficiencies,” Pfizer said. Overall, the cost savings will support “margin expansion through productivity gains” and provide “future growth opportunities,” Pfizer added. To install and execute the new cost savings, Pfizer will incur a one-time expenditure of $6 billion, with much of the figure going to severance, implementation and exit costs, in addition to non-cash expenditures for accelerated depreciation and asset write-downs. The program is a continuation of Pfizer’s reorganization, which kicked off in 2023 following its $43 billion acquisition of antibody-drug conjugate specialist Seagen. The buyout expanded Pfizer’s headcount to 88,000 at the end of that year and has since been in decline, falling to 75,000 at the end of 2025. As for Pfizer’s quarterly revenue surprise, analysts had expected a year-over-year decline, given the company’s 10% sales boom in the second quarter of 2025, which was attributed to contractual arrangements for the COVID products Comirnaty and Paxlovid. While the COVID products saw major dropoffs, including Paxlovid sales plummeting from $427 million in the second quarter of last year to $21 million in the same period this year, Pfizer’s growth products thrived, including blood thinner Eliquis, which was up 21%, and migraine therapy Nurtec, which saw an 18% increase. Pfizer’s cancer medications that were up included Orgovyx (+51%), Lorbrena (+41%) and Padcev (+23%), helping the oncology portfolio to a 9% bump. Even in the face of new competition from Alnylam and BridgeBio in ATTR-CM, Pfizer’s Vyndaqel family of drugs realized a 9% gain. Another positive was the rebound of RSV shot Abrysvo, which was up 46%. Interim chief financial officer Cecile Guegan said that Pfizer’s upgraded revenue guidance “reflects strong non-COVID product performance.” The uptick includes a $1.5 billion increase in expected sales from non-COVID products, along with a $1 billion reduction in the company’s projection of its COVID product sales, from $5 billion to $4 billion. “The performance that we have to date reflects the low infection level, mostly impacting Paxlovid,” Guegan added on a conference call Tuesday. “But we remain with our revenues for Comirnaty in the later part of the year, consistent with the vaccination season.”

Acquisition

06 Jul 2026

·www.businesswire.com

AbCellera Appoints Dr. Lynn Seely to its Board of Directors

VANCOUVER, British Columbia--(BUSINESS WIRE)--AbCellera (Nasdaq: ABCL) today announced the appointment of Lynn Seely, M.D., to its Board of Directors as an independent director. “Dr. Seely is a respected executive leader with a proven track record of successfully developing new medicines in endocrinology, oncology, and women’s health. I am pleased to welcome her to AbCellera’s Board of Directors and look forward to having her on our team,” said Carl Hansen, Ph.D., founder and CEO of AbCellera. Dr. Seely’s experience as a biopharmaceutical executive and board member includes an extensive background in strategic, clinical, and commercial execution, which are highly relevant to AbCellera's work in discovering and developing impactful antibody-based medicines. Dr. Seely currently serves as president and CEO of Lyell Immunopharma Inc., a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. Prior to Lyell, she was president, CEO, board member, and first employee of Myovant Sciences Inc., where she successfully commercialized innovative therapies for women’s and men’s health, including Myfembree® (relugolix, estradiol, and norethindrone acetate) and Orgovyx® (relugolix). Dr. Seely also served as the chief medical officer of Medivation Inc., where she led the clinical development of the oncology drug Xtandi® (enzalutamide) from first-in-human trials through global approvals, prior to its $14 billion acquisition by Pfizer Inc. “I look forward to serving on AbCellera’s Board of Directors as the Company advances its mission of discovering and developing first-in-class antibody-based medicines,” said Dr. Seely. “AbCellera is well positioned for growth as it moves multiple product candidates, developed by its exceptional research team and designed to bring meaningful new treatments to patients, into early- and late-stage clinical development.” Dr. Seely currently serves on the Board of Managers of Life Science Cares Bay Area. She previously served as the lead independent director for Blueprint Medicines Corp. prior to its $9.1 billion acquisition by Sanofi, and was a member of the Board of Managers for TORL BioTherapeutics LLC. Dr. Seely received her M.D. from the University of Oklahoma College of Medicine. She completed her residency and served as chief resident in internal medicine at Yale-New Haven Hospital, and completed a basic science and clinical fellowship in endocrinology and metabolism at the University of California, San Diego. About AbCellera Biologics Inc. AbCellera (Nasdaq: ABCL) is a clinical-stage biotechnology company focused on discovering and developing first-in-class antibody-based medicines in the areas of endocrinology, women’s health, immunology, oncology, and more. For more information, please visit www.abcellera.com.

Executive ChangeAcquisitionImmunotherapy

18 May 2026

·www.biospace.com

New Data from Sumitomo Pharma America at AUA 2026 Highlight Efficacy of Vibegron in Men Aged 75 and Older with Overactive Bladder and BPH

SMPA reinforces commitment to the urology community with findings from studies across overactive bladder and advanced prostate cancer portfolios MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Sumitomo Pharma America, Inc. (SMPA) today announced the presentation of new data from its urology and oncology portfolios at the American Urological Association (AUA) 2026 Annual Meeting, held on May 15–18 in Washington, D.C. The presentations include a featured subgroup analysis of the phase 3 COURAGE trial evaluating vibegron in older men, along with real-world evidence from the OPTYX study of relugolix in advanced prostate cancer. “Our presence at AUA 2026 underscores our deep-rooted commitment to advancing scientific understanding for patients managing complex urologic conditions,” said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. “By focusing on patient populations at particular risk, such as men over 75 with overactive bladder and on pharmacologic treatment for benign prostatic hyperplasia, and those navigating the complexities of advanced prostate cancer, we aim to provide clinicians with the robust data they need to make informed, patient-centered treatment decisions.” Safety and efficacy outcomes with vibegron are comparable in older and younger patients Data presented includes a poster on a subgroup analysis of the placebo-controlled phase 3 COURAGE trial, which evaluated the efficacy and safety of once-daily vibegron 75 mg in men with symptoms of overactive bladder (OAB) who were also receiving pharmacologic therapy for benign prostatic hyperplasia (BPH) (stable dose of α-blocker ± 5α-reductase inhibitors). The analysis found that men ≥75 years experienced clinically meaningful reductions from baseline at week 24 in average daily number of micturitions and urgency episodes with vibegron (n=92) compared with placebo (n=100). Micturitions were –2.3 in the vibegron group compared with –1.5 in the placebo group, and urgency episodes were –3.6 in the vibegron group compared with –2.3 in the placebo group. These results were comparable to the outcomes observed in men <75 years. Vibegron was generally well tolerated in this older population, with a safety pro to that observed in men <75 years. “Older men often face the dual challenge of managing OAB symptoms while on existing therapies for BPH. These findings are encouraging as they demonstrate that vibegron can provide meaningful symptomatic relief in this specific, often harder-to-treat population, with a safety pro to that of younger patients,” said Dr. Sender Herschorn, M.D., Professor of Surgery/Urology at the University of Toronto and lead author of the poster. Additional data presented in treatment of OAB and advanced prostate cancer In a separate podium presentation, SMPA shared a subgroup analysis from the COURAGE trial evaluating the effect of vibegron on sexual function in men. SMPA, in a poster presentation, also shared an interim analysis of testosterone suppression and recovery from the OPTYX study, a prospective, long-term observational study of relugolix (monotherapy and combination) in a real-world setting. Presentation Details Title Details IP15-20: Efficacy and safety of vibegron in men ≥75 years of age with symptoms of overactive bladder on pharmacotherapy for benign prostatic hyperplasia: a subgroup analysis of the COURAGE trial Poster Presentation Presenter: Dr. Sender Herschorn, MD, University of Toronto IP38-21: Testosterone suppression and recovery in patients with advanced prostate cancer treated with relugolix: an interim analysis of the OPTYX study Poster Presentation Presenter: Dr. Benjamin Lowenritt, MD, FACS, Chesapeake Urology PD26-08: Evaluating sexual function in men treated with vibegron for overactive bladder while on pharmacological therapy for benign prostatic hyperplasia: exploratory analysis from the phase 3 COURAGE trial Podium Presentation Presenter: Dr. Kenneth Peters, MD, Urology, Corewell Health William Beaumont University Hospital About GEMTESA ® (vibegron) In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since December 2020. GEMTESA was approved in December 2024, for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). GEMTESA works by selectively targeting beta-3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. About Overactive Bladder Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours). 1 Approximately 33 million U.S. adults experience the bothersome symptoms of OAB. 2 INDICATIONS AND USAGE GEMTESA ® is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred. WARNINGS AND PRECAUTIONS Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention. Angioedema Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway. ADVERSE REACTIONS Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Please see full Prescribing Information . ABOUT ORGOVYX ® (relugolix) ORGOVYX ® (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer. IMPORTANT SAFETY INFORMATION Contraindication ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components. Warnings and Precautions QT/QTc Interval Prolongation: Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes. Hypersensitivity: Angioedema was reported in 0.2% of patients treated with ORGOVYX in HERO. Hypersensitivity reactions, including pharyngeal edema and other serious cases of angioedema, have been reported post-marketing with ORGOVYX. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue ORGOVYX and promptly seek medical care. Discontinue ORGOVYX for severe hypersensitivity reactions and manage as clinically indicated. Embryo-Fetal Toxicity: The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX. Laboratory Testing: Therapy with ORGOVYX results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after ORGOVYX may be affected. The therapeutic effect of ORGOVYX should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured. Adverse Reactions Serious adverse reactions occurred in 12% of patients receiving ORGOVYX. Serious adverse reactions in ≥0.5% of patients included myocardial infarction (0.8%), acute kidney injury (0.6%), arrhythmia (0.6%), hemorrhage (0.6%), and urinary tract infection (0.5%). Fatal adverse reactions occurred in 0.8% of patients receiving ORGOVYX including metastatic lung cancer (0.3%), myocardial infarction (0.3%), and acute kidney injury (0.2%). Fatal and non-fatal myocardial infarction and stroke were reported in 2.7% of patients receiving ORGOVYX. Most common adverse reactions (≥10%) and laboratory abnormalities (≥15%) in patients receiving ORGOVYX were hot flush (54%), glucose increased (44%), triglycerides increased (35%), musculoskeletal pain (30%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), fatigue (26%), aspartate aminotransferase increased (18%), constipation (12%), and diarrhea (12%). Drug Interactions Co-administration of ORGOVYX with an oral P-gp inhibitor increases relugolix exposure, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first and separate dosing by at least 6 hours. Monitor patients for increased adverse reactions. Treatment with ORGOVYX may be interrupted for up to 2 weeks if a short course of treatment with a P-gp inhibitor is required. Resume ORGOVYX after the P-gp inhibitor is discontinued. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a 360 mg loading dose on the first day and continue with 120 mg once daily. Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases relugolix exposure, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended ORGOVYX dose of 120 mg once daily. Please see full Prescribing Information for ORGOVYX. 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.) focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn . The Sumitomo corporate symbol mark is a registered trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. ORGOVYX ® and its logo are registered trademarks of Sumitomo Pharma Co. Ltd., used under license. ©2026 Sumitomo Pharma America, Inc. All rights reserved. References Overactive bladder – symptoms and causes. Mayo Clinic. February 4, 2025. Accessed May 6, 2026. Gomelsky A, Dmochowski RR. Update on the management of overactive bladder: patient considerations and adherence. Open Access J Urol. 2011;3:7-17. doi:10.2147/OAJU.S7233 GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025 Contacts For further information: SMPA CONTACT: Dave Murdoch, Sumitomo Pharma America, Inc., david.murdoch@us.sumitomo-pharma.com , +1 (774) 405-5570

