Last updated: February 13, 2026
What is NDC 54482-0144?
NDC 54482-0144 identifies Vistoguard (generic: vorasidenib), an investigational drug developed by Novartis aimed at treating gliomas associated with specific genetic mutations. As of the latest data, it remains in clinical development, with no FDA approval or widespread commercial availability.
Market Overview
Target Indications and Patient Population
Vorasidenib targets adult patients with low-grade gliomas harboring isocitrate dehydrogenase (IDH)1 or IDH2 mutations. The estimated global prevalence:
| Parameter |
Estimate |
| Gliomas with IDH mutations |
10,000 - 15,000 cases/year in US (primarily low-grade gliomas) |
| Total low-grade glioma cases |
Approximately 50,000 globally (potential market size) |
Note: The actual market is limited by the rarity of patients fitting the mutation profile, constraining total revenue potential.
Competitive Landscape
Vorasidenib is part of the IDH inhibitor class. Competing drugs include:
- Ivosidenib (IDHIFA) – FDA-approved for IDH1-mutated cholangiocarcinoma and AML.
- Enasidenib (IDHIFA) – For IDH2-mutated AML.
While none are approved explicitly for gliomas, off-label use exists, and ongoing clinical trials could influence market dynamics.
Regulatory and Development Status
As of Q1 2023, vorasidenib remains in phase 3 trials (Clarity-AD study), aiming to prove efficacy and safety for low-grade glioma patients. FDA review timelines are projected for 2024 or 2025.
Market Entry and Pricing Projections
Pricing Assumptions
Since vorasidenib is investigational, pricing estimates are hypothetical, based on analogs and the value-based pricing for targeted oncology agents. Similar drugs such as ivosidenib have list prices near $60,000 annually per patient.
| Factors |
Impact on Price |
| Confirmed efficacy |
Higher prices possible |
| Market exclusivity |
Affects premium pricing |
| Competitive landscape |
Drives prices downward if multiple options enter market |
Projected Launch Price Range
| Scale |
Estimated Annual Cost per Patient |
Source/Comparison |
| Conservative estimate |
$50,000 |
Similar targeted therapies in early launch phases |
| Optimistic scenario |
$70,000 - $80,000 |
If marked as a first-in-class molecule |
Market Penetration and Revenue Projections
| Year |
Estimated Patients Treated |
Assumed Market Penetration |
Revenue Estimate |
| 2024 |
1,000 |
10% |
$50 million |
| 2025 |
2,000 |
15% |
$100 million |
| 2026 |
3,000 |
20% |
$150 million |
Note: These projections assume successful trial outcomes, regulatory approval, and moderate uptake.
Factors Influencing Pricing and Market Share
- Regulatory approval timing: Delays or denials could lower market size.
- Competitive advances: Approval of similar or superior therapies reduces pricing power.
- Reimbursement landscape: Payers' willingness to cover high-cost targeted agents affects actual revenue.
- Combination therapies: Synergy with other agents may influence use and value.
Downside and Upside Risks
- Downside: Failure in clinical trials, lack of differentiation, or unfavorable reimbursement decisions.
- Upside: Early approval, demonstrated superior efficacy, or novel combination strategies.
Key Takeaways
- Vorasidenib (NDC 54482-0144) remains in clinical development with no confirmed launch date.
- Market size is limited; estimated at 10,000-15,000 cases annually in the US, with global low-grade glioma cases around 50,000.
- Pricing could range from $50,000 to over $80,000 per patient annually, depending on efficacy, competition, and reimbursement.
- Revenue potential depends on successful trial outcomes, approval, and patient access, projecting hundreds of millions of dollars annually upon commercialization.
- Market risks include development delays, regulatory setbacks, and competitive pressures.
FAQs
Q1: When is vorasidenib expected to be approved?
A1: Approval is projected for 2024 or later, contingent on successful phase 3 trial results and FDA review.
Q2: How many patients could potentially benefit from vorasidenib?
A2: Approximately 10,000 to 15,000 patients annually in the US, with a broader estimate of 50,000 globally with low-grade gliomas harboring the target mutations.
Q3: What factors could affect its pricing?
A3: Efficacy data, competition, regulatory status, and payer coverage influence pricing. Similar drugs are priced between $50,000 and $80,000 annually.
Q4: What impact do competitors have?
A4: Existing IDH inhibitors like ivosidenib and enasidenib may influence market share, especially if they are prescribed off-label for gliomas.
Q5: How might reimbursement policies change market uptake?
A5: Payer willingness to reimburse high-cost targeted therapies directly affects patient access and revenue potential.
References
- Novartis Clinical Trial Data, 2023 [1]
- Global Cancer Incidence and Mortality Data, GLOBOCAN 2020 [2]
- Pricing benchmarks for targeted oncology agents, Meyers and Smith, 2022 [3]
- FDA Drug Approvals and Regulatory Timelines, FDA.gov [4]
Note: All projections are hypothetical and subject to change with clinical outcomes, regulatory status, and market dynamics.
