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AL

alitretinoin (Alitoc / BAL 4079 / BAL4079)

✓ Approved

Actelion · Small Molecule · Small Molecule

What is alitretinoin?

alitretinoin is a small molecule developed by Actelion. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesAlitoc, BAL 4079, BAL4079
CompanyActelion
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Actelion

Therapeutic Indications

alitretinoin is developed for 3 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Skin and subcutaneous tissue disordersDermatitis allergic✓ Approved
Skin and subcutaneous tissue disordersDermatitis atopic✓ Approved
Skin and subcutaneous tissue disordersPsoriasisPhase II

Related Research Articles

PubMedMedicina (Kaunas, Lithuania)2026-09-26

Real-World Effectiveness and Safety of Oral Alitretinoin in Chronic Hand Eczema with Exploratory Off-Label Indications: A 10-Year Single-Center Korean Study.

Lee Jeongsoo J, Park Joonsoo J

Background and Objectives: Oral alitretinoin (9-cis-retinoic acid), a dual retinoic acid receptor/retinoid X receptor agonist, is approved for severe chronic hand eczema (CHE) refractory to potent topical corticosteroids but is also prescribed off-label in routine practice. Long-term real-world data on both uses are limited. We evaluated 10-year prescribing patterns, effectiveness, tolerability, and lipid changes at one Korean academic center. Materials and Methods: Patients prescribed oral alitretinoin between January 2016 and December 2025 were identified from the hospital prescribing database; those with an evaluable course of ≥1 month formed the effective-treatment cohort and underwent chart review. Treatment success was defined as final chart-derived Investigator Global Assessment (IGA) 0/1. Success by initial dose was compared using Fisher exact test; paired lipid changes using paired t-test and Wilcoxon signed-rank test. Results: Of 161 patients, 38 (23.6%) received a single prescription; 99 formed the effective-treatment cohort (50 women, 49 men; mean age 50.7 ± 16.0 years). CHE was the leading indication (70/99, 70.7%), followed by palmoplantar pustulosis (PPP, n = 14), mycosis fungoides (MF, n = 6), parapsoriasis, porokeratosis, palmoplantar keratoderma, and Darier disease. Overall success was 66.7% (66/99) over a mean treatment duration of 12.4 months, highest in CHE (77.1%) and more variable off-label (PPP 42.9%; MF 33.3%). Initiation at 30 mg was associated with higher success than 10 mg (71.1% vs. 43.8%; p = 0.044), but this association did not persist after restriction to patients maintained on their initial dose (62.2% vs. 50.0%; p = 0.498) or after Firth penalized logistic regression adjusting for age, sex, and indication (adjusted odds ratio 1.84; 95% CI 0.56-5.90; p = 0.309). Adverse events occurred in 21 patients (21.2%), most commonly dyslipidemia (n = 12) and headache (n = 7); mean triglyceride rose 42.1 mg/dL and total cholesterol 14.0 mg/dL (both p < 0.001), and new elevation above conventional thresholds occurred in 25.8% (triglyceride) and 27.5% (total cholesterol) of patients with normal baseline values. Thirty patients (30.3%) discontinued, most often for insufficient effectiveness. Conclusions: Alitretinoin showed favorable effectiveness in CHE and variable, exploratory responses off-label. The apparent advantage of 30 mg initiation was not independent of indication and dose adjustment. Lipid elevation was common, supporting routine surveillance. Off-label findings, particularly in PPP and MF, should be interpreted cautiously given small subgroups and non-standardized retrospective assessment.

PMID 42796232
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PubMedMaterials today. Bio2026-08-28

Targeted blood-brain barrier penetration for traumatic brain injury therapy via RXR/PPAR-driven microglial M2 polarization.

Chen Songyu S, Lin Junyu J, Zhang Xiaxuan X, Zhou Lin L et al.

As a leading global cause of death and disability, traumatic brain injury (TBI) triggers a complex secondary injury process leading to long-term neurological impairment. Current therapeutic efficacy is limited by the blood-brain barrier (BBB) and the absence of integrated approaches to address neuroinflammation and neuroregeneration. We designed a biomimetic nanomedicine (Ali-NPs@Mexo) by encapsulating alitretinoin(Ali)-loaded albumin nanospheres within mesenchymal stromal cell (MSC)-derived exosomal membranes. This platform exploits the natural BBB-crossing and inflammation-targeting capabilities of exosomes to enhance localized drug delivery. Mechanistic studies revealed that Ali-NPs@Mexo triggers RXR/PPAR signaling to promote M1-to-M2 microglial polarization, thereby mitigating acute inflammation. Moreover, it protects neurons by inhibiting reactive astrogliosis and supporting the growth of neural stem cells and oligodendrocytes. In vivo, Ali-NPs@Mexo significantly improved functional and cognitive outcomes in mice. This integrated strategy of targeted immune-modulation and neuro-regeneration provides a translatable framework for effective TBI intervention.

PMID 42662602
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PubMedAnnals of dermatology2026-08-04

A Multi-Center, Open-Label, Single-Arm, Prospective Investigator Initiated Trial to Evaluate the Efficacy and Safety of Alitretinoin in Patients With Chronic Hand Eczema in Real-World Practice (DWALG_P401) and Overview of Korean Studies.

Kwon Min Jung MJ, Yu Jin Woo JW, Han Byeol B, Ahn Jiyoung J et al.

Chronic hand eczema (CHE) is a debilitating dermatologic condition often refractory to topical corticosteroids (TCS). Although oral alitretinoin has demonstrated efficacy in CHE, real-world multicenter data in Korean populations remain limited. To evaluate the real-world efficacy and safety of oral alitretinoin in Korean patients with severe CHE with insufficient response to TCS. This multicenter, prospective, open-label study enrolled 146 patients with severe CHE at tertiary hospitals in Korea. Patients received oral alitretinoin (30 mg once daily, with dose reduction to 10 mg permitted) for up to 24 weeks, with observation up to 36 weeks. The primary endpoint was achievement of "clear" or "almost clear" on the Physician's Global Assessment (PGA) at treatment completion. Secondary endpoints included the modified total lesion symptom score (mTLSS) and Patient's Global Assessment (PaGA). Safety was evaluated by monitoring adverse events (AEs) and laboratory abnormalities. Efficacy analyses were performed on the full analysis set (n=129). At treatment completion, 55 patients (42.64%) achieved a PGA response. Improvement increased from week 4 (1.83%) to week 36 (60.87%). PaGA showed consistent improvement, with 17.32% reporting "clear or almost clear" and 28.35% reporting "marked improvement" at treatment completion. mTLSS scores improved by 62.3% at treatment completion and by 75.7% at week 36. In the safety analysis (n=134), 44.03% experienced AEs, most commonly headache (29.10%). Oral alitretinoin at daily doses of 10 mg or 30 mg demonstrated effective symptom improvement and an acceptable safety profile in Korean patients with CHE in a real-world setting.

PMID 42547475
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PubMedAnnals of dermatology2026-08-04

Efficacy and Safety of Alitretinoin for Chronic Hand Eczema: A Meta-Analysis.

Lee Yu Jin YJ, Lee Jung Min JM, Choi Yun Jeong YJ, Han Tae Young TY et al.

Hand eczema is a common inflammatory dermatosis that can severely impair quality of life. Chronic or refractory cases often require systemic therapy. Alitretinoin, a vitamin A derivative, is approved for patients unresponsive to potent topical corticosteroids. This meta-analysis aimed to evaluate its efficacy and safety in chronic hand eczema. A PubMed search up to April 10, 2023, identified relevant studies. Outcomes included therapeutic response, adverse events, and laboratory changes. Efficacy was assessed using Physician Global Assessment (PGA), Patient Global Assessment (PaGA), and modified Total Lesion Symptom Score (mTLSS). Subgroup analyses by dosage and treatment duration, with meta-regression, were performed. Twenty-four studies were included. Overall improvement rates were 47.8% for PGA and 36.4% for PaGA, with greater benefit observed in PGA. Higher dosages produced superior efficacy in both PGA and PaGA, and meta-regression confirmed significant differences between 10 mg and 30 mg groups. Longer treatment in 30 mg subgroup was associated with better outcomes for PGA, PaGA, and mTLSS. Adverse events occurred in 48.3% of cases, most commonly headache, skin fissure, back pain, and dry eye. Triglyceride elevation was the most frequent laboratory abnormality. Alitretinoin showed favorable efficacy in chronic hand eczema. Consistent with previous studies, we observed a trend of increasing efficacy with higher dosages. Furthermore, at high dosage, greater efficacy was observed with longer durations of use. Adverse events were generally tolerable, supporting its role as a therapeutic option in refractory cases.

PMID 42547480
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PubMedExpert opinion on pharmacotherapy2026-07-10

Evaluation of delgocitinib for the treatment of moderate to severe chronic hand eczema in adults.

Piaskowski Nicole N, Globig Philipp P, Worm Margitta M

Chronic hand eczema (CHE) is a frequent inflammatory skin disorder associated with a substantial psychosocial and economic burden. Its prevalence ranges from 4.7% up to 10%. The therapeutic management of CHE remains challenging. Long-term use of topical corticosteroids, which are used as first-line therapy, can be associated with local side effects and a negative impact on the skin barrier. Alitretinoin, a vitamin A derivate licensed as a systemic treatment option in Europe, has demonstrated efficacy but is accompanied by systemic adverse effects. Delgocitinib is a novel topical anti-inflammatory pan-janus kinase inhibitor with negligible systemic exposure and a reduced risk of side effects. It has shown clinical efficacy in double blind placebo-controlled trials and most recently superiority against alitretinoin in terms of both, efficacy and safety. This review summarizes the data on delgocitinib as a topical treatment for CHE including pharmacokinetics, pharmacodynamics, efficacy and safety. Delgocitinib is a topical pan-janus kinase (JAK) inhibitor and represents a novel treatment option for CHE with a favorable safety and tolerability profile. Further data on long-term use and real-world effectiveness are still needed.

PMID 42429252
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PubMedJournal of the European Academy of Dermatology and Venereology : JEADV2026-06-09

Efficacy of oral alitretinoin for concomitant foot eczema in chronic hand eczema.

Cha Soobin S, Lee Jungsoo J, Shin Kihyuk K, Kim Hoon-Soo HS et al.

PMID 42261665
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