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open-label recFSH
RecFSH stimulates follicular growth and ovulation in women with infertility.
RecFSH stimulates follicular growth and ovulation in women with infertility. Used for Treatment of infertility in women.
At a glance
| Generic name | open-label recFSH |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Gonadotropin |
| Target | FSH receptor |
| Modality | Biologic |
| Therapeutic area | Reproductive Health |
| Phase | Phase 3 |
Mechanism of action
RecFSH, a recombinant form of follicle-stimulating hormone, works by binding to the FSH receptor on the surface of ovarian granulosa cells, triggering a cascade of downstream effects that ultimately lead to follicular growth and ovulation.
Approved indications
- Treatment of infertility in women
Common side effects
- Ovarian hyperstimulation syndrome
Key clinical trials
- Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015) (PHASE2)
- To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001) (PHASE3)
- A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693) (PHASE2)
- A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703) (PHASE3)
- An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029) (PHASE3)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)
- Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)
- Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)
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:
- open-label recFSH CI brief — competitive landscape report
- open-label recFSH updates RSS · CI watch RSS
- Organon and Co portfolio CI