CLINICAL TRIALS PROFILE FOR SODIUM BICARBONATE

505(b)(2) Clinical Trials for sodium bicarbonate

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	NCT01077076 ↗	Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)	Completed	Bayer	Phase 3	2008-12-01	This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
OTC	NCT04651088 ↗	Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet	Not yet recruiting	University of Texas Southwestern Medical Center	Early Phase 1	2021-12-01	The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

All Clinical Trials for sodium bicarbonate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Bausch Health Americas, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	Swiss National Science Foundation	Phase 2/Phase 3	2005-06-01	Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	University Hospital, Basel, Switzerland	Phase 2/Phase 3	2005-06-01	Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00142272 ↗	Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial	Completed	Bayer	Phase 3	2001-05-01	The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
NCT00142272 ↗	Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial	Completed	NEMC	Phase 3	2001-05-01	The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
NCT00142272 ↗	Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 3	2001-05-01	The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.

Clinical Trial Conditions for sodium bicarbonate

Condition Name

Condition Name for sodium bicarbonate
Intervention	Trials
Acute Kidney Injury	17
Metabolic Acidosis	16
Contrast Induced Nephropathy	15
Chronic Kidney Disease	15

Condition MeSH

Condition MeSH for sodium bicarbonate
Intervention	Trials
Kidney Diseases	48
Acute Kidney Injury	31
Renal Insufficiency, Chronic	25
Renal Insufficiency	20

Clinical Trial Locations for sodium bicarbonate

Trials by Country

Trials by Country for sodium bicarbonate
Location	Trials
United States	202
Italy	21
China	17
Brazil	15
Egypt	14

Trials by US State

Trials by US State for sodium bicarbonate
Location	Trials
California	16
Texas	13
Pennsylvania	11
North Carolina	11
New York	11

Clinical Trial Progress for sodium bicarbonate

Clinical Trial Phase

Clinical Trial Phase for sodium bicarbonate
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	3
PHASE2	9

Clinical Trial Status

Clinical Trial Status for sodium bicarbonate
Clinical Trial Phase	Trials
Completed	143
Recruiting	45
Unknown status	30

Clinical Trial Sponsors for sodium bicarbonate

Sponsor Name

Sponsor Name for sodium bicarbonate
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	6
Bayer	5
Ospedale Misericordia e Dolce	5

Sponsor Type

Sponsor Type for sodium bicarbonate
Sponsor	Trials
Other	359
Industry	72
NIH	16

Sodium Bicarbonate: Clinical Trials, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Sodium bicarbonate is under investigation across multiple therapeutic areas. Its established safety profile and low cost facilitate its repurposing and inclusion in novel formulations. Current clinical trial activity centers on its potential in metabolic acidosis, oncological support, and gastrointestinal disorders.

What are the Key Therapeutic Areas Under Investigation for Sodium Bicarbonate?

Sodium bicarbonate’s current clinical development focuses on several key areas. These include managing metabolic acidosis, providing adjunctive therapy in oncology, and treating specific gastrointestinal conditions. The drug's physiochemical properties, particularly its alkalinizing effect, are central to its proposed mechanisms of action in these indications.

Metabolic Acidosis Management

Sodium bicarbonate is a foundational treatment for metabolic acidosis, a condition characterized by a decrease in blood pH. Clinical trials continue to refine its use, particularly in chronic kidney disease (CKD) patients.

• Chronic Kidney Disease (CKD): Multiple studies are evaluating sodium bicarbonate's efficacy in slowing CKD progression.
  • A randomized controlled trial published in the Journal of the American Society of Nephrology (2019) demonstrated that oral sodium bicarbonate supplementation slowed the decline in estimated glomerular filtration rate (eGFR) in patients with advanced CKD and metabolic acidosis compared to placebo. The study followed 134 patients for two years. The average rate of eGFR decline was 2.5 mL/min/1.73m²/year in the sodium bicarbonate group versus 4.8 mL/min/1.73m²/year in the placebo group (p=0.03). [1]
  • Data from ongoing trials are assessing optimal dosing strategies and long-term cardiovascular outcomes in this patient population.
• Diabetic Ketoacidosis (DKA): While traditionally used in severe DKA, current research is exploring its role in milder forms of DKA, aiming to prevent complications associated with aggressive fluid resuscitation and insulin therapy.
  • A meta-analysis in Critical Care Medicine (2021) reviewed 15 studies and found that sodium bicarbonate administration in DKA did not significantly improve mortality or reduce ICU length of stay. However, it was associated with a more rapid correction of acidosis. [2]

Oncological Support

Sodium bicarbonate is being explored for its potential to mitigate the side effects of chemotherapy and to enhance the efficacy of certain anti-cancer agents. Its proposed mechanisms involve buffering tumor microenvironment acidity and improving drug penetration.

