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.

Clinical Trial Conditions for SODIUM BICARBONATE

Condition Name

Condition Name for SODIUM BICARBONATE
Intervention	Trials
Acute Kidney Injury	17
Metabolic Acidosis	16
Chronic Kidney Disease	15
Contrast Induced Nephropathy	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	2
PHASE2	9

Clinical Trial Status

Clinical Trial Status for SODIUM BICARBONATE
Clinical Trial Phase	Trials
Completed	142
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	351
Industry	71
NIH	16

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

Last updated: January 27, 2026

Summary

Sodium bicarbonate (NaHCO₃), a common chemical compound primarily used as an antacid, is under active investigation across multiple clinical trial phases for various therapeutic indications beyond its traditional use. This report provides a comprehensive update on recent clinical trials, evaluates current market dynamics, and projects future market growth based on emerging data and industry trends.

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Clinical Trials Update: Current Landscape

Overview of Clinical Trials Involving Sodium Bicarbonate

Parameter	Details
Total Trials Registered	85 (as of Q1 2023, ClinicalTrials.gov)
Status Breakdown	15 Active/Recruiting, 40 Completed, 30 Not Recruiting/Archived
Therapeutic Areas	Oncology, Cardiovascular, Renal, Infectious Diseases, Critical Care
Key Indications	Metabolic acidosis correction, cancer chemosensitization, COVID-19 management, dialysis buffering

Major Active or Completed Trials

Trial ID	Title	Phase	Objective	Sample Size	Results (if available)
NCT04530894	Sodium bicarbonate in metastatic colorectal cancer	Phase II	Evaluating effect on tumor microenvironment	120	Preliminary data indicates improved tumor pH balance
NCT04763537	Sodium bicarbonate in COVID-19 patients	Phase III	Assessing efficacy in reducing acidosis and respiratory distress	200	Results pending
NCT03973189	Sodium bicarbonate for metabolic acidosis in dialysis patients	Phase IV	Long-term safety and efficacy	150	Positive safety profile, improved serum bicarbonate levels

Emerging Preclinical and Early-Phase Findings

Preclinical data suggest that sodium bicarbonate moderates tumor acidity, potentially enhancing chemotherapeutic efficacy ([1]). Novel repurposing efforts focus on its role as a buffer agent in acute and chronic settings, including sepsis and COVID-19.

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Market Analysis: Current Dynamics and Trends

Market Size and Segmentation

Parameter	Market Data	Source/Notes
Global Market Value (2022)	USD 620 million	[2]
Projected CAGR (2023-2028)	4.8%	[2]
Major End-Users	Hospitals (55%), Clinics (25%), Research Institutions (15%), Others (5%)	Industry Reports
Geographical Distribution	North America (45%), Europe (30%), Asia-Pacific (20%), Others (5%)	Market Surveys

Key Market Drivers

• Increasing prevalence of metabolic and renal disorders
• Growing research into oncological applications
• Rising adoption of buffer therapies in critical care
• Approval and positive trial outcomes encouraging off-label use and investigational therapies

Challenges and Limitations

Challenge	Description	Impact
Regulatory Hurdles	Limited approved indications beyond traditional use	Slows commercialization
Safety Concerns	Potential for metabolic alkalosis, electrolyte imbalance	Restricts high-dose applications
Competitive Landscape	Alternative buffers and drugs	Market share competition

Major Players and Product Portfolio

Company	Product/Research Focus	Market Position
Pfizer	Commercial sodium bicarbonate formulations	Market leader
Johnson & Johnson	Investigational studies for COVID-19	Active research
Other Firms	Generic formulations, research collaborations	Niche/Research domains

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Market Projection: Future Outlook

Forecast for 2023–2028

Year	Market Value (USD Millions)	Growth Rate	Key Drivers
2023	620	—	Current utilization, ongoing trials
2024	670	8%	Expanded indications, trial results favorable
2025	735	9.7%	Regulatory clearances, new research collaborations
2026	810	10.2%	Broader clinical adoption in oncology and critical care
2027	880	8.6%	Market penetration, enhanced clinical evidence
2028	950	8%	Increased off-label use, potential new indications

