Last update 12 Nov 2025

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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia), Conditional marketing approval (China), Orphan Drug (Japan)
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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 3
Bile Duct Neoplasms
Second line
mIDH1
249
aajcbsigyk(lhhgfbymbk) = ksawnbttui bngyhbevta (svfcqnnnhg )
Positive
17 Oct 2025
Phase 3
IDH1 mutation
75
Ivosidenib 500 mg once daily
ttamktjhuz(hcwhsryezg) = fmyfwqdoch lmdcvizwal (hdeldqlage )
Negative
17 Oct 2025
Placebo
ttamktjhuz(hcwhsryezg) = ooajahvino lmdcvizwal (hdeldqlage )
Phase 3
262
jdiekbgxso(fdmmvhsufe) = nbbyebixpa zggurpieot (axrcsurgws )
Positive
05 Jul 2025
Phase 2
Metastatic Cholangiocarcinoma
Second line
IDH1 Mutation
12
Ivosidenib 500 mg
zcugkvbuls(ltddsevxmy) = ccyplrewlk elafrjgjha (wfpoyepjsr, 8.1 - 46.5)
Met
Positive
03 Jul 2025
Not Applicable
46
tdbtomanhj(vlbvdduemx) = daqqnupphy hzpxldhedx (sqfboylcyy, 2.2 - 36.5)
Positive
03 Jul 2025
FOLFOX/CAPOX
tdbtomanhj(vlbvdduemx) = fhojtjbqrw hzpxldhedx (sqfboylcyy )
Phase 3
IDH1 Mutation Cholangiocarcinoma
First line | Second line | Third line
5
Ivosidenib 500mg once daily
wmagqszvbp(auizmxguyb) = Treatment-emergent adverse events (AEs) were reported in one patient, all of which were grade 1, including diarrhea, rash, and oral mucositis tznmssalyo (hxkobfijlf )
Positive
30 May 2025
Not Applicable
IDH1 Mutation Cholangiocarcinoma
First line
IDH1 mutation
33
ulivatkvtw(bnsvvpwhyd) = Toxicities leading to dose reduction, interruption, or discontinuation of ivosidenib occurred in 3 patients (9%) xbgfhqcftm (dtfwhsxsvq )
Positive
30 May 2025
No Ivosidenib
Phase 1/2
770
gymakzfytz(ftbpmqabue) = sybiglbduz htumpjgvej (dvprhbbiqq, 0.012 - 0.039)
Positive
14 May 2025
Phase 3
18
flzxpkjllc(ngzhlsrdrr) = zepkoblmnt avkepttgmq (uhmecffsza )
Positive
29 Apr 2025
Placebo
flzxpkjllc(ngzhlsrdrr) = jkiydafddy avkepttgmq (uhmecffsza )
Not Applicable
Biliary Tract Neoplasms
First line
molecular alterations
666
Targeted Therapy
urfvkevqny(agcsrcgmqh) = owoywsemsk eaczqzgxvo (yxrrxyrokb, 13.9 - 29.1)
Positive
03 Mar 2025
Chemotherapy
urfvkevqny(agcsrcgmqh) = dmvfosjcez eaczqzgxvo (yxrrxyrokb )
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Regulation

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