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Carac® (Fluorouracil) Cream
Carac® (Fluorouracil) Cream is a Antimetabolite; Pyrimidine analog Small molecule drug developed by Actavis Inc.. It is currently in Phase 3 development for Actinic keratosis (topical cream formulation), Superficial basal cell carcinoma (topical). Also known as: 5-FU.
Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase and gets incorporated into DNA and RNA, disrupting nucleotide synthesis and causing cell death in rapidly dividing cells.
Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase and gets incorporated into DNA and RNA, disrupting nucleotide synthesis and causing cell death in rapidly dividing cells. Used for Actinic keratosis (topical cream formulation), Superficial basal cell carcinoma (topical).
At a glance
| Generic name | Carac® (Fluorouracil) Cream |
|---|---|
| Also known as | 5-FU |
| Sponsor | Actavis Inc. |
| Drug class | Antimetabolite; Pyrimidine analog |
| Target | Thymidylate synthase; DNA and RNA synthesis |
| Modality | Small molecule |
| Therapeutic area | Oncology; Dermatology |
| Phase | Phase 3 |
Mechanism of action
Fluorouracil (5-FU) is a prodrug that is converted intracellularly to active metabolites (FdUMP and FdUTP). FdUMP inhibits thymidylate synthase, blocking dTMP synthesis and DNA replication. The active metabolites also incorporate into RNA, disrupting protein synthesis. This mechanism preferentially affects rapidly dividing cells, including cancer cells and hyperproliferative skin cells.
Approved indications
- Actinic keratosis (topical cream formulation)
- Superficial basal cell carcinoma (topical)
Common side effects
- Local skin irritation (erythema, burning, pain)
- Erosion or ulceration at application site
- Photosensitivity
- Allergic contact dermatitis
- Hyperpigmentation or hypopigmentation
Key clinical trials
- Comparative Study Between Topical 5-fluorouracil and Latanoprost in Vitiligo. (PHASE2, PHASE3)
- Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease (PHASE3)
- Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream (PHASE3)
- Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis (PHASE3)
- Comparison of Five Treatments in Patients With Plantar Warts (PHASE4)
- Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo (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:
- Carac® (Fluorouracil) Cream CI brief — competitive landscape report
- Carac® (Fluorouracil) Cream updates RSS · CI watch RSS
- Actavis Inc. portfolio CI
Frequently asked questions about Carac® (Fluorouracil) Cream
What is Carac® (Fluorouracil) Cream?
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Who makes Carac® (Fluorouracil) Cream?
Is Carac® (Fluorouracil) Cream also known as anything else?
What drug class is Carac® (Fluorouracil) Cream in?
What development phase is Carac® (Fluorouracil) Cream in?
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What does Carac® (Fluorouracil) Cream target?
Related
- Drug class: All Antimetabolite; Pyrimidine analog drugs
- Target: All drugs targeting Thymidylate synthase; DNA and RNA synthesis
- Manufacturer: Actavis Inc. — full pipeline
- Therapeutic area: All drugs in Oncology; Dermatology
- Indication: Drugs for Actinic keratosis (topical cream formulation)
- Indication: Drugs for Superficial basal cell carcinoma (topical)
- Also known as: 5-FU
- Compare: Carac® (Fluorouracil) Cream vs similar drugs
- Pricing: Carac® (Fluorouracil) Cream cost, discount & access