IMPEKLO (clobetasol propionate) · PHARMOBEDIENT
IMPEKLO is FDA-approved to treat 4 conditions (same as CLOBEX).
Details
- Status
- Discontinued
- First Approved
- 2020-05-19
- Routes
- TOPICAL
- Dosage Forms
- LOTION
IMPEKLO Approval History
What IMPEKLO Treats
4 indicationsIMPEKLO is approved for 4 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dermatoses
- Plaque Psoriasis
- Rosacea
- Perioral Dermatitis
Same approved indications as CLOBEX (same active ingredient).
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02368886 results posted | RU021407I NCI-2015-00011, RU021407I | Ph 2 | completed | Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer |
| NCT05364515 PRGF | BTIIMD-01-EC/217LIQUEN | Ph 3 | withdrawn | Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva |
| NCT04364555 | LIKLO-1 | Ph 2, Ph 3 | active not recruiting | Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. |
| NCT05724446 CLOSE-3 | CLOBOF3-17IA03 | Ph 3 | recruiting | Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population |
| NCT04246801 CLOSE-1 results posted | CLOBOF3-16IA01 | Ph 3 | completed | Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1) |
| NCT04249076 CLOSE-2 results posted | CLOBOF3-16IA02 | Ph 3 | completed | Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2) |
| NCT03592342 | DT-001-R-004 | Ph 2 | completed | Intra-oral Treatment of OLP With Rivelin®-CLO Patches |
| NCT03535233 | AA22 | Ph 4 | completed | Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata |
| NCT02936492 | 17014 | Ph 1 | terminated | BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study |
| NCT01381445 | 113435 | Ph 1 | completed | A Study Assessing GW870086's Potential to Cause Skin Thinning |
| NCT02940002 | 17012 2016-000962-47 | Ph 1 | completed | BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test |
| NCT00828464 results posted | U0280-401 | Ph 4 | completed | Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis |
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.
IMPEKLO FDA Label Details
Indications & Usage
FDA Label (PDF)IMPEKLO is FDA-approved to treat 4 conditions — same approved indications as CLOBEX.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.