GR agonists(Glucocorticoid receptor agonists), RARα agonists(Retinoic acid receptor alpha agonists), RARβ2 agonists(Retinoic acid receptor beta agonists)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Plaque psoriasis

Inactive Indication

Acne Keloid

Originator Organization

Bausch Health Americas, Inc.

Active Organization

Bausch Health, Canada, Inc.Valeant Canada Ltd.Bausch Health Americas, Inc.

Inactive Organization-

License Organization

Sol-Gel Technologies Ltd.

Padagis US LLC

Drug Highest PhaseApproved

First Approval Date

United States (25 Apr 2019),

Plaque psoriasis

Regulation-

Structure/Sequence

Molecular FormulaC25H31ClF2O5

InChIKeyBDSYKGHYMJNPAB-LICBFIPMSA-N

CAS Registry66852-54-8

View All Structures (2)

Clinical Trials associated with Halobetasol Propionate/Tazarotene

NCT05872256

/ CompletedPhase 4IIT

A Demonstration of the Hair and Scalp Benefits of 0.045% Tazarotene/0.01% Halobetasol Lotion in Scalp Psoriasis

The objectives of this research are to demonstrate the following:1. To demonstrate improvement in hair growth and hair appearance following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.2. To demonstrate improvement in scalp itch reduction following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.3. To pictorially demonstrate improvement in moderate to severe scalp psoriasis with 12 weeks of once daily treatment with tazarotene/halobetasol lotion.4. To assessment patient perceptions of the value of a lotion in the treatment of moderate to severe scalp psoriasis.

Start Date01 Jun 2023

Sponsor / Collaborator

Ortho Dermatologics

NCT05608499

/ Active, not recruitingPhase 3IIT

Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN)

Acne keloidalis nuchae (AKN) is one of the chronic forms of scarring folliculitis, affecting predominantly the occipital scalp, seen mostly in men of African descent. Duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the FDA with dermatologic indication. Researchers are proposing the off-labeled use of Duobrii for the management of early-mild AKN. The research team hypothesizes that subjects will experience significant clinical improvement in lesion counts. Patients will be followed with visits scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. During these in-clinic visits, there will be surveys regarding the severity of AKN symptoms, photographs, and clinical assessments.

Start Date26 Oct 2022

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+1]

NCT05282771

/ CompletedEarly Phase 1

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) and Both Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Plaque Psoriasis

To evaluate the therapeutic equivalence and safety of halobetasol propionate and tazarotene topical lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (halobetasol and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the treatment of moderate to severe plaque psoriasis.

Start Date16 Apr 2021

Sponsor / Collaborator

Taro Pharmaceuticals U.S.A., Inc.

100 Clinical Results associated with Halobetasol Propionate/Tazarotene

100 Translational Medicine associated with Halobetasol Propionate/Tazarotene

100 Patents (Medical) associated with Halobetasol Propionate/Tazarotene

Literatures (Medical) associated with Halobetasol Propionate/Tazarotene

01 Nov 2021·Skin therapy letter

Fixed Combination Halobetasol Propionate and Tazarotene Lotion for Plaque Psoriasis.

Article

Author: Guenther, Lyn ; Metelitsa, Andrei ; Prajapati, Vimal H

A novel fixed combination lotion containing the super-potent corticosteroid halobetasol propionate 0.01% and retinoid tazarotene 0.045% (Duobrii™) has recently been introduced and indicated for the treatment of moderate to severe plaque psoriasis in adults. Studies have shown that there is synergy between the ingredients and that the product can be safely used intermittently for up to 1 year. Treatment success (i.e., Investigator Global Assessment [IGA] of clear/almost clear [IGA 0/1] and at least a 2-grade improvement from baseline) occurred in 58.8% of participants at some point in a 1-year clinical trial. Persistence of treatment success is common after treatment discontinuation. Most treatment-emergent adverse events are application site reactions, mild to moderate in intensity, and occur primarily during the first 12 weeks. Counselling should be considered to optimize treatment outcomes.

01 Sep 2020·ANNALS OF PHARMACOTHERAPY

Treating Psoriasis With Halobetasol Propionate and Tazarotene Combination: A Review of Phase II and III Clinical Trials

Review

Author: Feldman, Steven R. ; Bashyam, Arjun M. ; Ramachandran, Vignesh ; Bertus, Brooke

Objective: To review phase II and III clinical trial data to evaluate the efficacy and safety of the halobetasol propionate/tazarotene (HP/TAZ) combination lotion (Duobrii), a medication approved by the Food and Drug Administration in April 2019 for adults with plaque psoriasis. Data Sources: A systematic search (January 2005 to July 2019) of MEDLINE (PubMed) and EMBASE databases was performed using the terms halobetasol, tazarotene, halobetasol/tazarotene, Duobrii, and IDP-118. Study Selection and Data Extraction: Relevant English-language articles reporting on phase II and phase III clinical trials were included. Data from the individual trials were extracted independently and then cross-checked to ensure accuracy. Data Synthesis: HP/TAZ was safe and efficacious compared with HP alone, TAZ alone, or vehicle. More patients achieved treatment success, described as a ≥2-grade improvement on Investigator Global Assessment Scale, over 8 weeks of treatment and at the 4-week follow-up after treatment cessation. The most common adverse events were dermatitis, pain, and pruritus, which occurred more often in the TAZ groups compared with the HP/TAZ cohorts. Relevance to Patient Care and Clinical Practice: The once-daily HP/TAZ combination lotion simplifies psoriasis treatment and may facilitate adherence, which may improve psoriasis outcomes. Conclusions: HP/TAZ combination lotion is efficacious and safe for plaque psoriasis treatment, with more patients achieving end points and fewer side effects than in HP, TAZ, or vehicle-treated controls. Drug synergy may play a role. Importantly, patient adherence to a once-daily combinational therapy is likely to contribute to efficacy.

Skinmed

DUOBRII™ (Halobetasol Propionate and Tazarotene) Lotion for Topical Use: A Newly Approved Combination Corticosteroid and Retinoid Topical Treatment of Plaque Psoriasis in Adults.

Article

Author: Love, Robin P ; Gupta, Aditya K ; Vincent, Kimberly D ; Abramovits, William

News (Medical) associated with Halobetasol Propionate/Tazarotene

21 Aug 2025

·ir.bauschhealth.com

Bausch Health, Canada Inc. treatment for acne vulgaris, PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Quebec and Saskatchewan

