CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE (citric acid)
Development Insights
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
Companies
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE Approval History
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07218523 CLARITY | NER1006-01/2025 2025-522046-42-00 | Ph 3 | recruiting | A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy |
| NCT07173855 MAGNOLIA | ICU-25-018 | Ph 4 | recruiting | Effect of Protocolized Magnesium Replacement on Mortality and Atrial Fibrillation in Critically Ill Patients |
| NCT05144295 | 0305299 | Ph 3 | completed | Lubiprostone for Functional Constipation in the Under 18 Years Patients |
| NCT01525875 results posted | GCO 09-1157 FD-R-0003903 | Ph 2 | completed | Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE) |
| NCT03054805 results posted | 103-0519A3 | Ph 4 | completed | The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation |
| NCT03769402 | 52-376 | Ph 4 | completed | The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile |
| NCT01439945 results posted | NCCTG-N10C2 NCCTG-N10C2, CDR0000711021 | Ph 2 | completed | Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer |
| NCT03074448 | Kaiser CH | Ph 3 | completed | Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-endoscopy Bowel Preparation |
| NCT01008904 results posted | MCC-12062 HM12062, CDR0000650938 | Ph 2 | completed | Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer |
| NCT02211911 | 122.57 | Ph 1 | completed | Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE 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