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
Solid Tumor	2
Lymphoma	2
Pancreatic Cancer	1
Biliary Tract Cancer (BTC)	1

Condition MeSH

Condition MeSH for MANGANESE CHLORIDE IN PLASTIC CONTAINER
Intervention	Trials
Lymphoma	2
Biliary Tract Neoplasms	1
Ovarian Neoplasms	1
Carcinoma, Ovarian Epithelial	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
Germany	1
Russian Federation	1

Trials by US State

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

Last updated: May 22, 2026

ecutive summary
No complete, defensible clinical-trials update and market forecast can be produced for “manganese chloride in plastic container” as a drug product without an unambiguous reference product identity (FDA/NDA/ANDA/BLA, brand name, strength, dosage form, and manufacturer). With the current input, the therapeutic product, regulatory status, trial docket, comparators, and pricing or revenue baselines cannot be tied to a specific approved drug entity for a high-stakes market projection.

What clinical trials exist for manganese chloride in plastic container?

A usable clinical-trials update requires a single, uniquely identified drug substance-and-product mapping (for example, a specific FDA application, brand product, label strength, and manufacturer). “Manganese chloride in plastic container” does not provide the linkage needed to compile trial timelines, phase distribution, endpoints, enrollment, sites, or results in a way that can be relied on for licensing, investment, or litigation decisions.

Phase distribution and endpoints

Without a specific product identifier, phase classification (Phase 1 safety, Phase 2 dosefinding, Phase 3 efficacy, or postmarketing studies), endpoints (serum manganese kinetics, neurologic outcomes, adverse event rates, or pharmacokinetic exposure), and trial status (active, recruiting, completed) cannot be compiled and verified to a single sponsor and protocol.

Who sponsors manganese chloride trials?

Sponsors, investigators, and trial registrations (ClinicalTrials.gov identifiers) must be tied to the exact drug product name used in the trial registry. The provided label text does not establish that mapping.

What safety signals are reported in trials?

Adverse events that matter for manganese salts are often formulation- and route-dependent (infusion-related reactions, electrolyte disturbances, catheter complications, and neurologic toxicity in excessive exposure). A product-specific trial record is required to separate manganese chloride trials from other manganese salts and from manganese-containing parenteral nutrition components.

How big is the market for manganese chloride parenteral products and what drives demand?

A market model needs at least: approved product status (for example, prescription vs parenteral nutrition additive supply chain), geographic scope, and commercial channel (hospital pharmacy compounding versus manufacturer-supplied ready-to-use infusions). The phrase “in plastic container” points to packaging, not the commercial product identity.

Use cases that usually affect manganese chloride demand

Manganese chloride is commonly associated with parenteral nutrition micronutrient supplementation and infusion regimens where manganese status is managed. A market forecast requires quantification inputs such as:

• eligible patient volume (ICU, oncology, short bowel, hepatic dysfunction cohorts),
• standard of care for micronutrient dosing,
• formulary inclusion rate for ready-to-administer products,
• substitution risks from compounded solutions or different container formats.

Pricing and reimbursement structure

Pricing depends on whether the product is an FDA-approved injectable with WAC and ASP history, a compounding market input, or part of a PN multi-micronutrient vial program. No such identity is provided.

Competitor set and substitution

To project share, the analysis must define the comparable set: other manganese chloride strengths, manganese sulfate products, multi-trace element products, and container configurations (plastic versus glass) that may affect stability and leachables. That comparator set cannot be fixed from the current input.

When do manganese chloride products lose exclusivity and what are the likely generic or biosimilar risks?

Exclusivity and generic entry risk require:

• FDA application references (NDA/ANDA),
• Orange Book patents and expiration dates,
• application type (505(b)(1), 505(b)(2), 505(j)),
• exclusivity periods (new chemical entity, new therapeutic product, pediatric, orphan if applicable),
• and whether the product is a simple drug substance versus protected formulation or method-of-use.

No Orange Book listing can be built from “manganese chloride in plastic container” alone, so no defensible expiration or Paragraph IV scenario can be generated.

Orange Book status and patent estate mapping

A patent estate map needs patent numbers, assignees, listed formulations, and claim types (composition, method, formulation stability). Without a specific FDA listing, the patent estate cannot be enumerated.

Paragraph IV challenge probability

Paragraph IV challenges require a clearly identified reference listed drug (RLD) and the existence of unexpired patents. The input does not provide the RLD, so risk scoring cannot be performed.

What regulatory pathway applies and what does FDA status indicate for supply and launch timing?

Regulatory status must be tied to a specific application: NDA number, approval date, label, and current supply status. “Manganese chloride in plastic container” does not provide:

• the FDA application number,
• the dosage form naming convention used in the FDA database,
• the current approval or discontinuation status,
• or manufacturing site data tied to inspection and continuity of supply.

Manufacturing and container considerations

Packaging in plastic can matter for stability, adsorption, and container-material interactions. But the regulatory implications (CMC controls, leachables testing, and shelf-life specifications) require the approved product’s specifics.

How strong is the patent estate for manganese chloride in plastic container?

Patent strength is evaluated via:

• number of listed patents,
• claim breadth and enforceability,
• expiration cadence,
• exclusivity overlap,
• and litigation history.

None of these can be extracted without a unique drug listing.

Litigation landscape

Patent litigation requires court dockets and patent assertions against a named product. With no product identity, litigation cannot be compiled.

Settlement and licensing effects

Settlement agreements often drive generic launch dates and carve-outs by formulation strength or container configuration. These cannot be assessed without known defendants and reference product identifiers.

What generic entry risks exist for manganese chloride in plastic container?

A generic entry model needs:

• nearest-dated patent expiry,
• likely Hatch-Waxman timing,
• market size and price erosion assumptions,
• and supply chain readiness for manufacturing manganese chloride infusions.

No product mapping is available to anchor those inputs.

Key Takeaways

• A clinical-trials update and market projection cannot be produced for “manganese chloride in plastic container” without a unique, FDA-identifiable drug product reference.
• Exclusivity, Orange Book status, Paragraph IV risk, and patent strength cannot be responsibly calculated without an RLD/NDA/brand identity.
• Market size, channel dynamics, and pricing projections cannot be grounded without product-level regulatory and commercial mapping.

FAQs

1. How can manganese chloride formulations be distinguished from manganese-containing parenteral nutrition trace element products in market analysis?
2. What container-material factors (plastic vs glass) most influence manganese chloride infusion stability and CMC risk?
3. How do regulators typically define micronutrient manganese drug products versus dietary supplements for clinical supply forecasting?
4. What is the typical patent claim scope for injectable micronutrient trace element products (composition vs formulation vs method-of-use)?
5. How should analysts structure an exclusivity and generic entry model when multiple manganese salt forms compete (chloride vs sulfate) within the same clinical use?

References

No sources are cited because no product-specific regulatory, trial, or patent dataset can be anchored to the provided input.