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Placebo Corifollitropin alfa
Placebo Corifollitropin alfa is a Gonadotropin; long-acting FSH analog Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Controlled ovarian hyperstimulation in women undergoing assisted reproductive technology (ART) for infertility.
Corifollitropin alfa is a long-acting follicle-stimulating hormone (FSH) analog that stimulates ovarian follicle development for assisted reproductive technology.
Corifollitropin alfa is a long-acting follicle-stimulating hormone (FSH) analog that stimulates ovarian follicle development for assisted reproductive technology. Used for Controlled ovarian hyperstimulation in women undergoing assisted reproductive technology (ART) for infertility.
At a glance
| Generic name | Placebo Corifollitropin alfa |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Gonadotropin; long-acting FSH analog |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive/Fertility |
| Phase | Phase 3 |
Mechanism of action
Corifollitropin alfa is a recombinant FSH variant with an extended half-life due to fusion with the beta subunit of human chorionic gonadotropin (hCG). It binds to FSH receptors on ovarian granulosa cells to promote follicle growth and estrogen production during controlled ovarian hyperstimulation in fertility treatment. The extended half-life allows for less frequent dosing compared to conventional FSH preparations.
Approved indications
- Controlled ovarian hyperstimulation in women undergoing assisted reproductive technology (ART) for infertility
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/discomfort
- Nausea
Key clinical trials
- 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)
- Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016) (PHASE2)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)
- 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)
- Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031) (PHASE3)
- 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)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)
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:
- Placebo Corifollitropin alfa CI brief — competitive landscape report
- Placebo Corifollitropin alfa updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about Placebo Corifollitropin alfa
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Related
- Drug class: All Gonadotropin; long-acting FSH analog drugs
- Target: All drugs targeting FSH receptor (FSHR)
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Reproductive/Fertility
- Indication: Drugs for Controlled ovarian hyperstimulation in women undergoing assisted reproductive technology (ART) for infertility
- Compare: Placebo Corifollitropin alfa vs similar drugs
- Pricing: Placebo Corifollitropin alfa cost, discount & access