Data updated: May 26, 2026
OLUX E (clobetasol propionate)
Immunology
Approved 2007-01-12
1
Indication
--
Phase 3 Trials
19
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2007-01-12
- Patent Cliff
- 2028
- Routes
- TOPICAL
- Dosage Forms
- AEROSOL, FOAM
OLUX E Approval History
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2007 to 2018
Apr 2016 SUPPL
Mfg · Manufacturing (CMC)
What OLUX E Treats
1 FDA approvalsOriginally approved for its first indication in 2007 .
- Other (1)
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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| NCT05364515 PRGF | BTIIMD-01-EC/217LIQUEN | Ph 3 | withdrawn | Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva |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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
OLUX E FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
30 international docs across 15 countries
OLUX E Patents & Exclusivity
Latest Patent: Nov 2028
Patents (1 active)
US8460641
Expires Nov 5, 2028
Source: FDA Orange Book
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- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.