Sodium Bicarbonate: clinical trials recruiting now
3
Recruiting trials
8
Conditions studied
3
US states with sites
1
Countries
FDA drug label
- FDA-approved
- Yes. Sodium Bicarbonate appears in the FDA drug-label database. Marketed as Sodium Bicarbonate.
- Boxed warning
- The FDA label for Sodium Bicarbonate carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Uses: relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| cGMP deviations: Temperature abuse — Mckesson Medical-Surgical Inc. Corporate Office | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-04-13 |
| Lack of Assurance of Sterility — Exela Pharma Sciences LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-03-07 |
| Presence of Particulate Matter: Silicone — Exela Pharma Sciences LLC | Class I (FDA: reasonable probability of serious harm or death) | Ongoing | 2023-10-18 |
| Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient — LUPIN SOMERSET | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-03-19 |
| Failed Stability Specification; Out of specification for Osmolarity — Novel Laboratories, Inc. d.b.a LUPIN | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-07-29 |
Phase breakdown
Phase 1 1
Phase 2 2
Conditions being studied
Recruiting trials involving Sodium Bicarbonate
- Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
- Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
- Sympatholysis in Chronic Kidney Disease
Common questions
Is Sodium Bicarbonate FDA-approved?
Yes, marketed as Sodium Bicarbonate. Its FDA label carries a boxed warning.
How many recruiting trials involve Sodium Bicarbonate?
3 recruiting trials across 8 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.