NDAORALCAPSULE
Approved
May 2012
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
ABSORICA (isotretinoin) by PharmaIN is absorica/absorica ld is a retinoid, which when administered at the recommended dosage [see dosage and administration ] , inhibits sebaceous gland function and keratinization. First approved in 2012.
Drug data last refreshed 21h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABSORICA is an oral retinoid capsule containing isotretinoin, approved in 2012 for severe recalcitrant nodular acne. It works by inhibiting sebaceous gland function and keratinization, reducing sebum secretion and causing clinical improvement in nodular acne patients. The exact mechanism remains incompletely understood, but the drug represents a definitive treatment for the most severe acne cases.
$0.076BPart D
PeakProduct is at peak commercial maturity with moderate Part D penetration; sales teams likely stable or optimizing existing market coverage rather than expanding territory.
Mechanism of Action
ABSORICA/ABSORICA LD is a retinoid, which when administered at the recommended dosage [see Dosage and Administration ] , inhibits sebaceous gland function and keratinization. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in…
Pharmacologic Class:
Retinoid
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
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.