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Follitropin alfa (Primapur)
Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women undergoing fertility treatment.
Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women undergoing fertility treatment. Used for Ovulation induction and controlled ovarian hyperstimulation in women undergoing assisted reproductive technology (ART), Anovulation or oligo-ovulation in women with polycystic ovary syndrome (PCOS) or other fertility disorders.
At a glance
| Generic name | Follitropin alfa (Primapur) |
|---|---|
| Also known as | Follitropin alpha, Follitropin |
| Sponsor | IVFarma LLC |
| Drug class | Gonadotropin; recombinant FSH |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive/Fertility |
| Phase | Phase 3 |
Mechanism of action
Follitropin alfa binds to FSH receptors on granulosa cells of ovarian follicles, promoting follicular growth, maturation, and increased estradiol secretion. This hormone replacement therapy mimics the natural FSH surge needed to initiate and sustain the follicular phase of the menstrual cycle, enabling controlled ovarian stimulation for assisted reproductive technologies.
Approved indications
- Ovulation induction and controlled ovarian hyperstimulation in women undergoing assisted reproductive technology (ART)
- Anovulation or oligo-ovulation in women with polycystic ovary syndrome (PCOS) or other fertility disorders
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/bloating
- Nausea
Key clinical trials
- Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment (PHASE3)
- An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
- The Safety and Pharmacokinetics of Primapur and Gonal-f (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |