TheraRadar
Data updated: May 26, 2026

CETROTIDE (cetrorelix acetate)

Trial Activity: Mature 1 active trials
Women's Health Approved 2000-08-11

Development Insights

Assistance Publique - Hôpitaux de Paris conducting 2 trials (29%)
4 indications explored (Focused)
infertility (4 trials)
polycystic ovarian syndrome (2 trials)
in vitro fertilization (1 trials)
1
Indication
--
Phase 3 Trials
25
Years on Market

Details

Status
Discontinued
First Approved
2000-08-11
Routes
SUBCUTANEOUS
Dosage Forms
POWDER

Companies

Active Ingredient: CETRORELIX ACETATE

CETROTIDE Approval History

2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
30 FDA actions from 2000 to 2024
Nov 2024 SUPPL
Mfg · Manufacturing (CMC)
Jun 2024 SUPPL
Label · Labeling
Dec 2023 SUPPL
Label · Labeling

What CETROTIDE Treats

1 FDA approvals

Originally approved for its first indication in 2000 .

  • Other (1)
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Clinical Trial Registry

4 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
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)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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

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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