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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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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 Application2024-07-15
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
696 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—27347294142355
Female infertilityD007247EFO_0008560N9711718123679
Polycystic ovary syndromeD011085EFO_0000660E28.233893254
Fertilization in vitroD005307——13320935
SyndromeD013577——23352335
Ovulation inductionD010062——3868731
Breast neoplasmsD001943EFO_0003869C501413715
Healthy volunteers/patients———7111615
HypogonadismD007006—E23.0—126514
FertilityD005298——2—24412
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primary ovarian insufficiencyD016649EFO_0004266E28.3661—2231
Premature menopauseD008594—E28.31551—1926
EndometriosisD004715EFO_0001065N80211—811
Pituitary diseasesD010900—E23.7112—59
AzoospermiaD053713EFO_0000279N46.0——1—34
Thyroid neoplasmsD013964EFO_0003841——12——3
Thyroid diseasesD013959—E00-E07—12——3
Prostatic neoplasmsD011471—C61111—13
Ovarian pregnancyD065172—O00.2——1—12
OligospermiaD009845—N46.1——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Premature birthD047928EFO_0003917O6044——813
MenopauseD008593EFO_0003922N9522——36
LymphomaD008223—C85.912——13
Male breast neoplasmsD018567——11——12
LeukemiaD007938—C9511——12
Papillary thyroid cancerD000077273———1———1
Follicular adenocarcinomaD018263———1———1
InfectionsD007239EFO_0000544—11———1
LeiomyomaD007889—D2511———1
Ectopic pregnancyD011271—O0011———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——2————2
Therapeutic equivalencyD013810——2————2
Delayed pubertyD011628—E30.01———12
Area under curveD019540——1————1
AbsorptionD000042——1————1
Precocious pubertyD011629—E22.81————1
Asymptomatic diseasesD058070——1————1
PerimenopauseD047648——1————1
Ovarian neoplasmsD010051EFO_0003893C561————1
Ovarian epithelial carcinomaD000077216——1————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382—U07.1————55
Muscular dystrophiesD009136EFO_0000757G71.0————55
Ovarian diseasesD010049——————44
Endocrine system diseasesD004700EFO_0001379E34.9————44
Turner syndromeD014424Orphanet_881Q96————33
Gonadal dysgenesisD006059——————33
HemorrhageD006470MP_0001914R58————33
Ovarian cystsD010048—N83.1————33
HypopituitarismD007018EFO_0001380E23.0————33
Facioscapulohumeral muscular dystrophyD020391EFO_0000491G71.02————33
Show 145 more
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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