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gonadorelin

Trade name: factrel

Small moleculeapproved

Approved

Sep 30, 1982

Gonadorelin is a synthetic decapeptide prepared using solid phase peptide synthesis. GnRH is responsible for the release of follicle stimulating hormone and leutinizing hormone from the anterior pitutitary. In the pituitary GnRH stimulates synthesis and release of FSH and LH, a process that is controlled by the frequency and amplitude of GnRH pulses, as well as the feedback of androgens and estrogens. The pulsatility of GnRH secretion has been seen in all vertebrates, and it is necessary to ensure a correct reproductive function. Thus a single hormone, GnRH, controls a complex process of follicular growth, ovulation, and corpus luteum maintenance in the female, and spermatogenesis in the male. Its short half life requires infusion pumps for its clinical use. Gonadorelin is used for the treatment of amenorrhea, delayed puberty, and infertility the administration of gonadorelin is used to simulate the physiologic release of GnRH from the hypothalamus in treatment of delayed puberty, treatment of infertility caused by hypogonadotropic hypogonadism, and induction of ovulation in those women with hypothalamic amenorrhea. This results in increased levels of pituitary gonadotropins LH and FSH, which subsequently stimulate the gonads to produce reproductive steroids. — NCATS

Clinical trial activity

40 trials · 31 clinical orgs · 4 marketing orgs

Phase 1
5
Phase 2
16
Phase 3
9
Phase 4
5

Earliest trial started Mar 1, 1987 (NCT00004330)

Timeline

1980s

  1. Sep 30, 1982

    Wyeth — Earliest FDA Approval

  2. Sep 30, 1982

    West-Ward Pharmaceutical — NDA Secondary Org

  3. Sep 30, 1982

    Wyeth — NDA Organization

  4. Sep 30, 1982

    Hikma — Marketing Organization

  5. Sep 30, 1982

    Hikma — NDA Secondary Org

  6. Jan 1, 1989

    Earliest Phase 2 Sponsor(trial)

  7. Oct 10, 1989

    Ferring — NDA Secondary Org

1990s

  1. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewSep 30, 1982

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)C[C@H](NC(=O)CNC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O
Mol. weight
1182.31 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • abbott-41070
  • abbott-41070
  • ay-24031
  • ay-24031
  • cystorelin
  • cystorelin
  • factrel
  • factrel
  • factrel
  • fertagyl
  • fertiral lh-rh
  • gnrh
  • gnrh
  • gnrh
  • gnrh
  • gnrh-i
  • gnrh-i
  • gonadoliberin i
  • gonadoliberin i
  • gonadorelin
  • gonadorelin
  • gonadorelin
  • gonadorelin
  • gonadorelin
  • gonadorelin
  • gonadorelin
  • gonadorelin
  • gonadorelin
  • gonadorelin
  • gonadorelina
  • gonadorelina
  • gonadorelin acetate
  • gonadorelin acetate
  • gonadorelin acetate
  • gonadorelin acetate
  • gonadorelin acetate
  • gonadorelin decapeptide
  • gonadorelin decapeptide
  • gonadorelin diacetate
  • gonadorelin diacetate
  • gonadoréline
  • gonadoréline
  • gonadorelin hcl
  • gonadorelin hcl
  • gonadorelin hcl
  • gonadorelin hydrochloride
  • gonadorelin hydrochloride
  • gonadorelin hydrochloride
  • gonadorelin hydrochloride
  • gonadorelinum
  • gonadorelinum
  • gonadotropin releasing hormone
  • gonadotropin releasing hormone
  • gonadotropin releasing hormone
  • gonadotropin-releasing hormone
  • gonadotropin-releasing hormone
  • gonadotropin-releasing hormone
  • human gonadoliberin-i
  • human gonadoliberin-i
  • hypocrine
  • lh releasing factor
  • lh releasing factor
  • luteinizing hormone-releasing factor diacetate tetrahydrate
  • luteinizing hormone-releasing factor diacetate tetrahydrate
  • luteinizing hormone-releasing factor dihydrochloride
  • luteinizing hormone-releasing factor dihydrochloride
  • luteinizing hormone-releasing factor (swine)
  • luteinizing hormone releasing hormone
  • luteinizing hormone releasing hormone
  • lutrelef
  • lutrelef
  • lutrepulse
  • lutrepulse
  • lutrepulse kit
  • lutrepulse kit
  • relefact lh-rh

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04975347Phase 1Mar 31, 2022Harvard University
NCT04975334Phase 2Mar 31, 2022Harvard University
NCT05184374N/AJan 1, 2022Fudan University
NCT04648969Phase 2Jan 20, 2021Harvard University
NCT04390646N/AJun 30, 2020University of Lausanne
NCT04037605Early Phase 1 (Phase 1)Jul 24, 2019Los Angeles Biomedical Research Institute
NCT03989024Phase 4Jul 1, 2019Jiao Tong University
NCT04037254Phase 2Jun 3, 2019National Cancer Institute (NCI), NRG Oncology
NCT02956447Phase 2Mar 1, 2017Harvard University
NCT02908438Phase 1Sep 1, 2016Jiao Tong University
NCT02705014N/AJan 1, 2016Tsinghua University
NCT02431416N/AMay 1, 2015Orebro University
NCT02168062Phase 2Jun 1, 2014University of California, San Francisco
NCT01976728Phase 3Feb 1, 2014Ferring
NCT01952782Phase 1Jan 1, 2014Harvard University
NCT01863680Phase 3Jul 1, 2013Merck KGaA, Merck Serono
NCT01603420Phase 2/Phase 3 (Phase 3)Jul 1, 2012Proton Collaborative Group
NCT01439542Phase 2Sep 1, 2011University of Western Ontario
NCT01381016N/AJun 1, 2011University of Colorado, Denver
NCT01278290Phase 4Jul 1, 2010University of Buenos Aires
Showing 20 of 40 trials
Page 1 / 2

Organizations

Research & Development (31)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Harvard UniversityAcademic/Hospital10731989
National Institutes of Health (NIH)Government7331989
FerringFor profit3322005
Jiao Tong UniversityAcademic/Hospital3322010
Merck KGaAFor profit2222008
Merck SeronoFor profit2022008
National Cancer Institute (NCI)Government2022000
University of Colorado, DenverAcademic/Hospital2212010
Barts & The London NHS TrustAcademic/Hospital1112003
Department of Veteran AffairsGovernment1112001
EugoniaAcademic/Hospital1112003
Fudan UniversityAcademic/Hospital1112022
Los Angeles Biomedical Research InstituteAcademic/Hospital1112019
Mayo ClinicAcademic/Hospital1112004
Medical Research CouncilGovernment1111998
National Center for Research Resources (NCRR)Government1111987
NRG OncologyAcademic/Hospital1112019
Orebro UniversityAcademic/Hospital1112015
Proton Collaborative GroupAcademic/Hospital1112012
Radiation Therapy Oncology GroupAcademic/Hospital1112000
31 organizations
Page 1 / 2

Marketing (6)

OrganizationOrg typeRelationshipDate
FerringFor profitNDA2Oct 10, 1989
HikmaFor profitSYNSep 30, 1982
HikmaFor profitMKTGSep 30, 1982
HikmaFor profitNDA2Sep 30, 1982
West-Ward PharmaceuticalFor profitNDA2Sep 30, 1982
WyethFor profitNDASep 30, 1982