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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Commercial
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gonal-f | Biologic Licensing Application | 2025-09-02 |
| gonal-f rff redi-ject | Biologic Licensing Application | 2025-04-03 |
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
262 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | 1 | 2 | 4 | — | — | 7 |
| Fertilization in vitro | D005307 | — | — | — | 1 | 1 | — | 3 | 5 |
| Helping behavior | D006379 | — | — | — | — | 2 | — | — | 2 |
| Fertility | D005298 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovulation induction | D010062 | — | — | — | 1 | — | — | — | 1 |
| Fertilization | D005306 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | 1 | — | — | — | — | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | 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 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 2 | 2 |
| Anovulation | D000858 | — | — | — | — | — | — | 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
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Variants
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Follistim – Organon
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Follistim – Merck & Co
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Estimated US medical usage
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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706 adverse events reported
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