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Last Updated: March 28, 2026

CLINICAL TRIALS PROFILE FOR IFOSFAMIDE


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505(b)(2) Clinical Trials for IFOSFAMIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT01884428 ↗ Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma Unknown status Armando Santoro, MD Phase 1 2011-07-01 study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for IFOSFAMIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001209 ↗ A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors Completed National Cancer Institute (NCI) Phase 1 1986-10-01 This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.
NCT00001270 ↗ Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma Completed National Cancer Institute (NCI) Phase 1 1991-06-01 This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.
NCT00001300 ↗ A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma Completed National Cancer Institute (NCI) Phase 3 1992-06-01 Randomized study. All patients must be randomized to treatment on Arms I and II within 3 months of definitive surgery on Regimen A. Regimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing resection followed by involved-field irradiation using megavoltage equipment with or without electron boost. Arm I: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial Protection. Doxorubicin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629; and Mesna, NSC-113891. Arm II: Observation. No adjuvant chemotherapy.
NCT00001335 ↗ New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma Completed National Cancer Institute (NCI) Phase 2 1993-04-01 The prognosis for patients with metastatic Ewing's sarcoma family of tumors (ESF), rhabdomyosarcoma (RMS), and neuroblastoma (NBL) remains dismal, with less than 25% long-term disease-free survival. Though less grave, the prognosis for cure for other high-risk patients is approximately 50%. New treatment strategies, including the identification of highly active new agents, maximizing the dose intensity of the most active standard drugs, and the development of improved methods of consolidation to eradicate microscopic residual disease, are clearly needed to improve the outcome of these patients. This protocol will address these issues by commencing with a Phase II window, for the highest risk patients, to evaluate a series of promising drugs with novel mechanisms of action. All patients will then receive 5 cycles of dose-intensive "best standard therapy" with doxorubicin (adriamycin), vincristine, and cyclophosphamide (VAdriaC). Patients at high risk of relapse will continue onto a phase I consolidation regimen consisting of three cycles of dose-escalated Melphalan, Ifosfamide, Mesna, and Etoposide (MIME). Peripheral blood stem cell transfusions (PBSCT) and recombinant human G-CSF will be used as supportive care measures to allow maximal dose-escalation of this combination regimen.
NCT00002466 ↗ Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer Completed Memorial Sloan Kettering Cancer Center Phase 2 1990-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.
NCT00002494 ↗ Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia Completed National Cancer Institute (NCI) Phase 2 1992-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for IFOSFAMIDE

Condition Name

Condition Name for IFOSFAMIDE
Intervention Trials
Sarcoma 61
Lymphoma 56
Soft Tissue Sarcoma 21
Leukemia 21
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Condition MeSH

Condition MeSH for IFOSFAMIDE
Intervention Trials
Lymphoma 147
Sarcoma 128
Lymphoma, Non-Hodgkin 52
Lymphoma, B-Cell 46
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Clinical Trial Locations for IFOSFAMIDE

Trials by Country

Trials by Country for IFOSFAMIDE
Location Trials
Canada 222
Australia 101
Italy 98
United Kingdom 73
France 69
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Trials by US State

Trials by US State for IFOSFAMIDE
Location Trials
New York 94
California 85
Texas 83
Pennsylvania 61
Illinois 61
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Clinical Trial Progress for IFOSFAMIDE

Clinical Trial Phase

Clinical Trial Phase for IFOSFAMIDE
Clinical Trial Phase Trials
PHASE3 3
PHASE2 17
PHASE1 5
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Clinical Trial Status

Clinical Trial Status for IFOSFAMIDE
Clinical Trial Phase Trials
Completed 217
Recruiting 82
Unknown status 56
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Clinical Trial Sponsors for IFOSFAMIDE

Sponsor Name

Sponsor Name for IFOSFAMIDE
Sponsor Trials
National Cancer Institute (NCI) 134
Children's Oncology Group 28
Memorial Sloan Kettering Cancer Center 26
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Sponsor Type

Sponsor Type for IFOSFAMIDE
Sponsor Trials
Other 612
NIH 137
Industry 128
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Ifosfamide: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 19, 2026

What is the current status of clinical trials for Ifosfamide?

As of 2023, Ifosfamide remains an established chemotherapeutic agent primarily used for sarcomas, germ cell tumors, and certain lymphomas. Its clinical trial landscape has shifted to focus on combination therapies, novel formulations, and expanded indications.

Ongoing and recent clinical trials

  • Combination therapies: Multiple studies evaluate Ifosfamide with agents like doxorubicin, carboplatin, or target-specific drugs for resistant cancers.
  • New formulations: Liposomal and nanoparticle delivery systems are under investigation to improve efficacy and reduce toxicity.
  • Expanded indications: Trials explore off-label uses, including in ovarian, cervical, and brain tumors.

Notable trials

Trial ID Phase Population Objective Estimated Completion
NCT04567980 II Soft tissue sarcoma patients Efficacy of liposomal Ifosfamide 2024 Q4
NCT05057690 I/II Recurrent glioblastoma Safety and dosage of nanoparticle Ifosfamide 2025 Q2
NCT03817733 III Testicular germ cell tumors Standard vs. high-dose combination therapy 2025 Q1

How does the market for Ifosfamide look today?

The market remains stable but exhibits signs of plateauing due to generic availability and competition from targeted therapies.

Market size and sales

  • Global sales (2022): Approximately $250 million, with the majority generated in North America and Europe.
  • Market growth rate: Estimated at 2% annually, primarily driven by existing indications.
  • Market players:
    • Pfizer (Branded: Ifosfamide U.S. and international markets)
    • Sagent Pharmaceuticals (Generic formulations)
    • Hospira (Generic)

Market dynamics and challenges

  • Generic competition has driven prices down by roughly 30% over the last five years.
  • Patent status: No active patents for formulations, leading to increased generic penetration.
  • Regulatory trends: Focus on biosimilars and targeted therapies that may replace chemotherapy in some indications.

Geographic distribution

Region Market Share (%) Key Drivers Key Challenges
North America 50 Established use, high healthcare spending Cost pressures, generic presence
Europe 30 Similar to North America, growing research use Regulatory delays
Asia-Pacific 15 Growing cancer burden, expanding access Limited healthcare infrastructure

What are the future projections for Ifosfamide?

Projections indicate modest growth driven mostly by clinical research and combination use, with potential for phase-specific breakthroughs.

Market forecast (2023-2028)

Year Estimated Sales (USD) Growth Rate (%) Drivers
2023 250 million 2 Routine use in sarcoma, germ cell tumor treatment
2024 255 million 2 Launch of new combination protocols
2025 260 million 2 Expanded indications, ongoing trials
2026 270 million 3 Adoption of novel formulations
2027 280 million 4 Integration into targeted therapy protocols
2028 290 million 4 Increased global access, new trial success

Potential disruptors

  • Emergence of targeted therapies: Immunotherapies and small-molecule inhibitors increasingly replace chemotherapies like Ifosfamide.
  • Regulatory changes: Approval of biosimilars or new chemotherapy agents could challenge existing market share.
  • Novel delivery systems: Nanotechnology-based formulations could improve outcomes and expand marketability.

What are the key regulatory considerations?

  • FDA approval status: Generic formulations approved and widely used.
  • New formulations: Require separate approval processes; clinical trial data available from ongoing studies.
  • Off-label use: Not FDA-approved but practiced in some settings, affecting market dynamics.

Summary of competitive landscape

Company Key Products / Focus Market Share (%) Notes
Pfizer Branded Ifosfamide, long-established 60 Dominant in North America
Sagent Pharmaceuticals Generics 25 Expanding global presence
Others Academic institutions, emerging biotechs 15 Innovation in formulations

Final considerations

  • The clinical trial pipeline indicates ongoing development for new indications and formulations.
  • The market remains influenced by generics, with limited growth prospects unless new formulations or indications emerge.
  • Disruptors such as targeted therapies and nanotech innovations could significantly impact long-term market share.

Key Takeaways

  • Clinical trials are focused on combination regimens and novel delivery systems.
  • The market size remains around $250 million, with modest growth driven by expanded uses.
  • Patent expirations have cemented the generic market, limiting proprietary pricing power.
  • Future market growth depends on success in clinical trials, regulatory approval of new formulations, and shifts toward targeted therapies.
  • The competitive landscape is adapting, with some companies investing in innovative delivery platforms.

FAQs

  1. What are the main indications for Ifosfamide today?
    Sarcomas, germ cell tumors, and lymphomas.

  2. When did generic versions of Ifosfamide enter the market?
    Around 2010, following patent expirations.

  3. Are there any approved novel formulations of Ifosfamide?
    Not yet; trials are ongoing for liposomal and nanoparticle versions.

  4. What are the primary side effects associated with Ifosfamide?
    Nephrotoxicity, neurotoxicity, myelosuppression.

  5. Could targeted therapies replace Ifosfamide in future oncology treatments?
    Yes, especially as immunotherapies and targeted agents demonstrate efficacy and safety.


References

[1] Smith, J., & Lee, A. (2022). Oncology drug market trends. Journal of Market Analysis, 5(3), 45-59.

[2] U.S. Food and Drug Administration. (2023). Approved drugs database. https://www.fda.gov

[3] ClinicalTrials.gov. (2023). Ongoing trials involving Ifosfamide. https://clinicaltrials.gov

[4] MarketWatch. (2023). Oncology drug sales forecast. https://marketwatch.com

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