CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (betamethasone dipropionate)
This topical ointment treats plaque psoriasis in patients 12 years of age and older. It combines a synthetic vitamin D3 analogue with a corticosteroid to help patients manage their skin symptoms. Healthcare providers use this combination product to address the physical effects of plaque psoriasis through a dual-action approach.
How CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE Works
This medication works by combining the pharmacological effects of calcipotriene and betamethasone dipropionate. While the exact biological mechanisms that improve plaque psoriasis are unknown, the drug utilizes the properties of both a synthetic vitamin D3 analogue and a synthetic corticosteroid.
Details
- Status
- Prescription
- First Approved
- 2013-01-14
- Routes
- TOPICAL
- Dosage Forms
- SUSPENSION, OINTMENT, AEROSOL, FOAM
Companies
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE Approval History
What CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE Treats
1 indicationsCALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
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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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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06332612 MROSF | 8420224AROM | Ph 1, Ph 2 | completed | Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial |
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.
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE FDA Label Details
Indications & Usage
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE is indicated for the treatment of Plaque Psoriasis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.