Last reviewed · How we verify
Dovonex® cream
Dovonex® cream is a Vitamin D analog Small molecule drug developed by LEO Pharma. It is currently in Phase 2 development for Psoriasis.
Calcitriol binds to vitamin D receptors (VDRs) on keratinocytes, promoting differentiation and reducing inflammation.
Calcitriol binds to vitamin D receptors (VDRs) on keratinocytes, promoting differentiation and reducing inflammation. Used for Psoriasis.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Dovonex® cream |
|---|---|
| Sponsor | LEO Pharma |
| Drug class | Vitamin D analog |
| Target | Vitamin D receptor (VDR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 2 |
Mechanism of action
Calcitriol, the active form of vitamin D, plays a crucial role in regulating keratinocyte differentiation and immune responses in the skin.
Approved indications
- Psoriasis
Common side effects
- Skin irritation
- Pruritus
- Headache
Key clinical trials
- A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults
- A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products (PHASE2)
- A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris (PHASE1)
- Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris (PHASE2)
- A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis (PHASE2)
- Evaluation of the Vasoconstriction Properties of MC2-01 Cream (PHASE1)
- Vasoconstriction Trial With LEO 90100 Aerosol Foam (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:
- Dovonex® cream CI brief — competitive landscape report
- Dovonex® cream updates RSS · CI watch RSS
- LEO Pharma portfolio CI
Frequently asked questions about Dovonex® cream
What is Dovonex® cream?
How does Dovonex® cream work?
What is Dovonex® cream used for?
Who makes Dovonex® cream?
What drug class is Dovonex® cream in?
What development phase is Dovonex® cream in?
What are the side effects of Dovonex® cream?
What does Dovonex® cream target?
Related
- Drug class: All Vitamin D analog drugs
- Target: All drugs targeting Vitamin D receptor (VDR)
- Manufacturer: LEO Pharma — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Psoriasis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing