Follitropin
Gonal-f, Pergoveris (follitropin) is a protein pharmaceutical. Follitropin was first approved as Gonal-f on 1995-10-20. It has been approved in Europe to treat anovulation, assisted reproductive techniques, female infertility, and hypogonadism. The pharmaceutical is active against follicle-stimulating hormone receptor.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
| therapeutics | D013812 |
| investigative techniques | D008919 |
| reproductive and urinary physiological phenomena | D012101 |
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New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gonal-f rff | Biologic Licensing Application | 2022-08-08 |
Indications
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Agency Specific
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Clinical
Clinical Trials
177 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 | 5 | 9 | 25 | 21 | 22 | 80 | |
| Female infertility | D007247 | EFO_0008560 | N97 | 4 | — | 9 | 4 | 1 | 18 |
| Ovulation induction | D010062 | — | 4 | 5 | 2 | 1 | 12 | ||
| Fertilization in vitro | D005307 | — | 1 | 2 | 4 | 3 | 10 | ||
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | 1 | 3 | 2 | 2 | 9 |
| Anovulation | D000858 | — | — | 4 | 1 | 1 | 6 | ||
| Healthy volunteers/patients | — | 4 | — | — | 1 | — | 5 | ||
| Hypogonadism | D007006 | E23.0 | — | 1 | 1 | 1 | 1 | 4 | |
| Assisted reproductive techniques | D027724 | — | — | 2 | 1 | 1 | 4 | ||
| Aneuploidy | D000782 | — | — | — | 1 | 1 | 2 |
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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 | — | 4 | 5 |
| Fertility | D005298 | — | — | 1 | — | 1 | 2 | ||
| Oocyte donation | D018587 | — | — | 1 | — | 1 | 2 | ||
| Embryo transfer | D004624 | — | — | 1 | — | — | 1 | ||
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fertilization | D005306 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | — | — | — | 3 | 3 |
| Pregnancy rate | D018873 | — | — | — | — | 1 | 1 | ||
| Prostatic neoplasms | D011471 | C61 | — | — | — | — | 1 | 1 | |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | — | 1 | 1 |
| Reproduction | D012098 | — | — | — | — | 1 | 1 | ||
| Pregnancy outcome | D011256 | — | — | — | — | 1 | 1 | ||
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | — | 1 | 1 |
| Galactosemias | D005693 | E74.21 | — | — | — | — | 1 | 1 | |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FOLLITROPIN |
| INN | follitropin alfa |
| Description | Gonadotropin preparations are drugs that mimic the physiological effects of gonadotropins, used therapeutically mainly as fertility medication for ovarian hyperstimulation and ovulation induction. For example, the so-called menotropins consist of LH and FSH extracted from human urine from menopausal women. There are also recombinant variants.
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| Classification | Protein |
| Drug class | tricyclic compounds; atropine derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Target
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Safety
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1,663 adverse events reported
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