Delving into the Latest Updates on Relugolix with Synapse

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 Date01 Apr 2026

Sponsor / Collaborator

Baptist Health South Florida, Inc.

[+1]

NCT07440043

/ Not yet recruitingNot ApplicableIIT

An Ambispective, Single-center Observational Study Evaluating the Effectiveness of Relugolix Combination Therapy in Reducing Endometriosis-associated Pain Over 24 Weeks in a Real-world Clinical Setting

Endometriosis is a chronic, estrogen-dependent condition frequently associated with pelvic pain and reduced quality of life. Relugolix combination therapy (CT), an oral GnRH receptor antagonist-based treatment, has demonstrated efficacy in randomized clinical trials, but real-world data remain limited.
The RELAX study is a single-center, ambispective observational study evaluating the effectiveness of relugolix CT in reducing endometriosis-associated pain over 24 weeks in routine clinical practice. The primary endpoint is the change from baseline in pelvic pain measured by the Visual Analog Scale (VAS). Secondary outcomes include changes in pain-related symptoms, ultrasonographic findings, patient satisfaction, and safety.

Start Date25 Feb 2026

Sponsor / Collaborator-

NCT07111247

/ RecruitingPhase 4IIT

Insights in Endocervical Mucus Secretion

Single arm interventional study looking at biological outcomes at 4 time points throughout the cycle before and after taking an oral gonadotropin-releasing hormone antagonist (gnRH). Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected.

Start Date02 Jan 2026

Sponsor / Collaborator

Oregon Health & Science University

[+1]

100 Clinical Results associated with Relugolix

Login to view more data

100 Translational Medicine associated with Relugolix

Login to view more data

100 Patents (Medical) associated with Relugolix

Login to view more data

207

Literatures (Medical) associated with Relugolix

01 Mar 2026·European journal of obstetrics & gynecology and reproductive biology: X

Results of relugolix/estradiol/norethisterone acetate combination therapy in real-world clinical practice: Effectiveness, tolerability, and factors influencing discontinuation

Article

Author: Fernández-Parra, J ; Santalla-Hernández, A ; García-Rivera, M ; Esquinas-Orellana, N ; Benítez-Cejas, L M ; Naveiro-Fuentes, M

Objective:

To evaluate the real-world effectiveness, safety, and tolerability of relugolix/estradiol/norethisterone acetate combination therapy (relugolix CT) for managing symptomatic uterine fibroids in routine gynaecological practice.

Methods:

A retrospective, observational study was conducted at a tertiary hospital in Spain between June 2023 and January 2025. Adult women with symptomatic uterine fibroids treated with relugolix CT were included, either as a long-term treatment or preoperative management. Clinical outcomes were assessed at baseline, 6 months, and in a subset of patients, at 12 months. Primary endpoints included changes in total bleeding days, heavy menstrual bleeding (HMB) days, and UFS-QoL symptom severity scores (SSS), as well as treatment adherence and adverse events.

Results:

Among the 142 women who initiated treatment, Relugolix CT significantly reduced total bleeding days (from 12 to 2.2), HMB days (from 7.1 to 0.4), and UFS-QoL SSS (from 27.9 to 15.1) at 6 months (p < 0.05). Amenorrhea was achieved in 52.7 % at 6 months and 66 % at 12 months. Better clinical outcomes were linked to continued treatment. Adverse events were reported in 34.5 % of patients, primarily abdominal pain and vasomotor symptoms. Bone densitometry at 12 months showed no osteoporosis and mild osteopenia in a few patients. Discontinuation was most commonly due to planned surgery or perceived lack of efficacy.

Conclusion:

Relugolix CT demonstrates strong real-world effectiveness and tolerability for managing symptomatic uterine fibroids, with marked improvements in bleeding and quality of life, and a favourable safety profile.

