NDAORALCAPSULE
Approved
May 2012
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
19
Data completeness
6/8 — Strong
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. Approved for acne. First approved in 2012.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABSORICA is an oral retinoid capsule containing isotretinoin approved in 2012 for severe nodular acne and multiple off-label oncology and infectious disease indications. The drug inhibits sebaceous gland function and keratinization, reducing sebum secretion and clearing treatment-resistant acne. Its exact mechanism in severe acne remains unknown, but clinical efficacy correlates with reduced sebaceous gland size and differentiation.
$0.076MPart D
PeakProduct is in peak lifecycle phase with modest Part D utilization (42 claims, $76K annual), suggesting stable but niche commercial positioning with lean commercial teams.
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 (1)
Clinical Trials (19)
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
The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
Started Feb 2017
9 enrolled
Contraception
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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.