Urofollitropin
Bravelle (urofollitropin) is an unknown pharmaceutical. Urofollitropin was first approved as Bravelle on 2002-05-06. It is used to treat female infertility and polycystic ovary syndrome in the USA. The pharmaceutical is active against follicle-stimulating hormone receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
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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)
Urofollitropin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Bravelle | urofollitropin | Ferring Pharmaceuticals | N-21289 DISCN | 2002-05-06 | 1 products |
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FDA
EMA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| polycystic ovary syndrome | EFO_0000660 | D011085 | E28.2 |
| female infertility | EFO_0008560 | D007247 | N97 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J3355 | Injection, urofollitropin, 75 iu |
Clinical
Clinical Trials
202 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | 13 | 16 | 30 | 40 | 26 | 123 |
| Female infertility | D007247 | EFO_0008560 | N97 | 6 | 1 | 6 | 3 | 10 | 26 |
| Fertilization in vitro | D005307 | — | — | 1 | 3 | 2 | 6 | 4 | 15 |
| Ovulation induction | D010062 | — | — | 2 | 6 | 3 | 1 | 3 | 15 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | 1 | 7 | 3 | 3 | 14 |
| Hypogonadism | D007006 | — | E23.0 | — | 1 | 4 | 3 | 2 | 10 |
| Anovulation | D000858 | — | — | — | — | 4 | 1 | 1 | 6 |
| Intracytoplasmic sperm injections | D020554 | — | — | — | — | — | 4 | 1 | 5 |
| Syndrome | D013577 | — | — | — | 1 | 1 | 1 | 2 | 5 |
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | 1 | 1 | 3 | — | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Helping behavior | D006379 | — | — | — | 1 | 5 | — | — | 6 |
| Azoospermia | D053713 | EFO_0000279 | N46.0 | — | 1 | 1 | — | 1 | 3 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | — | 2 | — | 1 | 3 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | — | 1 | — | 1 | 2 |
| Fertility | D005298 | — | — | — | — | 1 | — | 1 | 2 |
| Embryo transfer | D004624 | — | — | — | — | 1 | — | — | 1 |
| Pituitary diseases | D010900 | — | E23.7 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | 1 | 2 | — | — | — | 2 |
| Fertilization | D005306 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | — | — | — | 2 | 3 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Vaccine immunogenicity | D000071497 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 7 | 7 |
| In vitro oocyte maturation techniques | D059471 | — | — | — | — | — | — | 2 | 2 |
| Ovarian pregnancy | D065172 | — | O00.2 | — | — | — | — | 1 | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Embryo culture techniques | D046149 | — | — | — | — | — | — | 1 | 1 |
| Aneuploidy | D000782 | — | — | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Urofollitropin |
| INN | urofollitropin |
| Description | Follitropin beta chain precursor (Follicle-stimulating hormone beta subunit) (FSH-beta) |
| Classification | Protein |
| Drug class | tricyclic compounds; atropine derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201520 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00094 |
| UNII ID | W9BB98U6HP (ChemIDplus, GSRS) |
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Urofollitropin
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Trends
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Additional graphs summarizing 610 documents
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Safety
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291 adverse events reported
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