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Org 36286 (CORIFOLLITROPIN ALFA)
Corifollitropin Alfa, marketed by Merck Sharp & Dohme Limited, is a follicle-stimulating hormone analog indicated for adolescent males with hypogonadotropic hypogonadism, positioning it in a niche but critical therapeutic area. The drug's mechanism of action, which closely mimics natural FSH, provides a significant advantage in stimulating follicle growth and ovulation effectively. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics and biosimilars.
At a glance
| Generic name | CORIFOLLITROPIN ALFA |
|---|---|
| Sponsor | Merck Sharp & Dohme Limited |
| Target | Follicle-stimulating hormone receptor |
| Modality | Recombinant protein |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2010 |
Approved indications
- Adolescent males with hypogonadotropic hypogonadism
- Ovulation induction
Common side effects
Key clinical trials
- Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. (PHASE3)
- PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study (PHASE4)
- Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA) (NA)
- Continuous Double Ovarian Stimulation. (PHASE4)
- One-shot Ovarian Stimulation Protocol (One-shot) (NA)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Org 36286 CI brief — competitive landscape report
- Org 36286 updates RSS · CI watch RSS
- Merck Sharp & Dohme Limited portfolio CI