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Fluorouracil/Calcipotriene
Fluorouracil inhibits thymidylate synthase to disrupt DNA synthesis, while calcipotriene promotes keratinocyte differentiation and immune modulation for topical anticancer effect.
Fluorouracil inhibits thymidylate synthase to disrupt DNA synthesis, while calcipotriene promotes keratinocyte differentiation and immune modulation for topical anticancer effect. Used for Actinic keratosis, Non-melanoma skin cancer (investigational).
At a glance
| Generic name | Fluorouracil/Calcipotriene |
|---|---|
| Sponsor | M.D. Anderson Cancer Center |
| Drug class | Antimetabolite + Vitamin D analog combination |
| Target | Thymidylate synthase; Vitamin D receptor (VDR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This combination pairs fluorouracil, a pyrimidine antimetabolite that blocks nucleotide synthesis and induces apoptosis in rapidly dividing cells, with calcipotriene, a vitamin D analog that enhances differentiation and has immunomodulatory properties. When combined topically, they work synergistically to target skin cancers by both direct cytotoxic and differentiation-promoting mechanisms.
Approved indications
- Actinic keratosis
- Non-melanoma skin cancer (investigational)
Common side effects
- Local skin irritation
- Erythema
- Burning/stinging
- Hypercalcemia (with systemic absorption)
Key clinical trials
- Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (PHASE4)
- Topical 5-Fluorouracil (5FU) Plus Calcipotriol in Children With Palmoplantar Wart (NA)
- 5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer (PHASE2, PHASE3)
- A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses (PHASE3)
- Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Precancerous Skin Lesions in Organ Transplant Recipients (PHASE2)
- Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC (PHASE1)
- Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis (PHASE4)
- Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients (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:
- Fluorouracil/Calcipotriene CI brief — competitive landscape report
- Fluorouracil/Calcipotriene updates RSS · CI watch RSS
- M.D. Anderson Cancer Center portfolio CI