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Orgovyx, Ryeqo(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
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 Application2021-06-07
orgovyxNew Drug Application2020-12-29
Indications
FDA
EMA
No data
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, MYOVANT SCIENCES
2025-12-18NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Relugolix, Orgovyx, Myovant Sciences
104491912037-09-29U-3020
107865012037-09-29U-3020
115835262037-09-29U-3020
103501702036-02-25DP
87354012024-02-04U-3019
Estradiol / Norethindrone Acetate / Relugolix, Myfembree, Myovant Sciences
110335512037-09-29U-3129
93468222024-02-17U-3129
73009352024-01-28DP
80582802024-01-28DS, DP
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
38 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C613531112
LeiomyomaD007889HP_0000131D25—161—8
MenorrhagiaD008595N92.0——31—4
Pelvic painD017699———1—1
MetrorrhagiaD008796HP_0100608N92.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EndometriosisD004715EFO_0001065N80124——7
AdenocarcinomaD000230111——3
ContraceptionD003267——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
Castration-resistant prostatic neoplasmsD0641291————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pregnancy rateD018873————11
Pregnancy complicationsD011248————11
High-risk pregnancyD018566————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 also under development for use in the treatment of endometriosis. It is taken by mouth once per day.
Classification
Small molecule
Drug classgonadotropin releasing hormone (GnRH) receptor antagonists (nonpeptide)
Image (chem structure or protein)
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
Clinical Variant
No data
Financial
Ryeqo - Myovant Sciences
$
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£
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Myfembree - Myovant Sciences
$
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£
₣
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Orgovyx - Myovant Sciences
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 257 documents
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Safety
Black-box Warning
Black-box warning for: Myfembree
Adverse Events
Top Adverse Reactions
0 adverse events reported
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