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fix dose r-FSH (Gonal-f)
fix dose r-FSH (Gonal-f) is a Gonadotropin Small molecule drug developed by Sisli Hamidiye Etfal Training and Research Hospital. It is currently FDA-approved for Ovarian stimulation in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF), Anovulation and oligo-ovulation in women seeking pregnancy. Also known as: puregon.
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 Ovarian stimulation in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF), Anovulation and oligo-ovulation in women seeking pregnancy.
At a glance
| Generic name | fix dose r-FSH (Gonal-f) |
|---|---|
| Also known as | puregon |
| Sponsor | Sisli Hamidiye Etfal Training and Research Hospital |
| Drug class | Gonadotropin |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / 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 their development and estrogen production. This controlled follicular stimulation is essential for assisted reproductive technologies to obtain multiple mature oocytes for fertilization. The fixed-dose formulation allows standardized dosing during ovarian stimulation cycles.
Approved indications
- Ovarian stimulation in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF)
- Anovulation and oligo-ovulation in women seeking pregnancy
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)
- 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)
- Recombinant Follicle-stimulating Hormone in Treatment for Infertility (PHASE3)
- Pergoveris FD and Liquid China BE Study (PHASE1)
- Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF) (PHASE4)
- Efficacy of Ovarian Stimulation Based on FSHR Genotype Status (PHASE3)
- The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI (PHASE4)
- EXpression PRofile Endometrium Samples Study (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:
- fix dose r-FSH (Gonal-f) CI brief — competitive landscape report
- fix dose r-FSH (Gonal-f) updates RSS · CI watch RSS
- Sisli Hamidiye Etfal Training and Research Hospital portfolio CI
Frequently asked questions about fix dose r-FSH (Gonal-f)
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Related
- Drug class: All Gonadotropin drugs
- Target: All drugs targeting FSH receptor (FSHR)
- Manufacturer: Sisli Hamidiye Etfal Training and Research Hospital — full pipeline
- Therapeutic area: All drugs in Reproductive Medicine / Fertility
- Indication: Drugs for Ovarian stimulation in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF)
- Indication: Drugs for Anovulation and oligo-ovulation in women seeking pregnancy
- Also known as: puregon
- Compare: fix dose r-FSH (Gonal-f) vs similar drugs
- Pricing: fix dose r-FSH (Gonal-f) cost, discount & access