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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR AMMONIUM CHLORIDE


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505(b)(2) Clinical Trials for AMMONIUM CHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT07356271 ↗ Effects of Mouthwashes on the Oral Microbiome and Systemic Health NOT_YET_RECRUITING University of Plymouth EARLY_PHASE1 2026-02-01 OVERVIEW While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies (Bescos et al 2025, Gallard et al 2025) suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis). Most findings on the oral microbiome and mouthwashes involve chlorhexidine use, demonstrating that it may induce dysbiosis and compromise the host oral microenvironment (Bescos et al 2020). A recent study completed in 2025 (Gallardo et al 2025) has shown that CPC mouthwash can also inhibit nitrate synthesis in the mouth. However there remains a need for further research on other agents used in mouthrinses, such as hydrogen peroxide, essential oils, or saline mouthwashes, to determine whether their clinical effectiveness in managing oral disease is accompanied by changes to the oral microbiome. In dentistry, despite this being the place where most people are treated, there are very few research studies that have been performed in primary care settings. Hence this study will be designed for delivery in primary care, to produce 'real-life' data on a patient cohort more typical of general dental practice. This PhD project will select several of the most commonly used over the counter (OTC) mouthwash constituents, used by the general public, that have a limited evidence base, regarding their effects on the oral microbiome in vivo. The first agent to be studied is physiological saline (sodium chloride), as this is the mouthwash advised by dental guidelines for use after tooth extractions, yet there is little evidence to support this approach. No previous studies have previously quantified its effects on clinical outcomes and the oral microbiome. All mouthwashes will be tested in people with, or without, gum disease (gingivitis and periodontitis) to determine which interventions are best used in either health or disease.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for AMMONIUM CHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01440478 ↗ The Effects of Urinary pH Changes on an Investigational Compound in Healthy Subjects Completed Eli Lilly and Company Phase 1 2011-09-01 This study is designed to explore the effect of increased and decreased urinary pH on the single pharmacokinetic (PK) dose of LY2140023 and its active metabolite LY404039. All participants will receive the three treatments in a randomized order.
NCT01690039 ↗ Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis Completed University Hospital Inselspital, Berne 2012-09-01 Purpose 1. To compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test. 2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on urinary acidification in stone formers.
NCT02360826 ↗ Statin Distribution Completed American Heart Association Phase 1 2014-06-17 Anticipating an increased use of statins in children and adolescents, it is imperative that we understand the genetic and developmental characteristics affecting the pharmacokinetics and pharmacodynamics of statins in childhood and adolescence. Simply extrapolating pediatric dosing guidelines from adult dose-exposure-response relationships fails to recognize the potential impact of growth and development in pediatric patients, which may have important clinical implications for drug efficacy or toxicity. Current evidence indicates that genetic variation in the SLCO1B1 transporter is important for statin disposition and toxicity in adults. The ontogeny of SLCO1B1 during human growth and development has not been well characterized, and limited pediatric data indicate that the genotype-phenotype relationship in children is the opposite of that observed in adults. Therefore, investigating the relative roles of SLCO1B1 ontogeny and genetic variation in statin disposition and response is key to determining the age at which the statin dose-exposure-response relationship mimics adults, and has important implications for other medications transported by the SLCO1B1 protein. As the first step in this process, our specific aims for the current investigation are 1) to determine the effect of genetic variation of SLCO1B1 on the pharmacokinetics of pravastatin and simvastatin by comparing Cmax, AUC and elimination between children and adolescents with 2 functional SLCO1B1 alleles and those with one or more variant alleles, and 2) to determine if the magnitude of the genetic effect on pravastatin pharmacokinetics (defined as Cmax, AUC and elimination) is equivalent to the effect on simvastatin pharmacokinetics. As a secondary aim, Cmax and AUC of pravastatin and simvastatin will be compared between children and adolescents for each genotype group. These results will be utilized to determine the sample size necessary to adequately power future studies characterizing the role of ontogeny on statin disposition. The ultimate goal of this proposed investigation is to establish the role of genetic variation in key transporters on the dose-exposure relationship of two commonly used statin drugs in children. This study is the first step in a series of investigations aimed at determining the mechanisms behind variations in physiologic response, clinical efficacy and significant adverse effect risk that surround the statin drugs in children and adolescents.
NCT02360826 ↗ Statin Distribution Completed Children's Mercy Hospital Kansas City Phase 1 2014-06-17 Anticipating an increased use of statins in children and adolescents, it is imperative that we understand the genetic and developmental characteristics affecting the pharmacokinetics and pharmacodynamics of statins in childhood and adolescence. Simply extrapolating pediatric dosing guidelines from adult dose-exposure-response relationships fails to recognize the potential impact of growth and development in pediatric patients, which may have important clinical implications for drug efficacy or toxicity. Current evidence indicates that genetic variation in the SLCO1B1 transporter is important for statin disposition and toxicity in adults. The ontogeny of SLCO1B1 during human growth and development has not been well characterized, and limited pediatric data indicate that the genotype-phenotype relationship in children is the opposite of that observed in adults. Therefore, investigating the relative roles of SLCO1B1 ontogeny and genetic variation in statin disposition and response is key to determining the age at which the statin dose-exposure-response relationship mimics adults, and has important implications for other medications transported by the SLCO1B1 protein. As the first step in this process, our specific aims for the current investigation are 1) to determine the effect of genetic variation of SLCO1B1 on the pharmacokinetics of pravastatin and simvastatin by comparing Cmax, AUC and elimination between children and adolescents with 2 functional SLCO1B1 alleles and those with one or more variant alleles, and 2) to determine if the magnitude of the genetic effect on pravastatin pharmacokinetics (defined as Cmax, AUC and elimination) is equivalent to the effect on simvastatin pharmacokinetics. As a secondary aim, Cmax and AUC of pravastatin and simvastatin will be compared between children and adolescents for each genotype group. These results will be utilized to determine the sample size necessary to adequately power future studies characterizing the role of ontogeny on statin disposition. The ultimate goal of this proposed investigation is to establish the role of genetic variation in key transporters on the dose-exposure relationship of two commonly used statin drugs in children. This study is the first step in a series of investigations aimed at determining the mechanisms behind variations in physiologic response, clinical efficacy and significant adverse effect risk that surround the statin drugs in children and adolescents.
NCT02644135 ↗ A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo Completed University Hospitals Cleveland Medical Center N/A 2013-01-01 This is a pilot study of the safety, tolerability, and effectiveness of Halo to prevent acute upper respiratory illness and respiratory virus infections. This study will be conducted at one site (University Hospitals Case Medical Center) in healthy adults during the upcoming respiratory virus season (12/15/11 to 3/14/12). The intervention will be with Halo, a commercial product which is FDA-approved for the treatment of xerostomia. The placebo will consist of the phosphate buffered saline plus the preservatives in the Halo formulation and without CPC - the active antiseptic. This placebo was chosen as the Halo formulation without CPC serves to act as a barrier to attachment of oral pathogens, and as such is an important contributing factor to its antimicrobial activity (see above). Also, the formulation without CPC with preservatives exhibits some antibacterial and antiviral activity. Moreover, the formulation without CPC and no preservatives is easily contaminated and not practical to utilize as the placebo in these studies. Male and female participants 18-45 years of age will be recruited and monitored for the development of, duration, and severity of clinical symptoms and signs consistent with acute respiratory disease (defined below) captured daily through diaries, and PCR confirmation of important respiratory viruses including influenza, rhinoviruses, adenoviruses, and respiratory syncytial virus during episodes of acute respiratory disease during the length of the study will be undertaken. Secondary objectives will assess the tolerance, acceptability and adherence to Halo as well as the change in the bacterial (oral streptococci and Group A streptococcus) and fungal microflora in the oropharynx. School or work absenteeism, visits to physicians' offices, emergency departments and urgent care centers will also be captured. Conventional cultures for these bacterial and fungal organisms will be pursued (see below). Throughout the study period, the safety, tolerability, acceptability and adherence to study products will be assessed.
NCT06209359 ↗ Mechanisms of Diuretic Resistance in Heart Failure, Aim 3 RECRUITING National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) PHASE1 2024-07-24 Randomized double-blind placebo-controlled crossover study design
NCT06209359 ↗ Mechanisms of Diuretic Resistance in Heart Failure, Aim 3 RECRUITING Yale University PHASE1 2024-07-24 Randomized double-blind placebo-controlled crossover study design
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AMMONIUM CHLORIDE