Clinical ResultPhase 3Drug Approval

100 Deals associated with Relugolix

External Link

KEGG	Wiki	ATC	Drug Bank
D10888	Relugolix	L01XX	DB11853

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Prostate Carcinoma	Canada	Sumitomo Pharma Co., Ltd.	10 Oct 2023
Castration-sensitive prostate cancer	European Union	Accord Healthcare SL	29 Apr 2022
Castration-sensitive prostate cancer	Iceland	Accord Healthcare SL	29 Apr 2022
Castration-sensitive prostate cancer	Liechtenstein	Accord Healthcare SL	29 Apr 2022
Castration-sensitive prostate cancer	Norway	Accord Healthcare SL	29 Apr 2022
Endometriosis	Japan	ASKA Pharmaceutical Co., Ltd.	24 Dec 2021
Prostatic Cancer	United States	Sumitomo Pharma America, Inc.	18 Dec 2020
Leiomyoma	Japan	ASKA Pharmaceutical Co., Ltd.	08 Jan 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Prostate Carcinoma	Phase 3	United States	Sumitomo Pharma America, Inc.	31 Jan 2025
Recurrent Prostate Carcinoma	Phase 3	United States	Pfizer Inc.	31 Jan 2025
Dysmenorrhea	Phase 3	United States	Sumitomo Pharma Switzerland GmbH	01 Nov 2017
Dysmenorrhea	Phase 3	Australia	Sumitomo Pharma Switzerland GmbH	01 Nov 2017
Dysmenorrhea	Phase 3	Brazil	Sumitomo Pharma Switzerland GmbH	01 Nov 2017
Dysmenorrhea	Phase 3	Chile	Sumitomo Pharma Switzerland GmbH	01 Nov 2017
Dysmenorrhea	Phase 3	Czechia	Sumitomo Pharma Switzerland GmbH	01 Nov 2017
Dysmenorrhea	Phase 3	Italy	Sumitomo Pharma Switzerland GmbH	01 Nov 2017
Dysmenorrhea	Phase 3	New Zealand	Sumitomo Pharma Switzerland GmbH	01 Nov 2017
Dysmenorrhea	Phase 3	Poland	Sumitomo Pharma Switzerland GmbH	01 Nov 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05605964 (CTgov)	Phase 3	Prostatic Cancer	387	Relugolix (Relugolix)	hyulmloscd = izxifasmjg jvgrqcnrrd (knthjebttw, xugdhgxmmf - szudpiavkg) View more	-	15 Jun 2026
				Leuprolide Acetate (Leuprolide Acetate)	hyulmloscd = tkdcthxjdi jvgrqcnrrd (knthjebttw, rfygtvqbcq - fbzdydxpjr) View more
NCT05467176 (OPTYX, ASCO2026)	Not Applicable	Metastatic Prostate Carcinoma	255	Relugolix monotherapy	euhqqnscaw(vcwiuluqve) = iwoazdwbsc lvmcwvvjuh (kegzaatqgj ) View more	Positive	29 May 2026
				Relugolix in combination with other systemic prostate therapies	euhqqnscaw(vcwiuluqve) = qzqwtkkydm lvmcwvvjuh (kegzaatqgj ) View more
NCT05467176 (OPTYX, AUA2026)	Not Applicable	Advanced Prostate Carcinoma	999	Relugolix monotherapy	pdxbclnvyc(queacbxmgo) = rueoyircbq oiqfltsdlu (ifrttfeold ) View more	Positive	15 May 2026
NCT07216248 (OPTIMAS, ASCO_GU2026)	Phase 2	Hormone-dependent prostate cancer	160	Relugolix + ARPI (intermittent)	qipfmvrari(lihnmqqsvq) = qsewifyqsx cvqnsfvtlx (qmqacsiaiq )	Positive	26 Feb 2026
ASTRO2025	Not Applicable	Prostatic Cancer	296	Relugolix	zyvkveqafe(rmtxxbwvfg) = ivjjylwmsd spuqfwynqi (jexvcffyms ) View more	Positive	27 Sep 2025
				Degarelix	zyvkveqafe(rmtxxbwvfg) = igkzectxkn spuqfwynqi (jexvcffyms ) View more
NCT05320406 (REVELUTION, CTgov)	Phase 2	Cardiotoxicity \| Localized Prostate Carcinoma \| Prostate Cancer, Hereditary, 7 ... View more	94	Radiation therapy (Arm I (Radiation Therapy Alone))	plwmotlqeh(fdxfvbkaof) = kjlmgaflwc qmobxkuyww (pslqjcsjbo, ctrvhdfszg - kkzzyceqwk) View more	-	22 Sep 2025
				Radiation therapy+Leuprolide (Arm II (Radiation Therapy Plus Leuprolide))	plwmotlqeh(fdxfvbkaof) = gwlmvwgfby qmobxkuyww (pslqjcsjbo, sdyatjvhdp - niopavtygl) View more
NCT05467176 (OPTYX study, ASCO2025)	Phase 3	Prostatic Cancer	999	Relugolix	atxlhybebf(pdcgazkabj) = tytvlmladn vuqcnpnqos (yrpzdakrmy ) View more	Positive	30 May 2025
NCT04666129 (ASCO_GU2025) Manual	Phase 1	Advanced Prostate Carcinoma	24	Relugolix 120 mg + Abiraterone 1000 mg + prednisone 5 mg/methylprednisolone 4 mg (Part 1)	bpxleuikab(ufnxvtqtwh) = lxscrjkpcg bpjgboasos (urjukdopgv, 3.2) View more	Positive	13 Feb 2025
				Relugolix 240 mg + Apalutamide 240 mg	bpxleuikab(ufnxvtqtwh) = wthmcfetvh bpjgboasos (urjukdopgv, 8.0) View more
ASCO_GU2025	Not Applicable	-	5,274	relugolix (Nonmetastatic Prostate Cancer (nmPC))	wiczscyqdx(wcdfvgplts) = yenqzvfzae aeditahweg (nnziuqzvqk, ±10 [99]) View more	-	13 Feb 2025
				relugolix (Metastatic Prostate Cancer (mPC))	wiczscyqdx(wcdfvgplts) = hwnfqvkamq aeditahweg (nnziuqzvqk, ±10 [99]) View more
NCT03103087 \| NCT03049735 (LIBERTY 2 \| LIBERTY 1, Pubmed \| Pain Manag)	Phase 3	Uterine Fibroids	-	Relugolix combination therapy	mcqbcdgbmy(tqnzqqvvnt) = dqfdpskaer oedqhmxbdg (fblzpxvfgb ) View more	Positive	01 Sep 2024
				Placebo	mcqbcdgbmy(tqnzqqvvnt) = nybegvnwnt oedqhmxbdg (fblzpxvfgb ) View more

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

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Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis