Delving into the Latest Updates on Relugolix with Synapse

An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Crossover Truncated Four Period Fully Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Relugolix 120 mg Tablets Manufactured By BDR Pharmaceuticals Internationals Pvt Ltd India With Orgovyx (Relugolix) 120 MG Tablets Distributed By Sumitomo Pharma America Inc In Healthy Adult Human Male Subjects Under Fed Conditions - NIL

Start Date01 Jul 2025

Sponsor / Collaborator

BDR Pharmaceuticals International Pvt Ltd.

NCT06671548 / Not yet recruitingPhase 3

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Designed Efficacy and Safety Study to Evaluate Relugolix Tablets in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. The main question[s] it aims to answer are:
* the benefit of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids
* the safety of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids

Start Date01 Jan 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

NCT06650579 / Not yet recruitingPhase 3IIT

Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: the REVELUTION-2 Trial

This phase III/IV trial compares the impact of leuprolide and abiraterone acetate (AA) versus relugolix and AA on the heart in hormone-naive patients with advanced prostate cancer receiving pelvic radiation therapy. Leuprolide is in a class of medications called gonadotropin-releasing hormone agonists (GNRHa). It prevents the body from making luteinizing hormone-releasing hormone (LHRH) and luteinizing hormone (LH). This causes the testicles to stop making testosterone (a male hormone) in men and may stop the growth of prostate tumor cells that need testosterone to grow. Abiraterone acetate, an androgen biosynthesis inhibitor, works by decreasing the amount of certain hormones in the body. Relugolix, a GNRH antagonist, works by decreasing the amount of testosterone produced by the body. This may slow or stop the spread of prostate tumor cells that need testosterone to grow. The use of hormone therapy with radiation therapy has been shown to improve survival, however, studies have suggested that the addition of hormone therapy may worsen heart (cardiac) disease and high blood pressure. In fact, studies have shown that the most common cause of death in prostate cancer patients is due to heart disease or heart attacks. Computed tomography (CT) scans create a series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine. In this study, sophisticated cardiac CT images are used to take pictures of patients' heart and coronary arteries to help assess damage to the heart. Using cardiac CT and blood tests, this trial may help doctors determine which patients are at risk of cardiac disease when treated with combination hormone therapy, as well as the differential risk of leuprolide versus relugolix in combination with abiraterone acetate.

Start Date16 Dec 2024

Sponsor / Collaborator

Emory University

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100 Clinical Results associated with Relugolix

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100 Translational Medicine associated with Relugolix

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100 Patents (Medical) associated with Relugolix

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149

Literatures (Medical) associated with Relugolix

01 Dec 2024·Advances in Therapy

A Podcast on Patient and Physician Perspectives on the Management of Endometriosis and Relugolix Combination Therapy

Article

Author: Mangum, Tara ; Agarwal, Sanjay K ; Agarwal, Sanjay K.

Endometriosis is a common disease, affecting approximately 5-10% of reproductively aged women. Symptoms, such as painful periods, negatively impact an individual's quality of life; however, these symptoms are often normalized, leading to delays in diagnosis and treatment, and worsening of the disease. In this podcast, a reproductive endocrinologist (Dr Sanjay K Agarwal) and patient advocate (Tara Mangum) provide their perspectives on the diagnosis and management of endometriosis. They also discuss Relugolix combination therapy as a treatment option for patients with endometriosis.Podcast available for this article.

01 Nov 2024·Journal of Obstetric, Gynecologic & Neonatal Nursing

Once Daily Oral Relugolix Combination Therapy Versus Placebo in Patients With Endometriosis-Associated Pain: Two Replicate Phase 3, Randomised, Double-Blind, Studies (SPIRIT 1 and 2)

Article

Author: Adams, Ellise D ; Adams, Ellise D.

The author describes the results of a study to examine the effect of three treatment regimens on pain associated with endometriosis.

01 Oct 2024·Fertility and Sterility

Impact of relugolix combination therapy on functioning and quality of life in women with endometriosis-associated pain

Article

Author: Abrao, Mauricio S ; Wilk, Krzysztof ; Zhong, Yi ; Becker, Christian M ; Reznichenko, Galyna ; Hunsche, Elke ; Perry, Julie ; Soulban, Graziella ; As-Sanie, Sawsan