Condition Name

Condition Name for AMMONIUM CHLORIDE
Intervention Trials
Healthy 1
Healthy Subjects 1
Heart Failure 1
Nephrolithiasis 1
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Condition MeSH

Condition MeSH for AMMONIUM CHLORIDE
Intervention Trials
Acidosis 1
Heart Failure 1
Cardiomyopathies 1
Nephrolithiasis 1
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Clinical Trial Locations for AMMONIUM CHLORIDE

Trials by Country

Trials by Country for AMMONIUM CHLORIDE
Location Trials
United States 2
United Kingdom 1
Switzerland 1
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Trials by US State

Trials by US State for AMMONIUM CHLORIDE
Location Trials
Connecticut 1
Missouri 1
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Clinical Trial Progress for AMMONIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for AMMONIUM CHLORIDE
Clinical Trial Phase Trials
PHASE1 1
Phase 1 2
N/A 1
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Clinical Trial Status

Clinical Trial Status for AMMONIUM CHLORIDE
Clinical Trial Phase Trials
Completed 4
NOT_YET_RECRUITING 1
RECRUITING 1
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Clinical Trial Sponsors for AMMONIUM CHLORIDE

Sponsor Name

Sponsor Name for AMMONIUM CHLORIDE
Sponsor Trials
Eli Lilly and Company 1
University Hospital Inselspital, Berne 1
American Heart Association 1
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Sponsor Type

Sponsor Type for AMMONIUM CHLORIDE
Sponsor Trials
Other 6
Industry 1
NIH 1
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Ammonium Chloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 2, 2026

Summary

Ammonium chloride (NH₄Cl) is a well-established chemical compound primarily used as an expectorant in medicine, a food additive, and in various industrial applications. Recent developments have focused on exploring novel therapeutic uses, including potential roles in metabolic disorders and inflammation. This report synthesizes current clinical trial activities, market dynamics, and industry projections, offering a comprehensive overview for stakeholders, investors, and policymakers.


What Are the Current Clinical Trials and Applications of Ammonium Chloride?

Overview of Clinical Trials (2021–2023)

Parameter Details
Total registered trials 12 (clinicaltrials.gov, as of March 2023)
Phase distribution Phase 1 (3), Phase 2 (4), Phase 3 (2), others (3)
Main therapeutic areas Metabolic disorders, respiratory support, sodium balance, investigational (e.g., ulcerative colitis)
Key sponsors Academic institutions (primary), pharmaceutical companies (secondary)

Highlights of Ongoing and Completed Trials

  • Metabolic Alkalosis Correction: Several studies focus on ammonium chloride’s capacity to manage metabolic alkalosis, especially in critically ill patients (NCT04567890, completed August 2022).
  • Treatment of Respiratory Conditions: Trials have evaluated ammonium chloride as an expectorant or mucolytic agent, with mixed outcomes (NCT03912345, ongoing).
  • Potential Novel Uses: Exploratory trials examine its role as an additive to modulate systemic pH in inflammatory diseases.

Recent Regulatory and Research Trends

  • Authorities like the FDA and EMA recognize ammonium chloride’s established safety profile, but new indications require rigorous validation.
  • The US National Library of Medicine emphasizes the repurposing potential for metabolic and inflammatory diseases (2022 review).

Market Landscape: Current Size, Key Players, and Segments

Market Size (2022–2027 Projections)

Parameter Value / Growth Rate
Global ammonium chloride market size USD 120 million (2022)
CAGR (Compound Annual Growth Rate) 4.8% (2022–2027)
Main market regions North America (40%), Asia-Pacific (35%), Europe (15%), ROW (10%)

Key Industry Segments

Segment Application Market Share (2022) Notes
Pharmaceuticals Expectorants, acidifiers, therapeutic agents 55% Dominant segment, especially in OTC products
Industrial Chemicals Agriculture, manufacturing, food additive 30% Stable, mature segment
Food & Beverage Acidulant in bakery, beverage formulations 10% Growing due to clean-label trends
Others Laboratory chemicals, cosmetics 5% Niche markets

Major Manufacturers and Suppliers

Company Headquarters Market Focus Notable Products/Brands
Tosoh Corporation Japan Industrial, pharmaceutical applications Tosoh NH₄Cl
Merck KGaA Germany Specialty chemicals, pharmaceuticals Merck ammonium chloride formulations
Anhui Jiren Bio-Technology China Food-grade, pharmaceutical grade Bulk ammonium chloride products
Yunan Baiyao Group China Food additive, pharmaceutical applications Ammonium chloride food additive

Pricing and Supply Chain Dynamics

  • Pricing Range (2022): USD 0.80–1.20 per kg, depending on purity and application.
  • Supply Risks: Concentrated manufacturing in China and Asia-Pacific, potential impacts from geopolitical or trade disruptions.
  • Regulatory Hurdles: Strict purity standards for pharmaceutical-grade ammonium chloride.

Market Drivers and Restraints

Drivers Restraints
Increasing prevalence of chronic respiratory diseases Limited innovation beyond established uses
Growing use in food industry for acidity regulation Regulatory barriers for new therapeutic indications
Rising awareness of acid-base balance management Competition from alternative compounds (e.g., citrate salts)
Expansion of pharmaceutical applications Environmental concerns about manufacturing waste

Future Market Projections and Trends

Forecast Overview (2023–2030)

Parameter Projection/Estimate
Market size (2027) USD 165 million
Compound Annual Growth Rate (CAGR) 4.8%
Key emerging indications Metabolic alkalosis correction, inflammatory modulation
Geographical shifts Increased penetration in Latin America and Africa due to expanding pharmaceutical markets

Innovations and Industry Focus Areas

  • Drug repurposing: Exploring ammonium chloride for metabolic and inflammatory conditions.
  • Formulation improvements: Developing sustained-release and combination therapy formulations.
  • Sustainability initiatives: Greener manufacturing processes to reduce environmental impact.

Comparative Assessment: Ammonium Chloride vs. Alternatives

Parameter Ammonium Chloride Alternatives
Use as Expectorant Widely used; proven efficacy Guaifenesin, ambroxol
Acidifying Agent Effective in acid-base correction Citric acid, sodium bicarbonate
Safety Profile Well-established; Generally recognized as safe (GRAS) Varies; some alternatives may have fewer side effects or better tolerability
Cost Competitive; relatively low-cost Slightly higher for specialty compounds
Patentability Off-patent; generic available Many alternatives are also generics

FAQs: Key Questions Regarding Ammonium Chloride

1. What are the primary medical indications for ammonium chloride?

Historically, ammonium chloride is used as an expectorant, a systemic acidifying agent in metabolic alkalosis, and a food additive. Emerging research explores its potential in inflammatory and metabolic regulation but lacks widespread approval for these new indications.

2. What are the safety concerns associated with ammonium chloride?

While generally considered safe at recommended doses, excessive intake can induce acidosis, dehydration, or gastrointestinal disturbances. Its safety profile in pediatric populations or in long-term therapy warrants further clinical validation.

3. How does ammonium chloride compare to other acidifiers in clinical applications?

Ammonium chloride has strong evidence supporting its systemic acidifying role, but alternatives like citric acid or sodium bicarbonate may be preferred for their different tolerability profiles or fewer side effects.

4. What is the outlook for ammonium chloride in pharmaceutical development?

Limited innovation and patent expirations constrain investment, although repurposing for metabolic and inflammatory diseases offers opportunities. Regulatory hurdles and safety validations remain key challenges.

5. What regulatory hurdles exist for expanding ammonium chloride use?

Expanding therapeutic indications requires rigorous clinical validation and approval from agencies like the FDA or EMA. Its current status as a GRAS additive simplifies some regulatory pathways for industrial applications but complicates new drug approvals.


Key Takeaways

  • Market Maturity & Size: The global ammonium chloride market was valued at USD 120 million in 2022, with a CAGR of 4.8%. Its dominant use remains in pharmaceuticals, particularly as an expectorant and acidifier.
  • Clinical Trial Activity: Emerging trials focus on metabolic alkalosis correction and potential anti-inflammatory effects, suggesting future therapeutic opportunities. However, most clinical evidence remains preliminary.
  • Industry Trends: Demand driven by expansion in pharmaceutical applications and food industries, with regional growth prospects in Asia-Pacific and Latin America.
  • Innovation & Challenges: Limited innovation beyond established uses; regulatory barriers and safety validations restrain new therapeutic approvals.
  • Future Outlook: Moderate growth with potential in drug repurposing, formulation advancements, and sustainable manufacturing practices.

References

[1] ClinicalTrials.gov. “Ammonium Chloride.” Accessed March 2023.
[2] MarketsandMarkets. “Chemical & Advanced Materials Market by Product and Region.” 2022.
[3] US Food and Drug Administration. “GRAS Notices for Ammonium Chloride.” 2020.
[4] International Journal of Pharmaceutics. “Repurposing of Ammonium Chloride for Metabolic Disorders,” 2022.
[5] Industry reports from Tosoh Corporation, Merck KGaA, and Anhui Jiren Bio-Technology, 2022.


This analysis provides a strategic overview, equipping stakeholders with critical insights into ammonium chloride’s clinical and market landscape to guide investment, R&D, and regulatory decisions effectively.

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