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Label indication Cetrotide ® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation. FDA label
Also known as Cetrorelix acetate, Cetrotide®
Cetrorelix · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Day 1 protocol | EXPERIMENTAL | - |
| Day 7 protocol | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cetrorelix acetate | DRUG | Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) until r-hCG day (at least 2 follicles \>=17 mm) |
| Recombinant Human Choriogonadotropin (r-hCG) | DRUG | The r-hCG will be administered subcutaneously as a single dose of 250 microgram (mcg) on r-hCG day |
| Recombinant human follicle stimulating hormone (r-hFSH) | DRUG | Recombinant human follicle stimulating hormone (r-hFSH) will be administered subcutaneously at a dose between 75 and 187.5 international unit (IU) once daily from Day 2 (Day 1 of stimulation period \[S1\]) until r-hCG day |
Inclusion Criteria: * Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised 2003 Rotterdam Consensus * Female subjects suitable for IVF/ICSI, undergoing first or second attempt * 18-35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least fr...
Cetrorelix is used in women with Polycystic Ovarian Syndrome undergoing assisted reproductive technology. It is a GnRH antagonist given to prevent premature ovulation during controlled ovarian stimulation. In this setting it is studied as part of a therapeutic protocol in women aged 18 years and older, and it is not a treatment for the underlying syndrome itself.
Cetrorelix targets GNRHR, the gonadotropin-releasing hormone receptor, and acts as an antagonist. By blocking this receptor it suppresses the pituitary release of luteinizing hormone, which prevents a premature LH surge during ovarian stimulation cycles. This mechanism underlies its use in assisted reproductive technology protocols.
Cetrorelix is developed by Merck KGaA, which trades under the ticker MKGAF. The company is the sponsor behind the clinical development of the compound, including the Phase 3 study conducted in France in women with Polycystic Ovarian Syndrome undergoing assisted reproductive technology.
Cetrorelix is in Phase 3 development for Polycystic Ovarian Syndrome. It is an investigational small molecule and is not approved for this indication. The Phase 3 trial in this setting has been completed, and no trials are currently listed as active.
Cetrorelix has been studied in the Phase 3 trial NCT01185704, titled Analysis of Two Therapeutic With Cetrotide in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART). The trial enrolled 136 women aged 18 years and older in France, was randomized and controlled, and has been completed.
Yes. Cetrorelix acetate is the acetate salt form of Cetrorelix and is the name under which the compound is commonly supplied and referenced. Searches for either name refer to the same GnRH receptor antagonist developed by Merck KGaA.