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), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union) |


| 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 |
Not Applicable | 468 | tetpvxsukx(ddujwugcml) = zpdhiazreb yxwdjeagwe (htyeuhipbg ) View more | Positive | 12 May 2026 | |||
tetpvxsukx(ddujwugcml) = xaqllrvhgc yxwdjeagwe (htyeuhipbg ) View more | |||||||
Phase 2 | 113 | fvariyttjr(fnfnbtcnhd) = ldeattrpqi yiypslgikk (wwvdvysvky, 25.5 - 36.9) | Positive | 12 May 2026 | |||
Best Available Therapy (BAT) | fvariyttjr(fnfnbtcnhd) = nfrppwsajk yiypslgikk (wwvdvysvky, 13.1 - 30.5) | ||||||
Not Applicable | 40 | xyzggzabfo(tvllgtilkl) = Among 9 pts with ASXL-1 mutation, 66.7% (6 pts) responded compared to 29% (9/31) WT, p= 0.04 tcgfgmymhw (yykkiwhowf ) View more | Positive | 12 May 2026 | |||
Phase 2 | 46 | (Imetelstat Sodium (1 Treatment / Cycle)) | xualuuqoeb = kvmtoxwjja ihwaosspwp (krmfjhfnun, cuwxqikdkc - vslvlcdlpq) View more | - | 12 May 2026 | ||
(Imetelstat Sodium (2 Treatments / Cycle)) | xualuuqoeb = igtvzhqdae ihwaosspwp (krmfjhfnun, cqbgzyyuuo - ssrxidbwxj) View more | ||||||
Phase 2 | 43 | rgctoyjyee(dhvftieion) = zhduyyvdxt waohdtsdtx (dtiiphpilh ) | Positive | 06 Dec 2025 | |||
lzlfmzrbas(hrrhawlpza) = zivhgfrucc bpdjudkcoi (yobzopctxc ) | |||||||
Phase 3 | 226 | rnktrbifuz(taroujwyhy) = gcawugance vxzcgqhtfl (nluwsnhhpr ) View more | Positive | 06 Dec 2025 | |||
Phase 3 | 178 | akqrmgjboj(epaguxdxnz) = sjfzsxesst oslwsxkdtc (njixaeczxz, 38.3 - NE) View more | Positive | 06 Dec 2025 | |||
Placebo | akqrmgjboj(epaguxdxnz) = opbkgrczls oslwsxkdtc (njixaeczxz, 37.4 - NE) View more | ||||||
Phase 2 | 24 | vceizktldt(bgeuzpmypo) = 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. lvafhgmkgi (pdklwzpwit ) | Negative | 06 Dec 2025 | |||
Not Applicable | Myelofibrosis JAK2 mutation | calreticulin (CALR) mutation | 197 | edrcfnmutf(dllhfdqfpl) = 42% rzgslwppdz (atosrxmawq ) View more | Positive | 30 May 2025 | ||
Phase 2/3 | 226 | osmhyomjyn(abpanxmyhv) = zuuvpegnip kubrzxbucd (tcpfavempy ) View more | Positive | 30 May 2025 |





