Last reviewed · How we verify

Sodium Bicarbonate Tablets

University of Colorado, Denver · Phase 1 active Small molecule ✓ Verified May 2026 Quality 10/100

Sodium Bicarbonate Tablets is a Small molecule drug developed by University of Colorado, Denver. It is currently in Phase 1 development.

Sodium bicarbonate tablets are being studied in clinical trials for various conditions, including Acute Myeloid Leukemia, Autosomal Dominant Polycystic Kidney Disease, Chronic Kidney Diseases, and Sickle Cell Anemia. The tablets are administered orally in a dose of 600 mg as part of the treatment regimen in these trials.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 nameSodium Bicarbonate Tablets
SponsorUniversity of Colorado, Denver
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Sodium Bicarbonate Tablets

What is Sodium Bicarbonate Tablets?

Sodium Bicarbonate Tablets is a Small molecule drug developed by University of Colorado, Denver.

Who makes Sodium Bicarbonate Tablets?

Sodium Bicarbonate Tablets is developed by University of Colorado, Denver (see full University of Colorado, Denver pipeline at /company/university-of-colorado-denver).

What development phase is Sodium Bicarbonate Tablets in?

Sodium Bicarbonate Tablets is in Phase 1.

What are the side effects of Sodium Bicarbonate Tablets?

Common side effects of Sodium Bicarbonate Tablets include Increase in antihypertensive therapy, New Lower Extremity Edema, Dialysis initiation, Increase in diuretic therapy, High serum bicarbonate level.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing