Drugs / Ganirelix
Ganirelix
also known as
Orgalutran · Ganirelix acetate · Antagon · Fyremadel · Ganilever · Ganirelix (Orgalutran) · Ganirelix acetate injection · Ganirelix gedeon richter · +4 more
Protein / enzyme biologic targets GNRHR via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Orgalutran | — | 2000-05-16 | europa.eu ↗ |
| Approved | US (FDA) | GANIRELIX ACETATE | — | 1999-07-29 | fda.gov ↗ |
Trials 30
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT05751252 | Apr 2024 → Feb 2025 | polycystic ovary syndrome | University Hospital, Lille | Completed | No outcome recorded |
| Phase 0 | NCT04037605 | Feb 2020 → Jul 2022 overdue | — | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Active not recruiting | No outcome recorded |
| Phase 0 | NCT00757185 | Feb 2008 → Apr 2012 | polycystic ovary syndrome | Yale University | Completed | No outcome recorded |
| Phase 0 | NCT00734279 | Mar 2006 → Nov 2010 | delayed puberty, self-limited, precocious puberty | University of Utah | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT03142893 | May 2017 → Oct 2020 overdue | — | Peter y. Liu | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01153581 | Feb 2006 → Dec 2012 | — | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT00988260 | Feb 2003 → Apr 2004 | ovarian hyperstimulation syndrome | Organon and Co | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT04414761 | Jun 2020 → Oct 2022 | — | ShangHai Ji Ai Genetics & IVF Institute | Completed | Missed primary |
| Phase 3 | NCT03767218 | Nov 2018 → May 2022 | female infertility | University Hospital Brussels | Completed | No outcome recorded |
| Phase 3 | NCT00823602 | Mar → Oct 2008 | infertility disorder | Yazd Research & Clinical Center for Infertility | Unknown | No outcome recorded |
| Phase 3 | NCT00725491 | May 2007 → Dec 2008 | — | Organon and Co | Completed | Met primary |
| Phase 414 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT06745466 | Nov 2024 → Oct 2026 expected | — | University of Delaware | Recruiting | No outcome recorded |
| Phase 4 | NCT04993924 | May 2021 → Mar 2022 | ovarian cyst | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT05071339 | Apr 2021 → Mar 2023 | — | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT03477929 | Nov 2017 → Dec 2018 | infertility disorder | Università degli Studi 'G. d'Annunzio' Chieti e Pescara | Unknown | No outcome recorded |
| Phase 4 | NCT03051087 | Oct 2016 → Mar 2018 | ovarian hyperstimulation syndrome | LG Life Sciences | Completed | No outcome recorded |
| Phase 4 | NCT01614067 | May 2012 → Jul 2014 | infertility disorder, ovarian dysfunction | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00826839 | Jan 2009 → Sep 2010 | infertility disorder | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00756028 | Jan 2009 → Dec 2014 | infertility disorder, ovarian hyperstimulation syndrome | Peter Hornnes, MD, DMSc | Completed | Met primary |
| Phase 4 | NCT00866008 | Oct 2008 → Jan 2011 | — | Bart CJM Fauser | Terminated | No outcome recorded |
| Phase 4 | NCT00830492 | Jan → Dec 2008 | ovarian hyperstimulation syndrome | Yazd Research & Clinical Center for Infertility | Completed | No outcome recorded |
| Phase 4 | NCT00417183 | Sep 2005 → Jun 2007 | infertility disorder | Eugonia | Unknown | No outcome recorded |
| Phase 4 | NCT00461422 | Jan 2004 → Jun 2007 | infertility disorder | The Baruch Padeh Medical Center, Poriya | Completed | No outcome recorded |
| Phase 4 | NCT00417144 | Nov 2003 → May 2007 | ovarian hyperstimulation syndrome, polycystic ovary syndrome | Eugonia | Unknown | Missed primary |
| Phase 4 | NCT00417066 | Sep 2003 → Jul 2006 | female infertility, primary ovarian failure | Eugonia | Completed | Met primary |
| Phase not applicable5 trials | ||||||
| — | NCT07409493 | Jan 2026 → Jun 2028 expected | infertility disorder | Hanoi Medical University | Recruiting | No outcome recorded |
| — | NCT02635607 | Jan → Dec 2016 | female infertility | Chong Qing Reproducive and Genetic Institute | Unknown | No outcome recorded |
| — | NCT01645241 | Jul 2012 → Dec 2013 | infertility disorder | Fundacion Dexeus | Completed | No outcome recorded |
| — | NCT01286051 | Jan 2011 → Sep 2012 | — | Houston Fertility Institute | Completed | No outcome recorded |
| — | NCT01424618 | Jan 2006 → Sep 2012 | — | Kelly, Maureen, M.D. | Unknown | No outcome recorded |
| Comparator or background therapy32 trials | ||||||
| Phase 1/2 | NCT04071574 Comparator | Feb 2018 → Aug 2019 | ectopic pregnancy, endometriosis, female infertility, hydrosalpinx +6 | Lebanese University | Completed | No outcome recorded |
| Phase 1/2 | NCT00823004 Comparator | Jun 2008 → Feb 2009 | ovarian hyperstimulation syndrome | Yazd Research & Clinical Center for Infertility | Completed | No outcome recorded |
| Phase 2 | NCT02429999 Comparator | Apr 2015 → Oct 2016 | — | Assiut University | Unknown | No outcome recorded |
| Phase 2 | NCT00702806 Background | Jul 2001 → Oct 2002 | infertility disorder | Organon and Co | Completed | No outcome recorded |
| Phase 2/3 | NCT01590173 Comparator | Jan 2012 → Jul 2016 | infertility disorder | National and Kapodistrian University of Athens | Completed | No outcome recorded |
| Phase 3 | NCT05994378 Comparator | Aug 2023 → May 2025 | female infertility | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06091436 Background | Mar → Dec 2023 | infertility disorder | Changchun GeneScience Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03300960 Comparator | Oct 2017 → Jun 2019 | infertility disorder | Instituto Valenciano de Infertilidad, IVI VALENCIA | Completed | No outcome recorded |
| Phase 3 | NCT01599494 Background | Mar 2014 → May 2015 | infertility disorder | Organon and Co | Withdrawn | No outcome recorded |
| Phase 3 | NCT02118051 Background | Sep 2013 → Jun 2017 | infertility disorder | La Fe Health Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT01816321 Background | Mar 2013 → May 2016 | infertility disorder, ovarian dysfunction | University Hospital Brussels | Completed | Missed primary |
| Phase 3 | NCT01636505 Comparator | Sep 2012 → Feb 2013 | — | European Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT00702845 Background | Dec 2006 → Jul 2007 | infertility disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00696800 Background | Jun 2006 → Nov 2007 | — | Organon and Co | Completed | Met primary |
| Phase 4 | NCT06175832 Comparator | Jan 2025 → Dec 2027 expected | — | University Hospital, Ghent | Recruiting | No outcome recorded |
| Phase 4 | NCT06637189 Comparator | Oct 2024 → Jun 2025 overdue | — | Ginefiv | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05954962 Comparator | Dec 2023 → Apr 2025 | — | Instituto Bernabeu | Completed | No outcome recorded |
| Phase 4 | NCT04983173 Background | Nov 2021 → Mar 2026 | infertility disorder | Fundacion Dexeus | Completed | No outcome recorded |
| Phase 4 | NCT04728659 Comparator | Oct 2020 → Jan 2022 | infertility disorder | Casa di Cura Privata Villa Mafalda | Unknown | No outcome recorded |
| Phase 4 | NCT04654741 Comparator | Sep 2020 → Feb 2022 | infertility disorder | Casa di Cura Privata Villa Mafalda | Unknown | No outcome recorded |
| Phase 4 | NCT02796105 Comparator | Jun 2016 → Jul 2017 | infertility disorder | Eugin | Completed | Met primary |
| Phase 4 | NCT02069808 Background | Apr 2014 → Feb 2017 | — | Michigan Reproductive Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01888744 Comparator | Sep 2010 → Jun 2013 | infertility disorder | University Hospital Brussels | Completed | No outcome recorded |
| Phase 4 | NCT00823472 Background | Jan 2009 → Oct 2010 | female infertility | UMC Utrecht | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00802360 Background | Dec 2008 → Nov 2009 | infertility disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00225433 Comparator | Sep 2005 → Dec 2006 | infertility disorder | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT07732348 Comparator | Sep → Dec 2026 expected | female infertility, ovarian disorder | Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) | Not yet recruiting | No outcome recorded |
| — | NCT06481696 Comparator | Jun 2024 → Dec 2025 | infertility disorder | Andros Day Surgery Clinic | Unknown | No outcome recorded |
| — | NCT04108039 Comparator | Sep 2019 → Jan 2022 | infertility disorder | Fundacion Dexeus | Completed | No outcome recorded |
| — | NCT03300518 Background | Nov 2017 → Jun 2021 | infertility disorder | Reproductive & Genetic Hospital of CITIC-Xiangya | Completed | Missed primary |
| — | NCT01669291 Comparator | Jul 2012 → May 2014 | infertility disorder | Main Line Fertility Center | Completed | No outcome recorded |
| — | NCT00608062 Background | Mar 2007 → Oct 2012 | arteriosclerosis disorder | University of Colorado, Denver | Completed | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ganirelix | “Patients will receive a verbal explanation over the phone and following consent will start GnRH antagonist injections \[Cetrotide (cetrolix) or Orgalutran (ganirelix) -...” NCT04993924 ↗45“Ovulation inhibition will be performed using ganirelix (Orgalutran, 0.25 mg/die) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first.” NCT04728659 ↗ “GnRH antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger” NCT04414761 ↗ “Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.” NCT03767218 ↗ “Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).” NCT00830492 ↗ “Administration of cetrorelix (cetrotide) or ganirelix (orgulatron) (0.25mg/day)” NCT04071574 ↗ “Administration of cetrorelix (cetrotide) or ganirelix (orgulatron) (0.25mg/day)” NCT04071574 ↗ “0.25 mg of Cetrorelix or Ganirelix starting in the presence of follicles” NCT04108039 ↗ “with ganirelix 0.25 mg (Orgalutran; Organon, Oss, The Netherlands)” NCT01590173 ↗ “Intervention pharmacon: GnRH-antagonist (Orgalutran®: Ganirelix)” NCT00756028 ↗ “GnRH antagonist: ganirelix 0.25 mg (Orgalutran®)” NCT04983173 ↗ |
| Known as | Antagon | “Ganirelix acetate (Antagon) will be used to prevent endogenous production of ovarian hormones in young women.” NCT06745466 ↗ |
| Known as | Fyremadel | “The pituitary suppression will be obtained by the administration of the GnRH antagonist ganirelix (0.25 mg per day, Fyremadel, Ferring S.p.A.)” NCT06481696 ↗ |
| Known as | Ganilever | “Ganilever (ganirelix acetate)” NCT03051087 ↗ |
| Known as | Ganirelix (Orgalutran) | “Ganirelix (Orgalutran)” NCT00866008 ↗ |
| Known as | Ganirelix acetate | “Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.” NCT01669291 ↗11“Ganirelix Type: Drug Group: B Description: Ganirelix acetate 0.25 mg administered by daily subcutaneous injection” NCT07732348 ↗ “Drug: Ganirelix Acetate” NCT05954962 ↗ |
| Known as | Ganirelix acetate injection | ChEMBL registry synonym — accepted as the source's own label CHEMBL1251 ↗ |
| Known as | Ganirelix gedeon richter | ChEMBL registry synonym — accepted as the source's own label CHEMBL1251 ↗ |
| Known as | Ganirest | ChEMBL registry synonym — accepted as the source's own label CHEMBL1251 ↗ |
| Known as | Orgalutran | “Patients will receive a verbal explanation over the phone and following consent will start GnRH antagonist injections \[Cetrotide (cetrolix) or Orgalutran (ganirelix) -...” NCT04993924 ↗17“GnRH Antagonist group (n=74): Will receive FSH injections (Orgalutran 0.25mg injections) when follicles reach ≥14mm” NCT07409493 ↗ “with ganirelix 0.25 mg (Orgalutran; Organon, Oss, The Netherlands)” NCT01590173 ↗ “Orgalutran (ganirelix) - depending on their primary prescription” NCT05071339 ↗ “Intervention pharmacon: GnRH-antagonist (Orgalutran®: Ganirelix)” NCT00756028 ↗ “Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)” NCT00417066 ↗ “Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)” NCT00417144 ↗ “Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)” NCT00417183 ↗ “GnRH antagonist (Orgalutran®) 0,25 mg subcutaneously” NCT01888744 ↗ “GnRH antagonist: ganirelix 0.25 mg (Orgalutran®)” NCT04983173 ↗ “Orgalutrán Ganirelix (GnRH antagonist)” NCT03300960 ↗ |
| Known as | orgulatron | “Administration of cetrorelix (cetrotide) or ganirelix (orgulatron) (0.25mg/day)” NCT04071574 ↗ |
| Known as | RS-26306 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1251 ↗ |
| Known as | RS-26306-298 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1251 ↗ |
| Action | Inhibit | “The efficacy and safety of the GnRH antagonist ganirelix was assessed” PMID 22429192 ↗ Mar 20121“Gonadotropin-releasing hormone receptor antagonist” CHEMBL1251 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL1251 ↗ |
| Route | Subcutaneous | “sc injection of Ganirelix 0.25 mg per day” NCT00461422 ↗ |
| Target | GNRHR | “Gonadotropin-releasing hormone receptor antagonist” CHEMBL1251 ↗ |