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Imetelstat

Trade name: RYTELO

Nucleic acidapprovedOrphan Drug FDAFast Track FDA

Approved

Jun 6, 2024

Clinical trial activity

40 trials · 22 clinical orgs · 1 marketing orgs

Phase 1
20
Phase 2
19
Phase 3
3
Phase 4
0

Earliest trial started Jul 1, 2003 (NCT00093873)

Timeline

2000s

  1. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Dec 23, 2015

    Orphan Drug Designation

2020s

  1. Jun 6, 2024

    Geron Corporation — Earliest FDA Approval

  2. Jun 6, 2024

    Geron Corporation — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFast trackJun 6, 2024

Chemistry & pharmacology

Loading structure…

SMILES

CC1(C)CNc2cc(NC(=O)c3cccnc3NCc3ccncc3)ccc21
Mol. weight
373.46 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • amg706
  • amg 706
  • amg 706
  • amg 706
  • amg-706
  • amg-706
  • amg-706
  • grn163l
  • grn163l
  • grn163l
  • grn163l
  • imetelstat
  • imetelstat
  • imetelstat
  • imetelstat
  • imetelstat sodium
  • imetelstat sodium

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06247787Phase 1Mar 28, 2025Geron Corporation, National Cancer Institute (NCI)
NCT05583552Phase 2Dec 31, 2022Australasian Leukaemia and Lymphoma Group, GCP-Service International Ltd. & Co. KG, German Myelodysplastic Syndrome Study Group, Geron Corporation, Groupe Francophone des Myelodysplasies, University of Leipzig, University of Paris, University of Queensland
NCT05371964Phase 1May 4, 2022Geron Corporation
NCT04576156Phase 3Dec 31, 2020Geron Corporation
NCT02598661Phase 3Nov 24, 2015Johnson and Johnson
NCT02426086Phase 2Jun 1, 2015Johnson and Johnson
NCT02011126Phase 2Jun 1, 2014National Cancer Institute (NCI)
NCT01916187Phase 1Jul 1, 2013Canadian Cancer Trials Group, Geron Corporation, University of Calgary
NCT01836549Phase 2Mar 1, 2013National Cancer Institute (NCI), Pediatric Brain Tumor Consortium
NCT01731951Phase 2Oct 1, 2012Johnson and Johnson
NCT01568632Phase 1Mar 1, 2012National Cancer Institute (NCI)
NCT01273090Phase 1May 1, 2011Baylor University, National Cancer Institute (NCI)
NCT01265927Phase 1Jan 1, 2011Breast Cancer Research Foundation, Geron Corporation, Indiana University
NCT01243073Phase 2Dec 1, 2010Geron Corporation
NCT01256762Phase 2Nov 1, 2010Geron Corporation, Indiana University
NCT01242930Phase 2Nov 1, 2010Geron Corporation, Johns Hopkins University
NCT01137968Phase 2May 1, 2010Geron Corporation, The University of Texas, Dallas
NCT01386866Phase 1May 1, 2009Amgen
NCT00427349Phase 2Sep 1, 2008Eastern Cooperative Oncology Group, National Cancer Institute (NCI), Northwestern University
NCT00732056Phase 1Jul 1, 2008Geron Corporation, Indiana University
Showing 20 of 40 trials
Page 1 / 2

Organizations

Research & Development (22)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Geron CorporationFor profit171342005
AmgenFor profit151532003
National Cancer Institute (NCI)Government6422008
Indiana UniversityAcademic/Hospital3122008
Johnson and JohnsonFor profit3322012
TakedaFor profit2022005
Australasian Leukaemia and Lymphoma GroupAcademic/Hospital1012022
Baylor UniversityAcademic/Hospital1012011
Breast Cancer Research FoundationAcademic/Hospital1012011
Canadian Cancer Trials GroupAcademic/Hospital1112013
Eastern Cooperative Oncology GroupAcademic/Hospital1112008
GCP-Service International Ltd. & Co. KGFor profit1112022
German Myelodysplastic Syndrome Study GroupAcademic/Hospital1012022
Groupe Francophone des MyelodysplasiesAcademic/Hospital1012022
Johns Hopkins UniversityAcademic/Hospital1012010
Northwestern UniversityAcademic/Hospital1012008
Pediatric Brain Tumor ConsortiumAcademic/Hospital1112013
The University of Texas, DallasAcademic/Hospital1012010
University of CalgaryAcademic/Hospital1012013
University of LeipzigAcademic/Hospital1012022
22 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
Geron CorporationFor profitNDAJun 6, 2024