Wednesday, July 8, 2026
🇺🇸 FDA

Drug profile · INN

relugolix

ORGOVYX

relugolix (ORGOVYX) is a gonadotropin-releasing hormone receptor antagonist. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved NMPA: clinical trials Systemic hormonal preparations (H01) H01CC54
US status approved
Patents linked 13
Pipeline programs 12
News articles 0
Drug details — relugolix
US status
approved
Class
Systemic hormonal preparations (H01)
Route
ORAL
Patents
13
Programs
12
Data quality
0.84
← All drugs Related patents Pipeline programs Drug news hub Event calendar

Quick answer

relugolix (ORGOVYX) is a gonadotropin-releasing hormone receptor antagonist. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN relugolix
Brand ORGOVYX
Mechanism Gonadotropin-releasing hormone receptor antagonist
Target Gonadotropin-releasing hormone receptor
Therapeutic class Systemic hormonal preparations (H01)
Route ORAL
Formulation TABLET
ATC code H01CC54

Mechanism of action

Gonadotropin-releasing hormone receptor antagonist

Primary target: Gonadotropin-releasing hormone receptor

Approval history

Authority Status Date
FDA approved —
EMA approved —
PMDA approved —
NMPA clinical trials —

Pipeline programs

Search pipeline
  1. 64091742PCR3001 Phase 3 · Janssen-Cilag International N.V · Metastatic Prostate Cancer
  2. CAAA617C12301 Phase 3 · Novartis India · PSMA-positive metastatic hormone-sensitive prostate cancer (
  3. EORTC-2238-GUCG Phase 3 · Ningbo Cancer Hospital · Metastatic hormone naïve prostate cancer (mHNPC)
  4. Relugolix Phase 3 · Takeda · Uterine Fibroids
  5. Relugolix Phase 3 · Myovant Sciences · Prostate Cancer
  6. CAAA617B12203 Phase 2 · Novartis India · PSMA PET scan positive Castration-Resistant Prostate Cancer
  7. CAAA802A12101 Phase 2 · Novartis India · PSMA-positive metastatic hormone sensitive prostate cancer (
  8. CAMO959A12103 Phase 2 · Novartis India · PSMA-positive mCRPC with prior exposure to at least one prio

Related & competitor drugs

Browse all drugs
  1. atazanavir sulfate Antiinfectives for systemic use (J05)
  2. cetrorelix acetate Gonadotropin-releasing hormone receptor antagonist
  3. colistimethate sodium Antiinfectives for systemic use (J01)
  4. covid-19 mrna vaccine Antiinfectives for systemic use (J07)
  5. daptomycin Antiinfectives for systemic use (J01)
  6. darunavir Antiinfectives for systemic use (J05)

Related patents

Browse patents

  1. US 12336990

    Treatment of prostate cancer

    Expires Mon Jun 19 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. US 12144809

    Treatment of prostate cancer

    Expires Mon Nov 14 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 12097198

    Treatment of prostate cancer

    Expires Mon Sep 19 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 11957684

    Treatment of heavy menstrual bleeding associated with uterine fibroids

    Expires Mon Apr 11 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 11793812

    Methods of treating endometriosis

    Expires Mon Oct 19 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 11583526

    Treatment of prostate cancer

    Expires Mon Feb 16 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 11306104

    Solid state forms of Relugolix

    Expires Mon Apr 14 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 11033551

    Methods of treating uterine fibroids

    Expires Mon Jun 10 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 10786501

    Treatment of prostate cancer

    Expires Mon Sep 24 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 10449191

    Treatment of prostate cancer

    Expires Mon Oct 17 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 10350170

    Solid preparation

    Expires Mon Jul 11 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  12. US 8058280

    Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof

    Expires Mon Nov 10 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  13. US 7300935

    Thienopyrimidine compounds and use thereof

    Expires Mon Nov 22 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is relugolix?

relugolix (ORGOVYX) is a gonadotropin-releasing hormone receptor antagonist. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for relugolix?

ORGOVYX is a marketed brand name for relugolix. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of relugolix?

relugolix has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.

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