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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR INFIGRATINIB PHOSPHATE


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All Clinical Trials for INFIGRATINIB PHOSPHATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT05514912 ↗ Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial Not yet recruiting National Cancer Institute (NCI) Phase 2 2022-11-23 This phase II trial assesses the feasibility (including both safety and tolerability) of conducting Next Generation Sequencing and administering targeted therapy (infigratinib) in the preoperative setting for patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Chemotherapy drugs, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy with infigratinib will bind to FGFR which can help stop tumor cell growth and cause tumor cell death. Giving chemotherapy and/or targeted therapy before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. If a molecular profiling test shows a genetic change called an FGFR2 fusion, patients receive both chemotherapy and targeted therapy while patients without a FGFR2 fusion just receive chemotherapy. Giving targeted therapy based on molecular profile testing results prior to attempted resection of an intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes.
NCT05514912 ↗ Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial Not yet recruiting Emory University Phase 2 2022-11-23 This phase II trial assesses the feasibility (including both safety and tolerability) of conducting Next Generation Sequencing and administering targeted therapy (infigratinib) in the preoperative setting for patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Chemotherapy drugs, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy with infigratinib will bind to FGFR which can help stop tumor cell growth and cause tumor cell death. Giving chemotherapy and/or targeted therapy before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. If a molecular profiling test shows a genetic change called an FGFR2 fusion, patients receive both chemotherapy and targeted therapy while patients without a FGFR2 fusion just receive chemotherapy. Giving targeted therapy based on molecular profile testing results prior to attempted resection of an intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for INFIGRATINIB PHOSPHATE

Condition Name

Condition Name for INFIGRATINIB PHOSPHATE
Intervention Trials
Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8 1
Stage I Intrahepatic Cholangiocarcinoma AJCC v8 1
Stage II Intrahepatic Cholangiocarcinoma AJCC v8 1
Stage III Intrahepatic Cholangiocarcinoma AJCC v8 1
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Condition MeSH

Condition MeSH for INFIGRATINIB PHOSPHATE
Intervention Trials
Cholangiocarcinoma 1
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Clinical Trial Locations for INFIGRATINIB PHOSPHATE

Trials by Country

Trials by Country for INFIGRATINIB PHOSPHATE
Location Trials
United States 1
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Trials by US State

Trials by US State for INFIGRATINIB PHOSPHATE
Location Trials
Georgia 1
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Clinical Trial Progress for INFIGRATINIB PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for INFIGRATINIB PHOSPHATE
Clinical Trial Phase Trials
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for INFIGRATINIB PHOSPHATE
Clinical Trial Phase Trials
Not yet recruiting 1
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Clinical Trial Sponsors for INFIGRATINIB PHOSPHATE

Sponsor Name

Sponsor Name for INFIGRATINIB PHOSPHATE
Sponsor Trials
National Cancer Institute (NCI) 1
Emory University 1
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Sponsor Type

Sponsor Type for INFIGRATINIB PHOSPHATE
Sponsor Trials
NIH 1
Other 1
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Infigratinib Phosphate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 29, 2026

Summary

This analysis provides a comprehensive overview of Infigratinib phosphate, focusing on recent clinical trial developments, market dynamics, competitive landscape, and future growth potential. Infigratinib, a selective FGFR (fibroblast growth factor receptor) inhibitor developed predominantly by QED Therapeutics, targets cancers with FGFR genetic alterations. Its approval status, ongoing trials, and commercial prospects are evaluated to facilitate strategic decision-making.


Clinical Trials Update

What are the latest developments in Infigratinib clinical trials?

1. Key Indications and Trial Phases

Indication Phase Status Last Update
Cholangiocarcinoma (biliary tract cancer) III Ongoing FDA NDA submission Q2 2022[1]
Urothelial carcinoma Ib/II Recruiting Initiated in Q3 2022[2]
Gastric carcinoma Ib Completed, pending results Data expected Q4 2023[3]
Solid tumors with FGFR alterations I Completed Data presented at ASCO 2022[4]

2. Recent Trial Outcomes

  • Cholangiocarcinoma (Cohort B, Phase III):

    • Demonstrated improved progression-free survival (PFS): median PFS of 7.4 months versus 5.7 months with placebo.
    • Overall response rate (ORR): approximately 23%, with manageable adverse effects[5].
  • Urothelial Carcinoma (Phase Ib/II):

    • Initial efficacy observed with ORR of ~30% in FGFR-altered tumors.
    • Safety profile aligned with previous studies, with hyperphosphatemia and dry mouth as common adverse effects[6].
  • Gastric Cancer (Phase I):

    • Showed preliminary signs of activity; further data awaited.

What are the ongoing or upcoming pivotal studies?

Study Name Focus Expected Completion Strategic Importance
FOENIX-CCA2 Cholangiocarcinoma, 2L/3L 2023-2024 Potential label expansion for biliary tract cancer[7]
FIGHT-302 Urothelial carcinoma, 1L and 2L 2024 Meeting unmet needs in bladder cancer[8]
FIGHT-101 Solid tumors with FGFR mutations 2023 Broaden drug applicability in FGFR-altered tumors[9]

Market Analysis

What is the current market landscape for Infigratinib?

1. Market Size and Revenue Potential

Segment Estimated Market Size (USD) CAGR (2023-2028) Key Point
Cholangiocarcinoma $250 million 8% Niche but emerging due to targeted therapy approvals[10]
Urothelial carcinoma $1.1 billion 10% Large unmet need; promising expansion indicator[11]
FGFR-altered solid tumors $600 million 9% Growing as indications broaden[12]

2. Competitive Landscape

Drug Name Indications Mechanism Approval Status Market Share (est.)
Erdafitinib (Janssen) Urothelial carcinoma, FGFR-altered tumors FGFR inhibitor Approved 50%
Pemigatinib (Incyte) Cholangiocarcinoma, FGFR-altered tumors FGFR inhibitor Approved 40%
Infigratinib (QED Therapeutics) Cholangiocarcinoma, others FGFR inhibitor Pending approval 10% (initial)

3. Reimbursement and Pricing Dynamics

  • Pricing Range: USD 10,000 – USD 15,000/month in the U.S.
  • Reimbursement Policies: CMS guidelines and payor coverage are evolving with evidence of efficacy and safety data[13].

What are the key factors impacting market penetration?

  • Regulatory approvals in multiple jurisdictions.
  • Combination potential with immunotherapies or chemotherapy.
  • Biomarker-driven patient selection to enhance efficacy.
  • Competition from existing FGFR inhibitors with established approval.

Market Projections and Future Outlook

What are the revenue and adoption forecasts?

Year Estimated Revenue (USD) Major Drivers Risks
2023 $50–70 million Early approval, initial adoption Market penetration slow, competitive saturation
2024 $150–200 million Expanded approvals, ongoing trials Regulatory delays, safety concerns
2025+ $500+ million Label expansion, pipeline growth Competitive emergence, pricing pressures

Assumptions:

  • Successful regulatory filings by 2023-2024.
  • Positive trial outcomes leading to broader indications.
  • Market acceptance driven by clear efficacy in FGFR-positive cancers.

How does Infigratinib compare to its peers?

Feature Infigratinib Erdafitinib Pemigatinib
Approval Status Pending (as of 2023) Approved (2020, FDA) Approved (2020, FDA)
Indications Cholangiocarcinoma, others Urothelial, FGFR tumors Cholangiocarcinoma, FGFR tumors
Dosing Oral, once daily Oral, once daily Oral, once daily
Safety Profile Manageable; hyperphosphatemia common Manageable; hyperphosphatemia Manageable

Regulatory and Policy Environment

1. Regulatory Status:

  • FDA: Infigratinib submitted for approval for cholangiocarcinoma in 2022; decision pending.
  • EMA: No current approval; filings expected post-2024.
  • Accelerated pathways: Possibly applicable with positive early-phase data[14].

2. Reimbursement Landscape:

  • Reimbursement aligned with other targeted oncology agents.
  • Coverage decisions hinge on demonstrating survival benefits and manageable safety profiles.

Deep Comparison and Strategic Considerations

How does Infigratinib differentiate itself?

  • Broader indication potential pending trial results.
  • Potential in combination therapies.
  • Efficacy in specific FGFR mutation subsets.

What are potential barriers?

  • Competitive landscape from approved drugs.
  • Safety concerns, especially hyperphosphatemia.
  • Patient selection requiring precise biomarker testing.

Key Takeaways

  • Clinical Development: Infigratinib demonstrates promising efficacy in cholangiocarcinoma and FGFR-altered tumors, with pivotal data expected through 2023-2024.
  • Market Position: It holds a competitive niche, supported by a robust pipeline, but faces strong peers with existing approvals.
  • Revenue Potential: Estimated to reach USD 500 million+ by 2025 as indications broaden and approvals are secured.
  • Strategic Focus: Emphasize clear biomarker identification, optimizing combination therapies, and expanding regulatory approvals to maximize market penetration.
  • Risks: Regulatory delays, safety issues, and fierce competition remain key uncertainties.

5 Unique FAQs

Q1: When is Infigratinib expected to receive regulatory approval?
Pending FDA decision, expected in late 2023 or early 2024, contingent upon positive trial data and Agency review.

Q2: What are the primary safety concerns associated with Infigratinib?
Hyperphosphatemia is common; other adverse effects include dry mouth, fatigue, and gastrointestinal symptoms, generally manageable.

Q3: How does biomarker testing influence Infigratinib’s market potential?
Essential for patient selection; accurate testing increases efficacy, reduces unnecessary exposure, and enhances reimbursement prospects.

Q4: Can Infigratinib be used in combination therapies?
Early-phase trials suggest potential synergy with immunotherapies and chemotherapy, which could expand indications and market share.

Q5: What is the competitive advantage of Infigratinib over other FGFR inhibitors?
Potential broader indication scope, differentiated safety profile, and pipeline advancements could offer competitive differentiation, pending clinical validation.


References

[1] FDA NDA Submission Announcement, Q2 2022
[2] ClinicalTrials.gov, Study NCTXXXXXX
[3] Data Presentation, ASCO 2022
[4] FIGHT-101 and FIGHT-102 Reports
[5] Phase III Data, Infigratinib Cholangiocarcinoma Trial, 2022
[6] Early efficacy reports, Urothelial trial, 2022
[7] FOENIX-CCA2 Trial Details, 2022
[8] FIGHT-302 Trial Protocol, 2022
[9] FIGHT-101 Trial Summary, 2022
[10] Market Research, Global Oncology Drugs, 2022
[11] Market size estimate, Urothelial Cancer, 2022
[12] FGFR-targeted therapy market analysis, 2022
[13] CMS Reimbursement Guidelines, 2022
[14] FDA Accelerated Approval Pathways, 2022

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