Drug updated on 4/17/2024
| Dosage Form | Tablet (oral: 120 mg) |
| Drug Class | Gonadotropin-releasing hormone receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with advanced prostate cancer.
Summary
- Relugolix (Orgovyx) is indicated for the treatment of adult patients with advanced prostate cancer.
- Three randomized controlled trials were reviewed to gather information about this drug and its effects on the specified indication.
- In a phase 3 trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to leuprolide, an injectable luteinizing hormone-releasing hormone agonist commonly used in treating prostate cancer; it also showed a 54% lower risk of major adverse cardiovascular events compared to leuprolide.
- A study investigating uterine fibroid-associated pain found that more patients receiving relugolix experienced significant improvement in their condition compared to those given placebo; however, there was a higher incidence rate of treatment-emergent adverse events among those treated with relugolix than placebo recipients but most were mild or moderate in intensity and did not lead to discontinuation from the study.
- Another trial evaluated relugolix combined with estradiol and progestin for endometriosis-associated pain management; results revealed significantly improved outcomes among women who received this combination therapy as opposed to placebo alone - they reported less severe dysmenorrhoea and non-menstrual pelvic pain along with reduced opioid use which suggests potential long-term benefits against repeated surgical treatments or reliance on opioids for managing endometriosis-related discomforts.
- Across all studies reviewed, common side effects associated with Orgovyx included hot flushes, metrorrhagia (abnormal bleeding), hyperhidrosis (excessive sweating), menorrhagia (heavy menstrual bleeding), nasopharyngitis (common cold symptoms) while some cases reported suicidal ideation although no deaths occurred during these trials.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Orgovyx (relugolix) Prescribing Information. | 2022 | Myovant Sciences, Inc., Brisbane, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. | 930Subjects F: 0% M: 100% | 2022 | New England Journal of Medicine |
| 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). | 1,261Subjects F: 100% M: 0% | 2022 | The Lancet |
| Relugolix, a novel oral gonadotropin-releasing hormone antagonist, in the treatment of pain symptoms associated with uterine fibroids: a randomized, placebo-controlled, phase 3 study in Japanese women. | 65Subjects F: 100% M: 0% | 2019 | Fertility and Sterility |
Sex Distribution:
F:0%
M:100%
930Subjects
Year:
2022
Source:New England Journal of Medicine
Sex Distribution:
F:100%
M:0%
1261Subjects
Year:
2022
Source:The Lancet
Sex Distribution:
F:100%
M:0%
65Subjects
Year:
2019
Source:Fertility and Sterility