Last reviewed · How we verify
Carac Cream
Carac Cream is a Antimetabolite, topical chemotherapy Small molecule drug developed by Wake Forest University Health Sciences. It is currently in Phase 3 development for Actinic keratosis (solar keratosis).
Carac Cream is a topical formulation of fluorouracil that inhibits thymidylate synthase to disrupt DNA synthesis in rapidly dividing cells, particularly actinic keratosis lesions.
Carac Cream is a topical formulation of fluorouracil that inhibits thymidylate synthase to disrupt DNA synthesis in rapidly dividing cells, particularly actinic keratosis lesions. Used for Actinic keratosis (solar keratosis).
-
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 | Carac Cream |
|---|---|
| Sponsor | Wake Forest University Health Sciences |
| Drug class | Antimetabolite, topical chemotherapy |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Oncology |
| Phase | Phase 3 |
Mechanism of action
Fluorouracil is a pyrimidine analog that interferes with nucleotide metabolism and DNA replication in hyperproliferative skin cells. When applied topically as a cream, it selectively targets and destroys abnormal keratinocytes characteristic of actinic keratosis while sparing normal surrounding tissue. The lower concentration formulation (0.5%) in Carac is designed to improve tolerability compared to higher-concentration fluorouracil products.
Approved indications
- Actinic keratosis (solar keratosis)
Common side effects
- Local skin irritation
- Erythema
- Burning sensation
- Erosion
- Hyperpigmentation
Key clinical trials
- Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV (NA)
- Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum (PHASE1)
- Topical 5-Fluorouracil (5FU) Plus Calcipotriol in Children With Palmoplantar Wart (NA)
- Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis (PHASE4)
- 5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer (PHASE2, 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)
- A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors (PHASE1)
- Microneedling Alone Versus Microneedling Coupled With Either Bleomycin or 5flourouracil in the Treatment of Plantar Warts (NA)
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 Cream CI brief — competitive landscape report
- Carac Cream updates RSS · CI watch RSS
- Wake Forest University Health Sciences portfolio CI
Frequently asked questions about Carac Cream
What is Carac Cream?
How does Carac Cream work?
What is Carac Cream used for?
Who makes Carac Cream?
What drug class is Carac Cream in?
What development phase is Carac Cream in?
What are the side effects of Carac Cream?
What does Carac Cream target?
Related
- Drug class: All Antimetabolite, topical chemotherapy drugs
- Target: All drugs targeting Thymidylate synthase
- Manufacturer: Wake Forest University Health Sciences — full pipeline
- Therapeutic area: All drugs in Dermatology/Oncology
- Indication: Drugs for Actinic keratosis (solar keratosis)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing