Comprehensive medication guide to Orgovyx including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
$10/month with the Orgovyx Copay Assistance Program for eligible commercially insured patients; Medicare Part D cost-sharing varies by plan and phase, with the 2026 annual out-of-pocket cap of $2,100.
Estimated Cash Pricing
$2,757–$2,945 retail for 30 tablets (30-day supply) at specialty pharmacies; no generic is available, and discount cards like GoodRx do not provide meaningful savings on this specialty medication.
Medfinder Findability Score
45/100
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Orgovyx is the brand name for relugolix, an oral prescription medication approved by the FDA on December 18, 2020 for the treatment of adult patients with advanced prostate cancer. It is manufactured by Sumitomo Pharma America in co-commercialization with Pfizer.
Orgovyx is classified as a GnRH (gonadotropin-releasing hormone) receptor antagonist and is the first and only oral GnRH antagonist approved for prostate cancer in the United States. It belongs to the broader category of androgen deprivation therapy (ADT) — treatments designed to lower testosterone to castrate levels and slow or stop prostate cancer growth.
Unlike older injectable GnRH agonists such as leuprolide (Lupron Depot) that first cause a testosterone flare before suppression, Orgovyx directly blocks GnRH receptors — providing rapid testosterone suppression without an initial surge. In the Phase 3 HERO trial, 96.7% of patients on Orgovyx maintained castrate testosterone levels through 48 weeks.
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Orgovyx (relugolix) works by competitively binding to GnRH (gonadotropin-releasing hormone) receptors in the pituitary gland — a small gland at the base of the brain. When GnRH receptors are blocked, the pituitary cannot receive GnRH signals from the hypothalamus and therefore does not release luteinizing hormone (LH) or follicle-stimulating hormone (FSH).
Without LH stimulation, the testicles stop producing testosterone. Since most advanced prostate cancer cells depend on testosterone to grow, this testosterone suppression slows or stops cancer progression. The process achieves what is called "medical castration" — the same hormonal outcome as surgical removal of the testicles, but without surgery.
Orgovyx's mechanism as a competitive antagonist means testosterone recovery after stopping treatment is faster than with GnRH agonists, which permanently downregulate the receptor. In the HERO trial, 55% of patients returned to normal testosterone levels within 90 days of stopping Orgovyx. The loading dose (360 mg on Day 1) rapidly saturates GnRH receptors, producing castrate testosterone levels in 56% of patients by Day 4.
360 mg (loading) — tablet (3 x 120 mg)
Day 1 loading dose only
120 mg — tablet
Once daily maintenance dose starting Day 2
Orgovyx is not available at standard retail pharmacies. It is distributed exclusively through specialty pharmacy networks, meaning patients must obtain it from a specialty pharmacy — not from CVS, Walgreens, or any retail location. This specialty-only distribution, combined with mandatory prior authorization requirements from virtually all insurance plans, creates real access barriers even though no active FDA shortage exists.
Patients who cannot reach their specialty pharmacy or need to find an alternative can use medfinder — a service that calls pharmacies near you to find which ones carry Orgovyx and can fill your prescription. The Orgovyx Support Program at 1-833-ORGOVYX (1-833-674-6899) can also assist with specialty pharmacy routing and insurance navigation.
Patients should be aware that if Orgovyx treatment is interrupted for more than 7 days, a new 360 mg loading dose is required upon restarting. This makes proactive refill management essential — refills should be initiated when 10-14 days of supply remain.
Orgovyx (relugolix) is not a controlled substance, so any licensed prescriber with DEA prescribing authority can legally write a prescription. However, because it is an advanced cancer therapy requiring expertise in prostate cancer staging, hormonal management, and cardiovascular monitoring, it is almost always prescribed by oncology or urology specialists.
Urologists — most common prescribers; diagnose and manage prostate cancer and ADT
Medical Oncologists — especially GU (genitourinary) oncologists for metastatic or castration-resistant disease
Radiation Oncologists — when ADT accompanies radiation therapy for high-risk localized disease
Nurse Practitioners and Physician Assistants — in urology and oncology specialty practices, often managing ongoing ADT therapy
Telehealth options are limited for new prescriptions of Orgovyx, as initial evaluation typically requires in-person examination and lab work. Some established patients may receive follow-up care and prescription renewals via telehealth at their specialist's discretion.
No. Orgovyx (relugolix) is not a controlled substance and is not scheduled by the Drug Enforcement Administration (DEA). It does not have abuse potential or the dependence characteristics that lead to DEA scheduling. Any licensed healthcare provider with prescribing authority can write a prescription for Orgovyx without special DEA authorization.
While Orgovyx is not controlled, it is a specialty medication that requires prior authorization from most insurance plans and must be filled at a specialty pharmacy. The primary barriers to access are insurance and distribution-related, not regulatory controls on the drug itself.
Most side effects of Orgovyx result from testosterone suppression rather than direct drug toxicity. The most commonly reported side effects (occurring in ≥10% of patients in the HERO trial) include:
Hot flashes (most common)
Fatigue
Musculoskeletal pain (joint pain, back pain, muscle aches)
Constipation and diarrhea
Elevated blood glucose
Elevated triglycerides
Decreased hemoglobin (anemia)
Elevated liver enzymes (ALT/AST)
QT/QTc interval prolongation — risk of dangerous heart arrhythmias; monitor ECG in at-risk patients
Hypersensitivity reactions — including angioedema; discontinue immediately for severe reactions
Embryo-fetal toxicity — can cause fetal harm; men must use contraception during treatment and for 2 weeks after stopping
Cardiovascular events — rare; report chest pain, shortness of breath, or cardiac symptoms immediately
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Degarelix (Firmagon)
GnRH receptor antagonist; monthly subcutaneous injection; no testosterone flare; most mechanistically similar to Orgovyx
Leuprolide (Lupron Depot, Eligard)
GnRH agonist; injection every 1-6 months; initial testosterone flare; generic available; widely accessible
Goserelin (Zoladex)
GnRH agonist; subcutaneous implant every 1-3 months; established efficacy for advanced prostate cancer
Triptorelin (Trelstar)
GnRH agonist; intramuscular injection every 1-6 months; alternative supply source from different manufacturer
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Oral P-gp inhibitors (amiodarone, azithromycin, clarithromycin, cyclosporine, ketoconazole)
majorIncreases relugolix blood levels; avoid co-administration. If unavoidable, take Orgovyx first and wait at least 6 hours.
Combined P-gp and strong CYP3A inducers (rifampin, carbamazepine, phenytoin, St. John's Wort)
majorDecreases relugolix blood levels, reducing effectiveness. Avoid; if unavoidable increase Orgovyx dose to 240 mg daily.
QT-prolonging drugs (antiarrhythmics, antipsychotics, certain antibiotics, certain antidepressants)
moderateAdditive QT prolongation risk. Monitor ECG and electrolytes; consider ECG at baseline and periodically.
Antidiabetes medications (metformin, insulin, GLP-1 agonists)
moderateADT increases blood glucose; diabetes medications may require dose adjustment during Orgovyx therapy.
Orgovyx (relugolix) represents a meaningful advancement in androgen deprivation therapy for advanced prostate cancer. As the only oral GnRH antagonist available in the U.S., it offers patients a daily pill instead of a monthly or quarterly injection, provides rapid testosterone suppression without an initial flare, demonstrates superior sustained castration rates versus leuprolide, and showed a 54% lower rate of major cardiovascular events in the HERO trial — a clinically meaningful advantage for patients with cardiovascular risk factors.
The main challenges with Orgovyx are access-related: its specialty-only distribution, mandatory prior authorization requirements, and list price of approximately $2,762 per month create real-world barriers even for insured patients. However, robust manufacturer support programs — including a $10/month copay assistance program for commercially insured patients and a bridge program providing up to 4 months of medication during coverage gaps — help many patients manage the cost.
If you're having trouble locating Orgovyx at a pharmacy near you, medfinder can help by calling specialty pharmacies in your area to find which ones have it in stock and can fill your prescription.
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