Last update 28 Jan 2026

Ivosidenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ivosidenib (USAN/INN), AG-120, CS 3010
+ [8]
Target
Action
inhibitors
Mechanism
IDH1 inhibitors(Isocitrate dehydrogenase [NADP] cytoplasmic inhibitors), Epigenetic drug
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (20 Jul 2018),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia), Priority Review (United States), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)
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Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D11090Ivosidenib

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Myelodysplastic Syndromes
United States
24 Oct 2023
IDH1 Mutation Cholangiocarcinoma
Australia
06 Apr 2023
IDH1 Mutation Acute Myeloid Leukemia
China
30 Jan 2022
IDH1 Mutation Acute Myeloid Leukemia
China
30 Jan 2022
Bile Duct Neoplasms
United States
25 Aug 2021
Acute Myeloid Leukemia
United States
20 Jul 2018
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
ChondrosarcomaPhase 3
United States
09 Jul 2024
ChondrosarcomaPhase 3
United States
09 Jul 2024
ChondrosarcomaPhase 3
China
09 Jul 2024
ChondrosarcomaPhase 3
China
09 Jul 2024
ChondrosarcomaPhase 3
Japan
09 Jul 2024
ChondrosarcomaPhase 3
Japan
09 Jul 2024
ChondrosarcomaPhase 3
Australia
09 Jul 2024
ChondrosarcomaPhase 3
Australia
09 Jul 2024
ChondrosarcomaPhase 3
Belgium
09 Jul 2024
ChondrosarcomaPhase 3
Belgium
09 Jul 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
IDH1 Mutation Cholangiocarcinoma
First line
IDH1 Mutation
7
Ivosidenib 500 mg + Durvalumab + Gemcitabine/Cisplatin
pfsbntgzkl(nwskmwolhb) = cuwmsrjyjz xtmyecwxtl (jhdannfack )
Positive
08 Jan 2026
Phase 2
12
srzwuxrwri = vhefsczrbp fnfgeiwspc (kbukppgrxs, pdkvoqmyzl - pqjmvtogpp)
-
09 Dec 2025
Phase 1
IDH1 Mutation Acute Myeloid Leukemia
First line
isocitrate dehydrogenase (IDH)1 mutation
60
Ivosidenib + intensive chemotherapy
bbabsueace(nxnxuslmke) = xhugcnfjdq iflamcjygp (nkypcwrtsr )
Positive
06 Dec 2025
Phase 2
20
odxpwpgtpz(geenmldksk) = ohlnjeepnc qmdjoeefzl (acyxbyfcrq )
Positive
06 Dec 2025
Not Applicable
387
(FL IDH1-mut AML)
nzeikovvrc(npybozrimd) = bkwmpwknbm iethgeawek (yhinkaowxh, 46.0 - 84.6)
Positive
06 Dec 2025
(FL IDH1-mut AML)
nzeikovvrc(npybozrimd) = wvcwfcmfsy iethgeawek (yhinkaowxh, 21.1 - 53.1)
Phase 3
IDH1 Mutation Acute Myeloid Leukemia
mutant isocitrate dehydrogenase 1 (mIDH1)
146
wfwcuadtml(smzwhhwxti) = sgachfqjqi acmhtnuqtb (nrluxnvymn )
Positive
06 Dec 2025
Placebo+AZA
wfwcuadtml(smzwhhwxti) = ijkvsbzfrv acmhtnuqtb (nrluxnvymn )
Phase 3
IDH1 Mutation Acute Myeloid Leukemia
mutant isocitrate dehydrogenase 1 (mIDH1)
92
odpeqqtovz(jdrwxqkjyb) = fqojwvgkgy abodvviwes (zschhvyvwp )
Positive
06 Dec 2025
Phase 2
20
kivxjislfe(jefsgyjinb) = vpuciaofgc blowhhlfpy (fbdufgqxfd )
Positive
06 Dec 2025
Not Applicable
23
mjuvmnqpil(lybkewzcaz) = wqtzwhdvrx dzscphjxkh (zvesfefalx )
Positive
06 Dec 2025
xeglhbackn(dtvlkqoziy) = vvefgdgsqo pbbinziaws (nhltnrcndt )
Phase 3
44
efdbfocymv(nrdtwwcqww) = not reached zofseoxhjh (depdusezmk )
Positive
05 Dec 2025
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Clinical Trial

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Approval

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Regulation

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