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Tazorac Cream, 0.1%
Tazorac Cream, 0.1% is a Retinoid Small molecule drug developed by Dr. Reddy's Laboratories Limited. It is currently in Phase 3 development for Acne vulgaris, Plaque psoriasis, Photoaging and fine wrinkles. Also known as: Tazarotene Cream, 0.1%, Reference Listed Drug.
Tazarotene is a retinoid that binds to retinoid receptors to regulate cell differentiation and reduce inflammation in the skin.
Tazorac Cream, 0.1%, is used to treat conditions such as Skin Carcinoma, Acne Vulgaris, Cutaneous T-Cell Lymphoma, and Neoplastic Syndrome, as indicated by ClinicalTrials.gov. The exact mechanism of action of Tazorac Cream is unknown, according to ChEMBL.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Tazorac Cream, 0.1% |
|---|---|
| Also known as | Tazarotene Cream, 0.1%, Reference Listed Drug |
| Sponsor | Dr. Reddy's Laboratories Limited |
| Drug class | Retinoid |
| Target | Retinoic acid receptor (RAR), particularly RAR-beta and RAR-gamma |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Tazarotene is a third-generation topical retinoid that selectively binds to retinoic acid receptors (RARs), particularly RAR-beta and RAR-gamma. This binding modulates gene expression to normalize keratinization, reduce sebum production, and decrease inflammatory mediators in the skin. It is used to treat acne and psoriasis by promoting skin cell turnover and reducing hyperkeratinization.
Approved indications
- Acne vulgaris
- Plaque psoriasis
- Photoaging and fine wrinkles
Common side effects
- Skin irritation (erythema, peeling, dryness)
- Photosensitivity
- Burning or stinging sensation
- Pruritus
Key clinical trials
- Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne (PHASE4)
- A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris (PHASE2)
- Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face (PHASE2)
- A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris (PHASE2)
- The Effect Of A Controlled Daily Skin Care Regimen On Retinoic Acid Tolerance (NA)
- A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris (PHASE3)
- A Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris (PHASE1)
- A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of 0.1% Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tazorac Cream, 0.1% CI brief — competitive landscape report
- Tazorac Cream, 0.1% updates RSS · CI watch RSS
- Dr. Reddy's Laboratories Limited portfolio CI
Frequently asked questions about Tazorac Cream, 0.1%
What is Tazorac Cream, 0.1%?
How does Tazorac Cream, 0.1% work?
What is Tazorac Cream, 0.1% used for?
Who makes Tazorac Cream, 0.1%?
Is Tazorac Cream, 0.1% also known as anything else?
What drug class is Tazorac Cream, 0.1% in?
What development phase is Tazorac Cream, 0.1% in?
What are the side effects of Tazorac Cream, 0.1%?
What does Tazorac Cream, 0.1% target?
Related
- Drug class: All Retinoid drugs
- Target: All drugs targeting Retinoic acid receptor (RAR), particularly RAR-beta and RAR-gamma
- Manufacturer: Dr. Reddy's Laboratories Limited — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Acne vulgaris
- Indication: Drugs for Plaque psoriasis
- Indication: Drugs for Photoaging and fine wrinkles
- Also known as: Tazarotene Cream, 0.1%, Reference Listed Drug
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing