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Orgalutran

(Ganirelix)

ApprovedSmall molecule

OOrganon and Co

Ganirelix is used to prevent premature ovulation in women undergoing fertility treatment by stopping the body from releasing an egg too early during assisted reproductive procedures.[2] Orgalutran is currently approved and in use across 6 indications[4].[1]

Orgalutran is one of 110 small molecule programs targeting Female Infertility. It is currently in Approved.

6

Indications

25

Total Trials

3

Active Trials

109

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Female InfertilityActive, not recruiting

Polycystic Ovary SyndromeApproved

EndometrialUnknown status

Postmenopausal WomenActive, not recruiting

Sleep RestrictionActive, not recruiting

InfertilityCompleted

Female InfertilityApproved

Active, not recruiting

Polycystic Ovary SyndromeApproved

Approved

EndometrialPreclinical

Unknown status

Postmenopausal WomenPhase 1

Active, not recruiting

Sleep RestrictionPhase 1

Active, not recruiting

InfertilityApproved

Completed

Competition

Competitive Landscape

71 competitors in Polycystic Ovary Syndrome

#DrugCompanyPhaseTrials

Femara

Orgalutran

OOrganon and Co

Actos

Victoza

Onglyza

Evista

Calciferol

Jazz Pharmaceuticals

Glucophage

Januvia

ZZydus Therapeutics Inc.

Invokana

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

Clinical

Trials by Indication[1]

Ovarian Stimulation5 trials

To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference

Completed· Changchun GeneScience Pharmaceutical Co., Ltd. logo

Changchun GeneScience Pharmaceutical Co., Ltd.·Phase 3·NCT06091436·176 enrolled

A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)

Completed·OOrganon and Co·Phase 3·NCT00696800·1,509 enrolled

Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients

Unknown status·EEugonia·Phase 4·NCT00417144·200 enrolled

Show 2 more trials

Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors. Undergoing Ovarian Stimulation

Completed·IInstituto Valenciano de Infertilidad, IVI VALENCIA·Phase 3·NCT03300960·318 enrolled

Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation

Completed·FFundacion Dexeus·N/A·NCT01645241·15 enrolled

GnRH Antagonist3 trials

Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI

Completed·IIVI Madrid··NCT00780858·662 enrolled

Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

Completed·EEugonia·Phase 4·NCT00417066·270 enrolled

Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation

Completed·MMichigan Reproductive Medicine·Phase 4·NCT02069808·38 enrolled

Effectiveness2 trials

Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist Protocol

Unknown status·CChong Qing Reproducive and Genetic Institute·N/A·NCT02635607·200 enrolled

Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient

Completed·RReproductive & Genetic Hospital of CITIC-Xiangya·N/A·NCT03300518·552 enrolled

Controlled Ovarian Stimulation2 trials

A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)

Completed·OOrganon and Co·Phase 3·NCT00725491·259 enrolled

An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029)

Withdrawn·OOrganon and Co·Phase 3·NCT01599494

Pregnancy1 trial

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

Completed·OOrganon and Co··NCT00703014·541 enrolled

11 more indications

Progestin-primed Ovarian Stimulation1 trial

Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A.

Not yet recruiting·GGinefiv·Phase 4·NCT06637189·144 enrolled

Embryo Transfer1 trial

Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

Completed·OOrganon and Co··NCT00702273·344 enrolled

Treatment1 trial

Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.

Completed·UUniversity Hospital, Lille·Phase 1·NCT05751252·20 enrolled

Endometrial1 trial

A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

Unknown status·—·N/A·NCT01424618·20 enrolled

GAN1 trial

Early Follicular Supplementation of Ganirelix in IVF 2004

Completed·TThe Baruch Padeh Medical Center, Poriya·Phase 4·NCT00461422·50 enrolled

Postmenopausal Women1 trial

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women

Active, not recruiting·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 1·NCT04037605·5 enrolled

Infants1 trial

Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)

Completed·OOrganon and Co··NCT00724789·2,066 enrolled

Ovarian1 trial

Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

Completed·UUniversitair Ziekenhuis Brussel·Phase 3·NCT01816321·150 enrolled

Trial1 trial

Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)

Completed·OOrganon and Co·Phase 2·NCT00988260·266 enrolled

Sleep Restriction1 trial

Hormonal Mechanisms of Sleep Restriction - Axis Study

Active, not recruiting·PPeter y. Liu·Phase 1·NCT03142893·80 enrolled

Unspecified2 trials

Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

Unknown status·YYazd Research & Clinical Center for Infertility·Phase 3·NCT00823602·2 enrolled

MENOPUR® Versus FOLLISTIM®

Completed· Ferring logo

Ferring·Phase 4·NCT00802360·173 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 29, 1999

GANIRELIX ACETATE

NDA NDA021057

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Ganirelix. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Orgalutran drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ganirelix compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ganirelix. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021057). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co 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: OOrganon and Co

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