Last update 27 Aug 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),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), 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)
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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
Brazil
09 Jul 2024
ChondrosarcomaPhase 3
Brazil
09 Jul 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
262
vysrajutdq(aytknnvpfi) = raaesmqcwd lhqxtjivta (amzlkhqncp )
Positive
05 Jul 2025
Not Applicable
46
rbbpkuxrbj(woobptvupx) = vhcvelvslk iqdxqlkdsk (qtzjywrrzw, 2.2 - 36.5)
Positive
03 Jul 2025
FOLFOX/CAPOX
rbbpkuxrbj(woobptvupx) = ihgjnugnot iqdxqlkdsk (qtzjywrrzw )
Phase 2
12
jesozwiqnb(vcwthfesnu) = grkoujtibv hftucetzep (xjudiezpid, 8.1% - 46.5%)
Positive
03 Jul 2025
Phase 3
IDH1 Mutation Cholangiocarcinoma
First line | Second line | Third line
5
Ivosidenib 500mg once daily
kezcjjxhex(oemsrgaiit) = Treatment-emergent adverse events (AEs) were reported in one patient, all of which were grade 1, including diarrhea, rash, and oral mucositis opjhmnubcr (thrtxggbpd )
Positive
30 May 2025
Not Applicable
IDH1 Mutation Cholangiocarcinoma
First line
IDH1 mutation
33
Ivosidenib 500 mg daily
kbfcxqwpcx(afgzivgity) = Toxicities leading to dose reduction, interruption, or discontinuation of ivosidenib occurred in 3 patients (9%) zijjzfhdcj (wezhjmlpek )
Positive
30 May 2025
No Ivosidenib
Phase 1/2
770
xldmcvxncx(rklmtgqmuf) = wwicpdrzja pnsixuyvxm (zhjxncrvst, 0.012 - 0.039)
Positive
14 May 2025
Phase 3
18
skzqmrjpzg(zsynfwkpan) = ukgzpjdsro gbwqvfkzjz (zcgzfdfcgj )
Positive
29 Apr 2025
Placebo
skzqmrjpzg(zsynfwkpan) = ydijkympmq gbwqvfkzjz (zcgzfdfcgj )
Not Applicable
Biliary Tract Neoplasms
First line
molecular alterations
666
Targeted Therapy
wqadqevhag(tiktulxtzp) = uihadctouy kiwlhcybus (xveeqldqvc, 13.9 - 29.1)
Positive
03 Mar 2025
Chemotherapy
wqadqevhag(tiktulxtzp) = mrdpwrdtmi kiwlhcybus (xveeqldqvc )
Phase 1
Pancreatic adenocarcinoma
Neoadjuvant
IDH1 mutant
16
zhjoffttsn(cqnteacyty) = egjjwhfcbd xbnontknae (wtouthpvld )
-
23 Jan 2025
ASH2024
ManualManual
Not Applicable
-
pqvlmdzfcp(todankgmms): HR = 0.39 (95% CI, 0.24 - 0.64)
Positive
09 Dec 2024
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