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Generic Fluorouracil Cream
Generic Fluorouracil Cream is a Antimetabolite; Pyrimidine analog Small molecule drug developed by Actavis Inc.. It is currently in Phase 3 development for Actinic keratosis (precancerous skin lesions), Superficial basal cell carcinoma, Squamous cell carcinoma in situ. 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 (precancerous skin lesions), Superficial basal cell carcinoma, Squamous cell carcinoma in situ.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | Generic Fluorouracil Cream |
|---|---|
| Also known as | 5-FU |
| Sponsor | Actavis Inc. |
| Drug class | Antimetabolite; Pyrimidine analog |
| Target | Thymidylate synthase; Thymidine monophosphate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology; Dermatology |
| Phase | Phase 3 |
Mechanism of action
Fluorouracil (5-FU) acts as an antimetabolite by blocking the enzyme thymidylate synthase, which is essential for DNA synthesis. It also incorporates into RNA, disrupting protein synthesis. As a topical cream formulation, it is used to treat precancerous and cancerous skin lesions by inducing apoptosis in abnormal keratinocytes.
Approved indications
- Actinic keratosis (precancerous skin lesions)
- Superficial basal cell carcinoma
- Squamous cell carcinoma in situ
Common side effects
- Local skin irritation and erythema
- Burning and pain at application site
- Erosion and ulceration
- Photosensitivity
- Allergic contact dermatitis
Key clinical trials
- Combination Topical Therapy for Treatment of Scalp Actinic Keratoses (EARLY_PHASE1)
- Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis (PHASE3)
- 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:
- Generic Fluorouracil Cream CI brief — competitive landscape report
- Generic Fluorouracil Cream updates RSS · CI watch RSS
- Actavis Inc. portfolio CI
Frequently asked questions about Generic Fluorouracil Cream
What is Generic Fluorouracil Cream?
How does Generic Fluorouracil Cream work?
What is Generic Fluorouracil Cream used for?
Who makes Generic Fluorouracil Cream?
Is Generic Fluorouracil Cream also known as anything else?
What drug class is Generic Fluorouracil Cream in?
What development phase is Generic Fluorouracil Cream in?
What are the side effects of Generic Fluorouracil Cream?
What does Generic Fluorouracil Cream target?
Related
- Drug class: All Antimetabolite; Pyrimidine analog drugs
- Target: All drugs targeting Thymidylate synthase; Thymidine monophosphate synthase
- Manufacturer: Actavis Inc. — full pipeline
- Therapeutic area: All drugs in Oncology; Dermatology
- Indication: Drugs for Actinic keratosis (precancerous skin lesions)
- Indication: Drugs for Superficial basal cell carcinoma
- Indication: Drugs for Squamous cell carcinoma in situ
- Also known as: 5-FU
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing