Gonal-f(follitropin alfa)
Gonal-f, Gonal-f RFF, 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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
| therapeutics | D013812 |
| investigative techniques | D008919 |
| reproductive and urinary physiological phenomena | D012101 |
Trade Name
FDA
EMA
Gonal-f, Gonal-f rff, Gonal-f rff rediject
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gonal-f rff | Biologic Licensing Application | 2022-08-08 |
| gonal-f rff | Biologic Licensing Application | 2022-08-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| infertility | EFO_0000545 | D007246 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
follitropin alfa, Gonal-f, EMD Serono, Inc. | |||
| 2107-05-24 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| S0126 | Injection, follitropin alfa, 75 iu |
Clinical
Clinical Trials
176 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 | 4 | 8 | 26 | 30 | 21 | 87 | |
| Female infertility | D007247 | EFO_0008560 | N97 | 4 | — | 7 | 4 | 1 | 16 |
| Fertilization in vitro | D005307 | — | 1 | 2 | 8 | 3 | 14 | ||
| Ovulation induction | D010062 | — | 4 | 5 | 2 | 1 | 12 | ||
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | 1 | 3 | 4 | 2 | 11 |
| Anovulation | D000858 | — | — | 4 | 1 | 1 | 6 | ||
| Hypogonadism | D007006 | E23.0 | — | 1 | 1 | 2 | 1 | 5 | |
| Healthy volunteers/patients | — | 4 | — | — | 1 | — | 5 | ||
| Intracytoplasmic sperm injections | D020554 | — | — | — | 4 | — | 4 | ||
| Assisted reproductive techniques | D027724 | — | — | 2 | 1 | 1 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | 4 | 5 |
| Fertility | D005298 | — | — | 1 | — | 1 | 2 | ||
| Embryo transfer | D004624 | — | — | 1 | — | — | 1 | ||
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | 1 | — | — | 1 |
| Oocyte donation | D018587 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fertilization | D005306 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | — | — | — | 2 | 2 |
| Pregnancy rate | D018873 | — | — | — | — | 1 | 1 | ||
| Prostatic neoplasms | D011471 | C61 | — | — | — | — | 1 | 1 | |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | — | 1 | 1 |
| Pregnancy outcome | D011256 | — | — | — | — | 1 | 1 | ||
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | — | 1 | 1 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | 1 | 1 | |
| In vitro oocyte maturation techniques | D059471 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FOLLITROPIN ALFA |
| INN | follitropin alfa |
| Description | Follitropin beta chain precursor (Follicle-stimulating hormone beta subunit) (FSH-beta) |
| Classification | Protein |
| Drug class | atropine derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201692 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | VV3HN9ZPB5 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 573 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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33 adverse events reported
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