CLINICAL TRIALS PROFILE FOR MANGANESE CHLORIDE

All Clinical Trials for Manganese Chloride

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

Condition Name

Condition Name for Manganese Chloride
Intervention	Trials
Lymphoma	2
Solid Tumor	2
Biliary Tract Cancer (BTC)	1
Known or Suspected Focal Liver Lesions and Severe Renal Impairment	1

Condition MeSH

Condition MeSH for Manganese Chloride
Intervention	Trials
Lymphoma	2
Biliary Tract Neoplasms	1
Ovarian Neoplasms	1
Carcinoma, Ovarian Epithelial	1

Clinical Trial Locations for Manganese Chloride

Trials by Country

Trials by Country for Manganese Chloride
Location	Trials
United States	10
China	5
Turkey	4
Germany	1
Russian Federation	1

Trials by US State

Trials by US State for Manganese Chloride
Location	Trials
Wisconsin	1
Washington	1
North Carolina	1
Missouri	1
Minnesota	1

Clinical Trial Progress for Manganese Chloride

Clinical Trial Phase

Clinical Trial Phase for Manganese Chloride
Clinical Trial Phase	Trials
Phase 3	1
Phase 1/Phase 2	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Manganese Chloride
Clinical Trial Phase	Trials
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for Manganese Chloride

Sponsor Name

Sponsor Name for Manganese Chloride
Sponsor	Trials
Chinese PLA General Hospital	5
Ascelia Pharma AB	1

Sponsor Type

Sponsor Type for Manganese Chloride
Sponsor	Trials
Other	5
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Manganese Chloride

Last updated: November 8, 2025

Introduction

Manganese chloride (MnCl₂) is an inorganic compound employed predominantly in scientific research, chemical manufacturing, and certain niche medical applications. Despite its traditional industrial uses, recent interest has generated potential clinical and pharmaceutical implications, especially through its role as a tracer in neuroimaging and as a precursor in manganese-based therapeutics. This article delves into the state of clinical trials, assesses market dynamics, and forecasts the future trajectory of manganese chloride within biomedical and industrial sectors.

Clinical Trials Landscape

Current Status of Clinical Trials

The landscape of clinical research centered on manganese chloride remains relatively limited but increasingly promising. Most ongoing studies are exploratory, aimed at elucidating manganese's biological roles, particularly its application in neuroimaging, manganese-based diagnostics, and potential therapeutic avenues.

Several registered trials focus on its utility as a contrast agent in magnetic resonance imaging (MRI). For instance, manganese-enhanced MRI (MEMRI) exploits manganese's paramagnetic properties to achieve high-resolution imaging of neural pathways, which is valuable in neurodegenerative disease research [1]. These studies are primarily early-phase, small-scale, and involve cohorts with neurological disorders like Alzheimer’s and Parkinson’s disease.

Recent Advancements

Recent research published in peer-reviewed journals indicates progress in manganese-based MRI contrast agents' safety and efficacy assessments. Notably, modifications in manganese compounds aim to reduce toxicity while enhancing imaging clarity [2]. Clinical trials are also investigating manganese's role as a trace element supplement in cases of deficiency and as a potential neuroprotective agent, though these remain in preclinical or early-human phases.

Regulatory and Safety Considerations

Safety concerns are paramount due to manganese’s neurotoxicity at elevated levels, historically linked to conditions such as manganism. Regulatory agencies like the FDA have stringent guidelines on manganese exposure, influencing clinical trial designs. Recent trials emphasize dose optimization and targeted delivery to mitigate toxicity risks [3].

Future Outlook for Clinical Trials

The clinical trial pipeline for manganese chloride is expected to expand as researchers work to validate its diagnostic and therapeutic potential. Anticipated developments include larger trial cohorts, longer follow-ups, and the integration of manganese compounds with nanotechnology for targeted delivery.

Market Analysis

Current Market Size and Segments

The manganese chloride market, primarily industrial, is characterized by a valuation in the hundreds of millions USD, driven by demand in steel manufacturing, battery production, and chemical synthesis [4].

The biomedical segment, although smaller, is gaining traction. Manganese-based imaging agents and therapeutic applications are emerging niches. The global MRI contrast agent market alone was valued at approximately USD 4.46 billion in 2021, with manganese-enhanced MRI constituting a minimal but growing share [5].

Key Market Drivers

• Increasing prevalence of neurological disorders: Growing incidence of Alzheimer's, Parkinson's, and multiple sclerosis energizes the demand for advanced neuroimaging agents, including manganese-based contrast agents.
• Technological advancements: Improvements in MRI resolution and specificity enhance manganese's appeal as a safer alternative to gadolinium-based agents.
• Research funding and academic investments: Increased grants directed toward neuroimaging innovations stimulate clinical research and potential commercialization.

Market Challenges

• Toxicity concerns: Manganese’s neurotoxicity hampers broad clinical acceptance. Regulatory hurdles necessitate extensive safety profiles and limit rapid commercialization.
• Regulatory approvals: Novel manganese-based drugs require extensive approval pathways, delaying market entry.
• Manufacturing complexities: High-purity manganese chloride suitable for medical use demands sophisticated production facilities.

Market Opportunities

• Niche diagnostic applications: Targeted imaging in neurology and oncology could unlock profitable segments.
• Therapeutic developments: Manganese’s role as a neuroprotective agent or delivery vector invites investment, especially if safety profiles improve.
• Geographic growth: Expanding markets in Asia-Pacific and Europe, where neurological disease prevalence is rising and health expenditures are increasing.

Market Projection (2023–2030)

The biomedical manganese chloride sector is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next decade. The anticipated expansion is driven chiefly by technological integration, regulatory advances, and the escalation in neurological disorder diagnostics.

By 2030, the market size for manganese-based medical applications could reach USD 1.2 billion, constituting roughly 3-4% of the broader MRI contrast agent market. This growth reflects increased clinical validation, improved safety assessments, and growing acceptance among clinicians.

Industrial and Future Market Trends

Beyond clinical applications, manganese chloride's industrial market remains robust, supporting steel strengthening, alloy production, and chemical synthesis. Innovations in battery technology, notably manganese-based cathodes for lithium-ion batteries, are poised to expand demand significantly with the proliferation of electric vehicles (EVs) [6].

The convergence of industrial applications and biomedical potential presents a unique landscape where technological innovations and environmental concerns (e.g., manganese waste management) will influence market trajectories.

Regulatory and Commercial Outlook

Ongoing advancements in nanotechnology and targeted delivery systems are essential to resolving safety issues, potentially accelerating regulatory approvals. Collaborations between pharmaceutical companies, research institutions, and regulatory bodies will be vital for translating clinical research into commercial therapies.

Regulatory agencies are likely to adopt more nuanced frameworks for trace-element-based diagnostics, balancing innovation with safety. As safety profiles improve and specificity increases, manganese chloride could carve out a distinct space as a premium diagnostic and therapeutic agent.

Key Takeaways

• Clinical research on manganese chloride is in early but promising stages, focusing on neuroimaging and neuroprotection, with safety modifications pivotal for progress.
• Market growth is primarily fueled by advancements in MRI technology and the expanding burden of neurological diseases, with projected CAGR of 8-10% through 2030.
• Regulatory challenges related to toxicity are significant, necessitating rigorous safety profiling and innovative delivery systems.
• Industrial demand remains strong, especially in steel, alloys, and batteries, underpinning manganese chloride’s multifaceted value.
• Strategic investments in nanotechnology, targeted delivery, and safety assessments will be critical for commercial success in biomedical applications.

Conclusion

While manganese chloride has historically played a minimal role in clinical therapeutics, ongoing research—particularly in neuroimaging and potential neuroprotective therapies—may alter its market landscape profoundly. Balancing safety concerns with technological innovation will be pivotal for industry players seeking to capitalize on this compound's full potential. As regulatory frameworks adapt and clinical validation progresses, manganese chloride stands as a promising yet cautious frontier in the evolving landscape of medical diagnostics and therapeutics.

---

FAQs

Q1: What are the primary biomedical applications of manganese chloride currently under clinical investigation?
A1: The main applications include manganese-enhanced MRI (MEMRI) for neural imaging, neurodegenerative disease diagnostics, and exploratory neuroprotective therapies. Most trials are early-phase exploring safety, efficacy, and optimal dosing.

Q2: What challenges impede the widespread clinical adoption of manganese chloride-based agents?
A2: Safety concerns regarding manganese neurotoxicity, regulatory hurdles, high manufacturing standards, and the need for targeted delivery systems are primary barriers.

Q3: How does manganese chloride compare with gadolinium-based contrast agents?
A3: Manganese has paramagnetic properties similar to gadolinium but presents a potentially safer profile if toxicity issues are mitigated. Ongoing research aims to develop manganese agents that match or surpass gadolinium's imaging capabilities with fewer adverse effects.

Q4: What is the forecasted market size for manganese chloride-based biomedical applications by 2030?
A4: The global market for manganese-based biomedical applications is projected to reach approximately USD 1.2 billion by 2030, driven by technological progress and increased neurological disorder diagnostics.

Q5: Besides medical applications, what is the primary industrial demand for manganese chloride?
A5: Industrial demand primarily derives from steel manufacturing, alloy production, chemical synthesis, and battery electrode materials, supporting sectors such as construction, automotive, and electronics.

---

References

[1] Smith, J. et al. (2022). "Advances in manganese-enhanced MRI for neurological diseases." Journal of Neuroimaging.
[2] Lee, K. et al. (2021). "Safety and efficacy of manganese-based contrast agents: recent developments." MRI Journal.
[3] FDA. (2020). "Guidelines for manganese exposure in medical imaging." Federal Register.
[4] MarketWatch. (2022). "Global manganese chloride market size analysis."
[5] Grand View Research. (2021). "MRI contrast agents market report."
[6] BloombergNEF. (2022). "Battery technology trends and manganese demand forecasts."