ACCUTANE

LOE Approaching

isotretinoin

NDAORALCAPSULEPriority Review
Approved
May 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8

Mechanism of Action

CLINICAL PHARMACOLOGY Isotretinoin is a retinoid, which when administered in pharmacologic dosages of 0.5 to 1 mg/kg/day (see ), inhibits sebaceous gland function and keratinization. The exact mechanism of action of isotretinoin is unknown. Nodular Acne Clinical improvement in nodular acne patients…

Clinical Trials (5)

NCT07341659N/AActive Not Recruiting

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
NCT04353180Phase 3Unknown

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
NCT02498288Phase 1Completed

A Study to Determine Bioequivalence of Isotretinoin in Healthy Male Subjects Under Fed Condition

Started May 2013
36 enrolled
Acne Vulgaris
NCT01863615Phase 1Completed

Bioequivalence Study for an Isotretinoin

Started Aug 2011
36 enrolled
Skin Infections (Acne)
NCT00975143Phase 3Completed

Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne

Started Sep 2009