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Drug ReportsFollitropin beta
Follistim, Puregon(follitropin alfa)
Bemfola, Gonal-f, Gonal-f RFF, Ovaleap, Pergoveris (follitropin alfa) is a protein pharmaceutical. Follitropin alfa was first approved as Gonal-f on 1995-10-20. It is used to treat infertility in the USA. It has been approved in Europe to treat anovulation, assisted reproductive techniques, female infertility, and hypogonadism.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
endocrine system diseasesD004700
therapeuticsD013812
investigative techniquesD008919
reproductive and urinary physiological phenomenaD012101
Trade Name
FDA
EMA
No data
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)
Follitropin beta
Tradename
Proper name
Company
Number
Date
Products
Follistimfollitropin betaOrganonN-20582 DISCN1997-09-29
2 products
Follistim AQfollitropin betaOrganonN-21273 DISCN2005-08-26
2 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
gonal-fBiologic Licensing Application2025-06-20
gonal-f rffBiologic Licensing Application2023-11-20
gonal-f rff redi-jectBiologic Licensing Application2025-04-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
infertilityEFO_0000545D007246
Agency Specific
FDA
EMA
Expiration
Code
follitropin alfa, Gonal-f, EMD Serono, Inc.
2107-05-24Orphan excl.
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
G03GA05: Follitropin alfa
HCPCS
Code
Description
S0126
Injection, follitropin alfa, 75 iu
Clinical
Clinical Trials
259 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfertilityD007246EFO_00005451247
Fertilization in vitroD0053071135
FertilityD00529811
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovulation inductionD01006211
FertilizationD00530611
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primary ovarian insufficiencyD016649EFO_0004266E28.311
Female infertilityD007247EFO_0008560N9711
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.177
AnovulationD00085811
Congenital abnormalitiesD000013EFO_0003915Q89.911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFollitropin alfa
INNfollitropin alfa
Description
Follitropin beta chain precursor (Follicle-stimulating hormone beta subunit) (FSH-beta)
Classification
Protein
Drug classatropine derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL1201692
ChEBI ID
PubChem CID
DrugBank
UNII IDVV3HN9ZPB5 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Follistim Organon
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Follistim Merck & Co
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Estimated US medical usage
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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667 adverse events reported
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