Asset profile
orismilast
Small molecule
Evidence outlook · lead readout
ADESOS (NCT05469464) · Atopic Dermatitis, Skin Diseases
The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.
ADESOS (NCT05469464): This randomized, quadruple-blind, placebo-controlled Phase 2 trial compared three orismilast doses with placebo in 233 adults with moderate-to-severe atopic dermatitis. The primary endpoint, percent change from baseline in EASI at Week 16, was not met: the drug-placebo differences were -4.6, -1.7, and -10.9 percentage points with p-values of 0.505, 0.812, and 0.118. Because a well-designed trial with a non-significant primary endpoint cannot be considered strong evidence, the study provides only moderate evidence for orismilast despite its otherwise robust design.
Also in development:Psoriasis · Phase 2
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Featured trials
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Competitive landscape
114 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 114 same-indication; 79 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Orismilast: this drug | Phase 2 | Small molecule | PDE4B/D | ||
| Abrocitinib (Cibinqo) | Approved | Small molecule | JAK1 | ||
| Adalimumab (Humira) | Approved | Monoclonal antibody | TNF-alpha | ||
| Apremilast (Otezla) | Approved | Small molecule | PDE4 | ||
| Baricitinib (Olumiant) | Approved | Small molecule | JAK, JAK1/2 | ||
| Bimekizumab (Bimzelx) | Approved | Monoclonal antibody | IL-17A/F | ||
| Brepocitinib (Lisraya) | Approved | Small molecule | TYK2/JAK1 | ||
| Brodalumab (Siliq) | Approved | Monoclonal antibody | IL-17 receptor A | ||
| Calcipotriene / Betamethasone Dipropionate Cream (Wynzora) | Approved | Small molecule | Vitamin D receptor + Glucocorticoid receptor | ||
| Calcipotriene / Betamethasone Dipropionate Foam (Enstilar) | Approved | Small molecule | Vitamin D receptor + Glucocorticoid receptor | ||
| Certolizumab Pegol (Cimzia) | Approved | Antibody fragment | TNF-alpha | ||
| Crisaborole (Eucrisa) | Approved | Small molecule | PDE4 | ||
| Desoximetasone (Topicort Spray) | Approved | Small molecule | Glucocorticoid receptor agonist | ||
| Deucravacitinib (Sotyktu) | Approved | Small molecule | TYK2 | ||
| Difamilast (Moizerto / Adquey) | Approved | Small molecule | PDE4 | ||
| Dupilumab (Dupixent) | Approved | Monoclonal antibody | IL-4R-alpha |
…and 99 more. Research shows the complete landscape.
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Upcoming events
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All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.