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Imetelstat - Geron Corporation

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Drug Profile

Imetelstat - Geron Corporation

Alternative Names: GRN 140719; GRN 163; GRN 163-L; GRN 719; GRN163L peptide; Imetelstat sodium; JNJ-63935937

Latest Information Update: 26 Mar 2024

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At a glance

  • Originator GCP-Service International; Geron Corporation
  • Developer GCP-Service International; Geron Corporation; Janssen Biotech
  • Class Antifibrotics; Antineoplastics; Lipids; Oligonucleotides
  • Mechanism of Action Telomerase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Myelofibrosis; Myelodysplastic syndromes
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Myelodysplastic syndromes
  • Phase III Myelofibrosis
  • Phase II Acute myeloid leukaemia
  • Suspended Multiple myeloma
  • No development reported Chronic myeloid leukaemia
  • Discontinued Breast cancer; Essential thrombocythaemia; Lymphoproliferative disorders; Non-small cell lung cancer; Polycythaemia vera; Solid tumours

Most Recent Events

  • 14 Mar 2024 The US FDA Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk Myelodysplastic syndromes (LR-MDS)
  • 12 Feb 2024 Geron in collaboration with Children's Oncology Group plans a phase I trial in Acute myeloid leukemia and Myelodysplastic syndrome (Second line therapy or greater, Combination therapy, In children, In adolescents, In infants, In adults) in July 2024 (IV) (NCT06247787)
  • 09 Dec 2023 Efficacy data from a phase II/III IMerge trial in Myelodysplastic syndromes presented at the 65th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2023)
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