Ganirelix Acetate

(ganirelix acetate)

ApprovedSmall molecule

OOrganon and Co

Ganirelix Acetate is one of 3 small molecule programs targeting Estrogen. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

EstrogenRecruiting

EstrogenApproved

Recruiting

Competition

Competitive Landscape

3 competitors in Estrogen

#DrugCompanyPhaseTrials

Ganirelix Acetate

OOrganon and Co

Approved

1 2

Bazedoxifene

Pfizer

Phase 2

1 3

Estrasorb

Novo Nordisk

Preclinical

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

Timeline

Expected Milestones

Q4 2027

ApprovedRecruiting

Estrogen

NCT06745466

Clinical

Trials by Indication[1]

Ovarian Stimulation2 trials

Delayed Start to Ovarian Stimulation

Terminated·UUniversity of California, San Francisco·Phase 4·NCT01614067·30 enrolled

Efficacy of Micronized Natural Progesterone Vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.

Recruiting·IInstituto Bernabeu·Phase 4·NCT05954962·150 enrolled

IVF1 trial

Luteal Phase FSH in the IVF Poor Responder

Completed·UUniversity of Pennsylvania·Phase 4·NCT00225433·20 enrolled

Progestin-primed Ovarian Stimulation1 trial

The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation Cycles

Unknown status·CCasa di Cura Privata Villa Mafalda·Phase 4·NCT04654741·396 enrolled

Tolerance1 trial

Sex Hormones and Orthostatic Tolerance

Completed·YYale University·Phase 2·NCT01153581·109 enrolled

GAN1 trial

Cetrorelix and Ganirelix Flexible Protocol for (IVF)

Unknown status·—·Phase 4·NCT03477929·100 enrolled

4 more indications

Polycystic Ovary Syndrome1 trial

Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Completed·YYale University·Phase 1·NCT00757185·28 enrolled

Efficacy and Safety1 trial

To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®

Completed·LLG Life Sciences·Phase 4·NCT03051087·255 enrolled

Estrogen1 trial

Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women

Recruiting·UUniversity of Delaware·Approved·NCT06745466·30 enrolled

Unspecified2 trials

Antagonist/Letrozole in Poor Responders

Completed·YYazd Research & Clinical Center for Infertility·Phase 1/2·NCT00823004·120 enrolled

Human Cerebral Blood Flow Regulation

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT04265053·110 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 29, 1999

GANIRELIX ACETATE

NDA NDA021057

May 15, 2001

GANIRELIX ACETATE

NDA NDA021057

Dec 20, 2002

GANIRELIX ACETATE

NDA NDA021057

Jun 30, 2008

GANIRELIX ACETATE

NDA NDA021057

Dec 19, 2014

GANIRELIX ACETATE

NDA NDA021057

Jan 12, 2015

GANIRELIX ACETATE

NDA NDA021057

Mar 10, 2016

GANIRELIX ACETATE

NDA NDA021057

May 3, 2016

GANIRELIX ACETATE

NDA NDA021057

Nov 30, 2018

FYREMADEL

NDA ANDA204246

Oct 22, 2020

GANIRELIX ACETATE

NDA NDA021057

Mar 16, 2021

FYREMADEL

NDA ANDA204246

Apr 7, 2022

GANIRELIX ACETATE

NDA ANDA212613

Jun 6, 2022

GANIRELIX ACETATE

NDA ANDA214996

Feb 28, 2023

GANIRELIX ACETATE

NDA ANDA215658

Aug 14, 2023

GANIRELIX ACETATE

NDA NDA021057

Aug 14, 2023

GANIRELIX ACETATE

NDA NDA021057

Aug 14, 2023

GANIRELIX ACETATE

NDA NDA021057

Aug 14, 2023

GANIRELIX ACETATE

NDA NDA021057

Nov 16, 2023

GANIRELIX ACETATE

NDA ANDA216075

Mar 20, 2024

GANIRELIX ACETATE

NDA ANDA214996

Jul 26, 2024

FYREMADEL

NDA ANDA204246

Sep 23, 2024

GANIRELIX ACETATE

NDA NDA021057

Apr 23, 2025

GANIRELIX ACETATE

NDA ANDA218855

Jun 16, 2026

FYREMADEL

NDA ANDA204246

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for ganirelix acetate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ganirelix acetate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ganirelix acetate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA ANDA204246). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: OOrganon and Co

Ganirelix Acetate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Ovarian Stimulation2 trials

IVF1 trial

Progestin-primed Ovarian Stimulation1 trial

Tolerance1 trial

GAN1 trial

Polycystic Ovary Syndrome1 trial

Efficacy and Safety1 trial

Estrogen1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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