Reproductive · FDA Approved
Follitropin Alfa (Gonal-F)
FDA-approved
01 · Overview
Follitropin alfa is a recombinant human follicle-stimulating hormone produced in Chinese hamster ovary cells, a heterodimeric glycoprotein of an alpha and a beta subunit. It binds FSH receptors on ovarian granulosa cells to stimulate follicular development, estradiol synthesis and oocyte maturation.
It is used for ovulation induction and for controlled ovarian stimulation in assisted reproduction. Gonal-F was approved under BLA 020378 and remains listed as a prescription product in the FDA drug approval database.
02 · Research summary & key findings
FDA approval was granted in September 1997 according to the FDA drug approval database. A 2026 Cochrane review found probably little or no difference between recombinant FSH and highly purified urinary FSH for live birth, clinical pregnancy or ovarian hyperstimulation syndrome (PMID 42445958). Against human menopausal gonadotropin, the same review found live birth and clinical pregnancy probably somewhat lower and ovarian hyperstimulation syndrome probably somewhat higher with recombinant FSH, so the recombinant product is not shown to be more effective (PMID 42445958). Its practical advantages are purity and batch-to-batch consistency rather than better pregnancy outcomes.
03 · Regulatory status
Follitropin Alfa (Gonal-F) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Follitropin Alfa (Gonal-F) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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04 · Administration routes
- Subcutaneous injection
References
- [1]Recombinant follicle-stimulating hormone (rFSH) versus other recombinant or urinary gonadotropins for ovarian stimulation in assisted reproductive technology cycles Cochrane Database Syst Rev, 2026. PMID 42445958
Primary literature
- PubMed: "Follitropin Alfa"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Follitropin Alfa"
Registered interventional and observational studies, including status and phase.
- PubChem: "Follitropin Alfa"
Chemical structure, molecular properties, and bioactivity data.
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