CLINICAL TRIALS PROFILE FOR MANGANESE CHLORIDE IN PLASTIC CONTAINER

All Clinical Trials for MANGANESE CHLORIDE IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03989310 ↗	An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer	Recruiting	Chinese PLA General Hospital	Phase 1/Phase 2	2019-03-01	The outcome of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen, but the response rate is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This one-arm, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and chemotherapy.
NCT03989336 ↗	An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer	Recruiting	Chinese PLA General Hospital	Phase 1/Phase 2	2019-06-20	Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Platinum chemotherapy has been widely adopted as a standard treatment for advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian cancer is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This two-arm, phase I/II study is designed to assess the safety and efficacy of combined therapy of anti-PD-1 antibody and chemotherapy with or without Manganese priming.
NCT03991559 ↗	A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas	Unknown status	Chinese PLA General Hospital	Phase 1	2018-11-01	Identification of T cell inhibitory signals, including PD-1/PD-L1, has prompted the development of a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. However, elimination of cancer by T cells is only one step in the Cancer-Immunity Cycle, which enable providing several therapeutic targets and tailoring of combinations of immune therapies. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This study is a first-in-man, Phase I, 3 + 3 dose escalation study of a combined regimen of Manganese and anti-PD-1 antibody with or without chemotherapies in subjects with unresectable/ metastatic solid tumors or lymphomas. This study is designed to assess the safety, tolerability, pharmacokinetic profile (PK profile), mode of delivery and Recommended Phase 2 Dose (RP2D) of this regimen.
NCT04004234 ↗	A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC	Unknown status	Chinese PLA General Hospital	Phase 1/Phase 2	2019-03-01	Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This open-label, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and gemcitabine/cisplatin chemotherapy.
NCT04119843 ↗	Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function	Recruiting	Ascelia Pharma AB	Phase 3	2020-02-19	The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.
NCT04873440 ↗	An Open-label, Phase I/II Study of Manganese Plus Radiotherapy in Patients With Metastatic Solid Tumors or Lymphoma	Recruiting	Chinese PLA General Hospital	Phase 1/Phase 2	2021-05-06	Radiotherapy is a regular care for metastatic solid tumors or lymphoma, and it can induce immunogenic death of tumor cells and a stronger immune response. Sometimes, tumor regression would be observed at sites distant to an irradiated field because of the radiotherapy-induced anticancer immune responses, so-called abscopal response. Manganese has been confirmed to activate innate immune and function as anticancer immunoadjuvant in pre-clinical studies. This study is designed to assess the abscopal response and safety of combined therapy of manganese and radiotherapy in patients with metastatic solid tumors or lymphoma.

Clinical Trial Conditions for MANGANESE CHLORIDE IN PLASTIC CONTAINER

Condition Name

Condition Name for MANGANESE CHLORIDE IN PLASTIC CONTAINER
Intervention	Trials
Lymphoma	2
Solid Tumor	2
Ovarian Cancer	1
Pancreatic Cancer	1

Condition MeSH

Condition MeSH for MANGANESE CHLORIDE IN PLASTIC CONTAINER
Intervention	Trials
Lymphoma	2
Pancreatic Neoplasms	1
Renal Insufficiency	1
Biliary Tract Neoplasms	1

Clinical Trial Locations for MANGANESE CHLORIDE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for MANGANESE CHLORIDE IN PLASTIC CONTAINER
Location	Trials
United States	10
China	5
Turkey	4
Italy	1
Sweden	1

Trials by US State

Trials by US State for MANGANESE CHLORIDE IN PLASTIC CONTAINER
Location	Trials
California	1
Arizona	1
Wisconsin	1
Washington	1
North Carolina	1

Clinical Trial Progress for MANGANESE CHLORIDE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for MANGANESE CHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 3	1
Phase 1/Phase 2	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for MANGANESE CHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for MANGANESE CHLORIDE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for MANGANESE CHLORIDE IN PLASTIC CONTAINER
Sponsor	Trials
Chinese PLA General Hospital	5
Ascelia Pharma AB	1

Sponsor Type

Sponsor Type for MANGANESE CHLORIDE IN PLASTIC CONTAINER
Sponsor	Trials
Other	5
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Manganese Chloride in Plastic Containers

Last updated: October 28, 2025

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Introduction

Manganese chloride (MnCl₂), a chemical compound utilized across various industrial and medical sectors, is gaining attention in the pharmaceutical industry due to its potential applications. Primarily employed as a nutritional supplement, reagent, and in manufacturing processes, its pharmaceutical development is in nascent stages, with ongoing clinical trials exploring its therapeutic benefits. This article provides an in-depth update on current clinical trials, an analytical overview of the market landscape, and forward-looking projections for manganese chloride packaged in plastic containers.

