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Cetrotide
Cetrotide, marketed by Wolfson Medical Center, is indicated for preventing premature luteinizing hormone surges, a critical issue in assisted reproductive technologies. The drug's key strength lies in its well-established mechanism and market presence, with a key composition patent expiring in 2028, providing a period of exclusivity. The primary risk is the potential increase in competition following the patent expiry, which could impact market share and revenue.
At a glance
| Generic name | Cetrotide |
|---|---|
| Also known as | cetrorelix acetate, cetrorelix, Cetrorelix acetate |
| Sponsor | Wolfson Medical Center |
| Target | Gonadotropin-releasing hormone receptor, Lutropin-choriogonadotropic hormone receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Premature Luteinizing Hormone Surges
- Prevention of premature ovulation
- Prevention of premature ovulation during controlled ovarian stimulation
Common side effects
- Ovarian Hyperstimulation Syndrome
- Nausea
- Headache
- Local site reactions (redness, erythema, bruising, itching, swelling, pruritus)
Serious adverse events
- Hypersensitivity reactions including anaphylactoid reactions
- Stillbirth
- Anencephaly
- Ventricular septal defect
- Bilateral congenital glaucoma
- Diaphragmatic hernia
- Trisomy 21
- Klinefelter syndrome
- Trisomy 18
Key clinical trials
- PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study) (NA)
- 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)
- Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A (PHASE3)
- Trial Comparing Subcutaneous Natural Progesterone (Prolutex) vs. Cetrorelix Acetate for Luteinizing Hormone Surge Suppression in Freeze-All IVF Cycles. (PHASE4)
- NATural Ovarian Stimulation (PHASE4)
- Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF (NA)
- Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF (NA)
- Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A (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:
- Cetrotide CI brief — competitive landscape report
- Cetrotide updates RSS · CI watch RSS
- Wolfson Medical Center portfolio CI