CETRORELIX ACETATE
CETRORELIX ACETATE is indicated for the treatment of Premature Luteinizing Hormone Surge.
Details
- Status
- Prescription
- First Approved
- 2022-08-12
- Routes
- SUBCUTANEOUS
- Dosage Forms
- POWDER
CETRORELIX ACETATE Approval History
What CETRORELIX ACETATE Treats
1 indicationsCETRORELIX ACETATE is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Premature Luteinizing Hormone Surge
CETRORELIX ACETATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CETRORELIX ACETATE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340827 | MS132705_0007 | Ph 3 | recruiting | 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) |
| NCT03181685 | Andros Day Surgery Clinic | Ph 4 | terminated | Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles |
| NCT01185704 ATTAC-PCO results posted | EMR200088-501 2007-007932-25, INI 28091 | Ph 3 | completed | Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CETRORELIX ACETATE FDA Label Details
Indications & Usage
CETRORELIX ACETATE is indicated for the treatment of Premature Luteinizing Hormone Surge.
Looking for the branded version?
CETROTIDE
Full clinical data, patents, trials, and competitive landscape for cetrorelix acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.