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Drug ReportsFollitropin delta
Follitropin
Bemfola, Gonal-f, Ovaleap, Pergoveris (follitropin) is a protein pharmaceutical. Follitropin was first approved as Gonal-f on 1995-10-20. It has been approved in Europe to treat anovulation, assisted reproductive techniques, female infertility, and hypogonadism. The pharmaceutical is active against follicle-stimulating hormone receptor.
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5Y
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FDA approval date
EMA approval 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
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
follistim aqBiologic Licensing Application2025-02-03
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
No data
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
— G03GA05: Follitropin alfa
— G03GA06: Follitropin beta
— G03GA10: Follitropin delta
HCPCS
Code
Description
J3355
Injection, urofollitropin, 75 iu
S0126
Injection, follitropin alfa, 75 iu
S0128
Injection, follitropin beta, 75 iu
Clinical
Clinical Trials
698 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfertilityD007246EFO_0000545—24126832
Polycystic ovary syndromeD011085EFO_0000660E28.2———1—1
SyndromeD013577—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Female infertilityD007247EFO_0008560N97—13—15
AnovulationD000858————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
FertilityD005298——1———12
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFollitropin
INNfollitropin alfa
Description
Gonadotropin preparations are drugs that mimic the physiological effects of gonadotropins, used therapeutically mainly as fertility medication for ovarian hyperstimulation and ovulation induction. For example, the so-called menotropins consist of LH and FSH extracted from human urine from menopausal women. There are also recombinant variants.
Classification
Protein
Drug classtricyclic compounds; atropine derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB1FL7, 1XWD, 4AY9, 4MQW, 7FIG, 7FIH, 7FII, 7T9I, 7UTZ, 7XW5, 8I2G, 8I2H
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297955
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDVV3HN9ZPB5 (ChemIDplus, GSRS)
Target
Agency Approved
FSHR
FSHR
Organism
Homo sapiens
Gene name
FSHR
Gene synonyms
LGR1
NCBI Gene ID
Protein name
follicle-stimulating hormone receptor
Protein synonyms
Follitropin receptor, FSH receptor
Uniprot ID
Mouse ortholog
Fshr (14309)
follicle-stimulating hormone receptor (Q9QWV8)
Alternate
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,058 adverse events reported
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