Bausch Health, Canada Inc. treatment for acne vulgaris, PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Quebec and Saskatchewan (English) LAVAL, QC, August 21, 2025 – Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,1 is now available to beneficiaries of the public drug plans of Quebec and Saskatchewan. This new public drug plan availability of CABTREO is in addition to that announced last month for those using the Ontario and Nova Scotia public drug plans as well as through the federal government’s Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations as well as those of the Correctional Service of Canada (CSC) and Veterans Affairs Canada. CABTREO is a new Canadian-made triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older. CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action – an antibiotic, a retinoid and an antibacterial agent – to provide a safe and effective treatment.1 “The addition of CABTREO to the Quebec and Saskatchewan public drug plans means more Canadians now have access to this innovative acne treatment – joining those already covered under most private insurance plans,” said Amy Cairns, General Manager, Bausch Health Canada. “Acne can have a significant impact on those living with it, and there is strong demand for new treatment options, increasing the importance of public drug plan coverage.” CABTREO, a prescription product, is a topical gel that is administered once daily to affected areas of the skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene and the oxidizing agent benzoyl peroxide with a broad-spectrum bactericidal activity.1 About Acne Vulgaris Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3 CABTREO Clinical Data and Safety Information CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with facial acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and a greater than 70% reduction in both inflammatory and noninflammatory lesions at Week 12.1 The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide or to any ingredient in the formulation), patients with a history of regional enteritis (Crohn’s disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1 Health Canada has not authorized CABTREO for pediatric use under the age of 12 years. CABTREO is for topical use only and is not for oral, ophthalmic or intravaginal use.1 About Dermatology at Bausch Health, Canada Inc. Bausch Health, Canada Inc. has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada Inc. dermatology portfolio includes several leading acne, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products. CABTREO is the fourth new dermatology treatment from Bausch Health, Canada Inc. approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLOTM (tazarotene lotion, 0.045% w/w), for the topical treatment of acne vulgaris in patients 10 years of age and older; BRYHALI™ (halobetasol propionate lotion 0.01% w/w), for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis in adults; and DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) to treat adults with moderate to severe plaque psoriasis.4 All four treatments – CABTREO, ARAZLO, BRYHALI and DUOBRII – are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn. The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca. Forward-looking Statements This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. REFERENCES 1 Bausch Health, Canada Inc., CABTREO Product Monograph,https://pdf.hres.ca/dpd_pm/00076715.PDF. 2 Canadian Dermatology Association, Acne, Quick Facts,https://dermatology.ca/public-patients/skin/acne/#:~:text=Acne%20affects%205.6%20million%20Canadians,adults%20ages%2020%20to%2040, accessed Aug. 20, 2024. 3 "What to Know about Hyperpigmentation Acne." Medical News Today, Jessica Caporuscio, April 28, 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne, accessed Aug. 20, 2024. 4 Bausch Health, Canada Inc., Canadian Product List, https://bauschhealth.ca/products/canadian-product-list/.

Clinical ResultPhase 3Drug Approval

09 Jul 2025

·ir.bauschhealth.com

Bausch Health, Canada Inc. treatment for acne vulgaris, PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Ontario, Nova Scotia and two federal programs

LAVAL, QC, July 9, 2025 – Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced that PrCABTREO™ (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,1 is now available to beneficiaries of the public drug plans of Ontario and Nova Scotia as well as through the federal government’s Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations and that of the Correctional Service of Canada (CSC). CABTREO is a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older. CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action – an antibiotic, a retinoid and an antibacterial agent – to provide a safe and effective treatment.1 "It is very encouraging for people with acne vulgaris who use the Ontario, Nova Scotia and federal drug plans to now have access to CABTREO along with those on most private drug insurance plans,” said Amy Cairns, General Manager, Bausch Health, Canada Inc. “We look forward to completing listing arrangements in the near future with other public drug plans across Canada.” "We are pleased that public drug plans are ensuring Canadians with acne have access to new treatments, recognizing the importance of making different options available," said Kathy Giangaspero, Executive Director of the Acne and Rosacea Society of Canada. “Acne can significantly impact a person’s mental and physical health, so this is a big win for the patient community.” CABTREO, a prescription product, is a topical gel that is administered once daily to affected areas of the skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene and the oxidizing agent benzoyl peroxide with a broad-spectrum bactericidal activity.1 About Acne Vulgaris Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3 CABTREO Clinical Data and Safety Information CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with facial acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and a greater than 70% reduction in both inflammatory and noninflammatory lesions at Week 12.1 The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide or to any ingredient in the formulation), patients with a history of regional enteritis (Crohn’s disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1 Health Canada has not authorized CABTREO for pediatric use under the age of 12 years. CABTREO is for topical use only and is not for oral, ophthalmic or intravaginal use.1 About Dermatology at Bausch Health, Canada Inc. Bausch Health, Canada Inc. has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada Inc. dermatology portfolio includes several leading acne, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products. CABTREO is the fourth new dermatology treatment from Bausch Health, Canada Inc. approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLO™ (tazarotene lotion, 0.045% w/w), for the topical treatment of acne vulgaris in patients 10 years of age and older; BRYHALI™ (halobetasol propionate lotion 0.01% w/w), for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis in adults; and DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) to treat adults with moderate to severe plaque psoriasis.4 All four treatments – CABTREO, ARAZLO, BRYHALI and DUOBRII – are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn. The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca. Forward-looking Statements This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. REFERENCES 1 Bausch Health, Canada Inc., CABTREO Product Monograph, https://pdf.hres.ca/dpd_pm/00076715.PDF. 2 Canadian Dermatology Association, Acne, Quick Facts, https://dermatology.ca/public-patients/skin/acne/#:~:text=Acne%20affects%205.6%20million%20Canadians,adults%20ages%2020%20to%2040, accessed Aug. 20, 2024. 3 "What to Know about Hyperpigmentation Acne." Medical News Today, Jessica Caporuscio, April 28, 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne, accessed Aug. 20, 2024. 4 Bausch Health, Canada Inc., Canadian Product List, https://bauschhealth.ca/products/canadian-product-list/.

Clinical ResultPhase 3Drug Approval

18 Dec 2023

·www.biospace.com

DUOBRII(TM) Lotion to Treat Moderate to Severe Plaque Psoriasis Now Available Through Quebec’s Public Drug Plan

LAVAL, QC / ACCESSWIRE / December 18, 2023 /Bausch Health Canada, part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), ("Bausch Health" or the "Company") today announced that DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene), the company's novel topical prescription drug for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe disease,1 is now available to patients enrolled in Quebec's public drug plan operated by the Régie de l'assurance maladie du Québec (RAMQ). DUOBRII is already available as a benefit on most other public drug plans in the rest of Canada, including the federal government's Non-Insured Health Benefits (NIHB) program, as well as most private drug insurance plans. "It is very good news for Quebecers with plaque psoriasis to have a new topical treatment option available to them through the Quebec public drug plan," said Dr. Steve Mathieu, a dermatologist at Hôpital Saint-Sacrement in Quebec City. "DUOBRII is a combination treatment for people with moderate to severe plaque psoriasis so it is a valuable new addition to our treatment options." DUOBRII is manufactured for distribution throughout Canada and the United States at the Company's Quebec manufacturing facility in Laval. It has been available in Canada by prescription since August 2020. "Bausch Health, Canada is very pleased that DUOBRII is now available to public drug plan beneficiaries in Quebec so they will be able to benefit from this innovative therapy for plaque psoriasis that is manufactured right here in Quebec," said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "We want to help Quebecers with moderate to severe plaque psoriasis to achieve their goal of a clear skin." About DUOBRII DUOBRII works in a unique way by combining halobetasol propionate, which reduces inflammation, and tazarotene that contributes to the normalization of skin cell growth. These well-known ingredients have long-established efficacy pro When halobetasol propionate and tazarotene are administered together in DUOBRII, they provide complementary effects due to their individual modes of action targeting different receptors and pathways to achieve anti-inflammatory control and epidermal morphologic restoration. The improvement that is seen in psoriatic patients appears to occur in association with the restoration of normal cutaneous morphology and the reduction of the inflammatory markers ICAM-1 and HLA-DR.2 DUOBRII is also distinct based on its Prismatrex™ technology, a polymeric emulsification system which provides a stable condition where emulsion droplets retained their distribution across time and temperature.3 About Psoriasis Psoriasis is a common, chronic and life-altering skin disease that affects approximately one million Canadians, with 90% of those affected suffering from plaque psoriasis.4 Plaque psoriasis disease is characterized by red elevated patches and flaking silvery scales, and symptoms can range from mild to severe. While the plaques can appear anywhere on the body, the most common places include the elbows, knees, scalp, chest and lower back. Because the disease typically affects visible parts of the body, the impact on patients extends well beyond the physical symptoms. Psoriasis can impact nearly every aspect of an individual's life including their ability to work and maintain social and intimate relationships. In addition to the tremendous medical burden experienced while trying to find a medication that controls the disease, the psychological impact is high. Approximately 70 per cent of individuals suffer from low self-confidence and approximately 50 percent of patients experience anxiety, and depression, respectively.5 About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Bausch Health, Canada Inc.'s prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at . REFERENCES 1 DUOBRII Product Monograph. Bausch Health, Canada Inc. June 16, 2020, p.3 2 DUOBRII Product Monograph. Bausch Health, Canada Inc. June 16, 2020, p.13. 3 Data in Health Canada New Drug Submission for DUOBRII 4 5 Investor Contact: Media Contact: ir@bauschhealth.com Kevin Wiggins (908) 541-2973 corporate.communications@bauschhealth.com (877) 281-6642 (toll free) (908) 927-1198 SOURCE: Bausch Health Companies Inc. View the original press release on accesswire.com

Drug Approval

100 Deals associated with Halobetasol Propionate/Tazarotene

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	D05	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Plaque psoriasis	United States	Bausch Health Americas, Inc.	25 Apr 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acne Keloid	Phase 3	United States	Bausch Health Americas, Inc.	26 Oct 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04720105 (CTgov)	Phase 4	Plaque psoriasis \| Acrokeratoelastoidosis of Costa \| Pustulosis of Palms and Soles	22	Duobrii®	qotmbzqjgy(pxtcjwcwhx) = wvubodgeqr bxdpmpgqub (emteefyjnt, 0.72) View more	-	27 Oct 2023
NCT02462070 (CTgov)	Phase 3	Plaque psoriasis	203	IDP-118 Lotion (IDP-118 Lotion)	dwfpuvpuqz = yztoaqvcnp zvpzfcyohi (lhcdriaaar, ixqtaxenhn - lvgkwqlmdj) View more	-	20 Aug 2020
				IDP-118 (IDP-118 Vehicle Lotion)	dwfpuvpuqz = zvshckrufb zvpzfcyohi (lhcdriaaar, bjeajbiydc - cpmxbbnokn) View more
NCT02462122 (CTgov)	Phase 3	Plaque psoriasis	215	IDP-118 Lotion (IDP-118 Lotion)	xmudkjzble = ecfvivvsiu kkbkobfaug (twjdvedauk, uayxqapbqf - zsxjlypexj) View more	-	20 Aug 2020
				IDP-118 (IDP-118 Vehicle Lotion)	xmudkjzble = kffhdzkeos kkbkobfaug (twjdvedauk, zsnfogqsvi - mhkbyegxul) View more
NCT02785159 (CTgov)	Phase 2	Plaque psoriasis	152	IDP-118 Lotion (IDP-118 Lotion)	srplwqlumg = bpbptipuei vozkgejayo (oavqngsbsq, rdfdaonnye - jbylrmddbp) View more	-	20 Aug 2020
				Tazorac Cream (Tazorac Cream)	srplwqlumg = pilsrexnjz vozkgejayo (oavqngsbsq, pmqpszreig - siumuvreqc) View more
NCT02045277 (CTgov)	Phase 2	Plaque psoriasis	212	IDP-118 Lotion (IDP-118 Lotion)	nxwwndcdkh = poyuiqjnaz bqxxpfornf (nqubcxpdlu, xrxmasyocg - hbauvzmjht) View more	-	20 Aug 2020
				IDP-118 (IDP-118 Monad HP Lotion)	nxwwndcdkh = dstdgairiv bqxxpfornf (nqubcxpdlu, meshpqkaos - gfraqvihwc) View more
NCT02785172 (CTgov)	Phase 2	Plaque psoriasis	154	IDP-118 Lotion (IDP-118 Lotion)	qgawsttisi = onpyujvche gfzdoswmdq (pwdzjumixx, sdjmqwfbfl - afssvzfpql) View more	-	20 Aug 2020
				Ultravate Cream (Ultravate Cream)	qgawsttisi = yjttudlxqq gfzdoswmdq (pwdzjumixx, rmgaucwfsg - vsuintxkeo) View more
NCT02462083 (CTgov)	Phase 3	Plaque psoriasis	555	IDP-118 Lotion	nkhdntqegy = vllambaagb qgnxyfutyw (sdqhgxvdcs, hjdqdtghkj - yqzofsmexy) View more	-	27 Jan 2020

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