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Follitropin alfa liquid formulation
Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women.
Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women. Used for Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF), Anovulation and ovulatory dysfunction in women.
At a glance
| Generic name | Follitropin alfa liquid formulation |
|---|---|
| Also known as | Gonal-f |
| Sponsor | Merck KGaA, Darmstadt, Germany |
| Drug class | Gonadotropin; recombinant FSH |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / Fertility |
| Phase | Phase 3 |
Mechanism of action
Follitropin alfa binds to FSH receptors on granulosa cells of ovarian follicles, promoting their growth and maturation. This leads to increased estrogen secretion and development of multiple follicles, which is essential for controlled ovarian hyperstimulation in assisted reproductive technology. The liquid formulation allows for flexible dosing and may improve patient convenience compared to powder formulations.
Approved indications
- Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF)
- Anovulation and ovulatory dysfunction in women
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/discomfort
- Nausea
- Ovarian cysts
Key clinical trials
- Pergoveris FD and Liquid China BE Study (PHASE1)
- Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization (PHASE3)
- To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen (PHASE3)
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 |
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