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A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

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Trial Profile

A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 14 May 2025

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At a glance

  • Drugs Imetelstat (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms IMerge
  • Sponsors Geron Corporation; Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 07 May 2025 According to a Geron Corporation media release, Research and development expenses for the three months ended March 31, 2025, were $15.1 million, compared to $29.4 million for the same period in 2024. The decrease was primarily due to the wind down of clinical trial costs associated with a decrease of activity in our Phase 3 IMerge MDS study after FDA approval of RYTELO in 2024.
  • 07 May 2025 According to a Geron Corporation media release, Geron expects to commercialize RYTELO in select EU countries commencing in 2026.
  • 11 Mar 2025 According to a Geron Corporation media release, company announced that the European Commission (EC) has granted marketing authorization for RYTELO (imetelstat) as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes. The marketing authorization of RYTELO approved by the EC is supported by data from the IMerge Phase 3 clinical trial.

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