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Cetrotide

(cetrorelix)

ApprovedSmall molecule

Cetrorelix is used to prevent premature ovulation in women undergoing fertility treatments like in vitro fertilization (IVF). It helps control the timing of egg release so doctors can retrieve eggs at the optimal moment for the procedure.[2] Cetrotide is currently approved and in use across 8 indications[4].[1]

Cetrotide is one of 227 small molecule programs targeting Benign Prostatic Hyperplasia. It is currently in Approved.

8

Indications

26

Total Trials

1

Active Trials

226

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Benign Prostatic HyperplasiaApproved

Polycystic Ovary SyndromeActive, not recruiting

Rheumatoid ArthritisActive, not recruiting

ObesityActive, not recruiting

EndometriosisActive, not recruiting

Ovarian Hyperstimulation SyndromeActive, not recruiting

HypertrophyActive, not recruiting

InfertilityApproved

Benign Prostatic HyperplasiaApproved

Approved

Polycystic Ovary SyndromePreclinical

Active, not recruiting

Rheumatoid ArthritisPhase 2

Active, not recruiting

ObesityPreclinical

Active, not recruiting

EndometriosisPhase 2

Active, not recruiting

Ovarian Hyperstimulation SyndromePhase 2

Active, not recruiting

HypertrophyPhase 3

Active, not recruiting

InfertilityApproved

Approved

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Cetrotide

Cimzia

Simponi

Johnson & Johnson

Arcoxia

Kevzara

AAzienda U.S.L. 1 di Massa e Carrara

Ilaris

Zelhou

Jiangsu Simcere Pharmaceutical Co., Ltd.

Cataflam

Rituxan

Certolizumab

Johnson & Johnson

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

N/AActive, not recruiting

Ovarian Stimulation

NCT06378268

Clinical

Trials by Indication[1]

GnRH Antagonist4 trials

Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI

Completed·—·Phase 4·NCT04724486·50 enrolled

Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes.

Completed·—·Phase 4·NCT04724343·50 enrolled

Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF

Terminated·SShangHai Ji Ai Genetics & IVF Institute·N/A·NCT03680053·220 enrolled

Show 1 more trial

Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer

Completed·NNippon Kayaku Co., Ltd.·N/A·NCT00628121·31 enrolled

Polycystic Ovary Syndrome3 trials

Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

Completed·—·Phase 4·NCT04727671·50 enrolled

Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI

Completed·—·Phase 4·NCT04727684·50 enrolled

Progestin-primed Ovarian Stimulation Protocol Versus GnRH Antagonist Protocol in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Cycles

Unknown status·MMansoura University·N/A·NCT05112692·200 enrolled

Ovarian Hyperstimulation Syndrome3 trials

Outcome of Cetrotide Therapy for Management of Women at High-risk of Ovarian Hyperstimulation Syndrome

Unknown status·—·Phase 2/3·NCT02823080·48 enrolled

Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome

Completed·—·Phase 2·NCT02784457·84 enrolled

Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS)

Unknown status·EEugonia·N/A·NCT02392520·40 enrolled

Ovarian Hyperstimulation2 trials

Efficacy and Safety of BG2109 During Controlled Ovarian Hyperstimulation in Female Subjects Undergoing ART Procedures

Unknown status·BBio Genuine (Shanghai) Biotech Co., Ltd.·Phase 2·NCT05738382·240 enrolled

Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)

Completed·CCentre for Endocrinology and Reproductive Medicine, Italy·Phase 3·NCT01709942·80 enrolled

Ovarian Stimulation2 trials

Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days

Completed·FFertility - Assisted Fertilization Center·N/A·NCT01468441·96 enrolled

PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study)

Active, not recruiting·MMỹ Đức Hospital·N/A·NCT06378268·626 enrolled

11 more indications

Obesity2 trials

Reproductive Hormonal Alterations in Obesity

Completed·UUniversity of Colorado, Denver·N/A·NCT01457703·62 enrolled

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

Completed·UUniversity of Colorado, Denver·N/A·NCT02478775·99 enrolled

Oocyte1 trial

Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity

Unknown status·SSouthern Cross Fertility Centre·N/A·NCT01595334·300 enrolled

Embryo Transfer1 trial

Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI

Completed·—·Phase 4·NCT03118830·204 enrolled

In Vitro Fertilization1 trial

Progesterone Primed Ovarian Stimulation Versus GnRH Antagonist in With Expected High Ovarian Response Undergoing in Vitro Fertilization

Unknown status·—·Phase 2/3·NCT05951400·200 enrolled

Endometriosis1 trial

A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis

Completed·SSolvay Pharmaceuticals·Phase 2·NCT00244452

Rheumatoid Arthritis1 trial

Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis

Completed·—·Phase 2·NCT00667758·104 enrolled

Progesterone1 trial

Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)

Completed· Ferring logo

Ferring·Phase 4·NCT01225835·124 enrolled

Cystic1 trial

Comparison Between Two Different Protocols in Polycystic Ovary Symdrome Women Undergoing Intra-cytoplasmic Injection

Unknown status·—·Phase 4·NCT04094467·150 enrolled

Hypertrophy1 trial

Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

Terminated·AAEterna Zentaris·Phase 3·NCT00449150·667 enrolled

Clinical Trial1 trial

PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial

Completed·KKasr El Aini Hospital·Phase 3·NCT06868576·328 enrolled

TIA1 trial

Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation

Completed·—·Phase 4·NCT01005784·146 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 11, 2000

CETROTIDE

NDA NDA021197

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for cetrorelix. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cetrotide drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — cetrorelix compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for cetrorelix. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021197). U.S. Food & Drug Administration.
[6]
SEC EDGAR — EMD Serono company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Gonadotropin-Releasing Hormone Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EMD Serono

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