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
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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)
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
265 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 | — | 9 | 19 | 41 | 56 | 46 | 165 |
| Female infertility | D007247 | EFO_0008560 | N97 | 7 | 1 | 8 | 4 | 7 | 26 |
| Fertilization in vitro | D005307 | — | — | 1 | 2 | 2 | 11 | 6 | 21 |
| Ovulation induction | D010062 | — | — | 1 | 7 | 5 | 5 | 4 | 21 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | 1 | 4 | 4 | 7 | 16 |
| Syndrome | D013577 | — | — | — | 1 | 1 | 2 | 6 | 10 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | 1 | 2 | 7 |
| Intracytoplasmic sperm injections | D020554 | — | — | — | — | — | 5 | 1 | 6 |
| Fertility | D005298 | — | — | 2 | — | 2 | 1 | 1 | 6 |
| Anovulation | D000858 | — | — | — | — | 4 | 1 | 1 | 6 |
Show 16 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Helping behavior | D006379 | — | — | 1 | 2 | 5 | — | — | 7 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | — | 1 | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | 1 | 2 |
| 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 | 2 | 2 | — | — | 3 | 6 |
| Male breast neoplasms | D018567 | — | — | 1 | 1 | — | — | 1 | 2 |
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | 1 | — | — | 1 | 2 |
| Fertilization | D005306 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Area under curve | D019540 | — | — | 1 | — | — | — | — | 1 |
| Absorption | D000042 | — | — | 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 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | — | 3 | 3 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 2 | 2 |
| Habitual abortion | D000026 | EFO_1000954 | N96 | — | — | — | — | 2 | 2 |
| Ovarian pregnancy | D065172 | — | O00.2 | — | — | — | — | 1 | 1 |
| Oogenesis | D009866 | — | — | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | — | — | 1 | 1 |
| Laparoscopy | D010535 | — | — | — | — | — | — | 1 | 1 |
| Hemostasis | D006487 | — | — | — | — | — | — | 1 | 1 |
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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) |
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Follistim – Organon
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Follistim – Merck & Co
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Safety
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Adverse Events
Top Adverse Reactions
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673 adverse events reported
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