Drugs / Ivosidenib
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute megakaryoblastic leukemia in adult 1 milestone | |||||
| Filed | US (FDA) | TIBSOVO | acute megakaryoblastic leukemia in adult | 2019-02-20 | “FDA has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO ® (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukemia” agios.com ↗ “Submitted a new drug application (NDA) to the U.S. Food and Drug Administration ( FDA ) for ivosidenib for the treatment of patients with R/R AML with an IDH1 mutation.” agios.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2017-12-26 | “Submitted a new drug application (NDA) to the FDA for ivosidenib for the treatment of patients with R/R AML with an IDH1 mutation.” agios.com ↗ “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for ivosidenib (AG-120)” agios.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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 2029 expected | 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| Phase 1 | NCT04655391 | Jun 2022 → Dec 2023 | acute myeloid leukemia | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT04955938 | Oct 2021 → Jun 2023 | myeloproliferative neoplasm | University of Chicago | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 1 | NCT04250051 | Dec 2020 → Jan 2022 | acute myeloid leukemia, myelodysplastic syndrome | Northwestern University | Terminated | No outcome recorded Stop: Enrollment |
| 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 1/26 trials · 1 met primary | ||||||
| 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 | NCT02677922 | Jun 2016 → Aug 2018 overdue | acute myeloid leukemia | Celgene Corporation | Active not recruiting | Met primary |
| Phase 222 trials · 1 met primary | ||||||
| Phase 2 | NCT07463768 | Sep 2026 → Sep 2030 expected | acute myeloid leukemia | French Innovative Leukemia Organisation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07507760 | Jun 2026 → Apr 2029 expected | acute myeloid leukemia | PETHEMA Foundation | 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 | 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 Stop: Enrollment |
| 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 | Met primary |
| 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 2/31 trial | ||||||
| Phase 2/3 | NCT03013998 | Nov 2016 → Dec 2032 expected | acute myeloid leukemia | Beat AML, LLC | Recruiting | No outcome recorded |
| Phase 39 trials · 2 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT02989857 | Feb 2017 → Jan 2019 | cholangiocarcinoma | Servier | Completed | Met primary |
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02665065 Comparator | Jun 2016 → Jun 2022 overdue | acute myeloid leukemia | Actinium Pharmaceuticals | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 39
| Date | Issuer | Release |
|---|---|---|
| 2021-03-01 | Agios Pharmaceuticals, Inc. | Regulatory Agios Submits Supplemental New Drug Application to FDA for TIBSOVO® (ivosidenib tablets) for Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma agios.com ↗
Agios has requested priority review for the application, which, if granted, could result in a six-month review process. |
| 2021-01-17 | Agios Pharmaceuticals, Inc. | Results Agios Presents Final Data from Phase 3 ClarIDHy Study of TIBSOVO® (ivosidenib tablets) in Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma agios.com ↗
The final analysis showed an improvement in the secondary endpoint of OS favoring patients randomized to TIBSOVO ® compared to those randomized to placebo; however, statistical significance was not reached. |
| 2020-11-05 | Agios Pharmaceuticals, Inc. | Results Agios Reports Business Highlights and Third Quarter 2020 Financial Results agios.com ↗ |
| 2020-11-04 | Agios Pharmaceuticals, Inc. | Results Agios to Present Broad Set of Clinical and Translational Data for Oncology and Rare Genetic Disease Programs at the Virtual 2020 ASH Annual Meeting agios.com ↗
Ivosidenib Improves Overall Survival Relative to Standard Therapies in Relapsed or Refractory Mutant IDH1 AML: Results from Matched Comparisons to Historical Controls |
| 2020-10-16 | Agios Pharmaceuticals, Inc. | Regulatory Agios Announces Withdrawal of European Marketing Authorization Application for TIBSOVO® as a Treatment for Relapsed or Refractory IDH1-mutant Acute Myeloid Leukemia agios.com ↗
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced the withdrawal of its European Marketing Authorization Application (MAA) for TIBSOVO ® (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. |
| 2020-09-21 | Agios Pharmaceuticals, Inc. | Results Agios Announces Final Overall Survival Data from Phase 3 ClarIDHy Study of TIBSOVO® (ivosidenib tablets) in Previously Treated IDH1-Mutant Cholangiocarcinoma Patients agios.com ↗
A consistent trend in improved OS was observed in patients treated with TIBSOVO ® compared to those randomized to placebo, but was not statistically significant. |
| 2020-05-19 | Agios Pharmaceuticals, Inc. | Results Agios Announces Publication of TIBSOVO® Phase 3 Data in The Lancet Oncology Demonstrating Significant Improvement in Progression-Free Survival Compared to Placebo in Previously Treated IDH1-Mutant Cholangiocarcinoma Patients agios.com ↗
The study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) in patients randomized to TIBSOVO ® compared with placebo patients. |
| 2020-05-14 | Agios Pharmaceuticals, Inc. | Results Agios to Present Updated Clinical Proof-of-Concept Data from the Phase 2 Study of Mitapivat in Thalassemia in Oral Presentation at the European Hematology Association Annual Congress agios.com ↗
Ivosidenib improves overall survival relative to standard therapies in relapsed or refractory mutant IDH1 AML: Results from matched comparisons to historical controls |
| 2019-12-16 | Agios Pharmaceuticals, Inc. | Regulatory Agios Receives FDA Breakthrough Therapy Designation for TIBSOVO® (ivosidenib) for the Treatment of Adult Patients with Relapsed or Refractory Myelodysplastic Syndrome with an IDH1 Mutation agios.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has granted Breakthrough Therapy designation for TIBSOVO ® (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible IDH1 mutation as detected by an FDA -approved test. |
| 2019-12-09 | Agios Pharmaceuticals, Inc. | Results Agios Presents Translational Data to Further Characterize the Role of TIBSOVO® (ivosidenib) Treatment in IDH1 Mutant Acute Myeloid Leukemia (AML) agios.com ↗
Combination Therapy with TIBSOVO ® and Azacitidine Results in Deep and Durable Molecular Remission in Newly Diagnosed IDH1 Mutant AML |
| 2019-11-22 | Agios Pharmaceuticals, Inc. | Results Agios Presents New Pharmacodynamic and Response Data from Both Cohorts of the Perioperative Study of Vorasidenib and TIBSOVO® (ivosidenib) in Patients with IDH1 Mutant Positive Low-Grade Glioma agios.com ↗
Preliminary Efficacy Data Show 31% Overall Response Rate for Both Vorasidenib and TIBSOVO ® with Postoperative Treatment |
| 2019-11-06 | Agios Pharmaceuticals, Inc. | Results Agios to Present Broad Set of Clinical and Translational Data for Oncology and Rare Genetic Disease Programs at the 2019 ASH Annual Meeting agios.com ↗
Important Translational Data for TIBSOVO ® Underscore the High Clinical and Molecular Remissions Rate Observed in Combination with Azacitidine in IDH1 Mutant AML and Expand Understanding of Resistance Mechanisms |
| 2019-09-30 | Agios Pharmaceuticals, Inc. | Results Data from Agios’ Phase 3 ClarIDHy Trial of TIBSOVO® Demonstrates Significant Improvement in Progression Free Survival (PFS) Compared to Placebo in Previously Treated IDH1 Mutant Cholangiocarcinoma Patients agios.com ↗ |
| 2019-06-03 | Agios Pharmaceuticals, Inc. | Results Agios Presents Updated Data from Phase 1 Studies of TIBSOVO® (ivosidenib) in Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy agios.com ↗
70% (16/23) of patients had a CR or CRh. |
| 2019-05-15 | Agios Pharmaceuticals, Inc. | Results Agios Announces the Randomized Phase 3 ClarIDHy Trial of TIBSOVO® (ivosidenib) Achieved its Primary Endpoint in Previously Treated IDH1 Mutant Cholangiocarcinoma Patients agios.com ↗
Treatment with TIBSOVO ® demonstrated a statistically significant improvement in progression-free survival (PFS) by independent radiology review compared with patients who received placebo. |
| 2019-05-02 | Agios Pharmaceuticals, Inc. | Regulatory Agios Announces FDA Approval of Supplemental New Drug Application (sNDA) for TIBSOVO® as Monotherapy for Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy agios.com ↗ |
| 2019-03-26 | Agios Pharmaceuticals, Inc. | Regulatory Agios Receives FDA Breakthrough Therapy Designation for TIBSOVO® (ivosidenib) in Combination with Azacitidine for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) with an IDH1 Mutation in Adult Patients Ineligible for Intensive Chemotherapy agios.com ↗
the U.S. Food and Drug Administration ( FDA ) has granted Breakthrough Therapy designation for TIBSOVO ® (ivosidenib) in combination with azacitidine |
