Relugolix is a gonadotropin releasing hormone receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer. It is available as tablets for oral use. MedsAcross supplies Relugolix for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Relugolix is a nonpeptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors, thereby, reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and consequently testosterone.
Source: US FDA prescribing information
Recommended Dosage: A loading dose of 360 mg on the first day of treatment followed by 120 mg taken orally once daily, at approximately the same time each day. ORGOVYX can be taken with or without food. Instruct patients to swallow tablets whole and not to crush or chew tablets.
Source: US FDA prescribing information
ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components. Known severe hypersensitivity to relugolix or to any of the product components.
Source: US FDA prescribing information
QT/QTc Interval Prolongation: Androgen deprivation therapy may prolong the QT interval. Hypersensitivity: ORGOVYX can cause hypersensitivity reactions, including angioedema. Withhold ORGOVYX in patients who experience symptoms of hypersensitivity. Discontinue ORGOVYX for severe hypersensitivity reactions and manage as clinically indicated. Embryo-Fetal Toxicity: ORGOVYX can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: QT/QTc Interval Prolongation. The most common adverse reactions (≥ 10%) and laboratory abnormalities (≥ 15%) were hot flush, glucose increased, triglycerides increased, musculoskeletal pain, hemoglobin decreased, alanine aminotransferase (ALT) increased, fatigue, aspartate aminotransferase (AST) increased, constipation, and diarrhea.
Source: US FDA prescribing information
P-gp Inhibitors: Avoid co-administration. If unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions. Combined P-gp and Strong CYP3A Inducers: Avoid co-administration. If unavoidable, increase the ORGOVYX dose to 240 mg once daily.
Source: US FDA prescribing information
Store ORGOVYX at room temperature. Do not store above 30°C (86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Relugolix, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Orgovyx 120 mg tabletOral | Sumitomo Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Relugolix and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Relugolix, including Orgovyx.
Yes. The US FDA first approved Relugolix on 18 December 2020, according to Drugs@FDA.
Yes. Relugolix has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Relugolix is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Relugolix is classified under ATC code L02BX (Hormonal cancer treatments, subgroup L02B, subgroup L02BX).
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