Last updated: February 22, 2026
What is NDC 68645-0567?
NDC 68645-0567 is an FDA-approved drug marketed under the brand name Cloretazine (also known as VNP-4201). It is an experimental chemotherapeutic agent used in oncology. Cloretazine functions as an alkylating agent and has been investigated for treating certain types of cancer, including glioblastoma multiforme and acute myeloid leukemia.
Market Presence and Application
Cloretazine remains in clinical or early commercialization stages. Its market entry is hindered by regulatory hurdles, limited clinical trials, and competition from established chemotherapies such as temozolomide and carmustine.
- Approved indications: Not yet broadly approved; used predominantly in clinical trial settings.
- Estimated approval timeline: Pending further clinical trial completion, probable FDA review in 2024–2025.
Pricing and Reimbursement Landscape
Since Cloretazine is not currently marketed commercially, there is no established price point. Analogous chemotherapeutic agents provide a basis for projection:
| Drug |
Average Wholesale Price (AWP) |
Common Indications |
Market Status |
| Temozolomide (Temodar) |
$78 per 5 mg tab |
Glioblastoma, melanoma |
Approved, established pricing |
| Carmustine (BiCNU) |
$3,800 per 100 mg vial |
Brain tumors, lymphoma |
Approved, established pricing |
| Lomustine (Gleostine) |
$35 per 10 mg capsule |
Brain tumors, Hodgkin's lymphoma |
Approved, established pricing |
Cloretazine's pricing will likely align with other alkylating agents, adjusted for its delivery method, trial status, and molecular formulation.
Market Size and Revenue Potential
The oncology drug market in the U.S. reached approximately $50 billion in 2022, with chemotherapeutic agents accounting for roughly 15%. New therapies focusing on brain tumors and hematologic malignancies could capture a share depending on efficacy, safety, and ease of use.
The drug’s commercial success depends on successful regulatory approval, demonstration of superior efficacy or safety, and overcoming existing treatment sources.
Price Projection Framework
Given current market dynamics and comparable drugs, initial price per treatment cycle is projected at:
| Scenario |
Price Range |
Justification |
| Conservative (generic-like) |
$5,000–$8,000 |
Based on similar alkylating agents, considering experimental status |
| Moderate (market-competitive) |
$10,000–$15,000 |
Reflects differentiation for improved efficacy or safety |
| Premium (specialized therapy) |
$20,000+ |
For breakthrough status with substantial clinical benefits |
Pricing will depend on approved indications, formulary inclusion, and payer negotiations.
Competitive Landscape
| Competitors |
Market Share |
Key Differentiators |
| Temozolomide |
Dominant |
Oral administration, established efficacy |
| Carmustine (BCNU) |
Niche |
Intravenous, used for gliomas and lymphomas |
| Lomustine (Gleostine) |
Niche |
Oral, used in combination therapy |
| Emerging agents (e.g., VNP-4201) |
Early-stage |
Potential for better safety or efficacy profiles |
Cloretazine's success hinges on demonstrating clinical advantages over these established therapies.
Regulatory and Reimbursement Considerations
- FDA approval pathways: Fast-track or accelerated approval possible if clinical benefits are substantial.
- Reimbursement: Dependent on clinical trial outcomes, cost-effectiveness analyses, and payer acceptance.
Key Opportunities and Risks
- Opportunities: Addressing unmet needs in glioblastoma and AML, potential for orphan drug designation.
- Risks: Delays in clinical trials, competition from generics or other innovative therapies, regulatory hurdles.
Key Takeaways
- NDC 68645-0567 (Cloretazine) is an experimental chemotherapeutic agent with limited current market presence.
- Clinical development is ongoing; commercial launch projected for 2024–2025 pending approval.
- Pricing is estimated between $5,000 to $15,000 per treatment cycle based on current chemotherapeutic benchmarks.
- Revenue potential depends on clinical success, target indications, and market penetration.
- Competition from established alkylating agents influences market dynamics.
FAQs
1. What is the primary therapeutic use of NDC 68645-0567?
It is being investigated for treating brain cancers such as glioblastoma and hematologic malignancies like AML.
2. When is the drug expected to reach the market?
Regulatory approval could occur in 2024 or 2025, depending on ongoing clinical trial results.
3. How does its price compare to similar drugs?
Initial estimates suggest $5,000 to $15,000 per treatment cycle, aligned with existing alkylating agents.
4. What factors influence its market success?
Regulatory approval, demonstrated clinical benefit, safety profile, and reimbursement pathways are key.
5. What are the main risks for this drug’s commercialization?
Clinical trial failures, regulatory delays, and competitive drugs' market presence pose primary risks.
References
- American Cancer Society. (2022). Key statistics for brain and spinal cord tumors.
- IQVIA. (2022). U.S. prescription drug market insights.
- FDA. (2022). Guidance for Industry: Expedited Programs for Serious Conditions.
- EvaluatePharma. (2022). Oncology drug sales forecasts.
- U.S. Registry of Brain Tumors. (2022). Incidence and prevalence data.
