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LEO 43204 gel
LEO 43204 is a topical calcineurin inhibitor that suppresses local immune responses in the skin.
LEO 43204 is a topical calcineurin inhibitor that suppresses local immune responses in the skin. Used for Atopic dermatitis, Eczema.
At a glance
| Generic name | LEO 43204 gel |
|---|---|
| Also known as | Ingenol Disoxate |
| 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 a topical formulation, it reduces inflammatory responses in dermatological conditions without the systemic immunosuppression associated with oral calcineurin inhibitors.
Approved indications
- Atopic dermatitis
- Eczema
Common side effects
- Application site burning or stinging
- Skin irritation
- Pruritus
Key clinical trials
- Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up (PHASE3)
- A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp (PHASE3)
- Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up (PHASE3)
- Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up (PHASE3)
- Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up (PHASE3)
- Biological Effects of LEO 43204 in Actinic Keratosis (PHASE1)
- A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel (PHASE1)
- Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions (PHASE1)
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 43204 gel CI brief — competitive landscape report
- LEO 43204 gel updates RSS · CI watch RSS
- LEO Pharma portfolio CI