Sodium Bicarbonate

(Macrogol3350 Na sulphate Na bicarbonate NaCl KCl)

Small molecule

AAbbott

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q2 2028

ApprovedNot yet recruiting

Metabolic Acidosis

NCT07424625

Clinical

Trials by Indication[1]

Pilot Study1 trial

MOVIPREP® Versus PICOLAX® Pilot Study

Completed·NNorgine·Phase 2·NCT00312481·65 enrolled

Phase II1 trial

MOVIPREP® Versus NaP Pivotal Phase III Study

Completed·NNorgine·Phase 3·NCT00322062·340 enrolled

Bowel Preparation1 trial

Clinical Evaluation of a New Reduced Volume Bowel Preparation

Completed·NNorgine·Phase 2·NCT00321230·30 enrolled

Acceptability1 trial

A Phase III Trial to Assess the Efficacy, Acceptability and Safety of Moviprep® Versus a 4L PEG+E Standard Solution

Completed·NNorgine·Phase 3·NCT00389233·360 enrolled

Chronic Kidney Diseases1 trial

Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD) Feasibility Trial

Active, not recruiting·DDylan MacKay·Preclinical·NCT05113641·37 enrolled

1 more indication

Metabolic Acidosis1 trial

THAM VErsus Sodium BiCarbOnate In CaRdiac SuRgical PatiEnts, A PragmatiC, Comparative-effectiveness Prospective Trial

Not yet recruiting·MMayo Clinic·Approved·NCT07424625·250 enrolled

Regulatory

FDA Approval Timeline[3]

Jun 3, 1986

SODIUM BICARBONATE IN PLASTIC CONTAINER

NDA NDA019443

Jul 9, 2026

SODIUM BICARBONATE

NDA NDA220790

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Macrogol3350 Na sulphate Na bicarbonate NaCl KCl. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Macrogol3350 Na sulphate Na bicarbonate NaCl KCl compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA220790). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Abbott company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: AAbbott