| 2019-02-25 | Agios Pharmaceuticals, Inc. | Results Agios Reports Updated Data from Phase 1 Study of Ivosidenib in Combination with Azacitidine Demonstrating Deep and Durable Responses in Newly Diagnosed IDH1 Mutant Acute Myeloid Leukemia (AML) Patients agios.com ↗
Overall, 78% (18/23) of patients had a response. |
| 2019-02-20 | Agios Pharmaceuticals, Inc. | Regulatory Agios Announces FDA Acceptance of Supplemental New Drug Application for TIBSOVO® (ivosidenib) for the Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation Not Eligible for Standard Therapy agios.com ↗
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the U.S. Food and Drug Administration ( FDA ) has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO ® (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation who are not eligible for standard therapy. |
| 2018-12-03 | Agios Pharmaceuticals, Inc. | Results Agios Presents Updated Data from the Ivosidenib Phase 1 Dose-Escalation and Expansion Trial in IDH1 Mutant Positive Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible for Standard Treatment and Myelodysplastic Syndrome (MDS) agios.com ↗
Single Agent Ivosidenib Demonstrated CR+CRh Rate of 42.4% and Overall Response Rate (ORR) of 57.6% in Newly Diagnosed AML Patients Ineligible for Standard Treatment |
| 2018-12-03 | Agios Pharmaceuticals, Inc. | Results Agios Announces Updated Data from Phase 1 Study of Ivosidenib or Enasidenib in Combination with Standard Induction and Consolidation Chemotherapy in Newly Diagnosed AML Patients With an IDH Mutation agios.com ↗ |
| 2018-11-01 | Agios Pharmaceuticals, Inc. | Results Agios to Present Updated Clinical Data at the 2018 ASH Annual Meeting agios.com ↗
Ivosidenib (AG-120) Induced Durable Remissions and Transfusion Independence in Patients with IDH1-Mutant Untreated AML: Results from a Phase 1 Dose Escalation and Expansion Study |
| 2018-07-20 | Agios Pharmaceuticals, Inc. | Regulatory FDA Grants Approval of TIBSOVO®, the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation agios.com ↗ |
| 2018-06-04 | Agios Pharmaceuticals, Inc. | Results New Data from Phase 1 Study of Ivosidenib or Enasidenib in Combination with Azacitidine Demonstrate Robust Responses and a Well Tolerated Safety Profile in Newly Diagnosed IDHm AML Patients agios.com ↗
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today presented encouraging new data from a Phase 1 study evaluating ivosidenib (AG-120) or enasidenib (IDHIFA®; AG-221) in combination with azacitidine in newly diagnosed isocitrate dehydrogenase (IDH) mutant acute myeloid leukemia (AML) patients. |
| 2018-06-02 | Agios Pharmaceuticals, Inc. | Results Updated Data from Ivosidenib Phase 1 Dose-Escalation and Expansion Trial in IDH1m Relapsed or Refractory AML Continue to Show Durable Responses as a Single Agent agios.com ↗
The data were presented in an oral session at the 2018 American Society of Clinical Oncology ( ASCO ) Annual Meeting. |
| 2018-02-15 | Agios Pharmaceuticals, Inc. | Regulatory FDA Accepts New Drug Application and Grants Priority Review for Ivosidenib in Relapsed or Refractory AML with an IDH1 Mutation agios.com ↗ |
| 2017-12-26 | Agios Pharmaceuticals, Inc. | Regulatory Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation agios.com ↗
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for ivosidenib (AG-120), an investigational oral treatment for patients with relapsed or refractory acute myeloid leukemia (R/R AML) and an isocitrate dehydrogenase-1 (IDH1) mutation. |
| 2017-12-11 | Agios Pharmaceuticals, Inc. | Results New Data from Ivosidenib Phase 1 Dose-Escalation and Expansion Trial Demonstrate Durable Responses in Patients with IDH1m Relapsed or Refractory AML agios.com ↗
New ivosidenib data from the expansion phase of the Phase 1 study is compelling and demonstrates impressive single-agent efficacy with durable responses in these high-risk relapsed or refractory AML patients |
| 2017-12-11 | Agios Pharmaceuticals, Inc. | Results Data from Phase 1 Studies of Ivosidenib or Enasidenib in Combination with Full Doses of Standard of Care Chemotherapy Demonstrate Tolerability and Preliminary Clinical Activity in Newly Diagnosed AML Patients With an IDH Mutation agios.com ↗
The Phase 1 frontline combination trials showed that ivosidenib and enasidenib are well tolerated when combined with standard induction chemotherapy or azacitadine and both trials demonstrated early encouraging signs of efficacy. |
