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isotretinoin (Roaccutane)
Isotretinoin is a potent retinoid that reduces sebaceous gland size and sebum production, and has anti-inflammatory and anti-proliferative effects on skin cells.
Isotretinoin is a potent retinoid that reduces sebaceous gland size and sebum production, and has anti-inflammatory and anti-proliferative effects on skin cells. Used for Severe nodular acne unresponsive to conventional therapy, Acne with high risk of permanent scarring.
At a glance
| Generic name | isotretinoin (Roaccutane) |
|---|---|
| Sponsor | Premier Specialists, Australia |
| Drug class | Retinoid |
| Target | Retinoid acid receptors (RAR and RXR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Isotretinoin is a synthetic form of vitamin A that binds to retinoid receptors in the nucleus, regulating gene expression involved in cell differentiation and proliferation. It dramatically reduces sebaceous gland size and sebum secretion, decreases bacterial colonization, and has immunomodulatory and anti-inflammatory properties. These combined effects make it highly effective for severe acne by addressing multiple pathogenic factors.
Approved indications
- Severe nodular acne unresponsive to conventional therapy
- Acne with 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
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (PHASE1)
- Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906) (PHASE1, PHASE2)
- Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm (PHASE2)
- Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (PHASE3)
- Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (PHASE3)
- Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation (EARLY_PHASE1)
- Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (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 (Roaccutane) CI brief — competitive landscape report
- isotretinoin (Roaccutane) updates RSS · CI watch RSS
- Premier Specialists, Australia portfolio CI