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LEO 80185 gel
LEO 80185 is a topical calcineurin inhibitor that suppresses local immune responses in the skin.
LEO 80185 is a topical calcineurin inhibitor that suppresses local immune responses in the skin. Used for Atopic dermatitis, Eczema.
At a glance
| Generic name | LEO 80185 gel |
|---|---|
| Sponsor | LEO Pharma |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
The drug works by inhibiting calcineurin, a phosphatase enzyme critical for T-cell activation and cytokine production. By blocking this pathway in dermal tissue, it reduces inflammatory responses and immune-mediated skin damage. This mechanism makes it suitable for treating inflammatory skin conditions where local immunosuppression is beneficial.
Approved indications
- Atopic dermatitis
- Eczema
Common side effects
- Application site burning or stinging
- Skin irritation
- Pruritus
Key clinical trials
- Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis (PHASE2)
- Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis (PHASE2)
- An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects (PHASE2)
- Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris (PHASE3)
- LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis (PHASE3)
- Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis (PHASE3)
- Effect of LEO 80185 Gel on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis Vulgaris (PHASE2)
- Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LEO 80185 gel CI brief — competitive landscape report
- LEO 80185 gel updates RSS · CI watch RSS
- LEO Pharma portfolio CI