| 2017-11-17 | Agios Pharmaceuticals, Inc. | Results Agios Presents Updated Phase 1 Data from Dose Expansion Cohort of Ivosidenib (AG-120) in Patients with IDH1 Mutant Positive Glioma agios.com ↗
The median treatment duration of 16 months and reduction in tumor growth rates compared to a pre-treatment interval is a signal of ivosidenib’s clinical activity in this population. |
| 2017-06-03 | Agios Pharmaceuticals, Inc. | Results Agios Presents Phase 1 Data from Dose-Escalation and Expansion Cohorts of AG-120 (Ivosidenib) in Patients with Previously Treated IDH1 Mutant Positive Cholangiocarcinoma agios.com ↗
These data support further development of AG-120 in our ongoing Phase 3 registration-enabling ClarIDHy study, where we aim to confirm the early efficacy signal and evaluate the potential to impact tumor biology. |
| 2016-12-05 | Agios Pharmaceuticals, Inc. | Results Agios Announces New Clinical Data from Dose-Escalation Portion of Phase 1 Trial of Single Agent AG-120 Showing Durable Molecular Responses in Patients with Advanced Hematologic Malignancies agios.com ↗
Agios Pharmaceuticals, Inc. (Nasdaq:AGIO) presented new clinical data from the ongoing Phase 1 study evaluating single agent AG-120 in advanced hematologic malignancies at the 2016 American Society of Hematology Annual Meeting and Exposition (ASH). |
| 2016-11-18 | Agios Pharmaceuticals, Inc. | Results Agios Announces Phase 1 Data from Dose Expansion Cohorts of AG-120 in Patients with IDH1 Mutant Positive Glioma and Chondrosarcoma agios.com ↗
These Phase 1 dose expansion data are encouraging, as they continue to demonstrate a well-tolerated safety profile for AG-120 at a fixed daily dose of 500 mg. |
| 2015-12-05 | Agios Pharmaceuticals, Inc. | Results Agios Announces Data from Ongoing Phase 1 Trial of AG-120 Showing Durable Responses in Patients with Advanced Hematologic Malignancies agios.com ↗
Data as of October 1, 2015 from 87 patients with advanced IDH1 mutant positive hematologic malignancies confirmed a favorable safety profile consistent with previously reported data and showed durable clinical activity in 78 dose-escalation patients. |
| 2015-11-08 | Agios Pharmaceuticals, Inc. | Results Agios Announces Data from Dose-Escalation Phase 1 Study of AG-120 in Patients with IDH1 Mutant Positive Advanced Solid Tumors agios.com ↗
Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a leader in the fields of cancer metabolism and rare genetic metabolic disorders, today announced the first data from the dose-escalation portion of the ongoing Phase 1 study evaluating single agent AG-120, a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-1 (IDH1), in advanced solid tumors. |
| 2015-06-12 | Agios Pharmaceuticals, Inc. | Results Agios Announces New Data from Ongoing Phase 1 Trial of AG-120 Showing Durable Clinical Activity in Patients with Advanced Hematologic Malignancies agios.com ↗
The study had an overall response rate of 31 percent (16 of 52 response-evaluable patients) and a complete remission rate of 15 percent (8 of 52 response-evaluable patients). |
| 2015-06-10 | Agios Pharmaceuticals, Inc. | Regulatory Agios Pharmaceuticals Announces FDA Orphan Drug Designation Granted to AG-120 for Treatment of IDH1-Mutant Positive Acute Myelogenous Leukemia agios.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has granted the company orphan drug designation for AG-120 for treatment of patients with acute myelogenous leukemia (AML). |
| 2015-05-18 | Agios Pharmaceuticals, Inc. | Regulatory Agios Announces FDA Fast Track Designation Granted to AG-120 for Treatment of Patients with Acute Myelogenous Leukemia with an IDH1 Mutation agios.com ↗
Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced that the U.S. Food and Drug Administration ( FDA ) has granted Fast Track designation to AG-120 for the treatment of patients with acute myelogenous leukemia (AML) who harbor an isocitrate dehydrogenase-1 (IDH1) mutation. |
| 2014-11-18 | Agios Pharmaceuticals, Inc. | Results Agios Pharmaceuticals Announces Early Phase 1 Data Showing Clinical Activity of AG-120 as a Single Agent in Advanced Acute Myeloid Leukemia (AML) agios.com ↗
Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced the first reported safety and clinical activity for AG-120 from the ongoing Phase 1 dose escalation study in patients with IDH1-mutant positive advanced hematologic malignancies, including acute myeloid leukemia (AML). |
All press releases naming this drug 48 releases
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 |