05 Feb 2026·ONCOLOGIST

Oral relugolix for the treatment of advanced prostate cancer

Article

Author: Hird, Amanda ; Lock, Michael ; Chow, Ronald

01 Feb 2026·European Journal of Obstetrics & Gynecology and Reproductive Biology

Efficacy and safety of relugolix therapy for symptomatic uterine fibroids: a systematic review and meta-analysis

Review

Author: Taj, Javeria ; Kalpina, Fnu ; Raza, Ahmed ; Shujaat, Tabia ; Bin Faheem, Muhammad Shaheer ; Jabeen, Laiba ; Qayyum, Maimoona ; Kaleem, Manal ; Kumar, Dinesh

INTRODUCTION:

Uterine fibroids are the most common benign tumors in premenopausal women and often necessitate fertility-sparing treatments. Relugolix, an oral GnRh antagonist has emerged as a promising non-surgical option. This systematic review and meta-analysis evaluate the efficacy and safety of relugolix for symptomatic uterine fibroids.

METHODS:

We searched PubMed, Embase, Cochrane CENTRAL, Scopus, and ClinicalTrials.gov through March 2025. Six studies (n = 511) were included in accordance with the PRISMA guidelines. Data were analysed using random-effects models in R (v4.5.0). Risk of Bias was assessed using ROB 2 tool. Continuous outcomes were reported as mean differences (MDs), dichotomous outcomes as odds ratios (ORs) or proportions, and heterogeneity using I² statistics, with sensitivity analyses for I² ≥ 50 %.

RESULTS:

Pooled analysis revealed a myoma volume reduction (MVR) of -30.18 %, with similar findings when compared to placebo (-28.50 %; p-value = 0.0070). Uterine volume decreased by -27.22 %. When compared with placebo, uterine volume significantly reduced by -30.31 (p-value = 0.0028). Amenorrhea was achieved by 63 % of patients, with relugolix-treated patients showing 31-fold higher odds versus controls (31.07 %; p-value < 0.0001). Haemoglobin levels improved in 46.3 % patients, while relugolix-treated patients achieved significant pain relief compared to controls (OR 9.02; p = value < 0.0001). Subgroup analyses showed that relugolix monotherapy produced greater reductions in myoma and uterine volumes than combination therapy, although both regimens were effective. Treatment as generally well-tolerated, with hot flushes being the most common adverse event. A small proportion reported persistent menorrhagia without indicating treatment failure. Other adverse events, such as headache, were also reported, though discontinuation rates were comparable to controls.

CONCLUSION:

Relugolix significantly reduces fibroid burden and symptoms with favourable safety profile. It offers a well-tolerated, fertility-preserving alternative to surgery. Further large-scale RCTs are needed to confirm these findings and optimize treatment protocols.

104

News (Medical) associated with Relugolix

16 Jan 2026

·www.einpresswire.com

NHS to offer thousands of men life-extending prostate cancer drug

Thousands of men with prostate cancer will be offered a life-extending drug on the NHS within weeks. For the first time patients whose prostate cancer has not spread will be able to receive the drug in England, known as abiraterone, as the health service widens access to the treatment. Around 2,000 men diagnosed with prostate cancer in the last three months whose cancer has not spread will get access to the treatment if it is of clinical benefit. An additional 7,000 men are expected to be diagnosed with prostate cancer each year and will be eligible for the drug, which stops the cancer spreading by starving the disease of the hormones it needs to grow, such as testosterone. Research has shown that for these earlier stage patients, the survival rate after six years is improved – with trials showing that the proportion of men alive after six years on abiraterone was 86% compared to 77% on standard treatment (hormone therapy with or without radiotherapy). NHS England has been able to give the green light to the drug for thousands more eligible patients thanks to the health service buying and delivering treatments at better value, following the clinical advice to roll this out last year. The NHS has set a target to save over £1 billion on clinically effective biosimilar drugs during this parliament – more than eight in 10 drugs the NHS now prescribes are lower cost biosimilar or generic drug – creating available funding for other treatments. The NHS in England already commissions abiraterone, a drug now available as a lower cost generic medicine, for advanced prostate cancer, having introduced a policy to commission the treatment in December 2024 – nearly one year ahead of positive NICE guidance recommending it in November 2025. National Clinical Director for Cancer at NHS England, Professor Peter Johnson, said : “For thousands of men with prostate cancer, this treatment option could be life-changing by helping keep their cancer at bay for several years. “The life-extending treatment available on the NHS within weeks will mean thousands of men can kick-start their year with the news that they will have a better chance of living longer and healthier lives. “The NHS will continue to work hard to offer people the most effective and evidence-based treatments, with several new prostate cancer drugs rolled over the last five years.” NHS England has worked with campaigners including Prostate Cancer UK to secure this rollout. In the past five years alone, the NHS in England has also commissioned new innovative targeted prostate cancer therapies, including the branded drugs enzalutamide, darolutamide, relugolix and apalutamide. National Director of Specialised Commissioning at NHS England, John Stewart said : “I am delighted that we are today able to confirm that we can move ahead and offer this important treatment to thousands more men, which I hope comes as welcome news for those that could benefit from this drug, as well as their families and friends. “I want to put on record my thanks to Prostate Cancer UK for their collaboration and partnership, supporting the health service to start offering this drug which could make a real difference to the lives of men with this type of prostate cancer.” Health and Social Care Secretary Wes Streeting said : “When you’re living with prostate cancer, every day with your loved ones matters. I’m delighted the NHS have taken the steps needed to make the drug available, giving thousands of men access to abiraterone – a treatment that significantly improves survival rates and can give patients precious extra years of life. “We’re backing the best clinical evidence, making smart funding decisions, and ensuring patients get the care they need when they need it most. “We’re serious about improving prostate cancer outcomes – treating it faster and giving loved ones more time together.” In parallel to the commissioning of abiraterone being confirmed, NHS England will also offer blood plasma treatment for people with the rare condition, Clarkson’s Syndrome, and genetic testing for parents with pre-existing conditions going through IVF as outcomes following clinical advice and enabled by long-term funding. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

05 Jan 2026

·www.fiercebiotech.com

Teverelix: A New Direction in Prostate Cancer and Urologic Health

None\n Cardiovascular (CV) disease is a leading cause of death among patients with prostate cancer. Yet for years, the mainstay treatments for this condition, namely GnRH agonists have themselves been associated with CV risks, especially in men already vulnerable to heart disease.Meanwhile, millions of men experience acute urinary retention (AUR) a sudden, painful inability to urinate often caused by an enlarged prostate and face limited non-surgical options to prevent it from coming back.Teverelix, a novel investigational therapy being developed by Medicus Pharma could offer a new approach to both of these persistent men’s health challenges.How Teverelix WorksTeverelix is a GnRH antagonist, which means it binds to gonadotropin-releasing hormone receptors in the pituitary gland, preventing the release of two hormones: luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This rapidly reduces testosterone levels an important step in slowing the growth of prostate cancer.Importantly, Teverelix also consistently suppresses FSH, which is under increasing study for its possible role in cardiovascular and metabolic health. This aspect of Teverelix’s mechanism could help patients with elevated CV risk, a population underserved by current therapies.Why a New Therapy Is NeededWhile other GnRH antagonists like degarelix (injectable) and relugolix (oral) are on the market, they have limitations and neither is currently approved specifically for prostate cancer patients with high CV risk.In the AUR space, the standard of care involves emergency catheterization and bladder decompression, followed by use of alpha blockers and 5-alpha-reductase inhibitors (5-ARIs). However, adherence to these chronic therapies can be poor, and side effects including sexual dysfunction and mood changes can be persistent. Further, 5-ARIs take a significant amount of time to shrink the prostate.What Makes Teverelix DifferentTeverelix has the potential to become the first GnRH antagonist specifically developed for prostate cancer patients with high cardiovascular risk. Its target label will focus on this subpopulation.In AUR, Teverelix may become the first pharmacologic therapy aimed at preventing recurrence after a first episode a significant innovation in an area that currently offers limited approved solutions for relapse prevention.Clinical Status and Regulatory PathwayTo date, Teverelix has completed around ~14 clinical studies involving over 400 patients. These trials have yielded detailed pharmacokinetic and pharmacodynamic (PK/PD) data and a consistent safety profile.Looking ahead:A Phase 2b trial is planned for 2026 to establish the optimal dosing for a future cardiovascular outcomes study in high CV-risk prostate cancer patients.In parallel, a randomized, three arm trial will begin evaluating Teverelix for the prevention of AUR recurrence, addressing a substantial unmet need.These trials will inform pivotal studies intended to support potential future regulatory filings in both indications.A Platform for the FutureBeyond men’s health, Medicus is exploring how Teverelix could be valuable in women’s health applications, such as endometriosis, a condition where hormonal control plays a central role. Early clinical work is underway, including collaborations in emerging global innovation ecosystems.Meanwhile, the company continues to invest in AI-driven development aimed at accelerating and de-risking clinical development.Final ThoughtsTeverelix is not just another hormonal therapy. With its potential cardiovascular friendly profile, exploratory utility in benign urology, and platform potential, it represents a compelling and differentiated approach in endocrine-driven diseases.

