Relugolix
Other Hormone Antagonists and Related Agents
Sold as Ryeqo · Orgovyx · MYFEMBREE
- Drug class
- Other Hormone Antagonists and Related Agents
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 10
- FDA reports (12 mo)
- 6,039
Overview
Plain-language summary, compiled from the cited regulatory records
Relugolix is a medication classified as an Other Hormone Antagonist and Related Agent [1]. It is approved for the treatment of adult patients diagnosed with advanced prostate cancer [1].
In the market, relugolix is available under various brand names, including Orgovyx [1]. This medication functions by antagonizing the gonadotropin-releasing hormone (GnRH) receptor [1].
There were 6,039 adverse event reports for relugolix in the past 12 months [2]. The most frequently reported adverse events include hot flush, fatigue, incorrect dose administered, asthenia, and arthralgia [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 5 | May 29, 2026 |
| EU European Union | EMA | 2 | May 20, 2026 |
| CA Canada | Health Canada | 2 | November 7, 2025 |
| US United States | FDA | 1 | October 10, 2025 |
GBUnited Kingdom· MHRA
5 products
Uses
Relugolix is indicated: -For the treatment of adult patients with advanced hormone-sensitive prostate cancer. -For the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
-As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.
How to take
EUEuropean Union· EMA
2 products
Uses
1).
How to take
CACanada· Health Canada
2 products
Uses
ORGOVYX (relugolix tablets, 120 mg) is indicated for the treatment of adult patients with advanced prostate cancer. 1 Pediatrics Pediatrics (<18 years of age): Safety and effectiveness of ORGOVYX in patients less than 18 years of age has not been established, therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Of the 622 patients who received ORGOVYX in the HERO study, 81% were 65 years of age or older, while 35% were 75 years of age or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
There was no clinically relevant impact of age on the pharmacokinetics of ORGOVYX or testosterone response based on population pharmacokinetic and pharmacokinetic/pharmacodynamic analyses in men 45 to 91 years of age.
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
How to take
Drug interactions
Known interactions involving Relugolix. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB001421272 · revised May 29, 2026
- [2]European Medicines Agency · EMEA/H/C/005267 · revised May 20, 2026
- [3]Health Canada (DPD) · 02542137 · revised November 7, 2025
- [4]FDA DailyMed · 077a92f6-9f1b-47… · revised October 10, 2025 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.