SORBITOL 3.3% IN PLASTIC CONTAINER (sorbitol)
SORBITOL 3.3% IN PLASTIC CONTAINER is indicated for the treatment of Irregular Bowel Movements; Pain; Weakness; Nausea.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1978-02-16
- Routes
- IRRIGATION
- Dosage Forms
- SOLUTION
SORBITOL 3.3% IN PLASTIC CONTAINER Approval History
What SORBITOL 3.3% IN PLASTIC CONTAINER Treats
4 indicationsSORBITOL 3.3% IN PLASTIC CONTAINER is approved for 4 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Irregular Bowel Movements
- Pain
- Weakness
- Nausea
SORBITOL 3.3% IN PLASTIC CONTAINER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SORBITOL 3.3% IN PLASTIC CONTAINER
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06826079 SNCCTGC | Union01 | Ph 2, Ph 3 | recruiting | Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer |
| NCT04330326 NAFLD | 309 | Ph 2 | completed | Metabolic Cofactor Supplementation in Obese Patients With Non-Alcoholic Fatty Liver Disease |
| NCT04044131 | Metabolic Cofactor Study | Ph 2 | completed | Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) Patients |
| NCT02634073 results posted | 204857 | Ph 4 | completed | A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers |
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.
SORBITOL 3.3% IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
SORBITOL 3.3% IN PLASTIC CONTAINER is indicated for the treatment of Irregular Bowel Movements; Pain; Weakness; Nausea.
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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