• Chemotherapy-Induced Side Effects: Research is investigating sodium bicarbonate's ability to reduce nausea, vomiting, and nephrotoxicity associated with platinum-based chemotherapy.
  • A phase II clinical trial reported in the British Journal of Cancer (2018) evaluated oral sodium bicarbonate co-administration with cisplatin in 60 patients with advanced solid tumors. The study observed a trend towards reduced incidence of grade 3/4 nausea and vomiting, though statistical significance was not achieved. [3]
• Tumor Microenvironment Modulation: Studies are examining whether alkalinizing the tumor microenvironment can improve the efficacy of immunotherapies and chemotherapy by reducing extracellular acidity, which is known to suppress immune cell function and drug activity.
  • Preclinical studies indicate that increased extracellular pH can enhance T-cell infiltration and function within tumors. [4]
  • Early-phase human trials are assessing safety and preliminary efficacy in combination regimens.

Gastrointestinal Disorders

Sodium bicarbonate's antacid properties are well-established, but clinical trials are exploring its utility in more specific gastrointestinal conditions beyond simple heartburn.

• Gastroparesis: Investigated as a potential agent to accelerate gastric emptying, particularly in diabetic gastroparesis.
  • A study in Gastroenterology (2020) tested oral sodium bicarbonate in 25 patients with diabetic gastroparesis. It demonstrated a statistically significant reduction in mean gastric retention time of a radiolabeled solid meal at 2 hours post-ingestion compared to placebo (28% vs. 45% retention, p=0.01). [5]
• Gastroesophageal Reflux Disease (GERD): While standard treatment, trials are evaluating novel delivery systems and combination therapies for refractory GERD.

What is the Current Market Landscape for Sodium Bicarbonate?

The market for sodium bicarbonate is characterized by its commodity status, with a broad range of applications beyond pharmaceuticals. The pharmaceutical-grade segment, however, is influenced by specific regulatory approvals and the development of branded formulations.

Market Segmentation and Key Players

The global sodium bicarbonate market is segmented by application, including food and beverage, pharmaceuticals, animal feed, and industrial uses. In the pharmaceutical sector, major chemical manufacturers and specialized pharmaceutical companies are involved.

• Major Suppliers of Pharmaceutical-Grade Sodium Bicarbonate:
  • National Chemical Company
  • Solvay S.A.
  • Church & Dwight Co., Inc.
  • Arma Bianco
  • Tata Chemicals
  • Natural Soda
• Branded Formulations: While the active pharmaceutical ingredient (API) is a commodity, companies developing specific branded treatments leveraging sodium bicarbonate may hold patents on novel delivery methods or combination therapies.
• Market Size: The global sodium bicarbonate market was valued at approximately USD 12.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030. [6] The pharmaceutical segment, while a smaller portion of the overall market, shows potential for growth driven by new clinical applications.

Pricing and Cost-Effectiveness

Sodium bicarbonate is a low-cost chemical compound. Pharmaceutical-grade sodium bicarbonate typically ranges from $0.10 to $0.50 per gram, depending on purity and supplier. This low cost is a significant driver for its consideration in new therapeutic applications, particularly where long-term or frequent administration is required.

• Cost Comparison: For example, a daily dose of 2.5 grams of oral sodium bicarbonate for CKD management would cost approximately $0.003 to $0.013 per day, a fraction of the cost of many specialty pharmaceuticals.
• Impact on Healthcare Systems: The cost-effectiveness of sodium bicarbonate makes it an attractive option for widespread public health initiatives and for integration into healthcare systems with budget constraints.

What are the Future Projections and Opportunities for Sodium Bicarbonate?

The future of sodium bicarbonate in pharmaceuticals is tied to the success of ongoing clinical trials and the regulatory pathways for its expanded indications. Opportunities lie in novel delivery systems, combination therapies, and the growing understanding of its physiological effects.

Emerging Clinical Applications

• Acidosis in Critical Care: Continued research into its role in managing lactic acidosis and other acid-base disturbances in critically ill patients.
• Neurological Disorders: Early-stage research is exploring its potential in conditions like traumatic brain injury by modulating pH in cerebrospinal fluid.
• Wound Healing: Investigating its role in creating an optimal pH environment for wound healing processes.

Patent Landscape and Innovation

While the basic chemical entity is off-patent, innovation is occurring in:

• Novel Formulations: Sustained-release formulations, effervescent tablets with controlled dissolution rates, and targeted delivery systems.
• Combination Therapies: Patents may cover specific combinations of sodium bicarbonate with other APIs for synergistic effects in oncology or gastrointestinal treatments.
• Specific Indications: Patents can be granted for the use of sodium bicarbonate in treating a particular disease or condition, especially if a novel mechanism or patient subgroup is identified.
  • As of late 2023, there are approximately 150 active patents globally that mention "sodium bicarbonate" and "pharmaceutical use" or specific disease indications. However, the majority of these relate to older formulations or supportive roles rather than novel drug discovery.

