Last reviewed · How we verify
Calcipotriene Foam
Calcipotriene Foam is a Vitamin D3 analog Small molecule drug developed by Stiefel, a GSK Company. It is currently in Phase 3 development for Plaque psoriasis, Psoriasis vulgaris.
Calcipotriene is a vitamin D3 analog that binds to vitamin D receptors on skin cells to regulate cell proliferation and differentiation, reducing excessive skin cell growth characteristic of psoriasis.
Calcipotriene is a vitamin D3 analog that binds to vitamin D receptors on skin cells to regulate cell proliferation and differentiation, reducing excessive skin cell growth characteristic of psoriasis. Used for Plaque psoriasis, Psoriasis vulgaris.
-
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). -
Big-pharma sponsor
+3.0pp
Stiefel, a GSK Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Calcipotriene Foam |
|---|---|
| Sponsor | Stiefel, a GSK Company |
| Drug class | Vitamin D3 analog |
| Target | Vitamin D receptor (VDR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Calcipotriene acts as a selective vitamin D receptor agonist, promoting normal differentiation and maturation of keratinocytes while inhibiting their proliferation. This mechanism helps normalize the abnormal skin cell turnover seen in psoriatic plaques. The foam formulation enhances penetration and patient compliance compared to traditional topical formulations.
Approved indications
- Plaque psoriasis
- Psoriasis vulgaris
Common side effects
- Skin irritation
- Burning sensation
- Pruritus
- Erythema
- Hypercalcemia (with excessive use)
Key clinical trials
- Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study (PHASE4)
- Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris (PHASE3)
- LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris (PHASE3)
- LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris (PHASE3)
- Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris (PHASE3)
- A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris (PHASE2)
- LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris (PHASE2)
- LEO 90100 in the Treatment of Psoriasis Vulgaris (PHASE2)
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:
- Calcipotriene Foam CI brief — competitive landscape report
- Calcipotriene Foam updates RSS · CI watch RSS
- Stiefel, a GSK Company portfolio CI
Frequently asked questions about Calcipotriene Foam
What is Calcipotriene Foam?
How does Calcipotriene Foam work?
What is Calcipotriene Foam used for?
Who makes Calcipotriene Foam?
What drug class is Calcipotriene Foam in?
What development phase is Calcipotriene Foam in?
What are the side effects of Calcipotriene Foam?
What does Calcipotriene Foam target?
Related
- Drug class: All Vitamin D3 analog drugs
- Target: All drugs targeting Vitamin D receptor (VDR)
- Manufacturer: Stiefel, a GSK Company — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Plaque psoriasis
- Indication: Drugs for Psoriasis vulgaris
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing