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Orismilast for moderate-to-severe atopic dermatitis: the potential therapeutic value of a new oral pharmacological alternative.
Br J Dermatol
January 2025
Laboratory of Social Pharmacy and Public Health, Faculty of Pharmacy, University of Coimbra, Portugal, Coimbra, Portugal.
Orismilast, a PDE4B/D inhibitor, in moderate-to-severe atopic dermatitis: Efficacy and safety from a multicenter, randomized, placebo-controlled, phase 2b dose-ranging study (ADESOS).
Br J Dermatol
January 2025
Department of Dermatology, Oregon Health & Science University, Portland, Oregon, USA.
Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease, characterized by eczematous skin lesions and pruritus. There is an unmet need for effective first-line systemic therapies with good safety profiles, particularly oral medications. Orismilast is a novel first-in-class oral phosphodiesterase-4 (PDE4) B/D inhibitor under investigation for the treatment of moderate-to-severe AD.
View Article and Find Full Text PDFOrismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS).
J Am Acad Dermatol
March 2024
Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; Central Connecticut Dermatology Research, Cromwell, Connecticut.
Background: Orismilast is a novel oral phosphodiesterase-4 (PDE4) B/D inhibitor being investigated as a potential treatment for moderate-to-severe psoriasis.
Objective: To evaluate efficacy and safety of orismilast modified-release formulation in moderate-to-severe psoriasis.
Methods: This multicenter, randomized (1:1:1:1 to 20, 30, 40 mg orismilast or placebo, twice daily), double-blinded, placebo-controlled, parallel-group, phase 2b, 16-week, dose-ranging study evaluated orismilast in adults with moderate-to-severe plaque psoriasis (NCT05190419).
Psoriasis: a focus on upcoming oral formulations.
Expert Opin Investig Drugs
November 2023
Dermatology Department IIB Sant Pau, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.
Introduction: Targeted therapies have greatly improved the quality of life of patients with psoriasis. Despite the extensive list of treatments available, multiple new drugs are being developed, especially oral therapies with potential advantages as regards comfort of administration. However, the efficacy and safety of these new oral therapies need to be improved to match those of novel biologics.
View Article and Find Full Text PDFOral orismilast: Efficacy and safety in moderate-to-severe psoriasis and development of modified release tablets.
J Eur Acad Dermatol Venereol
April 2023
Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University (LMU) Munich, Munich, Germany.
Background: Orismilast is a high-potency phosphodiesterase 4 (PDE4) inhibitor with enhanced selectivity for the PDE4B and PDE4D subtypes.
Objectives: The objective of this phase 2a trial was to examine the efficacy and safety of orismilast for psoriasis using a first-generation immediate-release (IR) formulation. The objective of the subsequent phase 1 trial was to test new formulations designed to minimize the gastrointestinal (GI)-related adverse events (AEs) observed with the first-generation IR formulation.
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