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Gonal-f® RFF
Gonal-f® RFF is a Gonadotropin; recombinant FSH Small molecule drug developed by Fertility Biotech AG. It is currently FDA-approved for Infertility in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF), Anovulation in women with polycystic ovary syndrome (PCOS) or other causes of anovulation. Also known as: Follitropin-alfa.
Gonal-f RFF is a recombinant human follicle-stimulating hormone (FSH) that stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment.
Gonal-f RFF is a recombinant human follicle-stimulating hormone (FSH) that stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment. Used for Infertility in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF), Anovulation in women with polycystic ovary syndrome (PCOS) or other causes of anovulation.
At a glance
| Generic name | Gonal-f® RFF |
|---|---|
| Also known as | Follitropin-alfa |
| Sponsor | Fertility Biotech AG |
| Drug class | Gonadotropin; recombinant FSH |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / Fertility |
| Phase | FDA-approved |
Mechanism of action
FSH binds to FSH receptors on granulosa cells of ovarian follicles, promoting follicular development and estrogen production. This leads to the growth of multiple follicles suitable for retrieval during assisted reproductive procedures such as in vitro fertilization (IVF). The RFF formulation is a ready-for-use pen device containing recombinant FSH.
Approved indications
- Infertility in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF)
- Anovulation in women with polycystic ovary syndrome (PCOS) or other causes of anovulation
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Injection site reactions (pain, bruising, redness)
- Headache
- Abdominal pain or bloating
- Nausea
Key clinical trials
- Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application (PHASE1)
- Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Gonal-f® RFF CI brief — competitive landscape report
- Gonal-f® RFF updates RSS · CI watch RSS
- Fertility Biotech AG portfolio CI
Frequently asked questions about Gonal-f® RFF
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Related
- Drug class: All Gonadotropin; recombinant FSH drugs
- Target: All drugs targeting FSH receptor (FSHR)
- Manufacturer: Fertility Biotech AG — full pipeline
- Therapeutic area: All drugs in Reproductive Medicine / Fertility
- Indication: Drugs for Infertility in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF)
- Indication: Drugs for Anovulation in women with polycystic ovary syndrome (PCOS) or other causes of anovulation
- Also known as: Follitropin-alfa
- Compare: Gonal-f® RFF vs similar drugs
- Pricing: Gonal-f® RFF cost, discount & access