NDATOPICALGEL
Approved
Oct 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
RETIN-A (tretinoin) by Bausch + Lomb. Approved for retinoid [epc]. First approved in 1978.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RETIN-A (tretinoin) is a topical retinoid gel approved in 1978 for acne vulgaris that works by decreasing follicular epithelial cell cohesiveness and increasing turnover to extrude comedones. With minimal systemic bioavailability (<0.3%), it is a well-established dermatology agent with decades of clinical use. The exact mechanism remains incompletely understood, but it is recognized as a foundational treatment in acne and photoaging.
LOE Approaching
As LOE approaches, RETIN-A brand team will shift focus to defensive strategies and lifecycle extensions; commercial team size likely stable but with emphasis on retention rather than growth.
Mechanism of Action
Pharmacologic Class:
Retinoid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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
A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema
Started Jun 2022
513 enrolled
Chronic Hand Eczema
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
Started Dec 2021
0Neuroblastoma
Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 ( Isotretinoin in Treatment of COVID-19) (Randomized)
Started Aug 2021
100,000 enrolled
COVID19
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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.