Drug Approval

02 Jan 2026

·www.einpresswire.com

July - September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

ADZYNMA (ADAMTS13, recombinant-krhn) Neutralizing antibodies with fatal outcome FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on November 21, 2025: FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura Asceniv (immune globulin intravenous, human-slra) Increased hypersensitivity reactions in patients receiving certain product lot FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on October 28, 2025: Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions Benlysta (belimumab) injection Severe cutaneous adverse reactions FDA is evaluating the need for regulatory action. Braftovi (encorafenib) capsules Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablet Sarcoidosis FDA is evaluating the need for regulatory action. Cabometyx (cabozantinib) tablets Cometriq (cabozantinib) capsules Lenvima (lenvatinib) capsules Thrombotic microangiopathy FDA is evaluating the need for regulatory action. Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Sarcoidosis FDA is evaluating the need for regulatory action. ELEVIDYS (delandistrogene moxeparvovec-rokl) Mesenteric vein thrombosis following product-related acute liver injury The "Warnings and Precautions" and "Adverse Reactions - Postmarketing Experience" sections of the labeling for Elevidys were updated in November 2025 to include life-threatening mesenteric vein thrombosis. FDA Safety Communication was issued on November 14, 2025: FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients Firmagon (degarelix for injection) Myfembree (relugolix, estradiol, and norethindrone acetate) tablets Orgovyx (relugolix) tablets Drug interaction FDA is evaluating the need for regulatory action. Ifex (ifosfamide) injection Pregnancy, puerperium and perinatal conditions FDA is evaluating the need for regulatory action. Ogsiveo (nirogacestat) tablets Visual impairment FDA is evaluating the need for regulatory action. Orgovyx (relugolix) tablets Hypertension FDA is evaluating the need for regulatory action. Rezzayo (rezafungin for injection) Hypersensitivity The "Warnings and Precautions", "Adverse Reactions" and "Patient Counseling Information" sections of the labeling were updated in December 2025 to include information about hypersensitivity reactions, including anaphylaxis. Rezzayo labeling Septocaine (articaine hydrochloride and epinephrine injection) Mepivacaine hydrochloride injection (a particular generic product) Wrong drug administered FDA is evaluating the need for regulatory action. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

100 Deals associated with Relugolix

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D10888	Relugolix	L01XX	DB11853

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Advanced Prostate Carcinoma	Canada	Sumitomo Pharma Co., Ltd.	10 Oct 2023
Castration-sensitive prostate cancer	European Union	Accord Healthcare SLU	29 Apr 2022
Castration-sensitive prostate cancer	Iceland	Accord Healthcare SLU	29 Apr 2022
Castration-sensitive prostate cancer	Liechtenstein	Accord Healthcare SLU	29 Apr 2022
Castration-sensitive prostate cancer	Norway	Accord Healthcare SLU	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.

Login

to view more data

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

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07216248 (OPTIMAS, ASCO_GU2026)	Phase 2	Hormone-dependent prostate cancer	160	Relugolix + ARPI (intermittent)	xjnamoycyx(jnvprcdwnx) = bxfdibtbup uygswitano (xvakivteae )	Positive	26 Feb 2026
NCT05320406 (REVELUTION, CTgov)	Phase 2	Cardiotoxicity \| Localized Prostate Carcinoma \| Prostate Cancer, Hereditary, 7 ... View more	94	Radiation therapy (Arm I (Radiation Therapy Alone))	iohdxeysad(plqwbiwgio) = qkxuzyvjtw qqzdjfldud (gzyjsbugbv, kysepmlzph - mefjqkxbpp) View more	-	22 Sep 2025
				Radiation therapy+Leuprolide (Arm II (Radiation Therapy Plus Leuprolide))	iohdxeysad(plqwbiwgio) = bhskbaqpam qqzdjfldud (gzyjsbugbv, srvobrvqvs - ukmpajgjeo) View more
NCT05467176 (OPTYX study, ASCO2025)	Phase 3	Prostatic Cancer	999	Relugolix	qpgxcfrgei(kypdegzwsq) = prlunbfyhv swyibqhrcl (mmcbaqwsyf ) 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)	gqeywijflh(tkvbomjhjo) = rbfahxezve vbkdvbvqsy (okmgxqnbph, 3.2) View more	Positive	13 Feb 2025
				Relugolix 240 mg + Apalutamide 240 mg	gqeywijflh(tkvbomjhjo) = gxccipehog vbkdvbvqsy (okmgxqnbph, 8.0) View more
ASCO_GU2025	Not Applicable	-	5,274	relugolix (Nonmetastatic Prostate Cancer (nmPC))	zacvtkotsz(ajutryqsnh) = plsssjjbzv lorgggolka (itlyizipzj, ±10 [99]) View more	-	13 Feb 2025
				relugolix (Metastatic Prostate Cancer (mPC))	zacvtkotsz(ajutryqsnh) = iqjhsqaicd lorgggolka (itlyizipzj, ±10 [99]) View more
NCT03103087 \| NCT03049735 (LIBERTY 2 \| LIBERTY 1, Pubmed \| Pain Manag)	Phase 3	Uterine Fibroids	-	Relugolix combination therapy	naxeaufkfh(dznrfkgbia) = ugpplhtyzt kxactmdjeo (geexsktqym ) View more	Positive	01 Sep 2024
				Placebo	naxeaufkfh(dznrfkgbia) = nafrvjmvbd kxactmdjeo (geexsktqym ) View more
NCT03751124 (CTgov)	Phase 3	Menorrhagia \| Uterine Fibroids	229	Relugolix+E2/NETA (Relugolix Plus E2/NETA (Group A))	tfqlurtwjq = axekrynbrg osgvmpucpv (icwagpccsp, pdmqnocisx - ejaxaebazg) View more	-	25 Jun 2024
				Placebo (Placebo (Group B))	tfqlurtwjq = hsjnmwiiml osgvmpucpv (icwagpccsp, cybinmrcke - idfumdjwlp) View more
NCT05467176 (OPTYX study, ASCO2024)	Not Applicable	Usher Syndromes PSA \| testosterone \| distant metastases	394	Relugolix monotherapy	dusctmqlro(bsurrklqcq) = folbaolmwc pzblufbbrf (jzvvtysuoc, 238.5) View more	-	24 May 2024
ASCO2024	Not Applicable	-	267	Relugolix	aiultecdea(zrfiqbzjeh) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment xwdhyiazux (akqgbxwhya )	-	24 May 2024
NCT03412890 (CTgov)	Phase 3	Menorrhagia \| Uterine Fibroids	477	Relugolix+E2/NETA (Relugolix Plus E2/NETA (Group A))	hykhrjxrrx = aellhikfmi nfivzhuccc (mgkydjksbt, wmkblahrsl - hynkzsykfj) View more	-	09 May 2024
				Relugolix+E2/NETA (Relugolix Plus Delayed E2/NETA (Group B))	hykhrjxrrx = kdsceiijku nfivzhuccc (mgkydjksbt, igqxyznwkg - prbsdfnfkm) View more