Truseltiq

(Infigratinib)

Phase 3Small molecule

Truseltiq is a small molecule that works as a FGFR Inhibitor.[2] It is being investigated across 7 indications, with its most advanced program in Phase 3.[1]

Truseltiq is one of 194 small molecule programs targeting Glioma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

193

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

GliomaActive, not recruiting

HypochondroplasiaActive, not recruiting

AdenocarcinomaActive, not recruiting

AchondroplasiaActive, not recruiting

Breast CancerActive, not recruiting

CholangiocarcinomaActive, not recruiting

Urothelial CarcinomaActive, not recruiting

GliomaPhase 1/Phase 2

Active, not recruiting

HypochondroplasiaPhase 2

Active, not recruiting

AdenocarcinomaPhase 2

Active, not recruiting

AchondroplasiaPhase 2

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

CholangiocarcinomaPhase 1

Active, not recruiting

Urothelial CarcinomaPhase 3

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Truseltiq

HHelsinn Healthcare SA

Phase 3

1 2

Trodelvy

Gilead

Preclinical

37 3

Tykerb

GSK

Preclinical

80 4

Tecentriq

Roche

Preclinical

36 5

Halaven

Eisai

Preclinical

38 6

Adriamycin

GGynecologic Oncology Group

Preclinical

87 7

Avastin

BBio-Thera Solutions

Preclinical

153 8

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

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

Clinical

Trials by Indication[1]

Glioma2 trials

Infigratinib in Recurrent High-Grade Glioma Patients

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

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Withdrawn·HHelsinn Healthcare SA·Phase 1/2·NCT05222165

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

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

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

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

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

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

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

Achondroplasia1 trial

Extension Study of Infigratinib in Children With Achondroplasia (ACH)

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

Trial1 trial

Phase I BLASST-3 Trial

Withdrawn·—·Phase 1·NCT04972253

Hypochondroplasia1 trial

Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia

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 3[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

Urothelial Carcinoma1 trial

Advanced or Metastatic Solid Tumors1 trial

Other Solid Tumors1 trial

Adenocarcinoma1 trial

Breast Cancer1 trial

Cholangiocarcinoma1 trial

Urothelial Cancer1 trial

Achondroplasia1 trial

Trial1 trial

Hypochondroplasia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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