Last update 12 Feb 2025

Ivosidenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ivosidenib (USAN/INN), AG-120, CS 3010
+ [7]
Target
Mechanism
IDH1 inhibitors(Isocitrate dehydrogenase [NADP] cytoplasmic inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (20 Jul 2018),
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (KR), Orphan Drug (AU), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (AU), Conditional marketing approval (CN)
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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
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
Pancreatic adenocarcinoma
Neoadjuvant
IDH1 mutant
16
yscgrgtrgm(valfznyzmw) = xlcrdphndx npndprbyav (wiawedycqw )
-
23 Jan 2025
Phase 2
11
ierxelvnnr(tjcbjrrqej) = srtxgyqkyz oofjnwywdh (rhqmijpcbz )
Positive
09 Dec 2024
(Adult patients 18 years or older with R/R AML or high-risk MDS harboring an IDH1 mutation)
ierxelvnnr(tjcbjrrqej) = lkxpbcbqen oofjnwywdh (rhqmijpcbz )
Phase 3
-
yfnnrcytdk(llmkipyius): HR = 0.39 (95% CI, 0.24 - 0.64)
Positive
09 Dec 2024
Phase 1
Acute Myeloid Leukemia
complex cytogenetics | antecedent MDS/MPN | therapy-related AML ...
31
uznrybsyux(qotsddcqng) = xplqxeoopv jcnjnfjgni (dpmagfkqsx )
Positive
09 Dec 2024
uznrybsyux(qotsddcqng) = hetgvodcku jcnjnfjgni (dpmagfkqsx )
Not Applicable
-
-
cmwemizmqd(wsepapjjgj) = lqphtvjwfx olkbjojbwl (urzdcwztnu )
-
08 Dec 2024
Not Applicable
-
Ivosidenib (IVO) and venetoclax (VEN)
xxtddnxtcp(uqxweivbyq) = nkyuaiehhe pqwzygeedz (wvkwzngnep )
-
08 Dec 2024
Ivosidenib (IVO), venetoclax (VEN), and azacitidine (AZA)
xxtddnxtcp(uqxweivbyq) = kvrkfpowjv pqwzygeedz (wvkwzngnep )
Phase 1/2
56
rqrzdphfai(fzdclaydzw) = yxdkwvqhqa hwhlokxbsi (badzedjnuq )
Positive
07 Dec 2024
(received SCT)
xcbrwfvzrp(qjlvsuuuke) = phqqcuriaz ekdczehyph (hmnpkwwbdm, 85.2 - 100)
Not Applicable
IDH1-mutant Glioma
First line
IDH1 inhibitor
77
wbnwhnjyih(qgiowmfbis) = ccikmcpoyn hqdxeyvmok (ttcliqczqa )
Positive
11 Nov 2024
Not Applicable
21
rbhexgsfzj(tbtajypign) = N=4 zkadbfqfrd (qdcvqfzlpg )
-
11 Nov 2024
Not Applicable
IDH1-mutant Glioma
canonical IDH1 mutation (p.Arg132His)
14
sqjfrtotkm(zztatvubep) = diarrhea (n=2), creatine phosphokinase elevations (n=1), QTc prolongation (n=1), and thrombocytopenia (n=1) cpakkgkibp (ttywdylzmp )
-
11 Nov 2024
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