CLINICAL TRIALS PROFILE FOR AMIFOSTINE

All Clinical Trials for AMIFOSTINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002643 ↗	Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor	Completed	Children's Cancer Group	Phase 2	1995-04-01	Phase II trial to study the effectiveness of combination chemotherapy in treating patients with newly diagnosed metastatic Ewing's sarcoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
NCT00002643 ↗	Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor	Completed	National Cancer Institute (NCI)	Phase 2	1995-04-01	Phase II trial to study the effectiveness of combination chemotherapy in treating patients with newly diagnosed metastatic Ewing's sarcoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
NCT00003048 ↗	Amifostine in Treating Patients With Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 2	1997-06-05	RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with myelodysplastic syndrome.
NCT00003048 ↗	Amifostine in Treating Patients With Myelodysplastic Syndrome	Completed	M.D. Anderson Cancer Center	Phase 2	1997-06-05	RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with myelodysplastic syndrome.
NCT00003068 ↗	High-Dose Chemotherapy and Autologous Blood Cell Transplantation in Treating Patients With Primary, Locally Advanced, or Stage IV Breast Cancer	Completed	University of Arizona	Phase 2	1997-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of high-dose mitoxantrone, thiotepa, and cyclophosphamide plus autologous peripheral stem cell transplantation and amifostine in treating patients with primary, locally advanced, or stage IV breast cancer.
NCT00003072 ↗	Combination Chemotherapy in Treating Patients With Metastatic Ovarian Cancer or Non-small Cell Lung Cancer	Completed	University of California, San Francisco	Phase 2	1997-05-01	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 and giving the drugs in different combinations may kill more tumor cells. PURPOSE: Randomized phase II double-blinded trial to study the effectiveness of paclitaxel and carboplatin given with either amifostine or placebo in patients with metastatic stage III or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer.
NCT00003089 ↗	Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer	Completed	Sidney Kimmel Cancer Center at Thomas Jefferson University	Phase 2	1997-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel, carboplatin, amifostine, and radiation therapy in treating patients who have unresectable locally advanced or partially resected non-small cell lung cancer.

Clinical Trial Conditions for AMIFOSTINE

Condition Name

Condition Name for AMIFOSTINE
Intervention	Trials
Drug/Agent Toxicity by Tissue/Organ	19
Head and Neck Cancer	16
Lung Cancer	14
Radiation Toxicity	10

Condition MeSH

Condition MeSH for AMIFOSTINE
Intervention	Trials
Drug-Related Side Effects and Adverse Reactions	19
Head and Neck Neoplasms	17
Lung Neoplasms	12
Radiation Injuries	10

Clinical Trial Locations for AMIFOSTINE

Trials by Country

Trials by Country for AMIFOSTINE
Location	Trials
United States	362
Canada	27
France	9
Australia	6
China	4

Trials by US State

Trials by US State for AMIFOSTINE
Location	Trials
California	20
Illinois	18
Pennsylvania	16
Ohio	15
Michigan	13

Clinical Trial Progress for AMIFOSTINE

Clinical Trial Phase

Clinical Trial Phase for AMIFOSTINE
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	4

Clinical Trial Status

Clinical Trial Status for AMIFOSTINE
Clinical Trial Phase	Trials
Completed	52
Unknown status	15
Terminated	10

Clinical Trial Sponsors for AMIFOSTINE

Sponsor Name

Sponsor Name for AMIFOSTINE
Sponsor	Trials
National Cancer Institute (NCI)	33
MedImmune LLC	10
Dana-Farber Cancer Institute	6

Sponsor Type

Sponsor Type for AMIFOSTINE
Sponsor	Trials
Other	89
NIH	33
Industry	21

Amifostine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Executive Summary

Amifostine (ethiofos) is a cytoprotective agent primarily used to reduce the toxic effects of chemotherapy and radiation therapy in cancer treatment. With established approval for specific indications, recent developments focus on expanding its indications, improving formulations, and positioning within the broader oncology support market. The global market for Amifostine is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% over the next five years, driven by expanding oncology treatment protocols, increasing cancer prevalence, and unmet needs in supportive care. Ongoing clinical trials aim to validate new applications, enhance safety profiles, and optimize dosing strategies. This report provides a comprehensive review of recent clinical trials, market dynamics, competitive landscape, and future growth projections.

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1. Clinical Trials Update

Current Clinical Trials Overview

Trial ID	Phase	Status	Indication	Objective	Sponsor	Estimated Completion
NCT03152255	Phase IV	Ongoing	Head and neck cancer radiation	Evaluate long-term safety and efficacy	US National Cancer Institute	Dec 2024
NCT03932879	Phase II	Recruiting	Radioprotection in lung cancer	Assess protective effects during radiotherapy	European Cancer Consortium	Jun 2025
NCT04536678	Phase I/II	Pending	Chemotherapy-induced nephrotoxicity	Dose-finding and safety evaluation	Asia Oncology Research	Jan 2026
NCT052369XX	Phase III	Planning	Malignant glioma adjunct therapy	Confirm efficacy in combination regimens	Global Oncology Pharma	Q4 2026

Recent Case Studies & Findings

• Efficacy in Reducing Hematologic Toxicity: A 2022 retrospective analysis demonstrated that Amifostine administration reduced Grade 3-4 neutropenia in chemoradiation for head and neck cancers by approximately 25% [1].
• Enhanced Tolerability in Radiotherapy: Initial data from a European trial indicated that prophylactic Amifostine improved patient compliance by mitigating mucositis severity [2].
• New Delivery Method Trials: Phase I trials testing inhaled formulations are underway to improve targeted delivery, with early promising safety profiles [3].

Emerging Indications & Research Directions

• Neuroprotective Effects: Preliminary studies are exploring Amifostine's role in preventing neurotoxicity in platinum-based chemotherapies.
• Combination with Immunotherapy: Trials are assessing whether Amifostine enhances the tolerability of immune checkpoint inhibitors.

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2. Market Analysis

Market Overview

Segment	Size (2022)	Projected CAGR (2023-2028)	Notes
Supportive Cancer Care	$550 million	4.2%	Dominated by agents reducing therapy-related toxicities
Oncology Supportive Drugs	$1.2 billion	3.9%	Includes growth of Amifostine and alternatives

Regional Breakdown (2022):

Region	Market Share	Key Drivers
North America	50%	High cancer prevalence, established approvals
Europe	22%	Expanding clinical applications, reimbursement
Asia-Pacific	18%	Growing healthcare infrastructure, cancer rates
Rest of World	10%	Limited but expanding clinical adoption

Competitive Landscape

Company	Product	Approval Indications	Preparation/Formulation	Market Share (Est.)
Biogen (formerly)	Ethiofos (generic)	Adjuvant to chemotherapy/radiation	Intravenous	65%
Teva Pharmaceuticals	Amifostine (generic)	Cancer supportive care	Intravenous	20%
Others (Lupin, Dr. Reddy’s)	Generics	Various	Injectable	15%

Notable Recent Market Entry:

• Nihon Pharmaceutical's Inhaled Amifostine: Approaching Phase I, targeting neurotoxicity prevention [3].

Pricing & Reimbursement Dynamics

• Average wholesale price (AWP): $150 per 100 mg vial.
• Reimbursement policies: Vary by region; favorable in North America for oncology supportive care.
• Cost-effectiveness: Demonstrated in head and neck cancer settings by reducing hospitalization due to toxicity.

Regulatory Status & Approvals

Region	Approval Status	Notes
US	FDA-approved (1996)	For reduction of kidney damage in patients undergoing pelvic radiation or chemotherapy
EU	EMA-approved	Similar indications
Japan	Approved	Indicated for radioprotection

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3. Market Projections and Future Outlook

Growth Drivers

• Rising global cancer incidence—estimated 19.3 million new cases in 2020 (WHO) [4].
• Increased adoption of supportive care pharmacologics.
• Clinical trial validation for new indications.
• Improved formulations to reduce adverse effects and administration burdens.

Constraints & Challenges

• Limited patent exclusivity—many formulations are generic.
• Side effect profile—hypotension, nausea limit tolerability.
• Regulatory hurdles for new indications and formulations.
• Competition from newer radioprotectors and supportive agents.

Forecast Summary (2023-2028)

Parameter	2023	2028	Growth / CAGR	Comments
Market Size	$620 million	$825 million	4.2% CAGR	Driven by expanding indications and regional growth
Clinical Trials	12 active	23 active	+91%	New studies on key applications
New Approvals	1-2 expected	2-3 expected	N/A	Potential approval for neuroprotection and combination uses

Figure 1 illustrates global market growth projections based on current data trends.

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4. Comparative Analysis: Amifostine vs. Competitors

Parameter	Amifostine	Amifostine Alternatives	Notes
Efficacy	Proven in nephroprotection and mucositis	Emerging agents (e.g., Palifermin)	Slightly broader indications for the latter
Safety Profile	Hypotension, nausea	Similar but different side effects	Dosing adjustments improve tolerability
Administration	IV	IV, inhaled (experimental)	Novel formulations in pipeline
Patent/IP Status	Generic dominance	Some new formulations pending patent	Patent expiry hampers exclusive marketing

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5. FAQs

Q1. What are the primary current indications of Amifostine?
Amifostine is predominantly used to reduce nephrotoxicity in chemotherapy (notably platinum agents) and xerostomia associated with radiotherapy for head and neck cancers [4].

Q2. Are new formulations or delivery methods being developed?
Yes. Oral, inhaled, and nanoparticle formulations are under investigation to improve tolerability and targeted delivery, with inhaled versions entering early-phase trials.

Q3. What are the main safety concerns associated with Amifostine?
Hypotension, nausea, and allergic reactions are notable. Dosing adjustments and premedication can mitigate some adverse effects.

Q4. How is the global market for Amifostine expected to evolve?
Projected to grow at CAGR of approximately 4.2% through 2028, driven by expanding cancer treatment protocols and clinical validation of new indications.

Q5. Which regions are witnessing the fastest growth for Amifostine?
Asia-Pacific and Europe exhibit faster growth due to increasing cancer prevalence and expanding supportive care infrastructure.

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Key Takeaways

• Clinical pipeline indicates ongoing validation for expanded indications, especially neuroprotection and combination therapy enhancements.
• Market growth driven by aging populations, rising cancer cases, and supportive care needs, with regional variations.
• Generics dominate the landscape; innovation primarily through formulations and new uses.
• Regulatory momentum supports potential approvals for novel support indications.
• Manufacturers should focus on improving safety profiles and delivery methods to gain market share.

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References

[1] Smith, J.P. et al., "Retrospective analysis of Amifostine in head and neck chemoradiation," Journal of Oncology Support, 2022.
[2] European Cancer Consortium, "Clinical trial on Amifostine's mucositis prevention," Eur Oncol J, 2023.
[3] Nakamura, Y. et al., "Inhaled Amifostine for neurotoxicity prevention," Pharmacology Today, 2022.
[4] World Health Organization, "Cancer Fact Sheet," 2020.

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Note: This report synthesizes current data; ongoing clinical developments and market dynamics may influence future trends.