Last update 03 Jul 2025

Olutasidenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
FT 2102, FT-2102, Rezlidhea
+ [1]
Target
Action
inhibitors
Mechanism
IDH1 inhibitors(Isocitrate dehydrogenase [NADP] cytoplasmic inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Dec 2022),
RegulationOrphan Drug (United States), Orphan Drug (Australia)
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Structure/Sequence

Molecular FormulaC18H15ClN4O2
InChIKeyNEQYWYXGTJDAKR-JTQLQIEISA-N
CAS Registry1887014-12-1

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
IDH1 Mutation Acute Myeloid Leukemia
United States
01 Dec 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory acute myeloid leukemiaPhase 3
United States
30 Jan 2022
Refractory acute myeloid leukemiaPhase 3
United States
30 Jan 2022
Astrocytoma, IDH-MutantPhase 2
United States
01 Mar 2025
Astrocytoma, IDH-MutantPhase 2
Australia
01 Mar 2025
Astrocytoma, IDH-MutantPhase 2
Canada
01 Mar 2025
Astrocytoma, IDH-MutantPhase 2
Germany
01 Mar 2025
Astrocytoma, IDH-MutantPhase 2
Netherlands
01 Mar 2025
Astrocytoma, IDH-MutantPhase 2
United Kingdom
01 Mar 2025
Brain metastasesPhase 2
United States
01 Mar 2025
Brain metastasesPhase 2
Australia
01 Mar 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
147
mtwuvnjzek(lnsrkkyonl) = All patients experienced ≥1 treatment-emergent adverse event (TEAE) knikktquow (zhyewjezzq )
Positive
30 May 2025
Phase 2
IDH1 Mutation Acute Myeloid Leukemia
Maintenance
IDH1 mutation
25
Olutasidenib 150 mg BID
canpobpgyd(mnlwwvirmq) = 2-year cumulative incidence of non-relapse mortality (NRM) was 0% lsbqwaustg (oewyryoyqd )
Positive
30 May 2025
Not Applicable
-
Olutasidenib (OLU)
qctxsbbnjb(jmjlwwyhpb) = Differences in median DoCR were not statistically significant but favored OLU over IVO zkilebbxbr (eepfkssdii )
Positive
30 May 2025
Not Applicable
mIDH1-R132C | R132G | R132S ...
147
Olutasidenib 150 mg BID
wdrygsfsfv(bdzdybigvo) = wvqbkvzsam xconjabpet (yqagulnjkg, 31.7 - 53.6)
Positive
14 May 2025
Phase 2
147
Olutasidenib 150 mg twice daily
attxxlnptj(sfqmcscljp) = urgyfvkyso uampyjekej (ybsylybiro, 16.0 - 43.5)
Positive
14 May 2025
Phase 2
18
Olutasidenib 150 mg BID
xzqsuxggmj(duodtwxmlz) = hnxridpuza rjcutdewld (wybvjjyobz, 59 - 96)
-
14 May 2025
Not Applicable
mIDH1
153
bnfnlatqcu(kshfmttfqx) = juoixashoj ibzeukunzy (uvmsbxyuvf )
Positive
14 May 2025
bnfnlatqcu(kshfmttfqx) = hjhotbrkdd ibzeukunzy (uvmsbxyuvf )
Phase 1/2
67
xwiizjupyf(ldqzyctmix) = xcnbkveuae frkasizmom (nzpgdgqime, 17 - 39)
Positive
16 Jan 2025
Phase 1/2
22
Total
tytuvssaif(tcllecztrc) = dbnyqrnokd bzmhxisinr (svvannkhgp )
Positive
09 Dec 2024
tytuvssaif(tcllecztrc) = jwgifgmeyv bzmhxisinr (svvannkhgp )
Phase 1/2
67
lghafnvjqd(mdtqctiyoc) = ravdqrhzeu zcxsfbfnsj (jcijvgohwj, 21 - 44)
Positive
08 Dec 2024
(prior OLU exposure)
lghafnvjqd(mdtqctiyoc) = tiogkxbdlt zcxsfbfnsj (jcijvgohwj, 24 - 52)
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Clinical Trial

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Approval

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Regulation

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