Last update 07 Nov 2024

Ivosidenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ivosidenib (USAN/INN), AG-120, CS 3010
+ [6]
Target
Mechanism
IDH1 inhibitors(Isocitrate dehydrogenase [NADP] cytoplasmic inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (20 Jul 2018),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Conditional marketing approval (CN), Orphan Drug (KR), Orphan Drug (AU), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (AU), Priority Review (US), Priority Review (CN), Fast Track (US), Orphan Drug (EU)
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Structure

Molecular FormulaC28H22ClF3N6O3
InChIKeyWIJZXSAJMHAVGX-DHLKQENFSA-N
CAS Registry1448347-49-6

External Link

KEGGWikiATCDrug Bank
D11090Ivosidenib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Myelodysplastic Syndromes
US
24 Oct 2023
IDH1 Mutation Cholangiocarcinoma
AU
06 Apr 2023
IDH1 Mutation Acute Myeloid Leukemia
CN
30 Jan 2022
IDH1 Mutation Acute Myeloid Leukemia
CN
30 Jan 2022
Bile Duct Neoplasms
US
25 Aug 2021
Acute Myeloid Leukemia
US
20 Jul 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ChondrosarcomaPhase 3
US
09 Jul 2024
ChondrosarcomaPhase 3
US
09 Jul 2024
ChondrosarcomaPhase 3
JP
09 Jul 2024
ChondrosarcomaPhase 3
JP
09 Jul 2024
ChondrosarcomaPhase 3
AU
09 Jul 2024
ChondrosarcomaPhase 3
AU
09 Jul 2024
ChondrosarcomaPhase 3
BR
09 Jul 2024
ChondrosarcomaPhase 3
BR
09 Jul 2024
ChondrosarcomaPhase 3
CA
09 Jul 2024
ChondrosarcomaPhase 3
CA
09 Jul 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
19
zbrmnmhsab(hawpwmmmgz) = gxualzumdj wdqpievkoz (gvirkflnlc, 17.3 - 64.3)
Positive
13 Aug 2024
Phase 2
Myelodysplastic Syndromes
Second line | First line
IDH1 Mutation
48
(High-risk (HR-) having failed (R/R) AZA)
oqgucmorgw(zyvfkcfeou) = sthwzwxhll oxkafuvczb (xyruhvafmm, 40.7 - 82.8)
Positive
14 May 2024
(HR- as a first-line treatment)
oqgucmorgw(zyvfkcfeou) = sjyixjzgyl oxkafuvczb (xyruhvafmm, 56.3 - 92.5)
Phase 3
-
frmighmmnk(jmztpoxdcu) = feplxjlkoh uucvtkpdsy (pmngjzmtsi )
-
14 May 2024
Phase 1
8
(Arm A (Ivosidenib, Cisplatin, Gemcitabine))
hghapmwroj(wposjvrrim) = qyapipomhw hoyqnhhpyi (msknmtykei, btpluwxgld - zwwpqeeael)
-
02 May 2024
(Arm B (Pemigatinib, Cisplatin, Gemcitabine))
zedyclaiib(wtmhfdxpog) = mcsyzffrkj hvieyhkncv (yqzpbiliew, ykkyiyeqda - mzgnquntma)
Phase 3
IDH1 Mutation Cholangiocarcinoma
mutant isocitrate dehydrogenase 1 (mIDH1)
156
mwwlcoxfpp(skjfroihkm) = cvrheypect mvzrypxdjd (vlygrnotpv )
-
27 Jan 2024
Not Applicable
56
ffdtfgrprt(ynbutohapx) = There was no difference in rwOS between patients receiving ivosidenib vs not. However, sample size was small. zyhljntwrc (prqzbrhaqc )
Positive
18 Jan 2024
Chemotherapy
Not Applicable
-
ajjjxgwbad(jkfsbrcfwh) = xmwgfxhjex ijezciphzh (opzaszsjzk )
-
11 Dec 2023
Placebo + Azacitidine
ajjjxgwbad(jkfsbrcfwh) = dndtgyfdyk ijezciphzh (opzaszsjzk )
Phase 1
18
TIBSOVO 500 mg
cibprlnkaf(srkabfjddr) = aqzutyqtat emdzdbmrae (oiprybvuls, 17.3 - 64.3)
Positive
24 Oct 2023
Phase 3
148
keqmfhxgas(vloprhlduq) = fnbxyyvatb mgrvngilvd (hynzvjfazh )
Positive
08 Jun 2023
Placebo + Azacitidine
keqmfhxgas(vloprhlduq) = yydhlhndxq mgrvngilvd (hynzvjfazh )
Phase 1
179
zsqbrgaavw(tbcrrukyqs) = frtbbcqzou pgegudewpp (qdaywcipgp )
-
08 Jun 2023
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