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Drug ReportsChoriogonadotropin alfa
Ovidrel, Ovitrelle(choriogonadotropin alfa)
Ovidrel, Ovitrelle (choriogonadotropin alfa) is a protein pharmaceutical. Choriogonadotropin alfa was first approved as Ovidrel on 2000-09-20. It is used to treat cryptorchidism, female infertility, and hypogonadism in the USA. It has been approved in Europe to treat anovulation, assisted reproductive techniques, and female infertility.
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Events Timeline
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YTD
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2Y
5Y
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Events
FDA approval date
EMA approval date
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Study first post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
endocrine system diseasesD004700
therapeuticsD013812
investigative techniquesD008919
reproductive and urinary physiological phenomenaD012101
Trade Name
FDA
EMA
Ovidrel (discontinued: Ovidrel)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Choriogonadotropin alfa
Tradename
Proper name
Company
Number
Date
Products
Ovidrelchoriogonadotropin alfaEMD SeronoN-21149 RX2003-07-14
1 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
ovidrelBiologic Licensing Application2023-12-26
pregnylBiologic Licensing Application2024-06-21
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03G: Gonadotropins and other ovulation stimulants
— G03GA: Gonadotropins
— G03GA08: Choriogonadotropin alfa
HCPCS
No data
Clinical
Clinical Trials
347 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfertilityD007246HP_0000789—915255570169
Female infertilityD007247EFO_0008560N9734461731
Polycystic ovary syndromeD011085EFO_0000660E28.255841230
SyndromeD013577——22551528
Fertilization in vitroD005307——12471023
HypogonadismD007006HP_0000044E23.01246619
Ovulation inductionD010062——24—1815
Kallmann syndromeD017436Orphanet_478E23.0——1539
Assisted reproductive techniquesD027724——1—2148
Ovarian hyperstimulation syndromeD016471————1438
Show 12 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primary ovarian insufficiencyD016649EFO_0004266E28.3132—26
PregnancyD011247EFO_0002950Z33.1——1—56
Pregnancy rateD018873————1—23
RecurrenceD012008———21—13
AnovulationD000858———11—13
Pituitary diseasesD010900—E23.7—11—13
Pre-eclampsiaD011225EFO_0000668O14——1—12
EclampsiaD004461HP_0100601O15——1—12
Klinefelter syndromeD007713EFO_1001006Q98.0——1—12
Spontaneous abortionD000022EFO_1001255O00.1—11——1
Show 4 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—1——34
Premature menopauseD008594HP_0008209E28.3111——23
Graft vs host diseaseD006086—D89.8132———3
Ischemic strokeD000083242———3———3
StrokeD020521EFO_0000712I63.9—3———3
LeiomyomaD007889HP_0000131D2511——12
AzoospermiaD053713EFO_0000279N46.0—1——12
Wounds and injuriesD014947—T14.8—1——12
Healthy volunteers/patients———21———2
InfectionsD007239EFO_0000544—11———1
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperandrogenismD017588——2———13
Retinal diseasesD012164HP_0000479H35.91————1
Hemophilia aD006467EFO_0007267D661————1
AtrophyD001284——1————1
GynatresiaD006175EFO_1001335—1————1
Postoperative painD010149—G89.181————1
Oocyte retrievalD054315——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Premature birthD047928EFO_0003917O60————33
Gestational trophoblastic diseaseD031901—O01.9————22
Down syndromeD004314EFO_0001064Q90————22
Premature obstetric laborD007752—O60————22
EunuchismD005058EFO_0007266E29.1————22
Male infertilityD007248EFO_0004248N46————22
Trophoblastic neoplasmsD014328——————22
MicrobiotaD064307——————22
Ovarian pregnancyD065172—O00.2————11
OogenesisD009866——————11
Show 39 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameChoriogonadotropin alfa
INNchoriogonadotropin alfa
Description
Choriogonadotropin beta chain [Precursor]; Glycoprotein hormones alpha chain [Precursor];
Classification
Protein
Drug classtricyclic compounds; atropine derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI4986
ChEMBL IDCHEMBL1201464
ChEBI ID—
PubChem CID—
DrugBankDB09126
UNII ID20ED16GHEB (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,783 adverse events reported
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