NDAORALCAPSULEPriority Review
Approved
Nov 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
VESANOID (tretinoin) by Pfizer is clinical pharmacology although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Approved for retinoid [epc]. First approved in 1995.
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VESANOID (tretinoin) is an oral retinoid capsule approved in 1995 for acute promyelocytic leukemia (APL), working through retinoic acid receptor activation to induce differentiation and maturation of leukemic cells. The exact mechanism remains incompletely understood, but tretinoin decreases cellular cohesiveness and stimulates epithelial cell turnover. This is a legacy product now approaching loss of exclusivity with multiple generic and brand competitors in the dermatology space.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30 score), the VESANOID brand team likely operates as a lean, maintenance-focused unit with limited growth investment.
Mechanism of Action
CLINICAL PHARMACOLOGY Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of…
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.