Tibsovo

(Ivosidenib)

ApprovedSmall molecule

Tibsovo is a small molecule that works as a Isocitrate Dehydrogenase [NADP] Cytoplasmic Inhibitor.[2] It is being used across 15 indications, with its most advanced program in Approved.[1]

Tibsovo is one of 401 small molecule programs targeting Paraganglioma. It is currently in Approved.

Indications

Total Trials

Active Trials

400

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

ParagangliomaApproved

Tic DisorderActive, not recruiting

ChondrosarcomaActive, not recruiting

Pancreatic AdenocarcinomaActive, not recruiting

Liver DiseaseApproved

Myelodysplastic SyndromeActive, not recruiting

Colorectal CancerActive, not recruiting

CholangiocarcinomaActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Myelodysplastic SyndromesActive, not recruiting

ParagangliomaApproved

Approved

Tic DisorderPhase 2

Active, not recruiting

ChondrosarcomaPhase 3

Active, not recruiting

Pancreatic AdenocarcinomaPhase 1

Active, not recruiting

Liver DiseaseApproved

Approved

Myelodysplastic SyndromePhase 2

Active, not recruiting

Colorectal CancerPhase 2

Active, not recruiting

CholangiocarcinomaPhase 3

Active, not recruiting

Acute Myeloid LeukemiaPhase 3

Active, not recruiting

Myelodysplastic SyndromesPhase 3

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

949 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Tibsovo

SServier

Approved

1 2

Eylea

Regeneron

Preclinical

5 3

Emend IV

PORTRAZZA

Versed

CConrado Roberto Hoffmann Filho

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Andriol

AAuxilium

Preclinical

1 8

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Bridion

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 10

Ketalar

AAultman Health Foundation

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

IDH1 Mutation

NCT07282262

Phase 2Not yet recruiting

Colorectal Cancer

NCT06593548

Phase 3Recruiting

Acute Myeloid Leukemia

NCT05907057

Phase 1Active, not recruiting

Pancreatic Adenocarcinoma

NCT05209074

Phase 1Recruiting

Acute Myeloid Leukemia

NCT05010772

Q1 2027

Phase 2Active, not recruiting

Tic Disorder

NCT03155620

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia8 trials

Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation

Withdrawn·—·Phase 1·NCT04655391

Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation

Recruiting·TTechnische Universität Dresden·Phase 2·NCT06717958·76 enrolled

An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.

Recruiting·SServier Affaires Médicales·Phase 3·NCT05907057·245 enrolled

Show 5 more trials

Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia

Active, not recruiting·NNorthwestern University·Phase 1·NCT04250051·2 enrolled

Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04774393·84 enrolled

Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05010772·125 enrolled

A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07392242·45 enrolled

Randomized, Sequential, Open-Label Study to Evaluate the Efficacy of IDH Targeted/Non- Targeted Versus Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)

Recruiting·AAlice Mims·Phase 2·NCT05401097·125 enrolled

Cholangiocarcinoma6 trials

Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma

Terminated·SServier Bio-Innovation LLC·Phase 1/2·NCT05921760·7 enrolled

A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Active, not recruiting·SServier·Phase 2·NCT06081829·12 enrolled

An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Recruiting·SServier Affaires Médicales·Phase 3·NCT05876754·220 enrolled

Show 3 more trials

Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Recruiting· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 1/2·NCT06501625·52 enrolled

Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma

Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT07260175·40 enrolled

Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma

Terminated·—·Phase 1·NCT04088188·8 enrolled

Ivosidenib3 trials

Ivosidenib as Post-HSCT Maintenance for AML

Recruiting·MMassachusetts General Hospital·Phase 2·NCT06707493·75 enrolled

Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects

Completed·AAgios Pharmaceuticals, Inc.·Phase 1·NCT03071770·60 enrolled

Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC

Completed·IiOMEDICO AG··NCT06181734·8 enrolled

Myeloproliferative Neoplasms2 trials

A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms

Withdrawn·UUniversity of Chicago·Phase 1·NCT04955938

Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation

Recruiting·UUniversity of Chicago·Phase 1·NCT06291987·18 enrolled

IDH1 Mutation2 trials

A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation

Completed·CCStone Pharmaceuticals·Phase 1·NCT04176393·30 enrolled

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.

