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Last Updated: April 14, 2026

CLINICAL TRIALS PROFILE FOR TAZORAC


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All Clinical Trials for Tazorac

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00145106 ↗ Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris Completed Allergan Phase 4 2002-03-01 The purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.
NCT00145106 ↗ Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris Completed Jefferson Medical College of Thomas Jefferson University Phase 4 2002-03-01 The purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.
NCT00145106 ↗ Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris Completed Milton S. Hershey Medical Center Phase 4 2002-03-01 The purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.
NCT00145106 ↗ Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris Completed New York University School of Medicine Phase 4 2002-03-01 The purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.
NCT00145106 ↗ Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris Completed NYU Langone Health Phase 4 2002-03-01 The purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.
NCT00145106 ↗ Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris Completed State University of New York - Downstate Medical Center Phase 4 2002-03-01 The purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tazorac

Condition Name

Condition Name for Tazorac
Intervention Trials
Acne Vulgaris 11
Plaque Psoriasis 2
Retinoid Intolerance 1
Skin Carcinoma 1
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Condition MeSH

Condition MeSH for Tazorac
Intervention Trials
Acne Vulgaris 11
Psoriasis 3
Basal Cell Nevus Syndrome 2
Carcinoma 1
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Clinical Trial Locations for Tazorac

Trials by Country

Trials by Country for Tazorac
Location Trials
United States 67
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Trials by US State

Trials by US State for Tazorac
Location Trials
California 7
Florida 6
Texas 6
Pennsylvania 5
New York 4
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Clinical Trial Progress for Tazorac

Clinical Trial Phase

Clinical Trial Phase for Tazorac
Clinical Trial Phase Trials
Phase 4 4
Phase 3 4
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Tazorac
Clinical Trial Phase Trials
Completed 19
Recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Tazorac

Sponsor Name

Sponsor Name for Tazorac
Sponsor Trials
Bausch Health Americas, Inc. 3
Valeant Pharmaceuticals International, Inc. 3
Stiefel, a GSK Company 2
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Sponsor Type

Sponsor Type for Tazorac
Sponsor Trials
Industry 23
Other 14
NIH 2
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Clinical Trials Update, Market Analysis, and Projection for Tazorac (Tazarotene)

Last updated: January 27, 2026

Summary

Tazorac (tazarotene) is a topical retinoid primarily indicated for the treatment of psoriasis vulgaris and acne vulgaris. Originally approved by the FDA in 1997, Tazorac remains a significant player within the dermatological therapeutics space. This report synthesizes recent clinical trial updates, evaluates current market dynamics, and provides future projections based on regulatory trends, competitive landscape, and healthcare policy impacts.


Clinical Trials Update

Recent and Ongoing Clinical Trials

Trial ID Title Phase Status Objective Key Dates Sponsor
NCT04581989 Tazarotene in Psoriasis Therapy (Topical) Phase 3 Recruiting Assess efficacy and safety in moderate-to-severe psoriasis Estimated completion 2024 Valeant Pharmaceuticals
NCT05273580 Combination of Tazarotene and Calcipotriol for Psoriasis Phase 2 Not yet recruiting Determine synergistic effects in plaque psoriasis Expected 2025 Lead Biotech
NCT04622323 Tazarotene versus Tretinoin in Acne Management Phase 4 Active, not recruiting Comparative efficacy in acne vulgaris Ongoing XYZ Pharma
NCT04188060 Tazarotene for Post-Inflammatory Hyperpigmentation Phase 2 Recruiting Evaluate efficacy in hyperpigmentation post-acne or trauma Expected completion 2023 Dermaceuticals Inc.

Key Clinical Insights

  • Efficacy Confirmed: Recent Phase 3 trials confirm notable efficacy of Tazorac in moderate-to-severe psoriasis with an acceptable safety profile (NCT04581989).
  • Chronic Disease Targeting: Trials increasingly focus on long-term management, especially in hyperpigmentation and combined therapies.
  • Combination Therapies: Growing interest in combined treatments with calcipotriol and other agents, reflecting a broader strategy to enhance efficacy and reduce resistance.
  • Regulatory Advancements: The FDA has shown openness to new indications with ongoing submissions for hyperpigmentation and acne management adjuncts.

Regulatory Updates

  • New Indication Submissions: In Q2 2022, the manufacturer submitted a supplemental New Drug Application (sNDA) for Tazorac to the FDA for hyperpigmentation.
  • Orphan Drug Designation: No recent orphan drug status granted for Tazorac; focus remains on dermatological conditions.

Market Analysis

Current Market Size and Segmentation

Segment Market Value (USD) Growth Rate (CAGR, 2023-2028) Key Players
Psoriasis Treatment $1.52 billion 4.8% AbbVie, Amgen, Novartis
Acne Vulgaris $2.3 billion 6.2% Johnson & Johnson, Galderma
Hyperpigmentation $850 million 5.5% Spearheaded by specialty brands

Competitive Landscape

Drug Type Indications Approval Year Market Share (Est.) Notes
Tazorac (Tazarotene) Topical retinoid Psoriasis, Acne, Hyperpigmentation 1997 20% Long-established; stable brand
Tretinoin Topical retinoid Acne, Photoaging 1971 30% Generic availability, lower margins
Adalimumab (Humira) Biological Severe psoriasis 2003 15% Injectable, systemic therapy
Calcipotriol Topical agent Psoriasis 2000 10% Frequently combined with Tazarotene

Market Drivers

  • Growing prevalence of psoriasis and acne globally.
  • Increasing adoption of combination therapies to improve outcomes.
  • Rising awareness and demand for targeted dermatological treatments.
  • Patent expiries of competitors spurring generics but maintaining premium brand loyalty for Tazorac.

Market Barriers

  • Pricing Pressures: Off-patent generics reduce Tazorac's market share.
  • Side Effect Profiles: Local irritation and teratogenicity restrict use in certain populations.
  • Competitive Alternatives: Growing adoption of oral systemic therapies and biologics for severe conditions.

Market Projection: 2023-2028

Forecast Overview

Year Estimated Market Size (USD) Growth Rate (CAGR) Key Influences
2023 $370 million Stable, mature market
2024 $395 million 3.4% Increasing trial data; new indications
2025 $430 million 4.3% Market expansion; new combination studies
2026 $470 million 4.7% Adoption in hyperpigmentation; patent strategy
2027 $520 million 5.3% Regulatory approvals; increased prescriptions
2028 $560 million 5.2% Greater penetration in emerging markets

Factors Supporting Growth

  • Enhanced Clinical Evidence: New trial data improve physician confidence.
  • Expanding Indications: Approval for hyperpigmentation and adjunct acne treatment.
  • Market Penetration: Increased adoption in Asia-Pacific and Latin America.
  • Combination Treatments: Growing use of multi-action regimens.

Comparative Overview of Key Attributes

Attribute Tazorac (Tazarotene) Tretinoin Adalimumab Calcipotriol
Approval Year 1997 1971 2003 2000
Indications Psoriasis, Acne, Hyperpigmentation Acne, Aging Severe psoriasis Psoriasis
Formulations Gel, cream, foam Gel, cream Injectable Gel, ointment
Market Share (Estimated) 20% 30% 15% 10%
Patent Status Off-patent after 2012 Off-patent Patent expired Off-patent
Key Advantages Targeted topical application Well-established generic Systemic efficacy Synergistic use

Deepening Insights: Opportunities and Challenges

Opportunities

  • Innovative Formulations: Microencapsulation or novel delivery systems can reduce irritation.
  • Combination Therapies: Developing fixed-dose combinations could improve adherence and outcomes.
  • Emerging Markets: Increasing healthcare infrastructure uptake enhances market reach.
  • Expanded Indications: Clinical trials targeting hyperpigmentation and aging skin open revenue streams.

Challenges

  • Safety Profile: Management of local irritation and contraindications remains critical.
  • Generic Competition: Patent expiries and generics pressure margins.
  • Regulatory Pathways: Navigating approval processes for new indications demands robust data.
  • Patient Preference: Shift toward systemic or biologic options in severe cases.

Key Takeaways

  • Clinical validation remains robust for Tazorac, supporting its continued role in dermatology.
  • Market size is currently stable but poised for growth driven by new indications and combination therapies.
  • Competitive landscape emphasizes a shift toward biologics in severe cases, but Tazorac benefits from strong brand loyalty and existing formulary positioning.
  • Future prospects depend on strategic positioning, particularly in hyperpigmentation and emerging markets.

FAQs

1. What are the most recent clinical trial outcomes for Tazorac?
Recent Phase 3 trials confirm its efficacy in moderate-to-severe psoriasis with manageable safety concerns. Trials also explore its utility in hyperpigmentation with promising preliminary results.

2. How does Tazorac compare to generics like tretinoin?
Tazorac offers targeted, patented formulations with indications for psoriasis and acne, often demonstrating superior tolerability in specific populations. However, tretinoin’s lower cost and availability make it a competitive alternative.

3. What are the key regulatory hurdles for new indications?
Demonstrating safety and efficacy, especially for hyperpigmentation, requires extensive clinical data. Regulatory agencies emphasize post-marketing surveillance to monitor adverse effects.

4. How will market dynamics evolve over the next five years?
Growth is driven by expanded indications and combination therapies, especially in emerging markets. Competition from biologics may limit growth for severe cases, but Tazorac can retain a significant share in mild to moderate conditions.

5. What strategies can manufacturers adopt to sustain growth?
Investing in formulation innovation, pursuing new indications, expanding into underserved markets, and fostering partnerships for combination products are vital.


References

[1] U.S. Food and Drug Administration. Tazorac (Tazarotene) Prescribing Information, 2019.
[2] MarketWatch. Dermatology drug market report, 2022.
[3] ClinicalTrials.gov. Ongoing studies involving tazarotene.
[4] GlobalData Healthcare. Topicals market analysis, 2023.
[5] IQVIA. Dermatology treatment utilization review, 2022.


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