Gonal-f(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
Gonal-f, Gonal-f rff, Gonal-f rff rediject (discontinued: Gonal-f, Gonal-f rff)
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)
Follitropin alfa
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Gonal-f | follitropin alfa | EMD Serono | N-20378 RX | 2001-02-28 | 2 products |
| Gonal-f RFF | follitropin alfa | EMD Serono | N-21765 RX | 2004-03-25 | 1 products |
| Gonal-f RFF RediJect | follitropin alfa | EMD Serono | N-21684 RX | 2004-05-25 | 3 products |
Show 2 discontinued
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
361 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 | — | 18 | 23 | 47 | 68 | 68 | 217 |
| Female infertility | D007247 | EFO_0008560 | N97 | 10 | 3 | 10 | 7 | 15 | 43 |
| Ovulation induction | D010062 | — | — | 3 | 7 | 6 | 6 | 5 | 26 |
| Fertilization in vitro | D005307 | — | — | 1 | 3 | 3 | 13 | 5 | 24 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | 2 | 5 | 5 | 8 | 20 |
| Hypogonadism | D007006 | — | E23.0 | 1 | 1 | 4 | 4 | 3 | 13 |
| Syndrome | D013577 | — | — | — | 1 | 1 | 2 | 6 | 10 |
| Healthy volunteers/patients | — | — | — | 5 | — | — | 1 | 2 | 8 |
| Assisted reproductive techniques | D027724 | — | — | — | — | 3 | 2 | 2 | 7 |
| Fertility | D005298 | — | — | 2 | — | 2 | 2 | 1 | 7 |
Show 18 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 |
| Pituitary diseases | D010900 | — | E23.7 | 1 | — | 1 | — | — | 2 |
| Embryo transfer | D004624 | — | — | — | — | 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 | 4 | 3 | — | — | 3 | 8 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 2 | 1 | — | — | 3 | 5 |
| Premature menopause | D008594 | — | E28.31 | 2 | 1 | — | — | 1 | 3 |
| Male breast neoplasms | D018567 | — | — | 1 | 1 | — | — | 1 | 2 |
| Infections | D007239 | EFO_0000544 | — | 1 | 1 | — | — | — | 1 |
| Leiomyoma | D007889 | — | D25 | 1 | 1 | — | — | — | 1 |
| Ectopic pregnancy | D011271 | — | O00 | 1 | 1 | — | — | — | 1 |
| Salpingitis | D012488 | — | N70.91 | 1 | 1 | — | — | — | 1 |
| Fertilization | D005306 | — | — | — | 1 | — | — | — | 1 |
| Papillary thyroid cancer | D000077273 | — | — | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | — | — | — | 1 | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Menopause | D008593 | EFO_0003922 | N95 | 1 | — | — | — | 1 | 2 |
| Area under curve | D019540 | — | — | 1 | — | — | — | — | 1 |
| Absorption | D000042 | — | — | 1 | — | — | — | — | 1 |
| Asymptomatic diseases | D058070 | — | — | 1 | — | — | — | — | 1 |
| Perimenopause | D047648 | — | — | 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 | — | — | — | — | 8 | 8 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 2 | 2 |
| In vitro oocyte maturation techniques | D059471 | — | — | — | — | — | — | 2 | 2 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | — | — | — | 2 | 2 |
| Habitual abortion | D000026 | EFO_1000954 | N96 | — | — | — | — | 2 | 2 |
| Ovarian pregnancy | D065172 | — | O00.2 | — | — | — | — | 1 | 1 |
| Oogenesis | D009866 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | — | — | 1 | 1 |
Show 20 more
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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Safety
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2,153 adverse events reported
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