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07282262·300 enrolled

16 more indications

Clonal Cytopenia of Undetermined Significance1 trial

Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT05030441·20 enrolled

Biliary Cancer1 trial

Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting·UUNICANCER·Phase 3·NCT05615818·800 enrolled

Myeloid Neoplasm1 trial

IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation

Completed·MMassachusetts General Hospital·Phase 1·NCT03564821·18 enrolled

MRD1 trial

MRD-positive AML Clinical Study

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT07131059·120 enrolled

Renal Impairment1 trial

A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

Recruiting·SServier Bio-Innovation LLC·Phase 1·NCT07006688·30 enrolled

Relapsed/Refractory AML1 trial

Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation

Approved for marketing·AAgios Pharmaceuticals, Inc.··NCT03245424

Colorectal Cancer1 trial

Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer

Not yet recruiting·FFudan University·Phase 2·NCT06593548·36 enrolled

Chondrosarcoma1 trial

Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen

Recruiting·SServier Bio-Innovation LLC·Phase 3·NCT06127407·136 enrolled

Myelodysplastic Syndromes1 trial

Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation

Recruiting· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 3·NCT06465953·48 enrolled

Myelodysplastic Syndrome1 trial

CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04493164·30 enrolled

Cancer of Unknown Primary Site1 trial

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

Completed· Roche logo

Roche·Phase 2·NCT03498521·529 enrolled

Pancreatic Adenocarcinoma1 trial

Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

Active, not recruiting·—·Phase 1·NCT05209074·16 enrolled

Hematologic Malignancies1 trial

Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03471260·96 enrolled

Tic Disorder1 trial

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)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,376 enrolled

Recurrent Ependymoma1 trial

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of AG-120 (Ivosidenib) in Patients With Tumors Harboring IDH1 Mutations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04195555·3 enrolled

Acute Myeloid Leukemia (AML)1 trial

A Phase 1b Multi-center Study of the FLT3 Inhibitor Gilteritinib in Combination With the IDH1 Inhibitor Ivosidenib or the IDH2 Inhibitor Enasidenib for Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-occurring FLT3/IDH1 or FLT3/IDH2 Mutations

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05756777·18 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 20, 2018

TIBSOVO

NDA NDA211192

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for Ivosidenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ivosidenib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ivosidenib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211192). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Tibsovo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Servier company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Isocitrate Dehydrogenase [NADP] Cytoplasmic Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: SServier

Patent Landscape[5]

Patent Cliff

Jun 21, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10610125Jun 21, 2030

9850277Jan 18, 2033

10717764Jan 18, 2033

11667673Jan 18, 2033

9474779Aug 19, 2033

5 more patents

10449184Mar 13, 2035

10799490Mar 13, 2035

9968595Mar 13, 2035

10653710Oct 18, 2036

10980788Jun 7, 2039

Tibsovo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Acute Myeloid Leukemia8 trials

Cholangiocarcinoma6 trials

Ivosidenib3 trials

Myeloproliferative Neoplasms2 trials

IDH1 Mutation2 trials

Clonal Cytopenia of Undetermined Significance1 trial

Biliary Cancer1 trial

Myeloid Neoplasm1 trial

MRD1 trial

Renal Impairment1 trial

Relapsed/Refractory AML1 trial

Colorectal Cancer1 trial

Chondrosarcoma1 trial

Myelodysplastic Syndromes1 trial

Myelodysplastic Syndrome1 trial

Cancer of Unknown Primary Site1 trial

Pancreatic Adenocarcinoma1 trial

Hematologic Malignancies1 trial

Tic Disorder1 trial

Recurrent Ependymoma1 trial

Acute Myeloid Leukemia (AML)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News