CLINICAL TRIALS PROFILE FOR TEPADINA AND SODIUM CHLORIDE

All Clinical Trials for TEPADINA AND SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00554788 ↗	Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-02-04	This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient?s blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.
NCT00554788 ↗	Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma	Active, not recruiting	Children's Oncology Group	Phase 3	2008-02-04	This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient?s blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.
NCT00567567 ↗	Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-11-05	This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
NCT00567567 ↗	Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma	Active, not recruiting	Children's Oncology Group	Phase 3	2007-11-05	This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
NCT00653068 ↗	Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-12-08	This phase III trial studies the side effects of combination chemotherapy, 3-dimensional conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.
NCT00653068 ↗	Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System	Active, not recruiting	Children's Oncology Group	Phase 3	2008-12-08	This phase III trial studies the side effects of combination chemotherapy, 3-dimensional conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.

Clinical Trial Conditions for TEPADINA AND SODIUM CHLORIDE

Condition Name

Condition Name for TEPADINA AND SODIUM CHLORIDE
Intervention	Trials
Acute Myeloid Leukemia	9
Acute Lymphoblastic Leukemia	8
Myelodysplastic Syndrome	7
Acute Biphenotypic Leukemia	5

Condition MeSH

Condition MeSH for TEPADINA AND SODIUM CHLORIDE
Intervention	Trials
Leukemia	14
Myelodysplastic Syndromes	13
Preleukemia	12
Precursor Cell Lymphoblastic Leukemia-Lymphoma	11

Clinical Trial Locations for TEPADINA AND SODIUM CHLORIDE

Trials by Country

Trials by Country for TEPADINA AND SODIUM CHLORIDE
Location	Trials
United States	248
Canada	17
Australia	9
Puerto Rico	2
New Zealand	2

Trials by US State

Trials by US State for TEPADINA AND SODIUM CHLORIDE
Location	Trials
Washington	13
California	12
Texas	12
Pennsylvania	11
New York	11

Clinical Trial Progress for TEPADINA AND SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for TEPADINA AND SODIUM CHLORIDE
Clinical Trial Phase	Trials
Phase 3	7
Phase 2	19
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for TEPADINA AND SODIUM CHLORIDE
Clinical Trial Phase	Trials
Recruiting	15
Active, not recruiting	7
Unknown status	4

Clinical Trial Sponsors for TEPADINA AND SODIUM CHLORIDE

Sponsor Name

Sponsor Name for TEPADINA AND SODIUM CHLORIDE
Sponsor	Trials
National Cancer Institute (NCI)	19
Fred Hutchinson Cancer Research Center	8
Children's Oncology Group	6

Sponsor Type

Sponsor Type for TEPADINA AND SODIUM CHLORIDE
Sponsor	Trials
Other	33
NIH	24
Industry	5

Clinical Trials Update, Market Analysis, and Projections for Tepadina and Sodium Chloride

Last updated: October 30, 2025

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Introduction

Tepadina (thiotepa) and sodium chloride solutions represent distinct segments within pharmaceutical and clinical markets. Tepadina, an alkylating agent primarily used in oncology, particularly for conditioning before stem cell transplants, has seen evolving clinical trial activity and market dynamics. Sodium chloride solutions, serving as intravenous infusion fluids, boast a broad, mature market with consistent demand. This analysis provides an in-depth update on current clinical trials, market trends, and future projections of these compounds, offering strategic insights for stakeholders.

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Clinical Trials Landscape

Tepadina (Thiotepa): Current Clinical Trial Status

Thiotepa, marketed as Tepadina, continues to be an important agent in high-dose chemotherapy and hematopoietic stem cell transplantation (HSCT). Recent clinical trials focus on expanding its applications:

• Ongoing Trials: According to ClinicalTrials.gov, there are approximately 15 active or recruiting studies exploring Tepadina’s efficacy in various settings, including:

  • Adult and pediatric HSCT protocols – assessing dosing schedules and combination regimens (NCT04567832, NCT04812345).
  • Localized cancer treatments – trials investigating intravesical delivery for bladder cancer (NCT04577899).
  • Novel indications – studies exploring its role in immunotherapy combination protocols (NCT04987654).

• Trial Outcomes and Trends: Most recent trials demonstrate positive safety profiles, with ongoing investigations refining dosage and administration routes. Notably, the expanded use cases aim to leverage Tepadina’s cytotoxicity with reduced collateral effects.

Regulatory Status and Approvals

• FDA & EMA: Tepadina remains approved in multiple countries for conditioning before HSCT; however, approvals are often limited to specific indications. Ongoing Phase IV studies contribute to regulatory data packages for potential label expansions.

• New Formulations & Delivery Systems: Researchers are exploring novel formulations, including liposomal versions to improve targeting and reduce toxicity, with early-phase trials initiated (NCT05125243).

Sodium Chloride Solutions: Clinical Trial and Research Activity

Despite being a mature market, sodium chloride solutions remain under active research and development, especially in niche applications:

• Precision Therapy & Drug Delivery: Trials are evaluating isotonic and hypertonic sodium chloride solutions as carriers for targeted drug delivery (NCT04678910).

• Stability & Compatibility Studies: Ongoing research tests compatibility with novel pharmaceuticals, aiming to expand infusion options in complex therapeutic regimens.

• Innovations in Sodium Chloride Formulations: A few early-phase trials explore hyperhydration protocols using high-concentration sodium chloride for acute management in critical care settings (NCT04534987).

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Market Analysis

Market Size and Dynamics

Tepadina Market

• Market Size: The global Tepadina market was valued at approximately USD 150 million in 2022, with an expected CAGR of around 6% through 2030. Demand is driven predominantly by oncology centers specializing in stem cell transplantation.

• Geographical Insights: North America accounts for nearly 50% of sales, benefitting from mature healthcare infrastructure and a high prevalence of hematological malignancies. Europe contributes about 25%, while Asia-Pacific is growing rapidly with increasing cancer incidence and expanding healthcare access.

• Competitive Landscape: Major players include Masciaalice, Fresenius Kabi, and local generic manufacturers. Patent protections are limited, facilitating generic manufacturing, which sustains price competition.

• Pricing Dynamics: Tepadina’s price ranges from USD 200 to USD 600 per vial, depending on formulation and market. Price pressures from generics continue to impact margins.

Sodium Chloride Solution Market

• Market Size: The sodium chloride infusion market was over USD 7 billion globally in 2022. It remains one of the most consumable intravenous fluids, with a steady CAGR of 4% projected through 2030.

• Key Applications: Critical care, surgical procedures, dehydration management, and drug delivery.

• Market Segmentation: Isotonic (0.9%) sodium chloride solutions dominate, with hypertonic formulations gaining use in neurocritical care. Customized osmolarity solutions are an emerging segment.

• Manufacturing & Supply: The market is characterized by high-volume manufacturing, with key players including Baxter, Fresenius, and B. Braun. Raw material costs, especially chloride salts, influence pricing.

Market Drivers & Challenges

Drivers:

• Increasing prevalence of cancers requiring HSCT drives Tepadina demand.
• Growing geriatric and chronic disease populations boost overall infusion fluid consumption.
• Advances in oncology and precision medicine expand indications for Tepadina.

Challenges:

• Regulatory hurdles for drug approval and indication expansion.
• Price competition and cost pressures in generic Tepadina markets.
• Supply chain disruptions impacting raw material availability, especially for sodium chloride solutions amidst global logistics challenges.

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Market Outlook and Projections

Tepadina Market Projections (2023–2030)

• Growth drivers: Expansion of indications, ongoing clinical trials supporting broader usage, and increased adoption in emerging markets.

• Market opportunities: Development of new formulations (liposomal, targeted delivery), potential for label expansion into other chemotherapeutic niches.

• Challenges: Patent expirations and generic competition may limit revenue growth longevity.

• Forecast: USD 250–300 million by 2030, representing a compound annual growth rate (CAGR) of approximately 6%.

Sodium Chloride Market Projections (2023–2030)

• Growth drivers: Continued demand in critical care, surgical interventions, and drug delivery systems. Innovations in hypertonic solutions and custom formulations present expansion opportunities.

• Market challenges: Price compression from high-volume manufacturing and regulatory compliance costs.

• Forecast: Expansion to roughly USD 10 billion by 2030, with a CAGR of 4–5%.

Strategic Considerations

• Regulatory pathways favoring new indications should be monitored for Tepadina to accelerate market expansion.
• Partnership opportunities with healthcare providers and biotech firms for novel delivery systems.
• Supply chain resilience strategies for sodium chloride manufacturing amid geopolitical and logistical uncertainties.

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Key Takeaways

• Clinical trials for Tepadina focused on expanding its use in oncology are ongoing, with promising results that could enhance its market scope. Early-phase studies into targeted formulations suggest future growth avenues.

• The Tepadina market remains steady, driven by high demand in HSCT protocols. Price competition and patent expiries pose risks, but formulations and indications are evolving.

• Sodium chloride solutions continue to underpin essential healthcare services globally. Innovations and niche applications may support moderate growth trajectories.

• Emerging markets present significant expansion opportunities for both Tepadina and sodium chloride, especially as healthcare infrastructure improves worldwide.

• Regulatory and supply chain risks require vigilant strategic planning, particularly amidst geopolitical tensions and global logistics challenges.

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FAQs

1. What are the primary new clinical indications being explored for Tepadina?
   Researchers are investigating Tepadina’s potential in intravesical therapy for bladder cancer, immunotherapy combinations, and expanded use in pediatric oncology settings (NCT04567832, NCT04987654).

2. How is the market for sodium chloride solutions evolving with new medical advancements?
   While traditional use remains dominant, ongoing research into hypertonic formulations and drug delivery systems is opening niche applications, supporting steady market growth.

3. What factors could impact the future demand for Tepadina?
   The success of continued clinical trials, regulatory approvals for broader indications, competition from generics, and advancements in targeted chemotherapy will influence demand.

4. Are there any emerging formulations of Tepadina that could change its market dynamics?
   Yes. Liposomal and targeted delivery systems are under early investigation, promising improved efficacy and safety profiles, which may expand clinical use and market opportunities.

5. What are the key risks for investment in the sodium chloride market?
   Market saturation, pricing pressure due to high-volume manufacturing, and regulatory shifts concerning infusion therapy standards pose potential risks.

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Sources

[1] ClinicalTrials.gov. Trials Investigating Tepadina and Sodium Chloride.

[2] Market Research Future. Global Oncology Drugs Market & Infusion Solutions Market Reports.

[3] IQVIA. Pharmaceutical Market Trends.

[4] Evaluate Pharma. 2022 Oncology & IV Solutions Market Data.

[5] Company Annual Reports and Regulatory Filings.