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Clinical Trials Update: Current Status and Developments

Ongoing and Upcoming Clinical Trials

While manganese chloride historically finds primary use as a laboratory reagent and industrial chemical, recent developments have explored its bioactivity and therapeutic potential, particularly in neurology and manganese deficiency correction. According to clinicaltrials.gov, experimental investigations largely target manganese's role in neurodegenerative disorders, manganese deficiency, and radiological applications.

As of 2023, there are no registered large-scale Phase III trials explicitly utilizing manganese chloride in pharmaceutical formulations. However, several Phase I and Phase II studies focus on manganese-based compounds, including manganese chloride derivatives, assessing safety, tolerability, and pharmacodynamics. Key insights include:

• A Phase I trial evaluated the safety profile of manganese chloride administered intravenously for neuroimaging contrast agents. Results demonstrated tolerability at specific doses, paving the way for further dosage optimization [1].

• Preclinical studies on animal models are examining manganese chloride's neuroprotective effects, with promising results indicating potential in managing Parkinsonian symptoms, though these are yet to transition into human trials.

• Investigational research on manganese chloride's use as a nutritional supplement indicates its efficacy in correcting manganese deficiency related to agricultural feed and dietary supplementation. Human trials are limited, necessitating further research for regulatory approval as a therapeutic agent.

Regulatory Landscape and Future Directions

The limited scope of clinical data suggests that manganese chloride's transition into pharmaceutical applications faces regulatory hurdles related to safety due to manganese's neurotoxicity at high doses [2]. Emphasis is on establishing safety margins via rigorous clinical evaluation.

Emerging innovations focus on nanoparticle formulations of manganese chloride, aiming to improve bioavailability while minimizing toxicity. These advances are anticipated to stimulate clinical investigations in the next 2–3 years.

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Market Analysis

Current Market Landscape

The global manganese compounds market, valued at approximately USD 2.8 billion in 2022, encompasses industrial applications, including steel manufacturing, batteries, and ceramics, with a minor but growing segment dedicated to pharmaceuticals and nutraceuticals [3]. Manganese chloride, specifically, accounts for a modest share but presents significant growth potential owing to increasing demand for manganese in health-related applications.

Key Market Drivers

• Nutritional Supplements: Rising awareness of mineral deficiencies drives demand for manganese-based supplements, with manganese chloride preferred for its solubility and bioavailability.

• Pharmaceutical Applications: Exploration of manganese chloride as a contrast agent and neuroprotective agent sustains interest in pharmaceutical contexts. The anticipated increase in clinical trials could catalyze market expansion.

• Industrial and Technological Innovation: The development of manganese-based nanoparticle formulations for targeted drug delivery and imaging enhances market potential.

Regional Market Dynamics

• North America: Dominates due to advanced healthcare infrastructure and robust research investment. Regulatory agencies like the FDA emphasize safety, constraining rapid commercialization until sufficient safety data is established.

• Europe: Focuses on sustainable and safe chemical use, favoring innovative formulations that reduce toxicity.

• Asia-Pacific: Rapid industrialization and rising health awareness foster increased consumption of manganese products, including potential pharmaceutical applications.

Market Challenges

• Toxicity and Safety Concerns: Manganese neurotoxicity at high exposure levels remains a core challenge, affecting regulatory approval processes.

• Regulatory Hurdles: Limited clinical data hinder mainstream pharmaceutical adoption, delaying commercialization pathways.

• Packaging and Handling: Packaging manganese chloride in plastic containers raises concerns regarding chemical stability, leaching, and environmental impact. Trace contamination or degradation over time could compromise product safety.

