CLINICAL TRIALS PROFILE FOR AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

505(b)(2) Clinical Trials for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

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.

All Clinical Trials for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

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.

Clinical Trial Conditions for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

Condition Name

Condition Name for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Intervention	Trials
Acidosis, Renal Tubular	1
Diuretic Resistance	1
Drug Distribution	1
Healthy	1

Condition MeSH

Condition MeSH for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Intervention	Trials
Acidosis, Renal Tubular	1
Acidosis	1
Heart Failure	1
Cardiomyopathies	1

Clinical Trial Locations for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

Trials by Country

Trials by Country for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Location	Trials
United States	2
United Kingdom	1
Switzerland	1

Trials by US State

Trials by US State for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Location	Trials
Connecticut	1
Missouri	1

Clinical Trial Progress for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

Clinical Trial Phase

Clinical Trial Phase for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Clinical Trial Phase	Trials
PHASE1	1
Phase 1	2
N/A	1

Clinical Trial Status

Clinical Trial Status for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Clinical Trial Phase	Trials
Completed	4
NOT_YET_RECRUITING	1
RECRUITING	1

Clinical Trial Sponsors for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

Sponsor Name

Sponsor Name for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Sponsor	Trials
Eli Lilly and Company	1
University Hospital Inselspital, Berne	1
American Heart Association	1

Sponsor Type

Sponsor Type for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Sponsor	Trials
Other	6
Industry	1
NIH	1

Last updated: April 30, 2026

Ammonium Chloride 0.9% in Normal Saline: Clinical Trial Update, Market Analysis, and Revenue Projection

What is the product and how is it used clinically?

“Ammonium chloride 0.9% in normal saline” is an injectable acidifying solution used to promote ammonium chloride therapy, typically aimed at conditions where metabolic or urinary alkalinization targets exist. In clinical practice, ammonium chloride formulations are used under physician direction where controlled acid load is appropriate, and administration is done via intravenous infusion (product-specific labeling governs indication scope and dosing).

Because this is a compounded or branded injectable solution in many jurisdictions, clinical evidence and market data often track at the level of (1) ammonium chloride injection products and (2) hospital formularies, rather than a single drug-wide global pipeline.

What does the clinical trials update show?

No complete, drug-specific, up-to-date public clinical trial registry record set can be confirmed for “ammonium chloride 0.9% in normal saline” as a distinct investigational product in the major registries at the time of this analysis. Public trial tracking for ammonium chloride tends to be fragmented across:

• older studies that predate modern registries,
• indication-specific trials for ammonium chloride (not concentration-specific),
• hospital/compounding practices where “0.9% in normal saline” reflects formulation strength rather than a distinct development program.

Clinical trials status summary (actionable): | Item | Confirmed publicly for this exact product (0.9% in normal saline) | What that means for R&D/market planning | |---|---:|---| | New investigational pipeline (recent registrant activity) | Not verifiable to a single, product-unique record set | Treat as a mature/established product type unless a label change or dossier update is identified in your target geography | | Registration-driven evidence base for “0.9% in normal saline” | Not verifiable as a single, clean dataset | Pricing and competitive dynamics will be driven more by supply, regulatory status, and hospital procurement than by brand-level outcomes | | Biomarker/endpoint-led modern pivotal trials | Not verifiable as product-unique | Avoid underwriting revenue projections on future clinical readouts for this exact formulation unless you have label-expansion intelligence |

Who are the typical competitors and what drives supply?

Competitive pressure for ammonium chloride injection generally comes from:

• generic injectable ammonium chloride products with overlapping strength and administration route,
• substitutable acidifying agents depending on hospital protocols,
• supply reliability and manufacturing batch release capacity (more important than differentiation in most formularies).

Competitive dynamics that matter most:

1. Regulatory status and listing in hospital formularies (tender-driven).
2. Availability and batch consistency (stock-outs shift volumes to whichever supplier maintains supply).
3. Procurement structure (single-source versus multi-source awards).
4. Substitution policies (therapeutic interchange based on pharmacy and therapeutic equivalence).

How big is the market and what segments matter?

A precise global market size for “ammonium chloride 0.9% in normal saline” requires product-specific claims, package size, dosing volume, and geography by tender category. Public datasets typically publish at higher level (ammonium chloride injection) or by therapeutic category (acidifying agents). For projection-grade decisions, market modeling should be built on your target geography and hospital procurement volumes rather than on generic molecule-level totals.

Segmentation framework (used for projection underwriting):

• By setting: inpatient hospitals vs specialty clinics.
• By procurement channel: government tenders, GPO contract, and direct hospital purchase.
• By supply class: branded originator vs generic interchangeable vs compounded supply.
• By dose intensity: based on dosing protocols and duration of use (hospital protocols determine throughput).

Revenue projection: base case model (what you can project from first principles)

Without validated, product-specific utilization and pricing inputs, a single numeric forecast would be structurally non-actionable. What can be delivered reliably is a projection model that ties revenue to volume, tender pricing, and price erosion typical for generics and injectable hospital products.

Projection equation

Annual revenue = (Annual units sold) × (Net price per unit)

Where:

• Annual units sold is driven by: hospital case volume using ammonium chloride, treatment days per patient, and share of supply for the formulation.
• Net price per unit is driven by: tender pricing, freight and distribution costs, and price erosion versus prior-year contracts.

Scenario bands (for underwriting)

Driver	Conservative band	Base band	Upside band
Unit volume CAGR (market share and adoption)	0% to 2%	2% to 5%	5% to 8%
Net price change vs prior contracts	-3% to -6%	-1% to -3%	0% to -1%
Share shifts from competitors (supply stability)	Minimal	Moderate	Large (if competitors face shortages or tenders swing)

Use for investment or R&D decisions:

• If your entry is via tender procurement, the revenue outcome is usually more sensitive to share capture and supply reliability than to clinical performance.
• If your plan is label change or new presentation (new pack size, strength, or stability profile), the revenue lift is driven by formulary acceptance and tender inclusion, not new trial outcomes.

Regulatory and market access implications

For injectable solutions, market access is typically constrained by:

• dossier compliance (CMC, sterility assurance, stability),
• country-specific labeling,
• pharmacovigilance and batch release requirements,
• hospital tender documentation and pharmacy interchange rules.

From a business perspective, the “go/no-go” timeline typically hinges on:

• regulatory dossier readiness,
• quality system and sterile manufacturing validation status,
• ability to meet tender delivery cadence (cold chain usually is not the limiting factor for normal saline solutions, but storage and logistics still matter by site requirements).

What is the near-term outlook?

The near-term outlook for ammonium chloride injection products is usually stable, with variability from:

• tender cycles,
• supplier continuity,
• interchange and procurement protocol updates,
• manufacturing disruptions.

In the absence of product-unique, modern pivotal trial activity, the market outlook should be treated as supply-and-procurement driven rather than evidence-driven.

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Key Takeaways

• “Ammonium chloride 0.9% in normal saline” behaves like an injectable hospital procurement product where differentiation is limited and volume is driven by tender inclusion, supply reliability, and interchange rules.
• Product-specific, modern clinical trial activity that cleanly maps to “0.9% in normal saline” is not verifiable as a distinct, current pipeline signal; this implies revenue underwriting should not rely on new trial outcomes for this exact formulation.
• Revenue projection should be modeled from tender economics: annual units sold × net tender price, using conservative-to-upside bands for volume CAGR and price erosion typical of injectable generics.

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FAQs

1) Is there a recent, product-unique clinical trial pipeline for ammonium chloride 0.9% in normal saline?

A verifiable, product-unique recent trial pipeline is not confirmed in public registries at the level needed to support a trial-driven revenue thesis for this exact formulation.

2) What most affects pricing and revenue for injectable ammonium chloride products?

Tender pricing, batch availability, and hospital formulary inclusion drive net price and share more than clinical differentiation.

3) How should a forecast be built for this product?

Use a volume-and-price model tied to target geography tender cycles: annual units sold multiplied by net price per unit, then apply scenario bands for volume CAGR and price erosion.

4) What are the main competitive threats?

Overlapping generic ammonium chloride injectable products, supply constraints among competitors, and protocol-driven substitution by alternative acidifying agents.

5) What is the most likely revenue “lever” for new entrants?

Contract award share and operational continuity that prevents stock-outs during tender delivery windows.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug approval reports and related regulatory information. FDA. https://www.fda.gov
[2] ClinicalTrials.gov. (n.d.). Search results for ammonium chloride and ammonium chloride injection. https://clinicaltrials.gov
[3] World Health Organization. (n.d.). WHO medicines and quality-related resources. https://www.who.int/health-topics/medicines-and-products