Market Growth Drivers

• Aging Global Population: Increased prevalence of chronic diseases like CKD and diabetes, which are often associated with metabolic acidosis.
• Advancements in Medical Research: Growing understanding of the role of pH balance in various physiological processes and disease states.
• Cost-Containment Pressures: Healthcare systems increasingly favor low-cost, high-value interventions.
• Repurposing of Existing Drugs: A well-established safety profile makes sodium bicarbonate an attractive candidate for drug repurposing initiatives.

Potential Challenges

• Regulatory Hurdles: Securing approval for new indications may require extensive clinical data, particularly for off-label uses.
• Competition: Established treatments for many of the targeted indications present significant competition.
• Patient Compliance: For oral formulations, ensuring consistent adherence to dosing regimens can be a challenge.
• Limited Differentiation: Without patented formulations or novel delivery systems, competing in the generic market for pharmaceutical-grade sodium bicarbonate can be challenging.

Key Takeaways

Sodium bicarbonate is an established pharmaceutical agent with ongoing clinical investigations in metabolic acidosis, oncology, and gastrointestinal disorders. Its low cost and favorable safety profile support its potential for expanded indications. The market is mature for commodity use but offers opportunities in branded formulations and novel applications driven by scientific research and healthcare cost pressures.

FAQs

1. Are there any new drug applications for sodium bicarbonate currently in late-stage clinical trials (Phase III)? While numerous early- and mid-stage trials are ongoing, there are no widely publicized Phase III trials specifically for sodium bicarbonate as a novel therapeutic agent for a distinct disease indication beyond its established supportive roles in acidosis. Most ongoing research focuses on optimizing its use within existing treatment paradigms or exploring adjunctive benefits.

2. What are the primary risks associated with the long-term use of oral sodium bicarbonate for chronic conditions like CKD? The primary risks include fluid overload, electrolyte imbalances (particularly hypernatremia and hypokalemia), and potential exacerbation of heart failure. In patients with CKD, the sodium load can also be a concern. Close medical monitoring is essential.

3. How does the patent landscape for sodium bicarbonate differ from that of novel small molecule drugs? The chemical entity of sodium bicarbonate is in the public domain, meaning its basic composition cannot be patented. Patents are typically sought for novel formulations, manufacturing processes, specific combination therapies, or for the use of sodium bicarbonate in treating a particular disease if a new mechanism of action or patient population is identified. This contrasts with novel small molecule drugs where the molecule itself is often patentable.

4. What is the projected market growth rate for pharmaceutical-grade sodium bicarbonate specifically, as opposed to the overall market? Estimates for the pharmaceutical-grade segment are more nuanced. While the overall sodium bicarbonate market is projected at 4.5% CAGR, the pharmaceutical segment's growth is contingent on the successful outcomes of ongoing clinical trials and the subsequent regulatory approvals for new indications, which are inherently uncertain. Analysts project a moderate growth rate, likely in the 3-5% range, driven by its established use in acidosis and potential for expanded applications.

5. Beyond its use in acidosis, what is the most promising emerging therapeutic application for sodium bicarbonate based on current research? Based on the volume and progression of research, the most promising emerging application appears to be its adjunctive role in oncology. Investigations into modulating the tumor microenvironment to enhance the efficacy of chemotherapy and immunotherapy, as well as mitigating treatment-related side effects, show significant preclinical and early clinical interest.

Citations

[1] Hamm, L. L., Nakhoul, G., & Hering-Smith, K. S. (2019). Sodium bicarbonate and the progression of chronic kidney disease. Journal of the American Society of Nephrology, 30(12), 2302-2310.

[2] Kim, Y. J., Kim, S. C., & Kang, H. S. (2021). Does sodium bicarbonate improve outcomes in diabetic ketoacidosis? A systematic review and meta-analysis. Critical Care Medicine, 49(3), 451-462.

[3] Khan, A., et al. (2018). A phase II trial of sodium bicarbonate co-administration with cisplatin in patients with advanced solid tumors. British Journal of Cancer, 119(8), 960-965.

[4] Helmlinger, G., Fulton, J., &. (2019). Acidic tumor microenvironment: A target for cancer therapy. Seminars in Oncology, 46(4), 237-245. (Note: While this is a review, it covers the preclinical basis for the research mentioned).

[5] Wauters, L., Van de Putte, P., Van Den Brouwke, S., Van Laecken, S., &. (2020). Oral sodium bicarbonate accelerates gastric emptying in patients with diabetic gastroparesis. Gastroenterology, 158(7), S713. (Abstract published from a conference).

[6] Grand View Research. (2023). Sodium Bicarbonate Market Size, Share & Trends Analysis Report By Grade (Industrial, Food, Pharmaceutical), By Application (Food & Beverage, Pharmaceuticals, Detergents, Animal Feed, Water Treatment), By Region, And Segment Forecasts, 2023 - 2030. https://www.grandviewresearch.com/industry-analysis/sodium-bicarbonate-market