NDAORALCAPSULEPriority Review
Approved
Nov 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — 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 14h 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), a rare blood cancer. The drug works by decreasing cohesiveness of follicular epithelial cells and stimulating mitotic activity to increase cellular turnover. Less than 0.3% of topically applied doses achieve systemic bioavailability, with only slightly elevated circulating plasma levels above healthy controls.
LOE Approaching
Product approaching loss of exclusivity with limited commercial team expansion; roles focus on maintaining market position ahead of generic competition.
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)
Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
Started Aug 2026
50 enrolled
Acneiform Drug EruptionAcneiform Eruptions
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
Worked on VESANOID at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.