Ivosidenib clinical trials
Ivosidenib is named as an intervention in 26 current clinical trials in our France, Germany, Australia, Spain, Netherlands, China, Italy, Canada, South Korea, Japan, Belgium, Brazil, Austria, Sweden, UK, USA, Ireland, Switzerland, Portugal, Israel, Czechia, Taiwan, Norway, Poland, Mexico and Denmark registers. 15 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Institut de Recherches Internationales Servier (5). The most-studied condition is Acute Myeloid Leukemia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Ivosidenib is approved
All regulators →Of the three regulators tracked here, the first to approve Ivosidenib was the US, on 20 Jul 2018. It is approved in 3 of the 3 regulators tracked here.
- 4 EU orphan designations, most recently for treatment of myelodysplastic syndromes (18 Jul 2025, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Ivosidenib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Ivosidenib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 7 Jun 2039 (US 10980788).
- Latest patent on the drug substance itself: 19 Aug 2033 (US 9474779).
- Exclusivity ODE-447: Orphan drug exclusivity: treatment of adult patients with relapsed or refractory myelodysplastic syndromes (mds) with a susceptible isocitr…, until 24 Oct 2030.
- Exclusivity ODE-368: Orphan drug exclusivity: treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an iso…, until 25 Aug 2028.
- Tibsovo for treatment of acute myeloid leukaemia: until 8 May 2033. Union Register
- Tibsovo for treatment of biliary tract cancer: until 8 May 2033. Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Ivosidenib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Ivosidenib works
All drug targets →- Isocitrate dehydrogenase [NADP] cytoplasmic inhibitor InhibitorTarget: IDH1 isocitrate dehydrogenase (NADP(+)) 1✓ In ChEMBL and the Guide to Pharmacology
- Myelodysplastic syndromePhase 3
- AdenocarcinomaPhase 2
- Biliary tract cancerPhase 2
- CancerPhase 2
- Central nervous system cancerPhase 2
- Central nervous system neoplasmPhase 2
- ChondrosarcomaPhase 2
- Colorectal cancerPhase 2
- Intrahepatic cholangiocarcinomaPhase 2
- LymphomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3989958, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9217, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Ivosidenib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Ivosidenib. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Ivosidenib with azacitidine for untreated acute myeloid leukaemia with an IDH1 R132 mutation NICE TA979 | Recommended | 5 Jun 2024 | Current |
| Ivosidenib for treating advanced cholangiocarcinoma with an IDH1 R132 mutation after 1 or more systemic treatments NICE TA948 | Recommended | 31 Jan 2024 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Ivosidenib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: TibsovoEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Ivosidenib
26 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Ivosidenib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Ivosidenib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
FILO-AML-01-MIVONU
A single arm phase II study investigating the efficacy and safety of the addition of ivosidenib to oral azacitidine (Onureg®) in patients over 55 with Acute Myeloid Leukemia (AML) and IDH1 mutation, in complete remission after intensive chemotherapy. A study of the French AML Intergroup.
2025-521322-14-00 · CTIS ↗ · Hemic and Lymphatic Diseases
|
Phase 2 | Authorised | French Innovative Leukemia Organization | France |
Ivosidenib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Ivosidenib on the HPRA medicines list.
- Tibsovo 250 mg Film-coated tabletLes Laboratoires Servier · EU/1/23/1728/001
Supply shortages
No entry for Ivosidenib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Ivosidenib
40 conditionsAll 40 conditions
| Condition (as registered) | Trials |
|---|---|
| Acute Myeloid Leukemia | 5 |
| Untreated AML | 3 |
| Leukemia, Myeloid, Acute | 2 |
| Newly Diagnosed Acute Myeloid Leukemia (AML) | 2 |
| AML Arising From Myelodysplastic Syndrome (MDS) | 2 |
| Myelodysplastic Syndromes | 2 |
| Cholangiocarcinoma | 2 |
| AML | 2 |
| Myelodysplastic Syndrome With Excess Blasts-2 | 1 |
| AML Arising From Antecedent Hematologic Disorder (AHD) | 1 |
| Relapsed or Refractory Acute Myeloid Leukemia (AML) | 1 |
| Other IDH1-mutated Positive Hematologic Malignancies | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Ann Arbor Stage III Non-Hodgkin Lymphoma | 1 |
| Ann Arbor Stage IV Non-Hodgkin Lymphoma | 1 |
| Histiocytic Sarcoma | 1 |
| Recurrent Ependymoma | 1 |
| Recurrent Ewing Sarcoma | 1 |
| Recurrent Hepatoblastoma | 1 |
| Recurrent Langerhans Cell Histiocytosis | 1 |
| Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen | 1 |
| IDH1-Mutated Malignancies | 1 |
| AML, Adult | 1 |
| IDH1 Gene Mutation | 1 |
| Ivosidenib | 1 |
| AML (Acute Myeloid Leukemia) | 1 |
| MDS (Myelodysplastic Syndrome) | 1 |
| Biliary Tract Cancer | 1 |
| Refractory | 1 |
| Relapsed | 1 |
| Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation | 1 |
| MDS | 1 |
| Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) | 1 |
| Myelodysplastic Syndromes (MDS) | 1 |
| IDH Mutation | 1 |
| Acute Myeloid Leukemia (AML) | 1 |
| Biliary Tract Neoplasms | 1 |
| Acute Myeloid Leukemia With Gene Mutations | 1 |
| Cholangiocarcinoma Non-resectable | 1 |
| Cholangiocarcinoma Metastatic | 1 |
Sponsors
lead sponsor per trial+ 2 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Ivosidenib trials
How many clinical trials are testing Ivosidenib?
26 current trials in our France, Germany, Australia, Spain, Netherlands, China, Italy, Canada, South Korea, Japan, Belgium, Brazil, Austria, Sweden, UK, USA, Ireland, Switzerland, Portugal, Israel, Czechia, Taiwan, Norway, Poland, Mexico and Denmark registers name Ivosidenib (also registered as AG-120) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Ivosidenib trials recruiting patients?
Yes. 15 of the 26 trials are recruiting: 5 with sites in France, 4 with sites in Germany, 3 with sites in Australia, 4 with sites in Spain, 3 with sites in Netherlands, 7 with sites in China, 3 with sites in Italy, 1 with sites in Canada, 2 with sites in South Korea, 2 with sites in Japan, 2 with sites in Belgium, 3 with sites in Brazil, 1 with sites in Austria, 1 with sites in UK, 2 with sites in USA, 1 with sites in Portugal, 1 with sites in Czechia, 1 with sites in Taiwan and 1 with sites in Denmark. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ivosidenib clinical trials?
Institut de Recherches Internationales Servier (5), National Cancer Institute (NCI) (2), Servier Affaires Médicales (2) and Servier Bio-Innovation LLC (2), among 17 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Ivosidenib clinical trials in Ireland?
Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Ivosidenib licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Ivosidenib, for example Tibsovo 250 mg Film-coated tablet (Les Laboratoires Servier). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ivosidenib shortage?
Not in the lists we track: Ivosidenib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ivosidenib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Ivosidenib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ivosidenib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.