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Higher Dose Sodium Bicarbonate
Higher Dose Sodium Bicarbonate is a Alkalinizing agent Small molecule drug developed by Jennifer Gassman, PhD. It is currently in Phase 3 development for Acute kidney injury prevention or treatment (Phase 3 investigational), Chronic kidney disease progression (Phase 3 investigational).
Higher dose sodium bicarbonate raises blood and urine pH to create an alkaline environment that may reduce kidney injury and improve renal function.
Higher dose sodium bicarbonate is being studied as a potential treatment for various conditions, including hematologic disease, acute kidney injury, multiple sclerosis, systemic inflammatory response syndrome, and oliguria, according to ClinicalTrials.gov. Sodium bicarbonate is a small molecule with the chemical name carbonic acid monosodium salt, classified as a small molecule modality, as per ChEMBL.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Higher Dose Sodium Bicarbonate |
|---|---|
| Sponsor | Jennifer Gassman, PhD |
| Drug class | Alkalinizing agent |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | Phase 3 |
Mechanism of action
Sodium bicarbonate is a buffer that increases systemic and urinary alkalinity. At higher doses, it is hypothesized to reduce tubular toxicity, decrease crystal formation in renal tubules, and mitigate ischemic injury in the kidneys. This mechanism is being investigated for renoprotection in various acute and chronic kidney disease settings.
Approved indications
- Acute kidney injury prevention or treatment (Phase 3 investigational)
- Chronic kidney disease progression (Phase 3 investigational)
Common side effects
- Hypernatremia
- Metabolic alkalosis
- Gastrointestinal disturbance
- Hypertension
Key clinical trials
- Intermediate Expanded Access Protocol CNMAu8.EAP03
- Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment (PHASE4)
- Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy
- Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD (PHASE2)
- Exercise-Induced Lactate and Cognitive Function (ExLBC) (NA)
- Root Caries Excavation with Air Water/powder Prophylaxis Device for ART Restorations (NA)
- IHD Versus CRRT for Severe Acute Kidney Injury in Critically Ill Patients (NA)
- The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Higher Dose Sodium Bicarbonate CI brief — competitive landscape report
- Higher Dose Sodium Bicarbonate updates RSS · CI watch RSS
- Jennifer Gassman, PhD portfolio CI
Frequently asked questions about Higher Dose Sodium Bicarbonate
What is Higher Dose Sodium Bicarbonate?
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Related
- Drug class: All Alkalinizing agent drugs
- Manufacturer: Jennifer Gassman, PhD — full pipeline
- Therapeutic area: All drugs in Nephrology
- Indication: Drugs for Acute kidney injury prevention or treatment (Phase 3 investigational)
- Indication: Drugs for Chronic kidney disease progression (Phase 3 investigational)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing