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Relugolix Combination Tablet
Relugolix combination tablet works by inhibiting gonadotropin-releasing hormone (GnRH) receptors, leading to a decrease in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) production, which in turn reduces testosterone levels.
Relugolix combination tablet works by inhibiting gonadotropin-releasing hormone (GnRH) receptors, leading to a decrease in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) production, which in turn reduces testosterone levels. Used for Prostate cancer, Endometriosis.
At a glance
| Generic name | Relugolix Combination Tablet |
|---|---|
| Also known as | TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A |
| Sponsor | Sumitomo Pharma Switzerland GmbH |
| Drug class | GnRH receptor antagonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting GnRH receptors, relugolix combination tablet effectively suppresses the production of LH and FSH, which are essential for the production of testosterone. This reduction in testosterone levels can help alleviate symptoms associated with conditions such as prostate cancer. The combination of relugolix with other medications, such as estradiol, further enhances the therapeutic effect.
Approved indications
- Prostate cancer
- Endometriosis
Common side effects
- Hot flashes
- Musculoskeletal pain
- Fatigue
Key clinical trials
- Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer (PHASE1)
- Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy (PHASE3)
- The COSMYC Trial (COmbined Suppression of MYC) (PHASE2)
- Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment (PHASE2)
- Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (PHASE1)
- A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis (PHASE3)
- The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial (PHASE3)
- A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Relugolix Combination Tablet CI brief — competitive landscape report
- Relugolix Combination Tablet updates RSS · CI watch RSS
- Sumitomo Pharma Switzerland GmbH portfolio CI