TIBSOVO (ivosidenib)
TIBSOVO is indicated for the treatment of Acute Myeloid Leukemia; Myelodysplastic Syndromes; Cholangiocarcinoma.
How TIBSOVO Works
Ivosidenib is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme. In cancer cells, mutant IDH1 produces the oncometabolite 2-hydroxyglutarate (2-HG), which blocks cellular differentiation. By inhibiting the mutant enzyme and lowering 2-HG levels, ivosidenib induces the differentiation of malignant blasts into mature, functional myeloid cells in patients with AML and MDS, and reduces tumor progression in IDH1-mutated cholangiocarcinoma.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-07-20
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- TABLET
TIBSOVO Approval History
What TIBSOVO Treats
3 indicationsTIBSOVO is approved for 3 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Cholangiocarcinoma
TIBSOVO Boxed Warning
DIFFERENTIATION SYNDROME IN AML AND MDS Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precauti...
WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS See full prescribing information for complete boxed warning. Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution ( 5.1 , 6.1 ).
TIBSOVO Target & Pathway
ProTarget
TIBSOVO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TIBSOVO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TIBSOVO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TIBSOVO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
28 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05401097 | OSU-21330 NCI-2022-01324, R01CA262496 | Ph 2 | recruiting | IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study) |
| NCT06465953 PyramIDH | S095031-178 2023-510155-37 | Ph 3 | recruiting | Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation |
| NCT06501625 | S095031-210 2024-514261-19-00 | Ph 1, Ph 2 | recruiting | Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation |
| NCT03155620 results posted | NCI-2017-01251 NCI-2017-01251, APEC1621SC | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) |
| NCT04195555 results posted | NCI-2019-08098 NCI-2019-08098, APEC1621K | Ph 2 | active not recruiting | Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial) |
| NCT06707493 | 24-641 | Ph 2 | recruiting | Ivosidenib as Post-HSCT Maintenance for AML |
| NCT07548710 | SAXUM_2026 | Ph 2 | recruiting | Study of SA+X in the Treatment of Newly Diagnosed AML |
| NCT05921760 results posted | CL1-95031-006 | Ph 1, Ph 2 | terminated | Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma |
| NCT05756777 | 22-174 | Ph 1 | recruiting | A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML) |
| NCT07260175 adIVO | adIVO 2024-520219-42-00, AIO-HEP-0125/ass. | Ph 2 | recruiting | Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma |
| NCT03471260 | 2017-0490 NCI-2018-00921, 2017-0490 | Ph 1, Ph 2 | recruiting | Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies |
| NCT07392242 | 25-224 | Ph 2 | recruiting | A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia |
| NCT05010772 | 2021-0237 NCI-2021-08496, 2021-0237 | Ph 1 | recruiting | Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission |
| NCT07282262 | NBLF001 | Ph 2 | recruiting | An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy. |
| NCT06081829 results posted | CL2-95031-008 | Ph 2 | active not recruiting | A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation |
| NCT04493164 | 2020-0096 NCI-2020-05258, 2020-0096 | Ph 2 | recruiting | CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome |
| NCT03498521 CUPISCO results posted | MX39795 2017-003040-20 | Ph 2 | completed | A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site |
| NCT04774393 | 2020-1220 NCI-2021-00893, 2020-1220 | Ph 1, Ph 2 | recruiting | Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia |
| NCT06291987 MPN | IRB23-1681 | Ph 1 | recruiting | Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation |
| NCT03564821 | 18-123 | Ph 1 | completed | IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation |
| NCT05209074 | CASE7221 | Ph 1 | active not recruiting | Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma |
| NCT05030441 | 202110038 | Ph 2 | active not recruiting | Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1 |
| NCT05615818 SAFIR-ABC10 | UC-GMP-2201 - PRODIGE 78 2022-000190-19, 2022-502403-30-00 | Ph 3 | recruiting | Personalized Medicine for Advanced Biliary Cancer Patients |
| NCT04250051 | NU 19H05 STU00210558, NU 19H05 | Ph 1 | active not recruiting | Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia |
| NCT04955938 | IRB21-0483 | Ph 1 | withdrawn | A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms |
| NCT04088188 results posted | ACCRU-ICRN-1701 NCI-2019-05811, ACCRU-ICRN-1701 | Ph 1 | terminated | Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma |
| NCT04176393 | CS3010-101 | Ph 1 | completed | A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation |
| NCT04655391 | 20456 NCI-2020-10595, 20456 | Ph 1 | withdrawn | Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TIBSOVO FDA Label Details
Indications & Usage
FDA Label (PDF)TIBSOVO is indicated for the treatment of Acute Myeloid Leukemia; Myelodysplastic Syndromes; Cholangiocarcinoma.
WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypo...
TIBSOVO Patents & Exclusivity
Patents (10 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TIBSOVO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 31 active patents
Trial Analysis
- • 28 total trials
- • Stage: Growth
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment