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LEO43204 gel
LEO43204 gel is a Retinoid Small molecule drug developed by LEO Pharma. It is currently in Phase 3 development for Psoriasis, Other inflammatory skin conditions. Also known as: Ingenol Disoxate.
LEO43204 is a topical retinoid that modulates retinoid receptor signaling to reduce inflammation and promote skin cell differentiation in dermatological conditions.
LEO43204 gel is a treatment for actinic keratosis, specifically studied for its efficacy and safety in field treatment on the face or chest. The exact mechanism of action of LEO43204 gel is currently unknown.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | LEO43204 gel |
|---|---|
| Also known as | Ingenol Disoxate |
| Sponsor | LEO Pharma |
| Drug class | Retinoid |
| Target | Retinoid receptors (RAR/RXR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
LEO43204 is a selective retinoid compound formulated as a gel for topical application. It binds to retinoid receptors in the skin, promoting keratinocyte differentiation and reducing inflammatory responses. This mechanism is typical of retinoid-class therapeutics used in inflammatory skin diseases.
Approved indications
- Psoriasis
- Other inflammatory skin conditions
Common side effects
- Skin irritation
- Erythema
- Pruritus
- Photosensitivity
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:
- LEO43204 gel CI brief — competitive landscape report
- LEO43204 gel updates RSS · CI watch RSS
- LEO Pharma portfolio CI
Frequently asked questions about LEO43204 gel
What is LEO43204 gel?
How does LEO43204 gel work?
What is LEO43204 gel used for?
Who makes LEO43204 gel?
Is LEO43204 gel also known as anything else?
What drug class is LEO43204 gel in?
What development phase is LEO43204 gel in?
What are the side effects of LEO43204 gel?
What does LEO43204 gel target?
Related
- Drug class: All Retinoid drugs
- Target: All drugs targeting Retinoid receptors (RAR/RXR)
- Manufacturer: LEO Pharma — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Psoriasis
- Indication: Drugs for Other inflammatory skin conditions
- Also known as: Ingenol Disoxate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing