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AboutPricing
Drug ReportsRelugolix
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
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 Application2024-07-22
orgovyxNew Drug Application2024-10-31
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
65 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MenorrhagiaD008595EFO_0003945N92.0415
LeiomyomaD007889D25415
Pelvic painD01769911
MetrorrhagiaD008796N92.111
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemorrhageD006470MP_0001914R5844
MyofibromaD04770844
EndometriosisD004715EFO_0001065N8033
Prostatic neoplasmsD011471C61213
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD00023011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients22
Indications Without Phase
No data
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
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
Mouse ortholog
Gnrhr (14715)
gonadotropin-releasing hormone receptor (Q61611)
Variants
No data
Financial
Revenue by drug
$
£
Ryeqo Myovant Sciences
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Orgovyx Myovant Sciences
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Myfembree 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 480 documents
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Safety
Black-box Warning
Black-box warning for: Myfembree
Adverse Events
Top Adverse Reactions
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12,082 adverse events reported
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