Wednesday, July 8, 2026

Drug profile · INN

ivosidenib

ivosidenib (TIBSOVO) is a isocitrate dehydrogenase [nadp] cytoplasmic inhibitor. Associated with Servier Laboratories (Aust.) Pty.. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L01) L01XM02
US status approved
Patents linked 9
Pipeline programs 12
News articles 0
Drug details — ivosidenib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
9
Programs
12
Data quality
0.89

Quick answer

ivosidenib (TIBSOVO) is a isocitrate dehydrogenase [nadp] cytoplasmic inhibitor. Associated with Servier Laboratories (Aust.) Pty.. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ivosidenib
Brand TIBSOVO
Mechanism Isocitrate dehydrogenase [NADP] cytoplasmic inhibitor
Target Isocitrate dehydrogenase [NADP] cytoplasmic
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01XM02

Mechanism of action

Isocitrate dehydrogenase [NADP] cytoplasmic inhibitor

Primary target: Isocitrate dehydrogenase [NADP] cytoplasmic

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. CL3-95031-007 Phase 3 · George Institute for · Locally advanced or metastatic conventional chondrosarcoma w
  2. IMFINZI for Advanced Biliary Cancer (ABC) Phase 3 · Ningbo Cancer Hospital · Advanced Biliary Cancer (ABC)
  3. IRST204.07 Phase 3 · Istituto Gentili Italia · Acute myeloid leukemia
  4. Tibsovo 250 mg film-coated tablets Phase 3 · George Institute for · ivosidenib maintenance after SOC adjuvant chemotherapy in cu
  5. AG-221-AML-005 Phase 2 · Celgene · Acute Myeloid Leukemia (AML)
  6. IIT2024067 Phase 2 · Chinese Academy of · AML
  7. Ivosidenib combined with venetoclax and azacitidine Phase 2 · First People's Hospital · Acute Myeloid Leukemia
  8. ivosidenib and nivolumab Phase 2 · Agios Netherlands · Advanced Solid Tumor

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 10980788

    Therapy for treating malignancies

    Expires Mon Apr 15 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10799490

    Pharmaceutical compositions of therapeutically active compounds

    Expires Mon Oct 08 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10717764

    Therapeutically active compounds and their methods of use

    Expires Mon Jul 16 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10653710

    Combination therapy for treating malignancies

    Expires Mon May 14 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 10610125

    Methods and compositions for cell-proliferation-related disorders

    Expires Mon Apr 02 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 10449184

    Pharmaceutical compositions of therapeutically active compounds

    Expires Mon Oct 17 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 9968595

    Pharmaceutical compositions of therapeutically active compounds

    Expires Mon May 10 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 9850277

    Therapeutically active compositions and their methods of use

    Expires Mon Dec 21 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 9474779

    Therapeutically active compositions and their methods of use

    Expires Mon Oct 20 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is ivosidenib?

ivosidenib (TIBSOVO) is a isocitrate dehydrogenase [nadp] cytoplasmic inhibitor. Associated with Servier Laboratories (Aust.) Pty.. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ivosidenib?

TIBSOVO is a marketed brand name for ivosidenib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ivosidenib?

ivosidenib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.