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
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| follistim aq | Biologic Licensing Application | 2023-11-17 |
| gonal-f | Biologic Licensing Application | 2023-11-29 |
| gonal-f rff | Biologic Licensing Application | 2023-11-28 |
| gonal-f rff redi-ject | Biologic Licensing Application | 2020-05-01 |
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
397 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 | HP_0000789 | — | 12 | 19 | 37 | 61 | 54 | 176 |
| Female infertility | D007247 | EFO_0008560 | N97 | 8 | 3 | 9 | 7 | 7 | 32 |
| Fertilization in vitro | D005307 | — | — | 1 | 2 | 3 | 12 | 5 | 22 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 2 | 3 | 5 | 10 | 21 |
| Ovulation induction | D010062 | — | — | 1 | 7 | 6 | 4 | 2 | 19 |
| Fertility | D005298 | — | — | 1 | — | 2 | 3 | 3 | 9 |
| Hypogonadism | D007006 | HP_0000044 | E23.0 | — | 1 | 1 | 3 | 2 | 7 |
| Anovulation | D000858 | — | — | — | — | 4 | 2 | 1 | 7 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | 1 | 2 | 7 |
| Assisted reproductive techniques | D027724 | — | — | — | — | 3 | 1 | 2 | 6 |
Show 16 more
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 | — | 8 | 9 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | 1 | — | 1 | 3 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | — | 1 | — | 1 | 2 |
| Embryo transfer | D004624 | — | — | — | — | 1 | — | 1 | 2 |
| Pregnancy rate | D018873 | — | — | — | 1 | 1 | — | 1 | 2 |
| Oocyte donation | D018587 | — | — | — | — | 1 | — | 1 | 2 |
| Azoospermia | D053713 | EFO_0000279 | N46.0 | — | — | 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 | 3 | 2 | — | — | 7 | 10 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 2 | 1 | — | — | 3 | 5 |
| Premature menopause | D008594 | HP_0008209 | E28.31 | 2 | 1 | — | — | 1 | 3 |
| Menopause | D008593 | EFO_0003922 | N95 | 2 | 1 | — | — | 1 | 3 |
| Male breast neoplasms | D018567 | — | — | 1 | 1 | — | — | 1 | 2 |
| Infections | D007239 | EFO_0000544 | — | 1 | 1 | — | — | — | 1 |
| Leiomyoma | D007889 | HP_0000131 | D25 | 1 | 1 | — | — | — | 1 |
| Ectopic pregnancy | D011271 | — | O00 | 1 | 1 | — | — | — | 1 |
| Salpingitis | D012488 | — | N70.91 | 1 | 1 | — | — | — | 1 |
| Fertilization | D005306 | — | — | — | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Area under curve | D019540 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Absorption | D000042 | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Precocious puberty | D011629 | — | E22.8 | 1 | — | — | — | — | 1 |
| Delayed puberty | D011628 | HP_0000823 | E30.0 | 1 | — | — | — | — | 1 |
| Asymptomatic diseases | D058070 | — | — | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | — | — | — | 3 | 3 |
| In vitro oocyte maturation techniques | D059471 | — | — | — | — | — | — | 2 | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 2 | 2 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | — | 2 | 2 |
| Ovarian pregnancy | D065172 | — | O00.2 | — | — | — | — | 1 | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Uterine inertia | D014593 | EFO_1001863 | O62.2 | — | — | — | — | 1 | 1 |
| Laparoscopy | D010535 | — | — | — | — | — | — | 1 | 1 |
| Hemostasis | D006487 | — | — | — | — | — | — | 1 | 1 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | — | 1 | 1 |
Show 31 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) |
Target
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Variants
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Trends
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Safety
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No Black-box warning
Adverse Events
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1,670 adverse events reported
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