Last reviewed 2026-05-14 · How we verify

Gonalef® (Follitropin alfa)

Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates the growth and maturation of ovarian follicles in women.

Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates the growth and maturation of ovarian follicles in women. Used for Infertility in women undergoing assisted reproductive technology (ART), Anovulation in women with polycystic ovary syndrome (PCOS).

At a glance

Mechanism of action

Follitropin alfa binds to FSH receptors on granulosa cells of ovarian follicles, promoting follicular development and estrogen production. This hormone is used in assisted reproductive technology to induce controlled ovarian hyperstimulation, enabling the retrieval of multiple mature oocytes for in vitro fertilization or other fertility treatments.

Approved indications

• Infertility in women undergoing assisted reproductive technology (ART)
• Anovulation in women with polycystic ovary syndrome (PCOS)

Common side effects

• Ovarian hyperstimulation syndrome (OHSS)
• Headache
• Injection site reactions
• Abdominal pain/bloating
• Nausea

Key clinical trials

• SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Gonalef® (Follitropin alfa) CI brief — competitive landscape report
• Gonalef® (Follitropin alfa) updates RSS · CI watch RSS
• Merck KGaA, Darmstadt, Germany portfolio CI