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.

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	14

Condition MeSH

Condition MeSH for sodium bicarbonate
Intervention	Trials
Kidney Diseases	48
Acute Kidney Injury	31
Renal Insufficiency, Chronic	24
Renal Insufficiency	20

Clinical Trial Locations for sodium bicarbonate

Trials by Country

Trials by Country for sodium bicarbonate
Location	Trials
United States	201
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
North Carolina	11
New York	11
Florida	11

Clinical Trial Progress for sodium bicarbonate

Clinical Trial Phase

Clinical Trial Phase for sodium bicarbonate
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	2
PHASE2	7

Clinical Trial Status

Clinical Trial Status for sodium bicarbonate
Clinical Trial Phase	Trials
Completed	142
RECRUITING	43
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
Ospedale Misericordia e Dolce	5
University of Colorado, Denver	5

Sponsor Type

Sponsor Type for sodium bicarbonate
Sponsor	Trials
Other	350
Industry	70
NIH	15

Clinical Trials Update, Market Analysis, and Projection for Sodium Bicarbonate

Last updated: October 28, 2025

Introduction

Sodium bicarbonate, commonly known as baking soda, has long been utilized in medical settings for its alkalizing properties, primarily treating metabolic acidosis, cardiac arrest, and certain kidney conditions. Recent advancements, emerging clinical research, and evolving market dynamics necessitate a comprehensive review of its current status within the pharmaceutical landscape. This report provides an in-depth analysis of recent clinical trials, market trends, and future projections concerning sodium bicarbonate as a therapeutic agent.

Clinical Trials Update

Recent Clinical Research and Developments

Over the past three years, clinical investigations into sodium bicarbonate have expanded beyond traditional indications, exploring novel applications in oncology, cardiology, and infectious diseases. Two key areas of focus include:

• Cancer Treatment Adjunct: Emerging studies suggest that sodium bicarbonate may modulate tumor microenvironments. A 2021 pilot trial assessed its role in buffering tumor acidity, potentially enhancing the efficacy of chemotherapy and immunotherapy [1]. While preliminary results are promising, larger randomized trials are necessary to establish clinical benefits.

• Sepsis and Critical Care: Multiple trials have investigated sodium bicarbonate's efficacy in managing sepsis-induced metabolic acidosis. A 2022 multi-center study involving 300 ICU patients concluded that judicious bicarbonate therapy improves acid-base balance without increasing adverse events, though its impact on mortality remains inconclusive [2].

Ongoing and Upcoming Trials

Currently, over 20 trials are registered globally, focusing on:

• Cardiovascular applications: Examining sodium bicarbonate’s role in metabolic acidosis during cardiac surgery.
• Renal disease: Investigating its capacity to slow CKD progression.
• Infectious diseases: Assessing potential in managing severe COVID-19-associated acidosis.

These efforts indicate sustained research interest, with expected results in the upcoming 1-3 years.

Regulatory and Clinical Guidelines

While sodium bicarbonate maintains its status as an established emergency treatment, recent regulatory reviews have emphasized standardization of dosing protocols, particularly in critical care settings. The American College of Chest Physicians (CHEST) guidelines continue to recommend cautious use, emphasizing personalized administration based on clinical context [3].

Market Analysis

Market Size and Historical Trends

The global sodium bicarbonate market was valued at approximately USD 1.0 billion in 2022, with an anticipated CAGR of 4.5% through 2028 [4]. Key segments include pharmaceutical applications, food industry, and industrial use. Pharmaceutical demand accounts for roughly 40% of total consumption, driven by its widespread use as an antacid and alkalizing agent.

Drivers of Market Growth

• Expanding Medical Applications: Growing clinical research supporting new therapeutic uses widens market prospects.
• Aging Population: Increased prevalence of chronic kidney disease, cardiovascular conditions, and metabolic disorders amplifies demand.
• Regulatory Approvals and Standardization: Improved guidelines facilitate broader clinical adoption.

Market Challenges

• Limited Innovation: Most formulations remain unchanged, with minimal pipeline activity for modified delivery systems.
• Regulatory Hurdles: Differing global standards can delay approvals for new indications.
• Competition: Generic manufacturers dominate, constraining premium pricing strategies.

Geographical Market Analysis

• North America: Leading market with high clinical adoption, driven by advanced healthcare infrastructure and ongoing clinical trials.
• Europe: Increasing prescription rates, particularly within the UK and Germany.
• Asia-Pacific: Fastest growth, due to rising healthcare infrastructure, increasing awareness, and aging demographics.

Future Market Projections

Based on current trends, the sodium bicarbonate market is poised to grow steadily over the next five years, with potential to reach USD 1.4 billion by 2028. The significant expansion is primarily linked to:

• Increased clinical research validating expanded therapeutic uses.
• Regulatory recognition supporting formulation standardization.
• Integration into combination therapies for complex diseases.

Furthermore, pharmaceutical companies are exploring novel formulations, such as controlled-release tablets and intravenous preparations, to enhance clinical efficacy and patient compliance.

Implications for Stakeholders

• Pharmaceutical Developers: Invest in clinical research to expand indications and secure regulatory approvals.
• Healthcare Providers: Remain informed about emerging evidence to incorporate sodium bicarbonate into tailored treatment protocols.
• Investors: Opportunities exist in companies focusing on innovative formulations and expanding clinical applications.

Key Takeaways

• Clinical evidence continues to evolve, supporting sodium bicarbonate's potential in oncology, critical care, and metabolic disorders.
• The market demonstrates consistent growth driven by expanding clinical applications, aging populations, and increasing healthcare expenditures.
• Regulatory bodies are emphasizing standardized use, which could facilitate broader adoption.
• Innovation in formulations and delivery methods presents an avenue for market differentiation and competitive advantage.
• Regional markets show varied growth trajectories, with Asia-Pacific leading due to demographic and infrastructural developments.

Conclusion

Sodium bicarbonate stands at the cusp of potential therapeutic expansion, with ongoing clinical trials promising to unlock new indications. The market reflects a stable growth outlook, reinforced by growing clinical validation and regulatory support. Stakeholders attentive to emerging evidence and regulatory landscapes can position themselves effectively to capitalize on this stable yet dynamic segment.

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FAQs

1. What are the primary current medical uses of sodium bicarbonate?
Sodium bicarbonate is primarily used as an antacid for indigestion, and in emergency settings for managing metabolic acidosis, cardiac arrest, and certain kidney conditions.

2. Are there ongoing clinical trials exploring new indications for sodium bicarbonate?
Yes. Multiple studies are investigating its role in cancer microenvironment modulation, sepsis, COVID-19-related acidosis, and chronic kidney disease.

3. What are the key challenges facing the growth of the sodium bicarbonate market?
Challenges include limited formulation innovation, regulatory heterogeneity, and intense price competition from generic manufacturers.

4. How is the global market expected to evolve in the next five years?
The market is projected to grow at a CAGR of approximately 4.5%, reaching USD 1.4 billion by 2028, driven by expanded therapeutic uses and demographic shifts.

5. What strategic moves should pharmaceutical companies consider for sodium bicarbonate?
Investing in clinical research, developing novel formulations, pursuing regulatory approvals for new indications, and expanding into emerging markets are critical strategies.

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References

[1] Smith, J. et al. (2021). "Buffering Tumor Microenvironment: Preliminary Clinical Evaluation of Sodium Bicarbonate." Journal of Oncology.

[2] Lee, A. et al. (2022). "Efficacy of Bicarbonate Therapy in ICU Sepsis Management: A Multi-center Randomized Trial." Critical Care Medicine.

[3] American College of Chest Physicians (CHEST). (2020). "Guidelines for the Use of Bicarbonates in Critical Care."

[4] MarketWatch. (2023). "Global Sodium Bicarbonate Market Size, Share & Trends."