Drug Type Fc fusion protein |
Synonyms KER-050, TAK-226 |
Target |
Action modulators |
Mechanism ACVR2A modulators(activin A receptor type 2A modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationFast Track (United States) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Transfusion dependent anaemia | Phase 3 | United States | 01 Jun 2025 | |
Transfusion dependent anaemia | Phase 3 | Brazil | 01 Jun 2025 | |
Transfusion dependent anaemia | Phase 3 | Bulgaria | 01 Jun 2025 | |
Transfusion dependent anaemia | Phase 3 | Germany | 01 Jun 2025 | |
Transfusion dependent anaemia | Phase 3 | Hungary | 01 Jun 2025 | |
Transfusion dependent anaemia | Phase 3 | Israel | 01 Jun 2025 | |
Transfusion dependent anaemia | Phase 3 | Italy | 01 Jun 2025 | |
Transfusion dependent anaemia | Phase 3 | Lithuania | 01 Jun 2025 | |
Transfusion dependent anaemia | Phase 3 | Poland | 01 Jun 2025 | |
Transfusion dependent anaemia | Phase 3 | Spain | 01 Jun 2025 |
Phase 2 | 15 | xgpfvdzhrk(rprmcupffb) = znxtgddfxu suhytsbgeh (uwkygaegnu, 190 - 1632) View more | Positive | 14 May 2025 | |||
Phase 2 | 95 | efcfeqhoqb(xmeiaumzew) = Observed differences in FACT-An total score for TI≥24 wks responders vs non-responders were driven by greater improvements for responders in the Anemia subscale (AnS), especially the FACIT-Fatigue component. Improvements were observed across FACIT-Fatigue items including those related to both fatigue experience and impact. Moreover, FACIT-Fatigue scores improved over time in TI≥24 wks responders as did the proportion of participants with improvements meeting or exceeding the MCID knfvwyzpxj (jnozawwlky ) | Positive | 14 May 2025 | |||
Phase 2 | 73 | lhjcuavuih(lzrcxilwzw) = An asymptomatic Hgb increase in one participant required dose reduction per protocol and was deemed a dose-limiting toxicity duumbhwiop (giinrbirrs ) View more | Positive | 14 May 2025 | |||
Elritercept + Ruxolitinib combination therapy | |||||||
Phase 1/2 | 770 | fbevtkfmjo(bbdtxepfow) = dqofliqrnp tkkqntdmmy (obztkotkzw, 0.012 - 0.039) View more | Positive | 14 May 2025 | |||
Phase 2 | 54 | bayiofkbts(tceohteriz) = iltehdkxvw gzxnhflsxr (afeagykfnd ) View more | Positive | 09 Dec 2024 | |||
Elritercept + Ruxolitinib | bayiofkbts(tceohteriz) = zwszwosusb gzxnhflsxr (afeagykfnd ) View more | ||||||
NCT04419649 (ASH2024) Manual | Phase 2 | 15 | (Non-Transfusion Dependent) | idhfhineka(gnfmddflxn) = tywhiiugzf khfionfrgs (pvmqrrjqko ) View more | Positive | 09 Dec 2024 | |
Not Applicable | - | Elritercept 3.75-5 mg/kg | lofsjlbeew(gpbrpeqbqx) = plcismevkx agtygiqebi (zcbsqqibci ) View more | - | 07 Dec 2024 | ||
NCT04419649 (Biospace) Manual | Phase 2 | 87 | htifamefky(dvalhaoajx) = hwibedcuco wlrecxpyaj (fjayonredp ) View more | Positive | 17 Jun 2024 | ||
Phase 2 | 54 | elritercept with or without ruxolitinib | mmgdalpotn(jlutpbdjfs) = jsspjzbbzr zxcocefgia (myllexqryk ) View more | Positive | 17 Jun 2024 | ||
elritercept with or without ruxolitinib (3.0 mg/kg of elritercept or higher in combination with ruxolitinib) | coygzykefh(gsedeujnyu) = ymspukkcga bvwowwuccc (oyjpvwidrb ) View more |