Tibsovo

(Ivosidenib)

ApprovedSmall molecule

Tibsovo is a small molecule that works as a Isocitrate Dehydrogenase [NADP] Cytoplasmic Inhibitor.[2] It is being used across 19 indications, with its most advanced program in Approved.[1]

Tibsovo is one of 325 small molecule programs targeting Paraganglioma. It is currently in Approved.

Indications

Total Trials

Active Trials

324

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

ParagangliomaApproved

Pancreatic AdenocarcinomaActive, not recruiting

Liver DiseaseApproved

Colorectal CancerNot yet recruiting

CholangiocarcinomaActive, not recruiting

Acute Myeloid LeukemiaRecruiting

Clonal Cytopenia of Undetermined SignificanceActive, not recruiting

Biliary Tract Cancer (BTC)Not yet recruiting

MalignanciesRecruiting

Myelodysplastic Syndromes (MDS)Recruiting

ParagangliomaApproved

Approved

Pancreatic AdenocarcinomaPhase 1

Active, not recruiting

Liver DiseaseApproved

Approved

Colorectal CancerPhase 2

Not yet recruiting

CholangiocarcinomaPhase 3

Active, not recruiting

Acute Myeloid LeukemiaPhase 3

Recruiting

Clonal Cytopenia of Undetermined SignificancePhase 2

Active, not recruiting

Biliary Tract Cancer (BTC)Phase 3

Not yet recruiting

MalignanciesPhase 1

Recruiting

Myelodysplastic Syndromes (MDS)Phase 3

Recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

254 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Stivarga

Bayer

Phase 3

39 2

Wellcovorin

GGlaxo Dba Glaxosmithkline

Phase 3

38 3

Tibsovo

SServier

Approved

1 4

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

4 5

Mitosol

UUroGen Pharma Ltd.

Phase 3

1 6

Botensilimab

AAgenus Inc.

Phase 3

9 7

TAS 102

Taiho Oncology, Inc.

Phase 3

8 8

5-Fu

TToray Industries, Inc

Phase 3

4 9

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Phase 3

2 10

Cytokine-Induced Killer Cells

TThe First People's Hospital of Changzhou

Phase 3

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

Timeline

Expected Milestones

Q4 2026

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

Advanced Malignant Solid Neoplasm

NCT03155620

Q2 2027

Phase 1Active, not recruiting

Acute Myeloid Leukemia (AML)

NCT05756777

Phase 2Active, not recruiting

Cholangiocarcinoma

NCT06081829

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia10 trials

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

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

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

Withdrawn·—·Phase 1·NCT04655391

Show 7 more trials

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

Oral Decitabine-Based Maintenance Therapy in Patients With AML in Remission

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

A Phase II Study of IDH1 Inhibition With Ivosidenib as Maintenance Therapy After Ivosidenib, Azacitidine, and Venetoclax for Acute Myeloid Leukemia

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

Phase Ib/II Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +/- Azacitidine in IDH1-Mutated Hematologic Malignancies

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT03471260·96 enrolled

Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS

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

Clinical Study of Sonrotoclax Combined With Azacitidine Plus Individualized Targeted Drugs in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia

Recruiting·RRuijin Hospital·Phase 2·NCT07548710·205 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

Cholangiocarcinoma5 trials

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

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

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

Terminated·—·Phase 1·NCT04088188·8 enrolled

Show 2 more trials

adIVO - A Phase II Trial of 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

An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Active, not recruiting·SServier Affaires Médicales·Phase 3·NCT05876754·299 enrolled

IDH1 Mutation3 trials

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

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

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

A Randomized, Placebo-Controlled Phase 2 Study of IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Acute Myeloid Leukemia Following Allogeneic Stem Cell Transplantation

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

Ivosidenib2 trials

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

Completed·IiOMEDICO AG··NCT06181734·8 enrolled

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

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

A Phase 1b Trial of Ivosidenib Combined With Ruxolitinib in IDH1-Mutated Advanced-Phase MPNs

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

17 more indications

AML2 trials

A Prospective, Single-arm, Open-label, Multicenter Phase II Trial Evaluating the Efficacy and Safety of Ivosidenib Maintenance Therapy After Allogeneic Stem Cell Transplantation (alloSCT) in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Neoplasia (MD) Carrying an IDH1 Mutation

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

Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT06265545·458 enrolled

Pancreatic Adenocarcinoma1 trial

Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

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

Biliary Cancer1 trial

Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting·UUNICANCER·Phase 3·NCT05615818·800 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

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

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

Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen1 trial

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 or 2 Systemic Treatment Regimens

Recruiting·SServier Bio-Innovation LLC·Phase 3·NCT06127407·156 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

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05756777·8 enrolled

Metastatic Cholangiocarcinoma1 trial

A Phase 1b/2, Safety Lead-in and Dose-Expansion, Open Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination With Durvalumab and Gemcitabine/Cisplatin as First-line Therapy in Participants With Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Active, not recruiting· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Preclinical·NCT06501625·55 enrolled

Myelodysplastic Syndromes (MDS)1 trial

A Phase 3, Multicenter, Open Label, Randomized, Non-comparative Two-arm Study of Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Adult Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an Isocitrate Dehydrogenase-1 (IDH1) Mutation (PyramIDH Study)

Recruiting· Institut de Recherches Internationales Servier logo

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

Clonal Cytopenia of Undetermined Significance1 trial

A Pilot Study of 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

AML, Adult1 trial

MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT07131059·537 enrolled

Malignancies1 trial

A Phase 1, Multicenter, Open-Label, Safety and Pharmacokinetic Study of Orally Administered Ivosidenib in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

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

Biliary Tract Cancer (BTC)1 trial

Investigating Precision Medicine in the Adjuvant Setting: a Phase 3 Clinical Trial in Biliary Tract Cancer

Not yet recruiting·UUNICANCER·Phase 3·NCT07745296·990 enrolled

Advanced Malignant Solid Neoplasm1 trial

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,377 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

Regulatory

FDA Approval Timeline[4]

Jul 20, 2018

TIBSOVO

NDA NDA211192

Jul 20, 2018

TIBSOVO

NDA NDA211192

Mar 17, 2020

TIBSOVO

NDA NDA211192

Mar 18, 2021

TIBSOVO

NDA NDA211192

Aug 25, 2021

TIBSOVO

NDA NDA211192

May 25, 2022

TIBSOVO

NDA NDA211192

Oct 24, 2023

TIBSOVO

NDA NDA211192

Sources

References

[1]
ClinicalTrials.gov — 40 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

Q2 2027

Trials by Indication[1]

Acute Myeloid Leukemia10 trials

Cholangiocarcinoma5 trials

IDH1 Mutation3 trials

Ivosidenib2 trials

Myeloproliferative Neoplasms2 trials

AML2 trials

Pancreatic Adenocarcinoma1 trial

Biliary Cancer1 trial

Relapsed/Refractory AML1 trial

Colorectal Cancer1 trial

Cancer of Unknown Primary Site1 trial

Myeloid Neoplasm1 trial

Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen1 trial

Acute Myeloid Leukemia (AML)1 trial

Metastatic Cholangiocarcinoma1 trial

Myelodysplastic Syndromes (MDS)1 trial

Clonal Cytopenia of Undetermined Significance1 trial

AML, Adult1 trial

Malignancies1 trial

Biliary Tract Cancer (BTC)1 trial

Advanced Malignant Solid Neoplasm1 trial

Recurrent Ependymoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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