Drugs / Ivosidenib
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | TIBSOVO | — | 2019-05-02 – 2023-10-24 | fda.gov ↗ |
| Approved | EU (EMA) | Tibsovo | — | 2023-05-04 | europa.eu ↗ |
| Approved | US (FDA) | TIBSOVO | — | 2018-07-20 | fda.gov ↗ |
Trials 61 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 120 trials | ||||||
| Phase 1 | NCT07006688 | Jan 2026 → Jul 2028 expected | cancer | Servier Bio-Innovation LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT06291987 | Sep 2024 → May 2026 overdue | myeloproliferative neoplasm | University of Chicago | Recruiting | No outcome recorded |
| Phase 1 | NCT05756777 | Oct 2023 → Apr 2027 expected | acute myeloid leukemia | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05209074 | Sep 2022 → Jul 2026 overdue | pancreatic ductal adenocarcinoma | Case Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04655391 | Jun 2022 → Dec 2023 | acute myeloid leukemia | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT04955938 | Oct 2021 → Jun 2023 | myeloproliferative neoplasm | University of Chicago | Withdrawn | No outcome recorded |
| Phase 1 | NCT05010772 | Oct 2021 → Dec 2026 expected | acute myeloid leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04088188 | Jan 2021 → Dec 2023 | cholangiocarcinoma | Academic and Community Cancer Research United | Terminated | No outcome recorded |
| Phase 1 | NCT04250051 | Dec 2020 → Jan 2022 | acute myeloid leukemia, myelodysplastic syndrome | Northwestern University | Terminated | No outcome recorded |
| Phase 1 | NCT04176393 | Nov 2019 → Feb 2021 | acute myeloid leukemia | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03564821 | Jan 2019 → May 2022 | myeloid hemopathy | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03343197 | Mar 2018 → Aug 2019 | low grade glioma | Servier | Completed | No outcome recorded |
| Phase 1 | NCT03282513 | Sep 2017 → Mar 2018 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03071770 | Mar → May 2017 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02831972 | Jun → Sep 2016 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02632708 | Dec 2015 → Dec 2018 overdue | therapy related acute myeloid leukemia and myelodysplastic syndrome | Servier | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02579707 | Oct 2015 → Feb 2016 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02489513 | Jun → Sep 2015 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02074839 | Mar 2014 → Dec 2026 expected | acute myeloid leukemia, myelodysplastic syndrome | Servier | Recruiting | No outcome recorded |
| Phase 1 | NCT02073994 | Mar 2014 → Jan 2024 | cholangiocarcinoma, chondrosarcoma, glioma | Servier | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT06611839 | Oct 2025 → Oct 2026 expected | acute myeloid leukemia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06501625 | Dec 2024 → Jul 2026 overdue | IDH-mutant anaplastic astrocytoma | Servier | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05921760 | Oct 2023 → Nov 2024 | cancer | Servier Bio-Innovation LLC | Terminated | No outcome recorded |
| Phase 1/2 | NCT04774393 | May 2021 → Nov 2027 expected | acute myeloid leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03471260 | Mar 2018 → Sep 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03013998 | Nov 2016 → Dec 2028 expected | acute myeloid leukemia | Beat AML, LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02677922 | Jun 2016 → Aug 2018 overdue | acute myeloid leukemia | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 222 trials | ||||||
| Phase 2 | NCT07463768 | Sep 2026 → Sep 2030 expected | acute myeloid leukemia | French Innovative Leukemia Organisation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07607418 | May 2026 → May 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07548710 | May 2026 → May 2027 expected | acute myeloid leukemia | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07507760 | Apr 2026 → Apr 2029 expected | acute myeloid leukemia | PETHEMA Foundation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07392242 | Jan 2026 → Jan 2028 expected | acute myeloid leukemia | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06707493 | Jan 2026 → Jan 2028 expected | acute myeloid leukemia, disease related to hematopoietic stem cell transplant | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07260175 | Nov 2025 → Dec 2030 expected | cholangiocarcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT06717958 | Jun 2025 → Oct 2029 expected | acute myeloid leukemia, myelodysplastic syndrome | Technical University Dresden | Recruiting | No outcome recorded |
| Phase 2 | NCT07007949 | Jun 2025 → Apr 2026 overdue | acute myeloid leukemia | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 2 | NCT06593548 | Nov 2024 → Nov 2026 expected | metastatic malignant neoplasm | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07282262 | May 2024 → Oct 2026 expected | biliary tract cancer | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06081829 | Oct 2023 → Oct 2024 overdue | cholangiocarcinoma | Servier | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05401097 | Sep 2022 → Sep 2027 expected | acute myeloid leukemia | Alice Mims | Recruiting | No outcome recorded |