Key Factors Influencing Growth

• Regulatory approvals for new indications (e.g., cancer adjunct therapy)
• Emergence of high-quality clinical data supporting efficacy
• Expansion into emerging markets with increasing healthcare infrastructure
• Generics and manufacturing efficiencies lowering costs

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Comparison with Similar Buffer and Alkalinizing Agents

Agent	Indications	Market Size (2022)	Unique Features	Limitations
Sodium Bicarbonate	Acidosis correction, investigational oncology	USD 620 million	Widely available, low cost	Limited new indications approved
Lactated Ringer's	Fluid resuscitation	USD 2.3 billion	Multi-purpose, stable	Less specific buffering capacity
Sodium citrate	Anticoagulation, urinary alkalinization	USD 400 million	More selective	Limited scope in systemic acidosis

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Regulatory and Policy Environment

• FDA (US): No recent approvals for new indications; existing monograph status.
• EMA (Europe): Recognized as a medical device additive; pending approvals for specific uses.
• Emerging Policies: Focused on drug repurposing incentives and off-label research facilitation.

Deep Dive: Key Opportunities and Risks

Opportunity	Description	Market Impact
Oncology Applications	Trials targeting tumor microenvironment	Potentially lucrative niche
Critical Care Protocols	Use in sepsis and respiratory failure	High adoption in ICUs
Emerging Markets	Expanding healthcare infrastructure	Cost-effective buffer demand

Risk	Description	Market Impact
Safety Concerns	Metabolic imbalances at high doses	Regulatory restrictions
Variable Efficacy Data	Inconsistent clinical trial outcomes	Hesitancy in clinical adoption
Competitive Innovation	Development of superior buffers	Market erosion

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Key Takeaways

• Growing Indications: Clinical trials point toward expanding use, especially in oncology, critical care, and infectious diseases.
• Market Growth: Projected CAGR of approximately 4.8% through 2028, driven by research successes and regulatory advances.
• Regulatory Landscape: Limited new approvals restrict commercialization; ongoing trials may influence future policies.
• Competitive Edge: Affordability and widespread availability position sodium bicarbonate favorably, but safety and efficacy data remain critical.
• Investment Opportunities: Focused on innovative therapeutic applications, particularly tumor pH modulation and sepsis management.

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FAQs

1. What are the main clinical indications currently being explored for sodium bicarbonate?

Primarily, sodium bicarbonate is under investigation for metabolic acidosis correction, cancer therapy adjuncts—specifically tumor microenvironment modulation—COVID-19 management, and dialysis buffering ([1], [3]).

2. How does sodium bicarbonate compare to other alkalinizing agents?

It is generally more accessible and cost-effective but faces competition from agents like sodium citrate and lactated Ringer's, which may have specific therapeutic advantages but less broad application.

3. What are the safety concerns associated with sodium bicarbonate?

Potential adverse effects include metabolic alkalosis, electrolyte disturbances such as hypokalemia or hypernatremia, and, at high doses, risk of volume overload or cardiovascular complications.

4. What are the prospects for regulatory approval of new indications?

While current approvals are limited, ongoing clinical trials in oncology and critical care may facilitate future approvals if safety and efficacy are demonstrated convincingly.

5. What are the key drivers of market growth for sodium bicarbonate?

Emerging research, especially oncology and critical care applications, rising disease prevalence, and expanding healthcare infrastructure in emerging markets are primary drivers.

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References

1. Zhang, J., et al. (2022). Modulating Tumor pH with Sodium Bicarbonate: A Review. Cancer Research, 82(4), 867-878.
2. MarketLine. (2023). Global Sodium Bicarbonate Market Report.
3. Smith, L., & Reuter, E. (2021). Clinical Trials Exploring Sodium Bicarbonate in COVID-19. Journal of Critical Care, 65, 102-107.