Truseltiq

(Infigratinib)

Phase 2Small molecule

Truseltiq is a small molecule that works as a FGFR Inhibitor.[2] It is being investigated across 2 indications, with its most advanced program in Phase 2.[1]

Truseltiq is one of 9 small molecule programs targeting Hypochondroplasia. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HypochondroplasiaEnrolling by invitation

AchondroplasiaEnrolling by invitation

HypochondroplasiaPhase 2

Enrolling by invitation

AchondroplasiaPhase 2

Enrolling by invitation

Competition

Competitive Landscape

9 competitors in Achondroplasia

#DrugCompanyPhaseTrials

Voxzogo

BioMarin Pharmaceutical

Phase 2

2 2

BMN 333

BioMarin Pharmaceutical

Phase 3

6 3

Truseltiq

HHelsinn Healthcare SA

Phase 2

1 4

Yuviwel

Ascendis Pharma

Phase 2

3 5

ABSK061

AAbbisko Therapeutics Co, Ltd

Phase 2

1 6

TYRA-300

TTyra Biosciences, Inc

Phase 2

1 7

Genotropin

EMD Serono

Preclinical

1 8

Transcon CNP

AAscendis Pharma Growth Disorders A/S

Phase 2

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

Clinical

Trials by Indication[1]

Glioma2 trials

Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations

Withdrawn·HHelsinn Healthcare SA·Phase 1/2·NCT05222165

Infigratinib in Recurrent High-Grade Glioma Patients

Terminated·NNader Sanai·Phase 1·NCT04424966·7 enrolled

Breast Cancer1 trial

Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

Terminated·JJennifer Lee Caswell-Jin·Phase 1·NCT04504331·4 enrolled

Trial1 trial

Phase I BLASST-3 Trial

Withdrawn·—·Phase 1·NCT04972253

Cholangiocarcinoma1 trial

Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT05510427

Adenocarcinoma1 trial

Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

Terminated·LLianBio LLC·Phase 2·NCT06206278·6 enrolled

6 more indications

Urothelial Cancer1 trial

Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT04228042·15 enrolled

Other Solid Tumors1 trial

Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations

Unknown status·LLianBio LLC·Phase 2·NCT05019794·80 enrolled

Advanced or Metastatic Solid Tumors1 trial

Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations

Completed·SSameek Roychowdhury·Phase 2·NCT04233567·17 enrolled

Achondroplasia1 trial

Extension Study of Infigratinib in Children With Achondroplasia (ACH)

Enrolling by invitation·QQED Therapeutics, a BridgeBio company·Phase 2·NCT05145010·300 enrolled

Urothelial Carcinoma1 trial

Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations

Terminated·QQED Therapeutics, a BridgeBio company·Phase 3·NCT04197986·39 enrolled

Hypochondroplasia1 trial

Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Hypochondroplasia: ACCEL OLE

Enrolling by invitation·QQED Therapeutics, a BridgeBio company·Phase 2·NCT07393373·135 enrolled

Regulatory

FDA Approval Timeline[4]

May 28, 2021

TRUSELTIQ

NDA NDA214622

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Infigratinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Infigratinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Infigratinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214622). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Truseltiq. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Helsinn Healthcare SA company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: FGFR Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: HHelsinn Healthcare SA

Patent Landscape[5]

Patent Cliff

Aug 6, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9067896Aug 6, 2028

8552002Aug 25, 2029

10278969Dec 11, 2034

11160804Dec 11, 2034

Truseltiq

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Glioma2 trials

Breast Cancer1 trial

Trial1 trial

Cholangiocarcinoma1 trial

Adenocarcinoma1 trial

Urothelial Cancer1 trial

Other Solid Tumors1 trial

Advanced or Metastatic Solid Tumors1 trial

Achondroplasia1 trial

Urothelial Carcinoma1 trial

Hypochondroplasia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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