CETROTIDE (cetrorelix acetate) · EMD SERONO
CETROTIDE is FDA-approved to treat 1 condition (same as CETRORELIX ACETATE).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2000-08-11
- Routes
- SUBCUTANEOUS
- Dosage Forms
- POWDER
CETROTIDE Approval History
What CETROTIDE Treats
1 indicationsCETROTIDE is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Premature Luteinizing Hormone Surge
Same approved indications as CETRORELIX ACETATE (same active ingredient).
EMD SERONO's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340827 | MS132705_0007 jRCT2031250671 | 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 |
| NCT02333253 | 11 | Ph 3 | completed | Delayed Start Versus Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase |
| 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.
CETROTIDE FDA Label Details
Indications & Usage
FDA Label (PDF)CETROTIDE is FDA-approved to treat 1 condition — same approved indications as CETRORELIX ACETATE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment