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Isotretinoin capsules
Isotretinoin is a potent retinoid that reduces sebaceous gland size and sebum production while normalizing epithelial cell differentiation in the skin.
Isotretinoin is a potent retinoid that reduces sebaceous gland size and sebum production while normalizing epithelial cell differentiation in the skin. Used for Severe recalcitrant nodular acne, Acne at high risk of permanent scarring.
At a glance
| Generic name | Isotretinoin capsules |
|---|---|
| Also known as | Oral retinoid, Adapalene gel |
| Sponsor | Centro Dermatológico Dr. Ladislao de la Pascua |
| Drug class | Retinoid |
| Target | Retinoic acid receptors (RAR and RXR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Isotretinoin is a highly effective vitamin A derivative that acts on sebaceous glands to dramatically reduce sebum production and normalize keratinization. It also has anti-inflammatory and antimicrobial effects on Cutibacterium acnes (formerly Propionibacterium acnes). The drug can induce long-term remission or cure of severe acne by fundamentally altering the pathogenic factors involved in acne formation.
Approved indications
- Severe recalcitrant nodular acne
- Acne at high risk of permanent scarring
Common side effects
- Cheilitis (lip inflammation)
- Dry skin and mucous membranes
- Elevated triglycerides
- Elevated liver enzymes
- Headache
- Photosensitivity
- Teratogenicity (if exposed during pregnancy)
Key clinical trials
- Study of Two Dosages of Roaccutane in Cystic Acne (PHASE4)
- Treatment of Plane Warts With Topical and Oral Retinoids (PHASE4)
- Acne Remission Maintenance by Weekend Systemic Isotretinoin (PHASE3)
- Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne (NA)
- A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (PHASE4)
- Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer (PHASE3)
- Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study (NA)
- Oral Liquid 13-cis-retinoic Acid (13-CRA) (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Isotretinoin capsules CI brief — competitive landscape report
- Isotretinoin capsules updates RSS · CI watch RSS
- Centro Dermatológico Dr. Ladislao de la Pascua portfolio CI