Data updated: May 26, 2026
SODIUM BICARBONATE IN PLASTIC CONTAINER (sodium bicarbonate)
Trial Activity: Stable 11 active trials
Metabolic
Approved 1986-06-03
Development Insights
Austin Health conducting 3 trials (7%)
60 indications explored (Broad Platform)
→ metabolic acidosis (8 trials)
→ chronic kidney disease (6 trials)
→ acute kidney injury (4 trials)
1
Indication
--
Phase 3 Trials
39
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1986-06-03
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
SODIUM BICARBONATE IN PLASTIC CONTAINER Approval History
1987
1988
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2026
Original
New Indication
New Form
Label Update
2 FDA actions from 1986 to 1986
Jun 1986 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
What SODIUM BICARBONATE IN PLASTIC CONTAINER Treats
1 FDA approvalsOriginally approved for its first indication in 1986 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 1986)
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Clinical Trial Registry
41 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04984226 Senergy-CKD | 1785131 5R01DK129793 | Ph 2 | recruiting | Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD |
| NCT07424625 | 25-002104 | Ph 4 | not yet recruiting | A Study of Tris-Hydroxymethyl Aminomethane (THAM) Versus Sodium Bicarbonate in Cardiac Surgical Patients |
| NCT05697770 SODa-BIC | ANZIC-RC/ASN001 | Ph 3 | active not recruiting | SODium BICarbonate for Metabolic Acidosis in the ICU |
| NCT05564130 BIHCA | 00004 | Ph 4 | active not recruiting | Bicarbonate for In-Hospital Cardiac Arrest |
| NCT07408076 | IRB-24-5580 IRB-24-5580 | Ph 1, Ph 2 | not yet recruiting | Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones |
| NCT05928936 | IRB00078214a 2R01HL135183 | Ph 2 | recruiting | Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD |
| NCT06999993 | 2022/0098 | Ph 2, Ph 3 | active not recruiting | Efficacy and Safety of Sodium Hyaluronate Gel Combined With Sodium Bicarbonate Versus Sodium Bicarbonate Alone in Prevention of Failed Back Surgery Syndrome |
| NCT06335537 | 2405 | Ph 1 | recruiting | Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers |
| NCT05005793 | 21-3447 R01DK130255 | Ph 4 | recruiting | Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients |
| NCT06047366 results posted | 17799 | Ph 4 | terminated | Combination of Buffered Anesthetic to Treat Mandibular Molars |
| NCT02411773 Sym-CKD | IRB00078214 2025P011323 | Ph 1 | recruiting | Sympatholysis in Chronic Kidney Disease |
| NCT06186622 | 18631 J2A-MC-GZPG | Ph 1 | completed | A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants |
| NCT02476253 (BICAR-ICU) | 9260 | Ph 3 | completed | Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill |
| NCT05719467 SAINT | 235247 | Ph 3 | recruiting | SAINT: Safe Induction of Labor Trial |
| NCT04530448 results posted | 2005006707 | Ph 4 | terminated | Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization |
| NCT02627846 LAMA | R1788 | Ph 4 | completed | Laser Ablation Versus Mechanochemical Ablation Trial |
| NCT02647892 | 0787-15-EP | Ph 4 | terminated | Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia |
| NCT05818007 | YYU-06/03.07.2019 | Ph 4 | completed | Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who Receiving Chemotherapy |
| NCT02046135 results posted | 13-007B | Ph 2 | terminated | Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery |
| NCT00888290 results posted | 2008-376 | Ph 2, Ph 3 | completed | Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects |
| NCT02303548 results posted | BicarbonateinCPR001 | Ph 2 | completed | Bicarbonate in Patients With Out-of-hospital Cardiac Arrest |
| NCT02502071 Alk-UA results posted | 15-0541 | Ph 4 | completed | Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults With Type 1 Diabetes |
| NCT04579419 | RC19/371 | Ph 3 | completed | Injection Site Pain Botulinum Toxin Reconstituted in NS With and Without Sodium Bicarbonate |
| NCT01452412 results posted | 2009-408 R01DK087783 | Ph 2, Ph 3 | completed | Alkali Therapy in Chronic Kidney Disease |
| NCT01894594 | 09-12-13 | Ph 1 | terminated | Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease |
| NCT01920126 | 4-2013-0376 | Ph 4 | completed | The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery |
| NCT02427594 ABC | Pro00058905 K23DK095949 | Ph 1 | completed | Acid-Base Compensation in Chronic Kidney Disease |
| NCT02226913 | 193396 | Ph 3 | completed | Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis |
| NCT02761577 | 16012011 | Ph 4 | completed | A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia |
| NCT02531919 | 1300000483 | Ph 1 | completed | Extended Use of Sodium Bicarbonate in Patients With Cancer |
| NCT02726737 | 941456 | Ph 3 | completed | Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block |
| NCT01846429 | MCC-17136 | Ph 1 | terminated | Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain |
| NCT00674115 results posted | 18133 CL2007-17, P07813 | Ph 3 | completed | A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) |
| NCT00706771 BLISS | TNH 18/08 | Ph 2 | completed | Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study |
| NCT00921518 results posted | CMC AKICS | Ph 2 | completed | Prevention of Acute Kidney Injury in Cardiac Surgery Patients |
| NCT01622296 BufferDent results posted | 1107214 | Ph 4 | completed | Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients |
| NCT00930436 BOSS | MDS001 | Ph 3 | terminated | Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease |
| NCT00878956 | H2007/02808 | Ph 2 | terminated | Bicarbonate in Cardiac Surgery |
| NCT00672334 Bic-MC | EudraCT 2007-002223-32 | Ph 2, Ph 3 | terminated | Sodium Bicarbonate in Cardiac Surgery Study |
| NCT01440478 | 12322 H8Y-EW-HBBX, 2011-003215-36 | Ph 1 | completed | The Effects of Urinary pH Changes on an Investigational Compound in Healthy Subjects |
| NCT00700375 results posted | SBECP | Ph 4 | completed | Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SODIUM BICARBONATE IN PLASTIC CONTAINER FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment