RIMSO-50 (dimethyl sulfoxide) · Viatris
RIMSO-50 (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis. RIMSO-50 has not been approved as being safe and effective for any other indication. There is no clinical evidence of effectiveness of dimethyl sulfoxide in the treatment of bacterial infections of the urinary tract.
Details
- Status
- Prescription
- First Approved
- 1978-04-04
- Routes
- INTRAVESICAL
- Dosage Forms
- SOLUTION
RIMSO-50 Approval History
What RIMSO-50 Treats
1 indicationsRIMSO-50 is approved for 1 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Interstitial Cystitis
RIMSO-50 Competitive Set
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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.
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Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03716583 MELADERM | 2018-001705-91 | Ph 2 | completed | Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer |
Active Pipeline
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Key Completed Trials
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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.
RIMSO-50 FDA Label Details
Indications & Usage
RIMSO-50 ® (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis. RIMSO-50 ® has not been approved as being safe and effective for any other indication. There is no clinical evidence of effectiveness of dimethyl sulfoxide in the treatment of bacterial infections of the urinary tract.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.