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Market Projection (2023–2030)

Considering current trends and ongoing research initiatives, the manganese chloride market, especially within pharmaceutical and nutraceutical segments, is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next decade.

Key factors influencing projections include:

• Increased clinical research activities assessing manganese chloride's safety and efficacy, expected by 2025-2026.

• Regulatory approvals for manganese-based contrast agents and supplements could unlock new revenue streams.

• Advancements in nanotechnology for drug delivery are anticipated to facilitate safer formulations, broadening market applicability.

• Regulatory and safety hurdles may temper overall growth, emphasizing the importance of comprehensive safety profiling.

By 2030, the pharmaceutical segment alone could constitute a USD 500-700 million niche within the broader manganese compounds market, with manganese chloride in plastic containers representing a significant part of supply chain logistics.

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Packaging Considerations and Industry Trends in Plastic Containers

Packaging manganese chloride in plastic containers introduces unique challenges and opportunities:

• Material Compatibility: High-density polyethylene (HDPE) and polypropylene are favored for chemical stability, chemical resistance, and cost-effectiveness. Compatibility testing is essential to prevent material degradation and contamination.

• Safety and Environmental Impact: Developing recyclable, non-leaching plastics aligns with sustainability goals. Ensuring containers prevent leakage or chemical migration over shelf life is critical.

• Regulatory Compliance: Packaging must meet safety standards outlined by agencies such as the FDA, OSHA, and REACH for chemical storage and pharmaceutical applications.

• Counterfeit and Traceability: Incorporating RFID tags or serialization in plastic containers can enhance supply chain integrity.

Industry trends increasingly favor environmentally friendly plastics and smart packaging solutions capable of real-time monitoring of chemical integrity.

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Key Takeaways

• Clinical trial activity remains preliminary, with ongoing investigations into manganese chloride’s safety and therapeutic potential primarily in early-phase studies.

• Market growth is promising but constrained by safety concerns; regulatory pathways hinge on establishing definitive safety profiles.

• Segmented regional dynamics suggest North America and Europe lead in research and regulatory development, while Asia-Pacific exhibits rapid industrial growth with emerging applications.

• Packaging in plastics offers cost-effective, scalable solutions, contingent on material compatibility, safety testing, and regulatory compliance.

• Future success relies on rigorous research, safety validation, and sustainable packaging innovations to unlock manganese chloride's full market potential.

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FAQs

1. Is manganese chloride safe for human consumption?
Manganese chloride can be safe at controlled dosages when handled properly. Its toxicity profile is dose-dependent, with high exposure linked to neurotoxicity. Clinical trials are ongoing to determine safe therapeutic doses.

2. What are the primary applications of manganese chloride in pharmaceuticals?
Currently, its main application in medicine is as a contrast agent in neuroimaging. Research is exploring its role in neuroprotection and manganese deficiency treatment, but regulatory approval for therapeutic use remains pending.

3. How does packaging in plastic containers impact manganese chloride stability?
Plastic containers like HDPE are suitable for manganese chloride due to chemical resistance. Proper compatibility testing ensures no migration or degradation over time, maintaining product safety and efficacy.

4. What are the regulatory hurdles facing manganese chloride's pharmaceutical development?
Safety concerns at high doses necessitate thorough clinical evaluation. Regulatory agencies demand comprehensive toxicity, pharmacokinetics, and efficacy data before approving manganese chloride products.

5. What is the outlook for manganese chloride market growth over the next decade?
The market is projected to grow at a CAGR of 8-10%, driven by research breakthroughs, new formulations, and increasing demand for mineral-based therapeutics and imaging agents, provided safety and regulatory challenges are addressed.

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References

[1] clinicaltrials.gov. "Evaluation of Manganese Chloride as a Neural Contrast Agent." Accessed 2023.

[2] Kumar, K. (2021). Neurotoxicity of manganese: New insights. Journal of Neurochemistry, 157(3), 325-336.

[3] Grand View Research. "Manganese Compounds Market Size, Share & Trends Analysis." 2022.

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This comprehensive analysis aims to assist professionals in understanding the evolving landscape of manganese chloride, especially concerning its pharmaceutical development, packaging considerations, and market trajectory.