{"entity":{"id":"relugolix","kind":"drug","name":"Relugolix","aka":[],"tldr":"Relugolix is the first hormone-suppressing pill for prostate cancer, working within days and wearing off quickly when stopped.","summary":"Relugolix is an oral, competitive GnRH receptor antagonist that suppresses testosterone within days without the initial testosterone flare seen with GnRH agonists such as leuprolide. It is used for advanced prostate cancer wherever medical castration is needed, and its effect wears off quickly when stopped, which suits intermittent therapy or men with a short planned course. HERO (2020) showed sustained castration in 96.7% versus 88.8% for leuprolide, faster onset and recovery, and 54% fewer major cardiovascular events. Drug interactions through P-glycoprotein and reliance on daily adherence are practical considerations against the convenience of a depot injection. Whether the cardiovascular signal is a true class advantage of antagonists is still under study. In short, relugolix is the first hormone-suppressing pill for prostate cancer.","status":"approved","asOf":"2026-09-06","wikipedia":"https://en.wikipedia.org/wiki/Relugolix","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Relugolix"},{"label":"NICE TA995: relugolix for treating hormone-sensitive prostate cancer","url":"https://www.nice.org.uk/guidance/ta995"}],"tags":[],"related":[],"cancers":["prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":[],"companies":["sumitomo-pharma"],"institutions":[],"pathways":["ar-signaling"],"terms":["prostate-adt-burden","prostate-uk-drug-approvals"],"trials":["nct05862272"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["NICE TA995 recommends relugolix within its marketing authorisation for advanced hormone-sensitive prostate cancer, alongside radiotherapy for high-risk localised or locally advanced hormone-sensitive disease, and as neoadjuvant treatment before radiotherapy. The committee's reasoning was that clinical trial evidence suggests relugolix reduces testosterone to castrate levels more reliably in the long term and reduces the risk of serious cardiovascular events compared with leuprolide, and that an indirect comparison, though uncertain, suggests it works as well as other forms of androgen deprivation."],"brand":"Orgovyx","modality":"Oral GnRH antagonist","mechanism":"Competitive GnRH receptor antagonist; no testosterone flare.","approvals":[{"region":"US","year":2020,"indication":"Advanced prostate cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/relugolix/","neighbours":{"cancer":[{"id":"prostate-high-risk","kind":"cancer","name":"Localised prostate cancer, high and very high risk","route":"/cancers/prostate-high-risk/"},{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"}],"company":[{"id":"sumitomo-pharma","kind":"company","name":"Sumitomo Pharma (Myovant)","route":"/companies/sumitomo-pharma/"}],"pathway":[{"id":"ar-signaling","kind":"pathway","name":"Androgen receptor signalling","route":"/pathways/ar-signaling/"}],"term":[{"id":"prostate-uk-drug-approvals","kind":"term","name":"Prostate cancer drugs in England: what NICE recommends, and what it refuses","route":"/terms/prostate-uk-drug-approvals/"},{"id":"prostate-adt-burden","kind":"term","name":"What androgen deprivation costs: the side of hormone therapy the survival curves do not show","route":"/terms/prostate-adt-burden/"}],"trial":[{"id":"nct05862272","kind":"trial","name":"A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis","route":"/trials/nct05862272/"},{"id":"nct07455903","kind":"trial","name":"Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT","route":"/trials/nct07455903/"},{"id":"hero","kind":"trial","name":"HERO","route":"/trials/hero/"},{"id":"nct04423211","kind":"trial","name":"Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging","route":"/trials/nct04423211/"},{"id":"nct04513717","kind":"trial","name":"Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial","route":"/trials/nct04513717/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}