Isotretinoin
- Generic Name
- Isotretinoin
- Brand Names
- Absorica, Accutane, Amnesteem, Claravis, Clarus, Epuris, Myorisan, Sotret, Zenatane
- Drug Type
- Small Molecule
- Chemical Formula
- C20H28O2
- CAS Number
- 4759-48-2
- Unique Ingredient Identifier
- EH28UP18IF
- Background
Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne. It was most widely marketed under the brand name Accutane, which has since been discontinued. Isotretinoin is associated with major risks in pregnancy and is therefore only available under the iPLEDGE program in the United States. The first isotretinoin-containing product was FDA approved on 7 May 1982.
- Indication
Isotretinoin is indicated to treat severe recalcitrant nodular acne and patients ≥12 years enrolled in the iPLEDGE program.
- Associated Conditions
- Acne conglobata, Neuroblastoma (NB), Rosacea, Sezary Syndrome, Early Mycosis Fungoides (MF), Refractory Acne vulgaris, Severe Recalcitrant nodular acne
Norgine Seeks EMA Approval for Eflornithine in High-Risk Neuroblastoma
• Norgine has submitted a marketing authorization application to the EMA for eflornithine to treat high-risk neuroblastoma (HRNB).
• The application follows prior submissions in Australia, Switzerland, and the United Kingdom under Project Orbis.
• Eflornithine is intended as an oral maintenance therapy to reduce relapse risk in pediatric and adult HRNB patients.
• FDA approved eflornithine in December 2023 based on trials showing improved event-free and overall survival.
FDA Grants Priority Review to CUTX-101 for Menkes Disease, Offering Hope for Rare Pediatric Condition
• The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, granting priority review for the treatment of Menkes disease, a rare genetic disorder.
• Clinical trials of CUTX-101 demonstrated an almost 80% reduction in mortality risk compared to untreated patients, significantly improving overall survival.
• CUTX-101 has been granted multiple designations, including Breakthrough Therapy and Orphan Drug, highlighting its potential to address a critical unmet need.
• Cyprium Therapeutics is eligible to receive up to $129 million in milestone payments and royalties, retaining ownership of a potential Priority Review Voucher.
FDA Approves Journey Medical's Emrosi™ for Rosacea Treatment
• The FDA has approved Emrosi™ (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults.
• Journey Medical anticipates launching Emrosi™ in late Q1 or early Q2 of 2025, expanding their dermatology-focused product portfolio.
• Clinical data presented at the 44th Fall Clinical Dermatology Conference highlighted Emrosi's higher dermal concentration compared to doxycycline.
• The approval marks a significant advancement in rosacea treatment, addressing a prevalent dermatological condition.
FDA Approves Journey Medical's Emrosi for Rosacea Treatment
• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules) for treating rosacea, a chronic inflammatory skin condition.
• Phase III clinical trials demonstrated Emrosi's statistically significant superiority over placebo and the current standard of care, Oracea, in reducing rosacea symptoms.
• Journey Medical anticipates Emrosi will be available to U.S. patients in the first half of 2025, aiming to establish it as a new standard of care.
• Emrosi's approval marks a potential shift in the rosacea treatment market, where Journey Medical seeks to become a leading player.
September 2024: FDA Actions Span Diabetes, Neurology, and Rare Diseases
• The FDA approved Embecta's tubeless patch pump for insulin delivery in adults with type 1 and type 2 diabetes, offering a 300-unit reservoir based on patient feedback.
• Sparsentan (Filspari) received full FDA approval to slow kidney function decline in adults with primary IgA nephropathy (IgAN), based on positive Phase 3 PROTECT study data.
• Approvals for arimoclomol (Miplyffa) and levacetylleucine (Aqneursa) mark the first specific treatments for neurological symptoms of Niemann-Pick disease type C (NPC).
• Dupilumab (Dupixent) gained approval for COPD, chronic rhinosinusitis with nasal polyps, and was submitted for label expansion for adult growth hormone deficiency.
Drug Development Updates
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