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Ulobetasol

Generic Name
Ulobetasol
Brand Names
Bryhali, Duobrii, Lexette, Ultravate, Ultravate X Ointment
Drug Type
Small Molecule
Chemical Formula
C22H27ClF2O4
CAS Number
98651-66-2
Unique Ingredient Identifier
9P6159HM7T

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

Published: Sep 5, 2025

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]

Continue reading the full research report

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.

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