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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 2024-07-15 |
| gonal-f rff | Biologic Licensing Application | 2023-11-28 |
| gonal-f rff redi-ject | Biologic Licensing Application | 2024-08-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| infertility | HP_0000789 | 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
322 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | HP_0000789 | — | 15 | 19 | 45 | 66 | 62 | 201 |
| Female infertility | D007247 | EFO_0008560 | N97 | 9 | 3 | 9 | 7 | 10 | 36 |
| Fertilization in vitro | D005307 | — | — | 1 | 2 | 3 | 12 | 5 | 22 |
| Ovulation induction | D010062 | — | — | 2 | 7 | 6 | 5 | 3 | 22 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | 2 | 4 | 5 | 8 | 19 |
| Syndrome | D013577 | — | — | — | 1 | 2 | 4 | 8 | 15 |
| Hypogonadism | D007006 | HP_0000044 | E23.0 | — | 1 | 2 | 5 | 3 | 11 |
| Assisted reproductive techniques | D027724 | — | — | — | — | 3 | 2 | 2 | 7 |
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | 1 | 1 | 3 | 2 | 7 |
| Anovulation | D000858 | — | — | — | — | 4 | 2 | 1 | 7 |
Show 18 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pituitary diseases | D010900 | — | E23.7 | 1 | 1 | 2 | — | — | 4 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | — | 1 | — | 1 | 2 |
| Embryo transfer | D004624 | — | — | — | — | 1 | — | — | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | 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 | — | — | 3 | 7 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 2 | 1 | — | — | 3 | 5 |
| Premature menopause | D008594 | HP_0008209 | E28.31 | 2 | 1 | — | — | 2 | 4 |
| 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 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | — | — | — | 1 | 2 |
| Menopause | D008593 | EFO_0003922 | N95 | 1 | — | — | — | 1 | 2 |
| Area under curve | D019540 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Absorption | D000042 | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Asymptomatic diseases | D058070 | — | — | 1 | — | — | — | — | 1 |
| Perimenopause | D047648 | — | — | 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 |
| In vitro oocyte maturation techniques | D059471 | — | — | — | — | — | — | 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 |
| Laparoscopy | D010535 | — | — | — | — | — | — | 1 | 1 |
| Hemostasis | D006487 | — | — | — | — | — | — | 1 | 1 |
Show 17 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 4,016 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
2,030 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use