| Phase 2 | NCT05030441 | Apr 2022 → Jan 2030 expected | clonal hematopoiesis of indeterminate potential | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04056910 | Sep 2021 → Nov 2023 | glioma | Jason J. Luke, MD | Completed | No outcome recorded |
| Phase 2 | NCT04493164 | Dec 2020 → Jun 2028 expected | acute myeloid leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04195555 | Jul 2020 → Mar 2025 overdue | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, ependymoma +10 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04278781 | Mar 2020 → Mar 2027 expected | chondrosarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04044209 | Feb 2020 → Sep 2021 | acute myeloid leukemia, myelodysplastic syndrome | Yale University | Withdrawn | No outcome recorded |
| Phase 2 | NCT03503409 | May 2019 → Apr 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | Groupe Francophone des Myelodysplasies | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03498521 | Jul 2018 → Feb 2023 | cancer of unknown primary site | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT03155620 | Jul 2017 → Mar 2025 overdue | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, conventional osteosarcoma +13 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT06713837 | Feb 2025 → Jan 2028 expected | acute myeloid leukemia | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Recruiting | No outcome recorded |
| Phase 3 | NCT06465953 | Dec 2024 → Nov 2027 expected | myelodysplastic syndrome | Servier | Recruiting | No outcome recorded |
| Phase 3 | NCT05615818 | Jul 2024 → Jun 2027 expected | biliary tract neoplasm | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT06127407 | Jul 2024 → Feb 2028 expected | chondrosarcoma | Servier Bio-Innovation LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT05907057 | Jun 2023 → Oct 2027 expected | acute myeloid leukemia | Servier | Recruiting | No outcome recorded |
| Phase 3 | NCT05876754 | May 2023 → Dec 2027 expected | cholangiocarcinoma | Servier | Recruiting | No outcome recorded |
| Phase 3 | NCT03839771 | Mar 2019 → Apr 2027 expected | acute myeloid leukemia, myelodysplastic syndrome with excess blasts-2 | HOVON Foundation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03173248 | Jun 2017 → Mar 2021 overdue | acute myeloid leukemia | Servier | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02989857 | Feb 2017 → Jan 2019 | cholangiocarcinoma | Servier | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07131059 | May 2024 → May 2026 overdue | acute myeloid leukemia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| — | NCT06265545 | Feb 2024 → Jan 2026 overdue | acute myeloid leukemia, refractory hematologic cancer | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03245424 | — | childhood acute myeloid leukemia | Agios Pharmaceuticals, Inc. | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02665065 Comparator | Jun 2016 → Jun 2022 overdue | acute myeloid leukemia | Actinium Pharmaceuticals | Active not recruiting | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ivosidenib | “Ivosidenib (AG-120) is a targeted mutant IDH1 inhibitor under evaluation in a phase 1 dose escalation and expansion study of IDH1-mutant advanced solid tumors including...” PMID 31028664 ↗ Apr 201950“Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation” NCT03173248 ↗ “The IDH1 inhibitor ivosidenib (AG-120) that will be administered orally on a continuous basis at the dose of 500 mg/day starting at day 1 of each cycle.” NCT04044209 ↗ “Ivosidenib alone or in combination with low dose hypomethylating agent or low dose cytarabine” NCT06713837 ↗ “Ivosidenib (AG-120) is an oral, targeted, small-molecule inhibitor of mutant IDH1.” PMID 29860938 ↗ Jun 2018 “Ivosidenib (for subjects with IDH1 mutation)” NCT02665065 ↗ |
| Known as | AG-120 | “An FDA-approved mutant IDH1 inhibitor, ivosidenib (AG-120), is actually a potent wtDH1 inhibitor under a nutrient-deprived microenvironment, reflective of the pancreatic cancer...” PMID 37034685 ↗ Mar 202319“Expanded Access Program for Ivosidenib (AG-120) Monotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation” NCT03245424 ↗ “Ivosidenib (AG-120) is an oral, targeted, small-molecule inhibitor of mutant IDH1.” PMID 29860938 ↗ Jun 2018 “a single oral dose of ivosidenib (AG-120) in Japanese and Caucasian subjects” NCT03071770 ↗ “The drug involved in this study is ivosidenib (AG-120)” NCT03564821 ↗ “Single 500 mg dose of AG-120 (Ivosidenib).” NCT03282513 ↗ |
| Known as | AK112 | “Ivosidenib (AK112)” NCT06593548 ↗ |
| Known as | Ivo | “• Ivosidenib (Ivo): The dosage is 500 mg, administered orally once daily (QD).” NCT07007949 ↗ |
| Action | Inhibit | “selective inhibitor of mutant IDH1” PMID 32208957 ↗ Mar 2020 |
| Modality | Small molecule | “Ivosidenib (AG-120) is an oral, targeted, small-molecule inhibitor of mutant IDH1.” PMID 29860938 ↗ Jun 2018 |
| Route | Oral | “AG-120 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle.” NCT02073994 ↗ |
| Target | IDH1 | “Ivosidenib (AG-120) is a selective inhibitor of mutant IDH1 approved in the United States for specific cases of acute myeloid leukemia.” PMID 32208957 ↗ Mar 2020 |