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ivosidenib

Trade name: tibsovo

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Jul 20, 2018

Ivosidenib (AG-120) is an inhibitor of isocitrate dehydrogenase 1 (IDH1) This experimental drug inhibits mutant IDH1, leading to increased differentiation and decreased proliferation in IDH1 positive tumors and thus is thought to be promising for the treatment of IDH1-mutated tumors. In vivo treatment with AG-120 of TF-1 cells, primary human AML patient samples expressing mutant IDH1 and primary human blast cells cultured ex vivo showed that AG-120 is effective at lowering 2-HG levels and restoring cellular differentiation. It showed promising results in a phase I trial in patients with relapsed or refractory acute myeloid leukemia and is being evaluated in Phase III in previously-treated subjects with nonresectable or metastatic cholangiocarcinoma with an IDH1 mutation. — NCATS

Clinical trial activity

53 trials · 46 clinical orgs · 2 marketing orgs

Phase 1
27
Phase 2
29
Phase 3
8
Phase 4
0

Earliest trial started Mar 1, 2014 (NCT02074839)

Timeline

2010s

  1. Jan 1, 2014

    Agios Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)

  2. Jun 9, 2015

    Orphan Drug Designation

  3. Jan 1, 2016

    Agios Pharmaceuticals, Inc. — Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

  5. Jul 20, 2018

    Agios Pharmaceuticals, Inc. — Earliest FDA Approval

  6. Jul 20, 2018

    Agios Pharmaceuticals, Inc. — NDA Secondary Org

  7. Jul 20, 2018

    Servier — Marketing Organization

  8. Jul 20, 2018

    Agios Pharmaceuticals, Inc. — NDA Organization

  9. Jul 20, 2018

    Servier — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackJul 20, 2018

Chemistry & pharmacology

Loading structure…

SMILES

FC1=CN=CC(=C1)N([C@H](C(=O)NC2CC(F)(F)C2)C3=CC=CC=C3Cl)C(=O)[C@@H]4CCC(=O)N4C5=NC=CC(=C5)C#N
Mol. weight
582.961 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningFirst in class

Sources

Also known as

  • ag120
  • ag120
  • ag-120
  • ag-120
  • ivosidenib
  • ivosidenib
  • ivosidenib

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07260175Phase 2Nov 18, 2025IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest, Institut für Klinische Krebsforschung IKF GmbH, Servier
NCT07006688Phase 1Sep 30, 2025Servier
NCT07007949Phase 2Jun 1, 2025Soochow University
NCT06707493Phase 2May 1, 2025Harvard University, Servier
NCT06925919Phase 1Apr 2, 2025IDBiologics, Inc.
NCT06717958Phase 2Feb 1, 2025Technical University of Dresden
NCT06465953Phase 3Dec 30, 2024Servier
NCT06501625Phase 1/Phase 2 (Phase 2)Dec 16, 2024Servier
NCT06593548Phase 2Nov 1, 2024Fudan University
NCT06611839Phase 1/Phase 2 (Phase 2)Oct 30, 2024China Academy of Chinese Medical Sciences
NCT06291987Phase 1Sep 19, 2024University of Chicago
NCT05615818Phase 3Jul 18, 2024Accord Research, Belgian Group of Digestive Oncology, Cancer Research UK, Center Eugene Marquis, Institut Mutualiste Montsouris, National Cancer Institute, France, Otsuka, Pierre Fabre, Servier, UNICANCER, Université catholique de Louvain, University of London, Zymeworks Inc.
NCT07131059N/AMay 11, 2024China Academy of Chinese Medical Sciences, People's Liberation Army of China
NCT07282262Phase 2May 1, 2024Chinese Academy of Medical Sciences
NCT06127407Phase 3Apr 1, 2024Servier
NCT06265545N/AFeb 22, 2024China Academy of Chinese Medical Sciences
NCT05921760Phase 1/Phase 2 (Phase 2)Oct 23, 2023Servier
NCT06081829Phase 2Oct 10, 2023Servier
NCT05756777Phase 1Jun 26, 2023Astellas, Memorial Sloan-Kettering Cancer Center
NCT05907057Phase 3Jun 14, 2023Servier
Showing 20 of 53 trials
Page 1 / 3

Organizations

Research & Development (46)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Agios Pharmaceuticals, Inc.For profit181242014
ServierFor profit11832023
National Cancer Institute (NCI)Government5122019
University of Texas at HoustonAcademic/Hospital4422018
China Academy of Chinese Medical SciencesAcademic/Hospital3322024
CelgeneFor profit2122015
Harvard UniversityAcademic/Hospital2222018
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital2222020
University of ChicagoAcademic/Hospital2212021
AbbVieFor profit1012018
Academic and Community Cancer Research UnitedAcademic/Hospital1112019
Accord ResearchFor profit1012024
AstellasFor profit1012023
Belgian Group of Digestive OncologyAcademic/Hospital1012024
Bristol-Myers SquibbFor profit1012019
Cancer Research UKAcademic/Hospital1012024
Case Western Reserve UniversityAcademic/Hospital1112022
Center Eugene MarquisAcademic/Hospital1012024
Chinese Academy of Medical SciencesAcademic/Hospital1112024
City of Hope National Medical CenterAcademic/Hospital1112020
46 organizations
Page 1 / 3

Marketing (4)

OrganizationOrg typeRelationshipDate
Agios Pharmaceuticals, Inc.For profitNDA2Jul 20, 2018
Agios Pharmaceuticals, Inc.For profitNDAJul 20, 2018
ServierFor profitMKTGJul 20, 2018
ServierFor profitNDA2Jul 20, 2018