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ivosidenib

Phase 3FDA approved

Undisclosed | Small molecule | Other |Agios Pharmaceuticals, Inc.|Trials Updated: Jan 11, 2018

ivosidenib development status

FDA approval on record Approved
Highest phase Phase 3 run by Institut de Recherches Internationales Servier (NCT06465953)
Phase scored for AGIOPhase 1
Registered trials 14 across 12 sponsors since May 2017

ivosidenib target and mechanism

Molecular targetIDH1
Target classInhibitor
ModalitySmall molecule

Also known as ivosidenib (AG-120)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

ivosidenib clinical trials

ivosidenib · 1 trial · 1 indication

Phase 1 1
NCT03071770Japanese Bridging Study of Ivosidenib (AG-120) in Healthy SubjectsHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects
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Study Endpoints

Primary Endpoints

AUC
Pharmacokinetic sampling for ivosidenib (AG-120) will be taken for 504 hours (21 days) after single dose

AG-120 Area Under the Curve

Cmax
Pharmacokinetic sampling for ivosidenib (AG-120) will be taken for 504 hours (21 days) after single dose

AG-120 Maximum Plasma Concentration

Secondary Endpoints

Incidence of Adverse Events
28 days after single-dose ivosidenib (AG-120)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ivosidenib (AG-120)EXPERIMENTAL -

Interventions

NameTypeDescription
ivosidenib (AG-120)DRUGA single-dose of ivosidenib (AG-120) administered in healthy Japanese and Caucasian subjects
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years. * Applicable to Caucasian Subjects Only: Non-Japanese subjects must be Caucas...

Countries:United States
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Frequently asked questions about ivosidenib

What is ivosidenib?

Ivosidenib is a small molecule drug candidate developed by Agios Pharmaceuticals, Inc. (ticker AGIO). It is an inhibitor of the IDH1 molecular target. The program is in Phase 1 clinical development, and the specific patient indications being studied have not been disclosed. It is also known as ivosidenib (AG-120).

What does ivosidenib target?

Ivosidenib targets IDH1, an isocitrate dehydrogenase enzyme. It is classified as an inhibitor of this molecular target. By inhibiting IDH1, the drug is designed to interfere with the enzyme's activity. The IDH1 target is the basis for its development as a small molecule therapeutic candidate.

Who makes ivosidenib?

Ivosidenib is developed by Agios Pharmaceuticals, Inc., which trades under the ticker symbol AGIO. Agios is the company responsible for the clinical program for ivosidenib, also referred to as AG-120. The drug is a small molecule IDH1 inhibitor in Phase 1 development.

What phase is ivosidenib in?

Ivosidenib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes a completed bridging study in healthy subjects. The drug remains under clinical evaluation as a small molecule IDH1 inhibitor.

What clinical trials is ivosidenib in?

Ivosidenib has been studied in a Phase 1 trial, NCT03071770, titled Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects. This trial was completed and enrolled 60 healthy male volunteers aged 18 years and older in the United States. It was an uncontrolled study.

Is ivosidenib the same as AG-120?

Yes, ivosidenib is also known as AG-120. The alternative name AG-120 refers to the same small molecule IDH1 inhibitor developed by Agios Pharmaceuticals, Inc. (AGIO). Both names are used interchangeably in reference to this Phase 1 investigational drug candidate.