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AboutPricing
Drug ReportsRelugolix
Orgovyx(relugolix)
Myfembree, Orgovyx, Ryeqo (relugolix) is a small molecule pharmaceutical. Relugolix was first approved as Orgovyx on 2020-12-18. It has been approved in Europe to treat leiomyoma and prostatic neoplasms. It is known to target gonadotropin-releasing hormone receptor.
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FDA Novel Drug Approvals 2020
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Orgovyx
Combinations
Myfembree
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Norethindrone acetate
+
Relugolix
Tradename
Company
Number
Date
Products
MYFEMBREEMyovant SciencesN-214846 RX2021-05-26
1 products, RLD, RS
Relugolix
Tradename
Company
Number
Date
Products
ORGOVYXMyovant SciencesN-214621 RX2020-12-18
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
myfembreeNew Drug Application2025-09-04
orgovyxNew Drug Application2025-10-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
acne vulgarisEFO_0003894D000152L70
endometriosisEFO_0001065D004715N80
primary ovarian insufficiencyEFO_0004266D016649E28.3
endometrial hyperplasia—D004714N85.0
hot flashes—D019584—
hypogonadism—D007006E23.0
premature menopause—D008594E28.31
Agency Specific
FDA
EMA
Expiration
Code
ESTRADIOL / NORETHINDRONE ACETATE / RELUGOLIX, MYFEMBREE, MYOVANT SCIENCES
2026-01-27M-289
2025-12-18NCE
2025-08-05I-898
2024-05-26NP
RELUGOLIX, ORGOVYX, SUMITOMO PHARMA
2025-12-18NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Estradiol / Norethindrone Acetate / Relugolix, Myfembree, Myovant Sciences
117938122038-05-03U-2360
110335512037-09-29U-3129
117951782033-09-27DS, DP
73009352025-01-28DP
80582802025-01-28DS, DP
93468222024-02-17U-3129
Relugolix, Orgovyx, Sumitomo Pharma
104491912037-09-29U-3020
107865012037-09-29U-3020
115835262037-09-29U-3020
103501702036-02-25DP
87354012024-02-04U-3019
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H01: Pituitary and hypothalamic hormones and analogues
— H01C: Hypothalamic hormones
— H01CC: Anti-gonadotropin-releasing hormones
— H01CC54: Relugolix, estradiol and norethisterone
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02B: Hormone antagonists and related agents
— L02BX: Other hormone antagonists and related agents in atc
— L02BX04: Relugolix
HCPCS
No data
Clinical
Clinical Trials
80 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeiomyomaD007889—D25—191112
MenorrhagiaD008595EFO_0003945N92.0——51—6
Pelvic painD017699———11114
MetrorrhagiaD008796—N92.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C618267—443
AdenocarcinomaD000230——373——12
EndometriosisD004715EFO_0001065N80128—112
MyofibromaD047708———17—19
HemorrhageD006470MP_0001914R58——4—15
Neoplasm metastasisD009362EFO_0009708——12——2
ContraceptionD003267————1——1
PainD010146EFO_0003843R52——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Castration-resistant prostatic neoplasmsD064129——23———5
EunuchismD005058EFO_0007266E29.111———1
HypogonadismD007006—E23.011———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pregnancy rateD018873——————22
Pregnancy complicationsD011248——————22
High-risk pregnancyD018566——————22
Uterine hemorrhageD014592——————11
Uterine neoplasmsD014594EFO_0003859C55————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRelugolix
INNrelugolix
Description
Relugolix, sold under the brand names Orgovyx and Relumina among others, is a gonadotropin-releasing hormone antagonist (GnRH receptor antagonist) medication which is used in the treatment of prostate cancer in men and uterine fibroids in women. It is taken by mouth.
Classification
Small molecule
Drug classgonadotropin releasing hormone (GnRH) receptor antagonists (nonpeptide)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CONC(=O)Nc1ccc(-c2sc3c(c2CN(C)C)c(=O)n(-c2ccc(OC)nn2)c(=O)n3Cc2c(F)cccc2F)cc1
Identifiers
PDB—
CAS-ID737789-87-6
RxCUI—
ChEMBL IDCHEMBL1800159
ChEBI ID—
PubChem CID10348973
DrugBankDB11853
UNII IDP76B05O5V6 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
GNRHR
GNRHR
Organism
Homo sapiens
Gene name
GNRHR
Gene synonyms
GRHR
NCBI Gene ID
2798
Protein name
gonadotropin-releasing hormone receptor
Protein synonyms
gnRH receptor, gnRH-R, gonadotropin-releasing hormone (type 1) receptor 1, leutinizing hormone releasing horomone receptor, leutinizing-releasing hormone receptor, luliberin receptor, type I GnRH receptor
Uniprot ID
Q92644
Mouse ortholog
Gnrhr (14715)
gonadotropin-releasing hormone receptor (Q61611)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Orgovyx – Myovant Sciences
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Myfembree – Myovant Sciences
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Ryeqo – Myovant Sciences
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 848 documents
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Safety
Black-box Warning
Black-box warning for: Myfembree
Adverse Events
Top Adverse Reactions
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28,952 adverse events reported
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