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r-FSH
r-FSH is a Gonadotropin Small molecule drug developed by Instituto Valenciano de Infertilidad, IVI VALENCIA. It is currently FDA-approved for Infertility in women undergoing assisted reproductive technology (ART), Ovulation induction in anovulatory women. Also known as: Follitropin alfa; Gonal-F®.
Recombinant follicle-stimulating hormone (r-FSH) stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment.
Recombinant follicle-stimulating hormone (r-FSH) stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment. Used for Infertility in women undergoing assisted reproductive technology (ART), Ovulation induction in anovulatory women.
At a glance
| Generic name | r-FSH |
|---|---|
| Also known as | Follitropin alfa; Gonal-F® |
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA |
| Drug class | Gonadotropin |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive/Fertility |
| Phase | FDA-approved |
Mechanism of action
r-FSH is a recombinant version of the naturally occurring pituitary hormone FSH that binds to FSH receptors on granulosa cells of ovarian follicles, promoting follicular development and estrogen production. This controlled stimulation is used in assisted reproductive technology to induce multiple follicle maturation for egg retrieval during in vitro fertilization (IVF) and other fertility procedures.
Approved indications
- Infertility in women undergoing assisted reproductive technology (ART)
- Ovulation induction in anovulatory women
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/bloating
- Nausea
Key clinical trials
- An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin (PHASE1)
- Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (NA)
- A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA) (PHASE3)
- Effectiveness of Low Dose Gonadotropin Stimulation Protocol Vs High Dose Gonadotropin Protocol in Poor Responders (EARLY_PHASE1)
- Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment (PHASE4)
- Inhibin B/AFC Ratio for Ovarian Response
- Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI (PHASE4)
- Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes. (PHASE4)
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:
- r-FSH CI brief — competitive landscape report
- r-FSH updates RSS · CI watch RSS
- Instituto Valenciano de Infertilidad, IVI VALENCIA portfolio CI
Frequently asked questions about r-FSH
What is r-FSH?
How does r-FSH work?
What is r-FSH used for?
Who makes r-FSH?
Is r-FSH also known as anything else?
What drug class is r-FSH in?
What development phase is r-FSH in?
What are the side effects of r-FSH?
What does r-FSH target?
Related
- Drug class: All Gonadotropin drugs
- Target: All drugs targeting FSH receptor (FSHR)
- Manufacturer: Instituto Valenciano de Infertilidad, IVI VALENCIA — full pipeline
- Therapeutic area: All drugs in Reproductive/Fertility
- Indication: Drugs for Infertility in women undergoing assisted reproductive technology (ART)
- Indication: Drugs for Ovulation induction in anovulatory women
- Also known as: Follitropin alfa; Gonal-F®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing