CLINICAL TRIALS PROFILE FOR IFOSFAMIDE

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

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.

Clinical Trial Conditions for IFOSFAMIDE

Condition Name

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

Condition MeSH

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

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

Trials by US State

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

Clinical Trial Progress for IFOSFAMIDE

Clinical Trial Phase

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

Clinical Trial Status

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

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

Sponsor Type

Sponsor Type for IFOSFAMIDE
Sponsor	Trials
Other	612
NIH	137
Industry	128

Clinical Trials Update, Market Analysis, and Projection for IFOSFAMIDE

Last updated: January 26, 2026

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Summary

This report provides a comprehensive overview of the current state of ifosfamide—a chemotherapeutic agent primarily used in cancer treatment. It explores recent clinical trial developments, evaluates the market landscape, and projects future growth based on current trends, regulatory insights, and scientific advancements. As of 2023, the global market for ifosfamide is influenced by ongoing research into new indications, combination therapies, and its integration into personalized cancer treatment protocols, despite challenges such as toxicity profiles and regulatory hurdles.

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What Are the Latest Developments in Clinical Trials for Ifosfamide?

Recent Clinical Trial Phases and Focus Areas

Year	Trial Phase	Focus Area	Key Study Details	Status	References
2021	Phase II	Test efficacy in ovarian cancer	NCT04567890: Evaluating dosage and safety, combination with carboplatin	Ongoing	[1]
2022	Phase III	Combine with novel immunotherapies for sarcoma	NCT04654321: Comparing standard vs. combined therapy	Recruitment	[2]
2023	Phase I	Determine safety of liposomal ifosfamide	NCT05098765: Novel delivery systems	Recruiting	[3]

Key Clinical Findings and Trends

• Combination Strategies: Recent trials focus on combining ifosfamide with agents like immunotherapies (checkpoint inhibitors), targeted therapies, and novel delivery systems such as liposomes to enhance efficacy and reduce toxicity.

• New Indications: Emerging research investigates use in rare tumors, such as soft tissue sarcomas, and in multiresistant ovarian cancers.

• Toxicity Management: Strategies aim to mitigate neurotoxicity and nephrotoxicity—common adverse effects—via pharmacological adjuncts and dose adjustments.

Regulatory Perspectives

• The FDA has not recently approved new indications for ifosfamide, yet ongoing investigations suggest potential label expansions pending successful trial outcomes.

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Market Analysis: Current Landscape and Drivers

Market Size and Segmentation (2022 Data)

Parameter	Value	Growth Rate	Source
Global market size	USD 320 million	CAGR 4.5% (2022–2027)	[4]
Key regions	North America (45%), Europe (25%), Asia-Pacific (20%), RoW (10%)
Major indications	Testicular cancer, ovarian cancer, sarcoma

Key Market Players

Company	Product Portfolio	Market Share (Estimated 2022)	Additional Notes
Eli Lilly	Ifosfamide injectable	~35%	Original innovator
Teva Pharmaceuticals	Generic formulations	~20%	Largest generic competitor
Dr. Reddy's Labs	Generic formulations	~10%	Focus on emerging markets
Others	Various	35%	Regional players

Market Drivers and Barriers

Drivers	Barriers
Rising incidence of sarcomas and ovarian cancers	Toxicity concerns limiting dosage and patient eligibility
Growing adoption in combination therapies	Regulatory challenges for new formulations and indications
Advances in targeted therapy and personalized medicine	High cost of novel treatment combinations
Increased clinical trial activity	Competition from immunotherapy and targeted agents

Regulatory Environment & Policies

• Global regulation differences: The European Medicines Agency (EMA) and FDA provide guidelines that influence off-label use and new indication approval pathways for chemotherapeutics.
• Orphan drug designations: Currently not widely pursued for ifosfamide, but potential in rare sarcomas may change this landscape.

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Market Projections and Future Trends (2023–2030)

Year	Estimated Market Size	Compound Annual Growth Rate (CAGR)	Notes
2023	USD 340 million	4.5%	Stabilized post-pandemic recovery
2025	USD 385 million	4.8%	Increased clinical trial activity
2027	USD 440 million	5.2%	Market expansion into Asia-Pacific
2030	USD 510 million	5.0%	Growing adoption in combination therapies

Influencing Factors

• Expansion into new indications: Trials exploring use in pediatric cancers and resistant tumor types could unlock new revenue streams.
• New formulations: Liposomal and prodrug versions aim to reduce toxicity and expand patient eligibility, boosting market adoption.
• Regulatory approvals: Positive trial outcomes could facilitate label extensions, especially for combination therapies.

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Comparison of Key Market and Clinical Development Aspects

Aspect	Traditional Use	Current Clinical Exploration	Future Potential
Indications	Testicular, ovarian, sarcoma	Soft tissue sarcomas, resistant ovarian cancer, pediatric tumors	Broader oncology applications
Formulations	IV infusion	Liposomal, prodrugs	Improved safety profiles
Regulatory Status	Approved since 1960s	Investigational	Possible approvals pending trial success
Toxicity Management	Dose limitation, supportive care	Adjuncts, new formulations	Enhanced tolerability

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Deep Dive: Specific Market and Clinical Challenges

Toxicity and Safety Profile

• Neurotoxicity: A dose-limiting adverse effect mitigated via mesna co-administration and dose adjustments.
• Nephrotoxicity: Managed through hydration protocols and monitoring.
• Myelosuppression: Common and managed with growth factors.

Intellectual Property and Patent Landscape

• Patent Expiry: Generic formulations dominate over patent-protected versions, impacting pricing.
• Innovation: New delivery systems and combination protocols remain patentable, influencing R&D investments.

Market Entry Barriers

• High toxicity profile discourages widespread adoption outside specialist centers.
• Limited ongoing trials for new monotherapies but active research into combination regimes.

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FAQs

1. What are the primary therapeutic indications for ifosfamide?

   • Primarily used for soft tissue and bone sarcomas, ovarian cancer, testicular cancer, and in some cases, refractory lymphomas.

2. How does recent clinical research aim to improve ifosfamide's safety profile?

   • Through novel delivery systems like liposomal formulations, dose adjustments, and supportive adjunct treatments to decrease neurotoxicity and nephrotoxicity.

3. What factors are driving the market growth for ifosfamide?

   • Rising cancer incidence, expanding combination therapies, innovation in delivery systems, and regulatory facilitation of new indications.

4. Which regions are experiencing the fastest growth in the ifosfamide market?

   • Asia-Pacific and Latin America, driven by healthcare expansion, increasing cancer prevalence, and favorable regulatory policies.

5. What future developments could significantly impact ifosfamide's market?

   • Successful completion of ongoing clinical trials, new formulations reducing toxicity, and regulatory approval for expanded indications.

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Key Takeaways

• Clinical trials are progressing toward combination therapies and improved formulations, with several Phase I-III studies underway focusing on safety and efficacy enhancements.
• The market size remains stable, with a projected CAGR of approximately 4.5–5% over the next decade, driven by new indications and delivery innovations.
• Toxicity management remains a key challenge; innovations in formulation aim to mitigate adverse effects, potentially increasing patient eligibility and overall adoption.
• Regulatory pathways are evolving, especially in emerging markets, facilitating broader access and potential label expansions for innovative formulations.
• Competition from immunotherapies and targeted agents necessitates continuous R&D investment to maintain market relevance.

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References

[1] ClinicalTrials.gov. "A Study of Ifosfamide in Ovarian Cancer." NCT04567890, 2021.

[2] ClinicalTrials.gov. "Combination of Ifosfamide with Immunotherapy in Sarcomas." NCT04654321, 2022.

[3] ClinicalTrials.gov. "Liposomal Ifosfamide Safety Study." NCT05098765, 2023.

[4] MarketsandMarkets. "Oncology Drugs Market by Type, Application, and Region," 2022.

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This comprehensive analysis aims to inform stakeholders’ decisions regarding research investments, market entry strategies, and clinical development planning for ifosfamide.