NDATOPICALGEL
Approved
Jan 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
AVITA (tretinoin) by Pfizer is (rar) nuclear receptors (rarα, rarβ, and rarγ) which may act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors and/or other mechanisms. Approved for retinoid [epc]. First approved in 1998.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVITA is a topical tretinoin gel, a retinoid that modulates gene expression and epithelial cell differentiation by activating retinoic acid receptors. It is indicated for acne treatment and works by decreasing follicular epithelial cell cohesiveness, reducing microcomedone formation, and accelerating comedone extrusion through increased cell turnover. The exact mechanism of action remains incompletely understood but involves both receptor-mediated and potentially non-receptor pathways.
LOE Approaching
Product is in late-stage maturity with significant generic competition; brand teams should prepare for market contraction and focus on differentiation or transition to new indications.
Mechanism of Action
(RAR) nuclear receptors (RARα, RARβ, and RARγ) which may act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
Started Aug 2026
50 enrolled
Acneiform Drug EruptionAcneiform Eruptions
Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer
Started Mar 2026
6 enrolled
Head and Neck CancerHead and Neck Small Cell CarcinomaMetastatic Head and Neck Cancer+1 more
Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.
Started Feb 2025
102 enrolled
Acne
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.
Started Oct 2023
62 enrolled
Neuroblastoma
Gravitas Feeding Tube System Placement Validation in Neonates
Started Oct 2023
100 enrolled
Nasogastric Tube
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.