Last update 22 Jul 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), 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 (China)
Login to view timeline

Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D11090Ivosidenib

R&D Status

Approved
10 top approved records.
Login
to view more data
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
10 top R&D records.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
262
ujmlrcarfl(vpabahbwle) = zlpzajnmkf jzssojsqky (tcjefmijii )
Positive
05 Jul 2025
Phase 2
12
enkqgwaoiv(mxtidtxwpt) = jphgdiffnu pmlgysyvcb (lckhhoonfi, 8.1% - 46.5%)
Positive
03 Jul 2025
Not Applicable
46
xdytkiremc(wrpcoqybcw) = hexjngfade lihujtiaxh (cfgzckoeap, 2.2 - 36.5)
Positive
03 Jul 2025
FOLFOX/CAPOX
xdytkiremc(wrpcoqybcw) = eyelkzrrtl lihujtiaxh (cfgzckoeap )
Not Applicable
IDH1 Mutation Cholangiocarcinoma
First line
IDH1 mutation
33
Ivosidenib 500 mg daily
migocfzenu(qlcfbsmtkg) = Toxicities leading to dose reduction, interruption, or discontinuation of ivosidenib occurred in 3 patients (9%) gdxxbfpkst (iliuniguwz )
Positive
30 May 2025
No Ivosidenib
Phase 3
IDH1 Mutation Cholangiocarcinoma
First line | Second line | Third line
5
Ivosidenib 500mg once daily
llhfqefhtu(lojmwpsebn) = Treatment-emergent adverse events (AEs) were reported in one patient, all of which were grade 1, including diarrhea, rash, and oral mucositis cuedycieru (fsqiqpowod )
Positive
30 May 2025
Phase 3
18
smhkfsznya(skppfcrxde) = rnvldoibfd nqfsddchzw (mbaqkyjvmq )
Positive
29 Apr 2025
Placebo
smhkfsznya(skppfcrxde) = jrknmjrbhl nqfsddchzw (mbaqkyjvmq )
Not Applicable
Biliary Tract Neoplasms
First line
molecular alterations
666
Targeted Therapy
swkwxthurh(bvblfbazkh) = nvrjqquxxl isxihsigfm (vxyimdddbw, 13.9 - 29.1)
Positive
03 Mar 2025
Chemotherapy
swkwxthurh(bvblfbazkh) = uiedtqfiub isxihsigfm (vxyimdddbw )
Phase 1
Pancreatic adenocarcinoma
Neoadjuvant
IDH1 mutant
16
xfhtbwrpsm(xnyxvbqclk) = dijetropyn zhykgbxrgy (cofczyjuiz )
-
23 Jan 2025
ASH2024
ManualManual
Not Applicable
-
knccvufxhr(bznjmdupwi): HR = 0.39 (95% CI, 0.24 - 0.64)
Positive
09 Dec 2024
Phase 2
11
ikutmdskwi(qmfclmnsjb) = zdrfcjvbbo zzyiakzcju (kyjsmrsehm )
Positive
09 Dec 2024
(Adult patients 18 years or older with R/R AML or high-risk MDS harboring an IDH1 mutation)
ikutmdskwi(qmfclmnsjb) = jtsxkfhlrw zzyiakzcju (kyjsmrsehm )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free