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Gonal-f pen
Gonal-f is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and maturation in women undergoing fertility treatment.
Gonal-f is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and maturation in women undergoing fertility treatment. Used for Ovarian stimulation in women undergoing assisted reproductive technology (ART) procedures, Anovulation or oligo-ovulation in women seeking fertility treatment.
At a glance
| Generic name | Gonal-f pen |
|---|---|
| Sponsor | Hangzhou YuYuan Bioscience Technology Co., Ltd. |
| Drug class | Recombinant gonadotropin (FSH) |
| Target | FSH receptor (FSHR) |
| Modality | Biologic |
| Therapeutic area | Reproductive/Fertility |
| Phase | Phase 3 |
Mechanism of action
Gonal-f mimics the natural FSH hormone by binding to FSH receptors on ovarian granulosa cells, promoting the growth and maturation of ovarian follicles. This leads to increased estrogen production and development of multiple follicles suitable for egg retrieval during assisted reproductive procedures. The pen formulation provides a convenient subcutaneous delivery method for patients requiring daily injections during ovarian stimulation cycles.
Approved indications
- Ovarian stimulation in women undergoing assisted reproductive technology (ART) procedures
- Anovulation or oligo-ovulation in women seeking fertility treatment
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Injection site reactions
- Headache
- 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)
- A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants (PHASE1)
- 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)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
- Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
- Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment (PHASE4)
- A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787) (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 pen CI brief — competitive landscape report
- Gonal-f pen updates RSS · CI watch RSS
- Hangzhou YuYuan Bioscience Technology Co., Ltd. portfolio CI