TheraRadar
Data updated: Jun 28, 2026

OLUX E (clobetasol propionate) · PHARMOBEDIENT

Immunology Approved 2007-01-12

OLUX E is FDA-approved to treat 4 conditions (same as CLOBEX).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
19
Years on Market

Details

Status
Discontinued
First Approved
2007-01-12
Patent Cliff
2028

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Patent cliff and revenue data

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Routes
TOPICAL
Dosage Forms
AEROSOL, FOAM

Companies

PHARMOBEDIENT
Active Ingredient: CLOBETASOL PROPIONATE

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
May 2018 SUPPL
Label · Labeling
FDA Letter Label
Apr 2016 SUPPL
Mfg · Manufacturing (CMC)
Apr 2013 SUPPL
Label · Labeling
FDA Letter Label

What OLUX E Treats

4 indications

OLUX E is approved for 4 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as CLOBEX (same active ingredient).

Source: FDA Label
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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NCT05364515 PRGF BTIIMD-01-EC/217LIQUEN Ph 3 withdrawn Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva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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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

FDA Label (PDF)

OLUX E is FDA-approved to treat 4 conditions — same approved indications as CLOBEX.

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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Revenue Insights

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Patent Timeline

  • • Cliff: 2028
  • • 1 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA022013 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.