Drugs / Imetelstat
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Rytelo | — | 2025-03-07 | europa.eu ↗ |
| Approved | US (FDA) | RYTELO | — | 2024-06-06 | fda.gov ↗ |
Trials 25 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT06247787 | Feb 2025 → Mar 2028 expected | childhood acute myeloid leukemia, childhood myelodysplastic syndrome, juvenile myelomonocytic leukemia | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 1 | NCT05371964 | May 2022 → Feb 2027 expected | myelofibrosis | Geron Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT01916187 | Jul → Nov 2013 | neuroblastoma | NCIC Clinical Trials Group | Withdrawn | No outcome recorded |
| Phase 1 | NCT01568632 | Mar → Oct 2012 | cancer, lymphoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 1 | NCT01273090 | May 2011 → Sep 2013 | central nervous system neoplasm, childhood malignant neoplasm, lymphoma, lymphoproliferative syndrome +1 | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1 | NCT01265927 | Jan 2011 → Aug 2012 | breast neoplasm | Indiana University | Completed | No outcome recorded |
| Phase 1 | NCT00732056 | Jul 2008 → Sep 2011 | breast cancer | Geron Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00718601 | Jul 2008 → Oct 2011 | plasma cell myeloma | Geron Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00594126 | Nov 2007 → Jul 2011 | plasma cell myeloma | Geron Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00510445 | Jul 2007 → Apr 2011 | lung cancer | Geron Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00310895 | Mar 2006 → Mar 2013 | — | Geron Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00124189 | Jul 2005 → Mar 2013 | lymphoproliferative syndrome | Geron Corporation | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT07549451 | Oct 2026 → May 2027 expected | myelodysplastic/myeloproliferative neoplasm | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05583552 | Jun 2023 → Mar 2025 overdue | acute myeloid leukemia, myelodysplastic syndrome | GCP-Service International West GmbH | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02426086 | Aug 2015 → Apr 2018 | myelofibrosis | Geron Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02011126 | Jun 2014 → Mar 2016 | Ewing sarcoma/peripheral primitive neuroectodermal tumor, hepatoblastoma, neuroblastoma, osteosarcoma +1 | Children's Oncology Group | Withdrawn | No outcome recorded |
| Phase 2 | NCT01836549 | Mar 2013 → Apr 2016 | anaplastic astrocytoma, anaplastic ependymoma, brainstem neoplasm, ependymoma +3 | Pediatric Brain Tumor Consortium | Terminated | No outcome recorded |
| Phase 2 | NCT01731951 | Oct 2012 → May 2018 | myelofibrosis, primary myelofibrosis | Geron Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01243073 | Dec 2010 → Oct 2013 | acquired polycythemia vera, essential thrombocythemia | Geron Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01242930 | Nov 2010 → Nov 2014 | plasma cell myeloma | Geron Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01256762 | Nov 2010 → Oct 2012 | female breast carcinoma | Geron Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01137968 | May 2010 → Sep 2013 | non-small cell lung carcinoma | Geron Corporation | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02598661 | Jan 2016 → Oct 2023 overdue | myelodysplastic syndrome | Geron Corporation | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04576156 | Apr 2021 → Jun 2028 expected | myelofibrosis | Geron Corporation | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05937568 | — | myelodysplastic syndrome | Geron Corporation | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07320235 Comparator | Jan 2026 → Jun 2030 expected | acute myeloid leukemia | Douglas Tremblay | Recruiting | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Imetelstat | “Part A Safety Run-In phase: Imetelstat in combination with Azacitidine” NCT07320235 ↗ |
| Known as | GRN163L | “A Phase II Trial to Evaluate the Activity of Imetelstat (GRN163L) in Patients with Essential Thrombocythemia or Polycythemia Vera Who Require Cytoreduction and Have Failed or...” NCT01243073 ↗7“Imetelstat Sodium (GRN163L)” NCT00718601 ↗ “Imetelstat Sodium (GRN163L)” NCT00510445 ↗ “Imetelstat Sodium (GRN163L)” NCT00594126 ↗ “Imetelstat Sodium (GRN163L)” NCT00310895 ↗ |
| Known as | Imetelstat Sodium | “Imetelstat Sodium (GRN163L) is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems.” NCT00124189 ↗8“To evaluate the safety and tolerability of imetelstat (imetelstat sodium) in myelofibrosis (MF).” NCT01731951 ↗ “Imetelstat sodium will be administered as intravenous (IV) every 28 days.” NCT05371964 ↗ “Imetelstat sodium IV infusion.” NCT02598661 ↗ “Imetelstat Sodium (GRN163L)” NCT00594126 ↗ “Imetelstat Sodium (GRN163L)” NCT00310895 ↗ “Imetelstat Sodium (GRN163L)” NCT00718601 ↗ “Drug: Imetelstat Sodium” NCT02011126 ↗ |
| Action | Inhibit | “Inhibition of telomerase may result in antineoplastic effects.” NCT00310895 ↗ |
| Modality | Oligonucleotide (other) | “Imetelstat, a 13-mer oligonucleotide that is covalently modified with lipid extensions” PMID 26332546 ↗ Sep 2015 |
| Route | Intravenous | “Weekly intravenous infusion” NCT00124189 ↗ |
| Target | TERT | “Target inhibition was demonstrated by reduction of telomerase activity and human telomerase reverse transcriptase level” PMID 34138638 ↗ Jun 2021 |