Drug Type Oligonucleotide |
Synonyms Imetelstat (USAN/INN), Imetelstat sodium, GRN 140719 + [11] |
Target |
Action inhibitors |
Mechanism Telomerase inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (06 Jun 2024), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Fast Track (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D09629 | Imetelstat | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Transfusion dependent anaemia | European Union | 07 Mar 2025 | |
| Transfusion dependent anaemia | Iceland | 07 Mar 2025 | |
| Transfusion dependent anaemia | Liechtenstein | 07 Mar 2025 | |
| Transfusion dependent anaemia | Norway | 07 Mar 2025 | |
| myelodysplastic anemia | United States | 06 Jun 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Myelodysplastic Syndromes | NDA/BLA | United States | 12 Jan 2024 | |
| Myelofibrosis | Phase 3 | United States | 12 Apr 2021 | |
| Myelofibrosis | Phase 3 | Argentina | 12 Apr 2021 | |
| Myelofibrosis | Phase 3 | Australia | 12 Apr 2021 | |
| Myelofibrosis | Phase 3 | Austria | 12 Apr 2021 | |
| Myelofibrosis | Phase 3 | Belgium | 12 Apr 2021 | |
| Myelofibrosis | Phase 3 | Brazil | 12 Apr 2021 | |
| Myelofibrosis | Phase 3 | Bulgaria | 12 Apr 2021 | |
| Myelofibrosis | Phase 3 | Colombia | 12 Apr 2021 | |
| Myelofibrosis | Phase 3 | Denmark | 12 Apr 2021 |
Phase 2 | 43 | wxmntbcony(rdsnrevtke) = dareezsccf zjonbtwvxt (pgbnytjorb ) | Positive | 06 Dec 2025 | |||
mwhxvyyour(adhgvphyyy) = jwixdbcepx cskkksalhh (floacgduyt ) | |||||||
Phase 2 | 24 | rbtysyphin(qhjbonxono) = 24 SAEs occurred in 19 patients from August 2024 until 8th May 2025, of which none were deemed related to imetelstat. The most common SAEs were febrile neutropenia (n=6), disease progression/transformation to AML (n=4), sepsis (n=2) and fever (n=2). Overall, 11/24 SAEs resulted in death (n=4 disease progression or AML, n=2 cardiac/cardiorespiratory arrest, n=1 febrile neutropenia, n=1 sepsis, general health alteration and death of unknown reason). 8 of the SAEs resolved without sequelae and 2 remained unresolved. In the first cohort, 30 SAEs occurred in 18 patients, with 3 deemed possibly related to imetelstat (pneumonia [n=2], febrile neutropenia [n=1]). The most common SAEs were disease progression/transformation to AML (n=9), pneumonia (n=3), febrile neutropenia (n=3), and sepsis (n=2). 10/30 SAEs resulted in death. ypdjdhlodg (alaprrzowj ) | Negative | 06 Dec 2025 | |||
Phase 3 | 178 | brvwcbaxrw(pbxqxhgdjy) = ddsaeshqwm xoptbqqygk (ohzhbjrffw, 38.3 - NE) View more | Positive | 06 Dec 2025 | |||
Placebo | brvwcbaxrw(pbxqxhgdjy) = aufkduxvjy xoptbqqygk (ohzhbjrffw, 37.4 - NE) View more | ||||||
Phase 3 | 226 | kycslzjdyw(leltiylsbp) = mgtwcgsshg wwvdhgkmun (hnvrscurlb ) View more | Positive | 06 Dec 2025 | |||
Phase 2/3 | 226 | zvpufjnpqr(pnaqvfnpup) = ucrlwpmgam vjrfmhqgwb (ezmuxrznkm ) View more | Positive | 30 May 2025 | |||
Not Applicable | Myelofibrosis JAK2 mutation | calreticulin (CALR) mutation | 197 | yravadntim(ocrbanfplc) = 42% rjmttaropj (jcygyomiig ) View more | Positive | 30 May 2025 | ||
Phase 3 | - | zorrscesrq(udlncbggvr) = xbynveyhad kqnczobdhc (ejsmqvtgln ) View more | Positive | 22 May 2025 | |||
Phase 3 | 226 | yjmrfszewq(gnmyndbodb) = neutropenia and thrombocytopenia were the most common adverse events seen with IME in LR-MDS rcqzdfmhfv (aysuwiozsj ) View more | Positive | 14 May 2025 | |||
Phase 3 | 78 | afwawshvfv(znadjlyrds) = hchjqfkfbz fucethynyz (evdmgodvjc ) View more | Positive | 14 May 2025 | |||
Phase 1/2 | 770 | fzmulsboxz(kaebywbumk) = wbbmpjfxcl gjjcrbinhh (raksrufxcf, 0.012 - 0.039) View more | Positive | 14 May 2025 |