OBJECTIVETo evaluate the effect of relugolix combination therapy (relugolix CT; 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethisterone acetate) for up to 2 years in the SPIRIT long-term extension study on functioning and health-related quality of life (QoL), using the Endometriosis Health Profile (EHP)-30 questionnaire, and assess how changes in QoL domains correlated with improvements in dysmenorrhea as well as nonmenstrual pelvic pain (NMPP).DESIGNLong-term extension study of the SPIRIT phase 3 trials.SETTINGClinics and University Hospitals.PATIENT(S)Premenopausal women with moderate-to-severe endometriosis pain who previously completed the randomized SPIRIT trials were eligible to enroll in an 80-week long-term extension where all women received relugolix CT.INTERVENTION(S)Relugolix CT (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg).MAIN OUTCOME MEASURE(S)Least squares (LS) mean changes in the EHP-30 domain and total scores from baseline (pivotal) were analyzed using a mixed-effects model. Results up to 104 weeks are reported by a pivotal trial treatment group with a focus on the relugolix CT group (i.e., relugolix CT or placebo for 24 weeks, or delayed relugolix CT [relugolix 40 mg monotherapy for 12 weeks, followed by relugolix CT for 12 weeks]). In addition, the relationships between changes in dysmenorrhea and NMPP as well as changes in EHP-30 scores were assessed.RESULT(S)In the 277 women treated with relugolix CT, LS mean EHP-30 pain domain scores improved by 57.8% (LS mean change: -32.8; 95% CI: -35.5, -30.1), 66.4% (LS mean change: -37.7; 95% CI: -40.3, -35.0), and 72.2% (LS mean change: -41.3; 95% CI: -43.9, -38.7) at weeks 24, 52, and 104, respectively. The proportions of women with clinically meaningful improvement in the EHP-30 pain domain were 75.9%, 83.6%, and 88.6% at weeks 24, 52, and 104, respectively. Non-pain EHP-30 domain and total scores likewise improved. A positive correlation between changes in dysmenorrhea/NMPP and all EHP-30 domain scores was observed. Results were similar for the delayed relugolix CT and placebo → relugolix CT groups.CONCLUSION(S)Sustained reduction of endometriosis-associated pain with relugolix CT observed up to 104 weeks was accompanied by improvements in functioning and health-related QoL. These findings complement the results of the pivotal SPIRIT trials, which showed that relugolix combination therapy significantly reduced dysmenorrhea, NMPP, and dyspareunia vs. placebo in premenopausal women with endometriosis-associated pain.CLINICAL TRIAL REGISTRATION NUMBERRegistration/clinicaltrials.gov identifier: SPIRIT Extension Study (NCT03654274).

55

News (Medical) associated with Relugolix

05 Sep 2024

·pmlive.com

MHRA authorises first in new class of treatment for endometriosis symptoms

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence for Gedeon Richter’s Ryeqo for adults with endometriosis symptoms, making it the first in a new class of treatments authorised in the UK for this patient population. Those eligible to receive the combination therapy, which consists of non-peptide gonadotrophin-releasing hormone receptor antagonist relugolix 40mg, estradiol 1mg and norethisterone acetate 0.5mg taken in a single once-daily tablet, will be of reproductive age and have a history of previous medical or surgical treatment for their endometriosis. Affecting approximately 176 million women worldwide, endometriosis is a chronic condition that occurs when tissue similar to the lining of the uterus grows outside of the uterus. Patients can experience a range of symptoms, including dysmenorrhoea (painful cramping, usually in the lower abdomen), heavy bleeding and pelvic pain, and the disease can be associated with sub-fertility or infertility. The MHRA’s decision was supported by positive results from the late-stage SPIRIT programme, in which significantly more patients achieved pain reduction with Ryeqo versus placebo at 24 weeks. In the SPIRIT 1 study, 75% of patients responded to Ryeqo for their dysmenorrhoea compared to 27% in the placebo arm. The same result was seen in the SPIRIT 2 trial, with 75% of dysmenorrhoea responders in the Ryeqo cohort compared to 30% for placebo. Additionally, 59% and 66% of patients responded to Ryeqo for their non-menstrual pelvic pain (NMPP) in SPIRIT 1 and 2, respectively, compared to 40% and 43% of those receiving placebo. Dysmenorrhoea and NMPP reduction was also sustained over two years with Ryeqo treatment, according to results from a long-term extension study. David Jordan, medical director UK and Ireland, Gedeon Richter, said: “The MHRA’s decision to licence relugolix combination therapy in endometriosis is fantastic news and we are delighted the need for more treatment options has been recognised. “We have been working hard to bring a new way of treating the condition to clinicians and women suffering with painful symptoms and we believe this authorisation will be a welcome step for redefining care.” Jordan added that the company is now engaging with the relevant health authorities throughout the UK “with a view to securing NHS reimbursement as soon as possible.”

Clinical ResultDrug Approval

14 Aug 2024

·firstwordpharma.com

NICE greenlights first oral prostate cancer ADT

The UK's National Institute for Health and Care Excellence (NICE) issued final guidance Wednesday recommending Orgovyx (relugolix) as an oral androgen deprivation therapy (ADT) for hormone-sensitive prostate cancer in England. The decision, following draft guidance released last month, offers eligible patients an alternative to injectable ADTs for the first time.The oral GnRH antagonist is marketed by Accord Healthcare in Europe under an agreement with Sumitomo Pharma. Pfizer co-markets the drug with Sumitomo in the US.NICE's recommendation states that Orgovyx is approved as an option for treating prostate cancer in adults with advanced hormone-sensitive disease, alongside radiotherapy for high-risk, localised or locally advanced disease, and as a neoadjuvant treatment before radiotherapy for high-risk localised or locally advanced disease.The drug was approved in Europe in 2022 based on the Phase III HERO trial, which compared daily oral Orgovyx to leuprolide, a synthetic ADT given by depot subcutaneous or intramuscular injection every three months. Results demonstrated that 96.7% of men receiving Orgovyx maintained castration from day 29 through 48 weeks, compared to 88.8% for leuprolide. The study also showed a lower incidence of major adverse cardiovascular events in the Orgovyx arm (2.9%) versus the leuprolide group (6.2%).Paul Tredwell, executive vice president at Accord for the EMENA region, stated, "The publication of NICE's final guidance is a hugely positive step for patients living with prostate cancer in England… We are pleased to provide an additional treatment choice to the clinical community and those eligible men living with prostate cancer."

Phase 3Clinical ResultDrug Approval

22 Jul 2024

·www.pharmaceutical-technology.com

UK NICE recommends Accord’s Relugolix for prostate cancer

Relugolix offers a more convenient and flexible treatment option than injectable therapies. Credit: NICE. The UK National Institute for Health and Care Excellence ( Nice ) has recommended Accord’s Relugolix (Orgovyx), as a treatment for advanced hormone-sensitive prostate cancer in its final draft guidance. The androgen deprivation therapy (ADT) is the first oral treatment of its kind to be endorsed by NICE and could potentially benefit 40,000 individuals. Other hormone treatments are administered through injections, while Relugolix is an oral tablet, providing patients with the convenience of at-home treatment. Prostate cancer cells need androgen hormones such as testosterone to proliferate. ADT works by reducing these hormone levels, either through medication or surgery, to inhibit the growth of prostate cancer cells. Relugolix functions by obstructing the production of testosterone in the testes, thereby lowering its levels. See Also: Acorda loses Nasdaq listing to cap biotech’s end Japan’s FY 2024 pricing reform expected to favour new listed innovative drugs ADT has been linked to an increased risk of cardiovascular issues, including heart attacks and heart failure. Clinical trials indicate that compared with leuprolide, Relugolix can maintain lower testosterone levels – crucial in halting cancer growth – and diminish the risk of severe cardiovascular events. An indirect treatment comparison suggests that Relugolix works as other ADTs. It also offers a more convenient and flexible treatment option relative to injectable therapies, which can reduce the need for travel and time away from work. NICE medicines evaluation director Helen Knight said: “We are continuing to focus on what matters most to people by recommending this innovative and effective treatment that can make a positive difference to people with advanced prostate cancer. “Relugolix provides a convenient and flexible treatment option compared with therapies that need to be injected, helping people to avoid travel and time off work and the evidence shows it can improve people’s quality of life.”

Drug Approval

100 Deals associated with Relugolix

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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	CA	Sumitomo Pharma Co., Ltd.	10 Oct 2023
Castration-sensitive prostate cancer	LI	Accord Healthcare SLU	29 Apr 2022
Castration-sensitive prostate cancer	IS	Accord Healthcare SLU	29 Apr 2022
Castration-sensitive prostate cancer	EU	Accord Healthcare SLU	29 Apr 2022
Castration-sensitive prostate 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.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Prostate Carcinoma	Phase 2	DE	Takeda Pharmaceutical Co., Ltd.	04 Apr 2017
Advanced Prostate Carcinoma	Phase 2	JP	Takeda Pharmaceutical Co., Ltd.	04 Apr 2017
Advanced Prostate Carcinoma	Phase 2	SE	Takeda Pharmaceutical Co., Ltd.	04 Apr 2017
Advanced Prostate Carcinoma	Phase 2	FI	Takeda Pharmaceutical Co., Ltd.	04 Apr 2017
Advanced Prostate Carcinoma	Phase 2	CA	Bushu Pharmaceuticals Ltd.	04 Apr 2017
Advanced Prostate Carcinoma	Phase 2	FI	Bushu Pharmaceuticals Ltd.	04 Apr 2017
Advanced Prostate Carcinoma	Phase 2	AT	Takeda Pharmaceutical Co., Ltd.	04 Apr 2017
Advanced Prostate Carcinoma	Phase 2	SK	Takeda Pharmaceutical Co., Ltd.	04 Apr 2017
Pain	Phase 2	JP	Takeda Pharmaceutical Co., Ltd.	26 Mar 2016
Leiomyoma	Phase 2	JP	Takeda Pharmaceutical Co., Ltd.	05 Mar 2016

