NDAORALCAPSULE
Approved
Nov 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
19
Data completeness
6/8 — Strong
ABSORICA LD (isotretinoin) by Fosun Pharma 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 2019.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABSORICA LD is an oral retinoid formulation of isotretinoin approved in 2019 for severe recalcitrant nodular acne and multiple off-label oncology and infectious disease indications. The drug inhibits sebaceous gland function and keratinization, reducing sebum secretion through suppression of sebaceous gland differentiation. The exact mechanism in non-acne indications remains unknown.
$0.063MPart D
Peak9.2 years to LOELow commercial activity on Medicare Part D with minimal claim volume suggests this is a niche product with limited commercial team investment and stable, modest revenue trajectory.
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 (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.