Overview
Ulobetasol is a highly potent corticosteroid. It is structurally related to clobetasol. Due to its high potency, it is mainly prescribed in the treatment of severe plaque psoriasis and corticosteroid responsive dermatoses. Ulobetasol was granted FDA approval on 17 December 1990.
Indication
Ulobetasol cream and ointment are indicated in the treatment of inflammatory and pruritic corticosteroid responsive dermatoses. Ulobetasol lotion is indicated in the treatment of plaque psoriasis.
Associated Conditions
- Psoriasis Vulgaris (Plaque Psoriasis)
- Corticosteroid responsive, Inflammatory Dermatosis
- Corticosteroid responsive, pruritic Dermatosis
Research Report
A Comprehensive Monograph on Ulobetasol (Halobetasol): Pharmacology, Clinical Efficacy, and Safety Profile
Section 1: Executive Summary
Ulobetasol is a synthetic topical corticosteroid characterized by its super-high potency, placing it in the most powerful class of such agents used in dermatology.[1] Known interchangeably by its International Nonproprietary Name (INN), Ulobetasol, and its United States Adopted Name (USAN), Halobetasol, this small molecule drug is structurally analogous to clobetasol.[3] It is clinically indicated for the short-term treatment of inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses, including severe conditions like eczema, dermatitis, and plaque psoriasis.[3]
The therapeutic effects of Ulobetasol—anti-inflammatory, antipruritic, and vasoconstrictive—are derived from its primary mechanism as a potent agonist of the nuclear glucocorticoid receptor.[3] This interaction modulates gene expression, leading to the inhibition of pro-inflammatory pathways, such as those mediated by NF-Kappa B, and the promotion of anti-inflammatory proteins like lipocortins. This dual action results in a powerful and rapid suppression of cutaneous inflammation.[2]
Ulobetasol is available in multiple formulations, including 0.05% cream and ointment for general dermatoses, and more recent 0.01% and 0.05% lotions and a 0.05% foam developed specifically for plaque psoriasis.[6] A combination product, Duobrii®, which pairs 0.01% ulobetasol propionate with the retinoid tazarotene, is also available for psoriasis, representing a strategy to enhance efficacy and manage the disease through multiple pathways.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/09/18 | Phase 4 | Completed | |||
2022/11/08 | Phase 3 | Terminated | |||
2022/03/16 | Early Phase 1 | Completed | |||
2020/09/30 | Phase 4 | UNKNOWN | Skin Sciences, PLLC | ||
2019/06/20 | Phase 4 | Completed | |||
2017/10/02 | Phase 2 | Withdrawn | |||
2017/07/11 | Phase 4 | Terminated | |||
2017/02/23 | Phase 1 | Completed | |||
2016/05/27 | Phase 2 | Completed | |||
2016/05/27 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Physicians Total Care, Inc. | 54868-4907 | TOPICAL | 0.5 mg in 1 g | 10/27/2010 | |
Physicians Total Care, Inc. | 54868-5482 | TOPICAL | 0.5 mg in 1 g | 10/27/2010 | |
Bausch Health US, LLC | 0187-0653 | TOPICAL | 0.1 mg in 1 g | 1/1/2020 | |
Bryant Ranch Prepack | 72162-2258 | TOPICAL | 0.5 mg in 1 g | 2/23/2024 | |
Bryant Ranch Prepack | 63629-8665 | TOPICAL | 0.5 mg in 1 g | 7/18/2023 | |
Mayne Pharma | 51862-606 | TOPICAL | 0.5 mg in 1 g | 3/31/2023 | |
Sun Pharmaceutical Industries, Inc. | 10631-122 | TOPICAL | 0.5 mg in 1 g | 9/2/2020 | |
Taro Pharmaceuticals U.S.A., Inc. | 51672-1322 | TOPICAL | 0.5 mg in 1 g | 1/29/2020 | |
Taro Pharmaceuticals U.S.A., Inc. | 51672-1321 | TOPICAL | 0.5 mg in 1 g | 5/12/2017 | |
Mayne Pharma | 51862-604 | TOPICAL | 0.5 mg in 1 g | 3/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
BRYHALI | bausch health, canada inc. | 02506262 | Lotion - Topical | 0.01 % / W/W | 8/6/2021 |
DUOBRII | bausch health, canada inc. | 02499967 | Lotion - Topical | 0.01 % / W/W | 8/4/2020 |
ULTRAVATE | bausch health, canada inc. | 01962701 | Cream - Topical | 0.05 % / W/W | 12/31/1993 |
ULTRAVATE | bausch health, canada inc. | 01962728 | Ointment - Topical | 0.05 % / W/W | 12/31/1993 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.