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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

PubMedAnnals of dermatology2026-04-07

The Clinical Efficacy and Mechanism of Action of Alitretinoin in the Treatment of Alopecia Areata.

Shin Jung-Min JM, Go Bogyeong B, Seo Young-Joon YJ, Kim Chang Deok CD et al.

Alitretinoin, a pan-retinoid receptor agonist approved for chronic hand eczema, exhibits immunomodulatory effects that may benefit alopecia areata (AA). However, clinical evidence for its use in AA is limited. To evaluate alitretinoin's clinical efficacy and immunological mechanism in patients with AA. We reviewed retrospectively twenty-one patients with AA who were treated with alitretinoin, either as monotherapy (n=9) or add-on therapy (n=12). Treatment response was assessed using the Severity of Alopecia Tool (SALT) scores, and in vitro studies used human outer root sheath cells stimulated with interferon-γ and polyinosinic:polycytidylic acid to investigate the drug's effects on inflammatory pathways. Both groups showed significant reductions in SALT scores (p=0.04 and p=0.02, respectively). Patients with baseline SALT scores below 50 demonstrated superior improvement. Adverse events were mild, with headache (33.3%) and cheilitis (4.8%) being the most common. In vitro, alitretinoin suppressed interleukin-6 and tumor necrosis factor-α expression, decreased phosphorylation of signal transducer and activator of transcription (STAT) 1/STAT3, and downregulated major histocompatibility complex class I expression, suggesting restoration of hair follicle immune privilege. Alitretinoin appears to be a safe and potentially effective treatment for patients with mild to moderate AA unresponsive to conventional therapies. Its role as a monotherapy or adjunctive option in selected cases warrants further investigation through larger controlled studies.

PMID 41942382
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PubMedDermatology and therapy2026-03-24

A Retrospective Real-World Comparison of Topical Delgocitinib and Localized Cream Psoralen-Ultraviolet A in Chronic Hand Eczema.

Weißinger Stefan S, Oppel Eva E, Kurzen Nils N, Ertl Carolin C et al.

Chronic hand eczema (CHE) remains difficult to treat, particularly in patients unresponsive or intolerant to topical corticosteroids. Although topical delgocitinib, the first topical JAK inhibitor approved for CHE, provides a steroid-free alternative, comparative real-world data versus localized cream psoralen-ultraviolet A (PUVA) are missing. This retrospective real-world study compared the short-term effectiveness and patient-reported outcomes of topical delgocitinib and localized cream PUVA in patients with CHE under routine-care conditions. This retrospective cohort study analyzed anonymized routine-care data of patients with moderate-to-severe CHE treated between 2024 and 2025 at a tertiary center. Patients received topical delgocitinib twice daily or localized cream PUVA with as-needed topical corticosteroids (TCS). Twenty-two patients per group completed 12 weeks of delgocitinib or 20-25 PUVA sessions plus TCS (per-protocol). Disease severity (Physician's Global Assessment, PGA), quality of life (Dermatology Life Quality Index, DLQI), and symptom numerical rating scales (pruritus, pain, sleep disturbance) were assessed at baseline and treatment end. Both therapies significantly improved all endpoints (p < 0.001). Median DLQI improvement was 10 with delgocitinib versus 7.5 with PUVA (p = 0.15). PGA 0/1 responses were 82% vs 73% (p = 0.72). DLQI improvement ≥ 4 points occurred in 91% vs 77% (p = 0.41). Relapses were more frequent after PUVA. Two delgocitinib non-responders improved with alitretinoin. Most delgocitinib responders continued proactive low-frequency use to maintain remission; one remained clear 3 months after stopping treatment. Delgocitinib and PUVA provided comparable short-term clinical efficacy in CHE, with a numerically greater DLQI reduction for delgocitinib. Proactive delgocitinib maintenance may help sustain disease control. Subtype-adapted treatment strategies could further optimize outcomes.

PMID 41872419
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PubMedJournal of drugs in dermatology : JDD2026-03-04

Expert Consensus on Advanced Topical Nonsteroidal Therapies for Chronic Hand Eczema.

Armstrong April W AW, Nong Yvonne Y, Bunick Christopher G CG, Chovatiya Raj R et al.

Chronic hand eczema (CHE) is a common, heterogeneous inflammatory skin disease associated with substantial symptom burden, impaired hand function, reduced quality of life, and work-related disability. Despite its clinical impact, evidence-based guidance for long-term, steroid-sparing topical management has been limited. To develop expert consensus statements on the role of advanced topical nonsteroidal therapies in CHE management. A panel of seven dermatologists with expertise in CHE conducted a structured literature review, prioritizing CHE-specific trials when available. Evidence was evaluated using the Strength of Recommendation Taxonomy (SORT). Draft statements were refined through a Delphi consensus process, with consensus predefined as ≥75% agreement. The panel reached consensus on six statements addressing advanced topical nonsteroidal therapies in CHE. These agents were recognized as important steroid-sparing options appropriate for long-term use. Delgocitinib cream is currently the only topical therapy with CHE-specific regulatory approval and is considered an appropriate first-line advanced topical treatment. Clinical trial data show that advanced topical nonsteroidal therapies provide rapid and sustained improvements in erythema, scaling, fissuring, pruritus, and pain. Delgocitinib demonstrated sustained improvements in patient-reported outcomes and superior health-related quality-of-life benefits compared with oral alitretinoin in severe CHE. Treatment has also been associated with improved work productivity and daily functioning. These therapies have favorable safety profiles, with adverse events largely limited to local reactions, minimal systemic exposure, and no requirement for routine laboratory monitoring. Other topical nonsteroidal agents may have a role in selected patients, although CHE-specific data remain limited. This consensus provides practical guidance supporting individualized, steroid-sparing CHE management while identifying areas for future research. &nbsp.

PMID 41779760
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PubMedClinics in dermatology2026-02-16

Vitamins and the skin: Vitamin A and retinoids in dermatology.

Dessinioti Clio C, Katsambas Andreas A

Vitamin A and analogs are widely used in dermatology, with retinoids being natural and synthetic vitamin A derivatives. Topical retinoids (especially tretinoin and tretinoin precursors) can diminish photoaging and contribute to the thickening and restoration of skin collagen. Retinoids used as therapeutic agents include oral retinoids (eg, isotretinoin, acitretin, alitretinoin, and bexarotene) and topical retinoids (eg, isotretinoin, tretinoin, adapalene, tazarotene, and trifarotene). Although retinoids have traditionally been used for skin disorders of keratinization, such as psoriasis, pityriasis rubra pilaris, Darier disease, and ichthyoses, there is a variety of indications of retinoids for the treatment of skin diseases, including diseases of the pilosebaceous unit such as acne vulgaris, pigmentary disorders such as melasma, or cutaneous malignancies such as cutaneous T-cell lymphoma. Other retinoids with distinct routes of administration (oral or topical) and distinct dosing or safety profiles are recommended for different skin disorders. We discuss the mode of action and indications of retinoids used as pharmacologic agents in dermatology and provide an update on their use, effectiveness, and tolerability.

PMID 41692081
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PubMedDermatitis : contact, atopic, occupational, drug2026-02-06

The Patient Journey: From Diagnosis to Therapeutic Management of Chronic Hand Eczema.

Patruno Cataldo C, Del Gaudio Marika M, Potestio Luca L, Martina Emanuela E et al.

Chronic hand eczema (CHE) is a frequent and heterogeneous condition associated with long-lasting symptoms, functional impairment, and high psychosocial and socioeconomic burden. Diagnostic evaluation relies on detailed history taking, physical examination, and patch testing, which remains the gold standard for identifying relevant sensitizations. Disease severity can be assessed with clinician-reported instruments, such as the Hand Eczema Severity Index, and patient-reported outcomes, particularly the Quality of Life in Hand Eczema Questionnaire (QOLHEQ). Management requires a structured, stepwise approach integrating preventive measures with pharmacological interventions. Topical corticosteroids remain the first-line treatment, whereas phototherapy and systemic options, including alitretinoin and immunosuppressants, are indicated in refractory cases. Recently, novel agents such as topical delgocitinib and biologics like dupilumab have expanded the therapeutic armamentarium, particularly for atopic CHE. Preventive strategies, implemented at primary, secondary, and tertiary levels, are crucial for reducing recurrences and improving long-term outcomes. Despite these advances, there is still a lack of standardized diagnostic tools, validated severity measures, and evidence-based treatment algorithms. Future efforts should focus on patient-centered, multidisciplinary care and further research to optimize disease control and quality of life in CHE.

PMID 41649146
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PubMedJournal of virology2026-01-27

Retinoids enhance NK effector function against HIV-infected CD4 T cells.

McMahon Elyse K EK, Lochner Jonathan S JS, Lynch Rebecca M RM, Bosque Alberto A

Novel approaches to sensitize latently infected cells to apoptosis may provide additional methods to eliminate latent reservoirs. Prior research identified several retinoids as potential drugs that increase the sensitivity of HIV-infected cells to cell death. Retinoids are derivatives of vitamin A that target retinoid receptors causing antiproliferative and proapoptotic activity. Several are FDA-approved or in clinical trials. The aim of this study was to evaluate the ability of vitamin A, three of its natural metabolites, and nine synthetic derivatives to sensitize HIV-infected CD4 T cells to NK natural cytotoxicity and antibody-dependent cellular cytotoxicity (ADCC). From the retinoids tested, alitretinoin, tazarotene acid, and AM80 significantly enhanced NK natural cytotoxicity in the presence of IL-15. Mechanistically, these retinoids increased NK degranulation upon target recognition in an HLA-F/KIR3DS1-dependent manner. Furthermore, these retinoids enhanced ADCC by transcriptionally increasing CD16 expression on NK cells. In conclusion, our study has identified at least three retinoids capable of enhancing NK natural cytotoxicity and ADCC against HIV-infected cells. These or other retinoids could be used to reduce HIV persistent reservoirs.IMPORTANCEThis study highlights how retinoids, compounds derived from vitamin A, can help the immune system target HIV-infected cells more effectively. HIV often hides in immune cells, making it difficult to fully eliminate the virus. We found that certain retinoids, including alitretinoin, tazarotene acid, and AM80, improve the function of natural killer (NK) cells-key immune cells that target infected cells. These retinoids boost NK cell activity by increasing their ability to release toxic molecules that kill infected cells and by enhancing their response to antibodies targeting HIV. This makes the infected cells more vulnerable to being eliminated. Since some of these retinoids are already approved for medical use, they could offer a promising way to reduce persistent HIV reservoirs in the body and improve efforts to cure the infection.

PMID 41589894
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