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03751124 (CTgov)	Phase 3	Menorrhagia \| Uterine Fibroids	229	Relugolix+E2/NETA (Relugolix Plus E2/NETA (Group A))	qukryhvqpq(woolyduija) = qkrtsdswcd rtufksnflf (crtmnuexwi, wyvvnwlqjg - riulqxvejg) View more	-	25 Jun 2024
				Placebo (Placebo (Group B))	qukryhvqpq(woolyduija) = isgimjvuev rtufksnflf (crtmnuexwi, sdvxknqetr - vlldllfine) View more
ASCO2024	Not Applicable	-	267	Relugolix	(spodzbjhiy) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment zfqxkjteli (bxaiphsoqs )	-	24 May 2024
NCT03412890 (CTgov)	Phase 3	Menorrhagia \| Uterine Fibroids	477	Relugolix+E2/NETA (Relugolix Plus E2/NETA (Group A))	apwazfgamo(pahdqbxlir) = rkwouhbaeu zjenqpmvhy (yunkncdawo, lbxxnsoopo - wwiluxxbvp) View more	-	09 May 2024
				Relugolix+E2/NETA (Relugolix Plus Delayed E2/NETA (Group B))	apwazfgamo(pahdqbxlir) = tvhfnaldvi zjenqpmvhy (yunkncdawo, pvkarqlqzf - rpfmmosemw) View more
AUA2024	Not Applicable	Advanced Prostate Carcinoma	-	Leuprolide	(xwfkuxaatq) = yqyeszpogr pmztnktmke (egeqbjohfm )	-	01 May 2024
				Relugolix	(xwfkuxaatq) = pnkqhedevi pmztnktmke (egeqbjohfm )
HERO study (ASCO_GU2024)	Not Applicable	Advanced Prostate Carcinoma	152	Relugolix	(jvzhavyjje) = 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. ekiyjzhkje (itvmmszouq )	Positive	25 Jan 2024
NCT03654274 (SPIRIT, Pubmed) Manual	Phase 3	Pain	1,044	Relugolix +oestradiol+norethisterone acetate	kuwpaxdzar(rxlunzlpkh) = xaexlpreha ursknxiimm (hqfqqiguip ) View more	Positive	18 Jan 2024
NCT03654274 (SPIRIT, CTgov)	Phase 3	Pain \| Endometriosis	802	Relugolix+E2/NETA (Relugolix Plus E2/NETA (Group A))	bbbcmoyord(ozjamwtdll) = iffxflglux tuhmcbxvdx (hselmisgej, siyncfkeyk - dycdwkrbwg) View more	-	20 Jul 2023
				Relugolix+E2/NETA (Relugolix Plus Delayed E2/NETA (Group B))	bbbcmoyord(ozjamwtdll) = otexzjiuqn tuhmcbxvdx (hselmisgej, pwhhrkqdwa - nccjzzuaeh) View more
NCT04523207 (Apa-RP, ASCO2023) Manual	Phase 2	Localized Prostate Carcinoma Maintenance	12	Apalutamide+Relugolix	minpqasnch(pdgyvpyypu) = rdcrrbriml ecusyiganv (lhmcivsgtz ) View more	Positive	31 May 2023
NCT04523207 (Apa-RP, Pubmed)	Phase 2	Localized Prostate Carcinoma Adjuvant	12	Relugolix monotherapy	(seykpwyiai) = Hot flush was the most common TEAE reported, in six and four patients, respectively jwvwlxkpmb (cuywiitvyv ) View more	-	06 Dec 2022
				Relugolix + Apalutamide coadministration
NCT03085095 (HERO, ESMO_ASIA2022) Manual	Phase 3	Advanced Prostate Carcinoma	297	relugolix (Asian men)	xjszscjlly(bowrckexjf) = ljtjlqqkos fbvilxefmf (nmutjzzgce, 93.3 - 98.8) View more	Positive	02 Dec 2022
				leuprolide (Asian men)	xjszscjlly(bowrckexjf) = icdvbygyjg fbvilxefmf (nmutjzzgce, 81.2 - 93.8) View more