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Tacalcitol ointment
Tacalcitol ointment is a Vitamin D analog Small molecule drug developed by LEO Pharma. It is currently in Phase 3 development for Treatment of psoriasis.
Tacalcitol ointment is a synthetic vitamin D3 analog that modulates the vitamin D receptor.
Tacalcitol ointment is a small molecule used to treat Psoriasis Vulgaris. It is a synthetic derivative of vitamin D3, specifically 1,24-dihydroxyvitamin D3.
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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 | Tacalcitol ointment |
|---|---|
| Sponsor | LEO Pharma |
| Drug class | Vitamin D analog |
| Target | Vitamin D receptor |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
By activating the vitamin D receptor, tacalcitol ointment influences the expression of genes involved in cell differentiation and proliferation, leading to its therapeutic effects.
Approved indications
- Treatment of psoriasis
Common side effects
- Skin irritation
Key clinical trials
- Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris (PHASE3)
- Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds (PHASE3)
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:
- Tacalcitol ointment CI brief — competitive landscape report
- Tacalcitol ointment updates RSS · CI watch RSS
- LEO Pharma portfolio CI
Frequently asked questions about Tacalcitol ointment
What is Tacalcitol ointment?
How does Tacalcitol ointment work?
What is Tacalcitol ointment used for?
Who makes Tacalcitol ointment?
What drug class is Tacalcitol ointment in?
What development phase is Tacalcitol ointment in?
What are the side effects of Tacalcitol ointment?
What does Tacalcitol ointment target?
Related
- Drug class: All Vitamin D analog drugs
- Target: All drugs targeting Vitamin D receptor
- Manufacturer: LEO Pharma — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Treatment of psoriasis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing