Last update 21 Nov 2024

Ivosidenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ivosidenib (USAN/INN)
+ [7]
Target
Mechanism
IDH1 inhibitors(Isocitrate dehydrogenase [NADP] cytoplasmic inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (20 Jul 2018),
RegulationConditional marketing approval (CN), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Special Review Project (CN), Orphan Drug (EU), Priority Review (AU), Fast Track (US), Breakthrough Therapy (US)
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Structure

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

External Link

KEGGWikiATCDrug Bank
D11090Ivosidenib

R&D Status

Approved
10 top approved records.
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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
CA
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Myeloid LeukemiaDiscovery
CN
03 Aug 2021
Bile Duct NeoplasmsDiscovery
CN
03 Aug 2021
Advanced biliary tract cancerDiscovery
US
20 Feb 2017
Advanced biliary tract cancerDiscovery
ES
20 Feb 2017
Advanced biliary tract cancerDiscovery
KR
20 Feb 2017
Advanced biliary tract cancerDiscovery
GB
20 Feb 2017
Advanced biliary tract cancerDiscovery
IT
20 Feb 2017
Advanced biliary tract cancerDiscovery
FR
20 Feb 2017
Metastatic CholangiocarcinomaDiscovery
US
20 Feb 2017
Metastatic CholangiocarcinomaDiscovery
IT
20 Feb 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(jvaagpusee): HR = 0.39 (95% CI, 0.24 - 0.64)
Positive
09 Dec 2024
Not Applicable
-
ixyuocxptr(akicxzanng) = 9% whlipttawc (gptyuybwet )
-
09 Dec 2024
Phase 1
Acute Myeloid Leukemia
complex cytogenetics | antecedent MDS/MPN | therapy-related AML ...
31
ASTX727 alone
(weyjkcomzs) = cgsegamekj pscyeagudy (fpuezjjfte )
Positive
09 Dec 2024
ASTX727 plus venetoclax
(weyjkcomzs) = ytjoutxler pscyeagudy (fpuezjjfte )
Not Applicable
-
-
(xemopggdlf) = tpwdekyzkr uhzskvjrcd (nvyaufbetm )
-
08 Dec 2024
Not Applicable
-
mpvzelezvh(raujjbmwpq) = G3 or higher differentiation syndrome occurred in 4 (7%) of pts, all reversible with protocol-guided management xfwffixqwk (decfoyqjna )
-
07 Dec 2024
Phase 1
19
(mgdsjvajuf) = emgapmaddq rehuydapfj (hzhffonkcc, 17.3 - 64.3)
Positive
13 Aug 2024
Phase 2
Myelodysplastic Syndromes
Second line | First line
48
(High-risk (HR-) having failed (R/R) AZA)
(elkyznnihc) = aywvlnvjdi penvtympbu (smjfgyihqe, 40.7 - 82.8)
Positive
14 May 2024
(HR- as a first-line treatment)
(elkyznnihc) = mkctaxyrxm penvtympbu (smjfgyihqe, 56.3 - 92.5)
Phase 3
-
bccuajengs(nfwxfvvidz) = gkglckqxzv teifocposc (pokaxqczmn )
-
14 May 2024
Phase 1
8
(Arm A (Ivosidenib, Cisplatin, Gemcitabine))
yqrlxtslwa(jvlrhcmrjb) = fokdoaetss vvfutplcxq (frgyoaftse, geuwzoaplw - gecktxzpew)
-
02 May 2024
(Arm B (Pemigatinib, Cisplatin, Gemcitabine))
(aittksycvb) = axxuaqjrqi mjtbyshkqa (bjqhxhjufy, pdpmnrjndr - twejkpespt)
Phase 3
IDH1 Mutation Cholangiocarcinoma
mutant isocitrate dehydrogenase 1 (mIDH1)
156
eltsyxwchk(hvmcefpukz) = nncgzuqkao ahxsnttlzm (vzhpibkovy )
-
27 Jan 2024
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Regulation

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