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TACALCITOL
TACALCITOL is a tacalcitol drug. It is currently in Phase 3 development for Plaque psoriasis.
TACALCITOL works by binding to the Vitamin D3 receptor, which helps to reduce inflammation and modulate the immune response.
Tacalcitol is a small molecule with the synonyms 1.ALPHA.,24-DIHYDROXYVITAMIN D3, BONALFA, CURATODERM, TACALCITOL. It is being studied as a treatment for Psoriasis Vulgaris in clinical trials, including a Phase 3 study comparing it to calcipotriol plus betamethasone dipropionate gel.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 |
|---|---|
| Drug class | tacalcitol |
| Target | Vitamin D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Think of it like a key fitting into a lock. TACALCITOL is the key that fits into the Vitamin D3 receptor lock, which helps to turn off the signals that cause inflammation and skin cell growth. This helps to reduce the symptoms of plaque psoriasis, such as redness and scaling.
Approved indications
- Plaque psoriasis
Common side effects
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 CI brief — competitive landscape report
- TACALCITOL updates RSS · CI watch RSS
Frequently asked questions about TACALCITOL
What is TACALCITOL?
How does TACALCITOL work?
What is TACALCITOL used for?
What drug class is TACALCITOL in?
What development phase is TACALCITOL in?
What does TACALCITOL target?
Related
- Drug class: All tacalcitol drugs
- Target: All drugs targeting Vitamin D3 receptor
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Plaque psoriasis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing