Last reviewed · How we verify
Recombinant FSH (rFSH)
Recombinant FSH (rFSH) is a Gonadotropin Small molecule drug developed by AGUNCO Obstetrics and Gynecology Centre. It is currently FDA-approved for Infertility in women undergoing assisted reproductive technology (ART), Anovulation and ovulatory dysfunction in women seeking pregnancy.
Recombinant FSH (follicle-stimulating hormone) stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment.
Recombinant FSH (follicle-stimulating hormone) stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment. Used for Infertility in women undergoing assisted reproductive technology (ART), Anovulation and ovulatory dysfunction in women seeking pregnancy.
At a glance
| Generic name | Recombinant FSH (rFSH) |
|---|---|
| Sponsor | AGUNCO Obstetrics and Gynecology Centre |
| Drug class | Gonadotropin |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / Fertility |
| Phase | FDA-approved |
Mechanism of action
rFSH 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 hormone replacement 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 procedures.
Approved indications
- Infertility in women undergoing assisted reproductive technology (ART)
- Anovulation and ovulatory dysfunction in women seeking pregnancy
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Injection site reactions
- Headache
- Abdominal pain/bloating
- Nausea
Key clinical trials
- rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study
- Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment (NA)
- Does Recombinant FSH (rFSH, i.g. Gonal F®) as Compared to Human Menopausal Gonadotrophin (hMG) Affect Telomere Length of Cumulus Cells During Antral Follicle Growth and Impact Blastocyst Status?
- Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection
- Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET). (PHASE4)
- Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
- Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women (PHASE3)
- Dysregulation of FSH in Obesity: Functional and Statistical Analysis (NA)
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:
- Recombinant FSH (rFSH) CI brief — competitive landscape report
- Recombinant FSH (rFSH) updates RSS · CI watch RSS
- AGUNCO Obstetrics and Gynecology Centre portfolio CI
Frequently asked questions about Recombinant FSH (rFSH)
What is Recombinant FSH (rFSH)?
How does Recombinant FSH (rFSH) work?
What is Recombinant FSH (rFSH) used for?
Who makes Recombinant FSH (rFSH)?
What drug class is Recombinant FSH (rFSH) in?
What development phase is Recombinant FSH (rFSH) in?
What are the side effects of Recombinant FSH (rFSH)?
What does Recombinant FSH (rFSH) target?
Related
- Drug class: All Gonadotropin drugs
- Target: All drugs targeting FSH receptor (FSHR)
- Manufacturer: AGUNCO Obstetrics and Gynecology Centre — full pipeline
- Therapeutic area: All drugs in Reproductive Medicine / Fertility
- Indication: Drugs for Infertility in women undergoing assisted reproductive technology (ART)
- Indication: Drugs for Anovulation and ovulatory dysfunction in women seeking pregnancy
- Compare: Recombinant FSH (rFSH) vs similar drugs
- Pricing: Recombinant FSH (rFSH) cost, discount & access