CLINICAL TRIALS PROFILE FOR MANGANESE SULFATE

All Clinical Trials for manganese sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00010634 ↗	Complementary Naturopathic Medicine for Periodontitis	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 2	1999-09-01	This study aims to assess selected naturopathic medicines for adult periodontitis and to identify variables that influence successful outcomes when traditional and alternative approaches to preventing and treating periodontal diseases are combined. Collaboration between Kaiser Permanente, Oregon Health Science University and the National College of Naturopathic Medicine provides an unsurpassed environment for such investigations. Periodontitis is a major cause of tooth loss and negatively impacts systemic health. The limitations of traditional periodontal treatment have compelled scientists and clinicians to investigate new remedies, and naturopathic medicine holds several promising interventions. Because they are used to improve elements of host resistance that are known to be important in periodontal health and disease, three naturopathic medicines are potential adjuncts in preventing and treating periodontitis. Connective tissue components are enzymatically degraded in periodontitis. In naturopathy, Connective Tissue Nutrient Formula (CTNF) (vitamins A, C and D, glucosamine sulfate, oligoproanthocyanindins, copper, zinc, manganese, boron, silicon, magnesium, and calcium) is prescribed specifically to enhance the integrity of key connective tissue elements and improve their resistance to degradation. Periodontitis begins when permeability of the oral sulcular epithelium permits pathogenic bacterial components to invade deeper periodontal connective tissues. In naturopathy, glutamine is prescribed to reduce oral-intestinal epithelial membrane permeability. Chronic activation of the hypothalamic-pituitary-adrenal (HPA) axis during the stress response, is a risk factor for periodontitis. Adaptogenic herbs (AH) (Panax ginseng, Withania somnifera and Eleutherococcus senticosus) are prescribed by naturopathic physicians to reverse the impact of bacterial and psychosocial stressors. Because glutamine, CTNF and AH target pathophysiologic mechanisms known to underline periodontitis, they are compelling candidates in clinical and mechanistic investigations of complementary medicine approaches to the management of periodontitis. Kaiser Permanente adult periodontitis patients will serve as subjects and receive standard periodontal treatment. Three of the four randomly assigned groups will also receive supplements of glutamine, CTNF, or AH. We will determine the effects of these supplements on clinical outcomes (attachment loss, pocket depths, indicators of inflammation, plaque composition, need for periodontal surgery, acute periodontal problems, tooth loss). In addition to completing the battery of self-report measures (stress, coping, quality of life), study subjects will provide samples of blood, saliva, gingival cervicular fluid and bacterial dental plaque. These samples will be examined as part of the Laboratory Core to identify biologic and genetic characteristics that correlate with successful outcomes. Storage of portions of the samples will allow future examination of additional variables as part of the Developmental Projects carried out as the Craniofacial Complementary & Alternative Center is established and Phase III trials are undertaken.
NCT03824925 ↗	Efficacy of Zinc on Concurrent Chemo-radiotherapy Induced Taste Alterations	Completed	Dow University of Health Sciences	Phase 3	2016-12-01	Taste changes are common in cancer patients receiving concurrent chemoradiation which become a significant complaint and a cause of distress and morbidity. Loss of gustatory function further advances to malnutrition, weight loss, reduced quality of life, poor compliance and even diminished response to drug therapy. Taste is an essential sensation which serves oral intake of food and enables to prevent the ingestion of potentially harmful and poisonous substances. The sense of taste is crucial for an individual's well-being and psychological health. Taste changes may advance to reduced appetite, dietary insufficiency, food repulsion affecting body weight and anorexia further leading to impaired immunity, decline in health status and malnutrition. As taste impairment is not a life-threatening event therefore it might not be reported by some patients. Hence, this aspect is neglected despite being a common and distressing side-effect of chemoradiation. Due to the location of the cancer and the long-term effects of cancer therapies, patients with oral cavity cancers have a specially high prevalence of chemosensory disorders. Zinc is comparatively non-toxic if taken orally, and rather non-toxic in contrast to other trace metals such as manganese and iron. Zinc is an integral element in both the maintenance and repair of taste buds. It is involved in promoting the diffusion of taste stimuli to taste buds. Salivary zinc has been found in association with Gustin (carbonic anhydrase, CA VI), a zinc-metalloprotein enzyme that may be involved with providing nutrition to the human taste buds. Zinc influences the synthesis of gustin required for the growth, development, maintenance and production of taste buds and regulation of taste function. The hypothesis was: Null hypotheses: There is no difference in the taste acuity between test and control group with the administration of zinc sulfate. Alternative hypotheses: There is a difference in the taste acuity between test and control group with the administration of zinc sulfate. Thus, the present study aimed to observe changes in taste function of oral cancer patients by detection and recognition thresholds before beginning their treatment (before chemoradiation and intervention), at the end of chemoradiation and a month after and to evaluate the preventive effect of zinc sulfate on chemoradiation-induced taste changes. To the best of our knowledge, similar study has not been conducted before in our region.
NCT05451654 ↗	NanoMn®_COVID-19 A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus D	Recruiting	Medesis Pharma SA	Phase 1/Phase 2	2022-02-04	This is a prospective, multicenter, randomized (3:1), placebo- controlled, parallel-group, double-blind trial. Patients will be randomized into two arms of treatment: - Placebo + SoC (N=30) - NanoManganese® + SoC (N=90) Patients will be treated and followed-up for 10 days: - Arterial oxygen partial pressure (PaO2) will be measured at baseline and at days 3, 5 and 10, - Oxygen saturation, vital signs including respiration rate, pulse rate, blood pressure and body temperature, disease severity (7-point ordinal scale and NEWS2 score) will be measured at baseline and daily, - Hematology and biochemistry measurements will be done at baseline and at day 3, 5 and 10, - Pharmacokinetic (Blood Mn concentration) measurements will be done at baseline and at day 3, 5 and 10, - Biomarkers will be measured at baseline and at day 3, 5 and 10. At the end of the 10-day treatment period, a follow-up visit will be planned between day 15 and day 22. The following. assessments/examinations will be performed: oxygen saturation, vital signs including respiration rate and body temperature, disease severity (7-point ordinal scale and NEWS2 score), electrocardiogram (ECG), hematology, biochemistry, concomitant therapies, and adverse events.

Clinical Trial Conditions for manganese sulfate

Condition Name

Condition Name for manganese sulfate
Intervention	Trials
COVID-19 Pandemic	1
Periodontitis	1
Taste, Altered	1

Condition MeSH

Condition MeSH for manganese sulfate
Intervention	Trials
COVID-19	1
Dysgeusia	1
Periodontitis	1

Clinical Trial Locations for manganese sulfate

Trials by Country

Trials by Country for manganese sulfate
Location	Trials
Pakistan	1
United States	1
Brazil	1

Trials by US State

Trials by US State for manganese sulfate
Location	Trials
Oregon	1

Clinical Trial Progress for manganese sulfate

Clinical Trial Phase

Clinical Trial Phase for manganese sulfate
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for manganese sulfate
Clinical Trial Phase	Trials
Completed	2
Recruiting	1

Clinical Trial Sponsors for manganese sulfate

Sponsor Name

Sponsor Name for manganese sulfate
Sponsor	Trials
National Center for Complementary and Integrative Health (NCCIH)	1
Dow University of Health Sciences	1
Medesis Pharma SA	1

Sponsor Type

Sponsor Type for manganese sulfate
Sponsor	Trials
NIH	1
Other	1
Industry	1

Last updated: May 22, 2026

Manganese Sulfate Clinical Trials Update, Market Analysis and Forecast: Exclusivity, Competitive Landscape, and Regulatory Pathways

Manganese sulfate is a generic, commodity-grade mineral supplement used for oral and parenteral manganese replacement and as an ingredient in nutrition and pharmacologic preparations. The market is driven by (1) hospital and infusion demand for trace-element replacement, (2) enteral/parenteral nutrition (TPN/EN) protocols, and (3) disease- or deficiency-related use cases. IP and regulatory questions depend on whether the product is marketed as a nutritional ingredient versus a drug with specific dosing, concentration, and route-specific labeling. Competitive supply is dominated by established generic sterile and non-sterile manufacturers, with limited meaningful patent-driven exclusivity in the base substance.

What clinical trials exist for manganese sulfate (and what are the latest updates)?

Short answer: Public clinical-trial activity for manganese sulfate is typically embedded in deficiency/trace-element replacement studies, parenteral nutrition regimens, or broader comparative nutrition formulations rather than large, drug-development programs targeting manganese sulfate itself as a new active.

Where manganese sulfate trial endpoints usually appear

Trials and observational studies typically evaluate:

• Biochemical manganese status (blood/plasma, hair is less common in regulated endpoints)
• Safety outcomes tied to trace-element accumulation (hepatic/neurologic toxicity signals)
• Clinical outcomes tied to underlying conditions requiring manganese replacement (short bowel, malabsorption, chronic TPN patients)

Trial types seen in the space

• Interventional trace-element supplementation studies within EN/TPN protocols
• Comparative formulation studies (different trace-element mixes and concentrations)
• Safety pharmacology and tolerability components focused on accumulation risk

What to look for in the next update cycle

For investors and pipeline monitors, the most material “update” signals are:

• New protocols adding manganese at defined mg/day in TPN trace-element cocktails
• Label expansions tied to specific populations such as pediatric TPN or hepatic impairment
• Any switch from non-drug supplement labeling to drug-device combinations (less common)

How big is the manganese sulfate market today, and what’s driving demand?

Short answer: The market is primarily a hospital supply chain market for trace-element replacement and TPN-related nutrition formulations, plus retail dietary supplement demand for oral manganese. Pricing is typically commodity-linked, and growth tracks (1) utilization of parenteral and enteral nutrition and (2) macro trends in chronic GI disorders and long-term infusion care.

Demand drivers

• Parenteral nutrition intensity: Patients requiring long-duration TPN and facility protocols that use standardized trace-element additives
• Pediatric TPN programs: Higher dosing frequency in pediatric regimens, with tighter safety monitoring
• Malabsorption and short-bowel syndromes: Increased manganese deficiency screening and supplementation
• Regulatory and clinical practice: Protocol updates that standardize trace-element dosing

Pricing and margin reality

• Base manganese sulfate is commoditized.
• Margin depends on whether the product is supplied as a sterile injectable, a defined-concentration TPN additive, or a retail supplement with brand differentiation.
• Sterile and packaged-infusion presentation increases cost-to-serve and can preserve modest profitability versus bulk chemical sales.

Who are the key manufacturers and suppliers competing in manganese sulfate?

Short answer: Competition typically sits across generic chemical suppliers, sterile injectables manufacturers, and nutrition component suppliers that formulate trace-element mixes.

Competitive categories

1. Bulk/commodity manganese sulfate producers
2. API-to-formulation manufacturers for TPN additives
3. Sterile injectable packaged suppliers
4. Retail oral supplement brands using manganese sulfate as an ingredient

What matters commercially

• Ability to supply sterile, stable, and infusion-compatible packaging at scale.
• Availability of manganese sulfate in trace-element mix formats used by nutrition compounding pharmacies and product lines.
• Supply reliability during global logistics or raw material cycles.

What is the regulatory status of manganese sulfate in the US and EU?

Short answer: Manganese sulfate is generally regulated as a dietary ingredient for oral use and as an ingredient in injectable nutrition products, with specific marketed products holding distinct regulatory pathways based on dosage form and labeling claims.

US regulatory treatment

• If marketed as a nutrient/supplement: it is subject to dietary supplement framework.
• If marketed in a regulated injectable nutrition product: it can be an approved drug component within a broader approved product, or an ingredient in an FDA-regulated sterile preparation depending on how it is marketed and compounded.

EU regulatory treatment

• Oral manganese sulfate generally aligns with food supplement regulation in member states.
• Injectable trace-element products fall under medicinal product authorization frameworks for the finished dosage form, not the bulk chemical itself.

What patents protect manganese sulfate, and how strong is the patent estate?

Short answer: The manganese sulfate molecule itself is old and generally not protected by meaningful composition-of-matter patents in most jurisdictions. The practical IP protection tends to be:

• Formulation patents (concentration, stabilizers, delivery system)
• Manufacturing processes (sterility, impurity control, particle size where relevant)
• Method-of-use claims tied to specific dosing schedules or patient populations
• Patents on branded finished dosage forms or combination trace-element products

Where patent value usually concentrates

• Sterile injectable presentations: stability and shelf-life improvements
• TPN trace-element blends: fixed compositions and administration regimens
• Pediatric protocols: dosing schedules and safety thresholds if claimed
• Controlled impurities: defined impurity limits can support formulation-specific filings

When does manganese sulfate lose exclusivity, and is there any Orange Book exclusivity?

Short answer: Because manganese sulfate is typically a generic/commodity substance, exclusivity at the API level is usually not the driver. Exclusivity, where it exists, tracks the finished dosage form or specific formulation product approvals.

Orange Book and exclusivity reality

• For manganese sulfate as an API ingredient, Orange Book exclusivity is unlikely to be meaningful.
• For specific finished products that list manganese sulfate in a trace-element injection format, exclusivity depends on that product’s NDA/ANDA history and listed patents.

Practical approach to launch timing

• Monitor the finished-product labeling and patent listings (where applicable).
• The competitive question is usually whether a manufacturer has a commercially protected finished product and whether that product still has unexpired listed patents.

Which companies are challenging manganese sulfate products via Paragraph IV?

Short answer: Paragraph IV challenges are typically associated with finished injectable or oral drug products with active patent listings. For manganese sulfate as a commodity ingredient, Paragraph IV activity is usually limited or not publicly prominent unless a specific branded/approved finished product is still under patent coverage.

What to monitor

• FDA Orange Book entries for specific manganese sulfate-containing finished products
• Recent ANDA approvals that reference those products
• Any public settlement terms indicating non-infringement determinations or eligibility dates

What generic entry risks exist for manganese sulfate?

Short answer: The principal entry risks are less about IP litigation and more about:

• Sterility assurance and regulatory compliance for injectable-grade supply
• Stability under storage and infusion simulation conditions
• Pricing pressure in a commodity market
• Ingredient quality and impurity controls (trace contaminants)

Manufacturing and compliance barriers

• Sterile fill-finish capacity
• Validation for infusion compatibility (container-closure and adsorption concerns)
• Batch-to-batch impurity profiling

How does manganese sulfate compare with other manganese salts for clinical and commercial use?

Short answer: In practice, manganese sulfate is one of the most common manganese salts used for supplementation. Alternatives (e.g., manganese chloride, gluconate) can vary by solubility, taste, and compatibility, but clinical differentiation is usually limited unless supported by formulation-specific evidence and labeling.

Formulation impacts

• Oral solubility and GI tolerability
• Injection compatibility with TPN trace-element mixes
• Stability and shelf-life in sterile containers

What formulations are protected by patents for manganese sulfate products?

Short answer: When patents matter, they usually protect the finished dosage form and trace-element combination composition.

Patent-typical claim clusters in this space

• Defined concentration ranges (mg/mL) and dosing regimens
• Stabilized formulations with specified chelators or buffers
• Methods for preparing sterile solutions with defined impurity limits
• Container-closure and administration system compatibility claims

What FDA milestones matter for manganese sulfate products?

Short answer: Milestones are primarily tied to finished-product submissions (NDA/ANDA) that include manganese sulfate, rather than the API chemical itself.

Key monitoring points

• ANDA approvals for manganese sulfate-containing oral products
• Approval of sterile trace-element injection products using manganese sulfate
• Label updates tied to pediatric dosing and safety

Market projection: what growth rates and scenarios apply to manganese sulfate through 2030?

Short answer: Growth is expected to be modest and largely volume-driven rather than innovation-driven. Scenario outcomes depend on parenteral nutrition utilization, pediatric TPN protocols, and supplement retail uptake.

Base case projection logic

• Volume growth from chronic GI disease prevalence and sustained TPN use
• Share shifts among suppliers based on sterility capacity and infusion-ready presentation
• Price compression consistent with commodity ingredient markets

Upside and downside scenarios

• Upside: Higher adoption of standardized trace-element regimens, expanded pediatric coverage, and improved supply reliability enabling substitution
• Downside: Substitution to alternative manganese salts in certain protocols, reimbursement tightening, and supply-price shocks

Key Takeaways

• Manganese sulfate is a commoditized manganese salt; meaningful exclusivity typically attaches to finished dosage forms, sterile presentations, or trace-element combination formulations, not to the API itself.
• Clinical trial activity is usually embedded within trace-element replacement and nutrition regimen studies, with endpoints focused on manganese status and toxicity risk management.
• Market demand is driven by EN/TPN protocols and hospital supplementation workflows, plus retail oral supplement usage.
• Competitive advantage is mainly execution: sterility, stability, infusion compatibility, quality controls, and supply chain reliability rather than patent-based differentiation.

FAQs

1) Is manganese sulfate used more in hospitals or retail supplements?
Hospital/clinical demand typically dominates for trace-element replacement in EN/TPN, with retail supplement use providing a secondary channel.

2) Does manganese sulfate have meaningful IP protection?
Direct composition protection for the API is generally limited; practical IP usually relates to finished formulations, sterile presentations, and specific dosing regimens if claimed.

3) Are manganese sulfate products subject to FDA Paragraph IV challenges?
Paragraph IV activity is usually relevant only to specific finished products that still have listed patents; it is not commonly about manganese sulfate as a stand-alone ingredient.

4) What regulatory factor most affects injectable manganese sulfate supply?
Sterility assurance, infusion compatibility, and stability under labeled storage conditions for the finished sterile product.

5) What determines whether a generic manganese sulfate product can launch quickly?
For finished products, the key constraints are regulatory approval readiness (quality, sterility, stability data package) and whether any listed patents on that finished product remain unexpired.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-22).
2. FDA. Dietary Supplement Labeling guidance and regulatory overview. (Accessed 2026-05-22).
3. EMA. European public assessment reports and medicinal product authorization framework. (Accessed 2026-05-22).