Last updated: March 2, 2026
What is the Drug Associated with NDC 50268-0126?
NDC 50268-0126 corresponds to Crenolanib, an investigational kinase inhibitor primarily developed for treating various cancers, including gastrointestinal stromal tumors (GIST) and acute myeloid leukemia (AML) with FLT3 mutations.
Market Landscape
Indications and Market Potential
Crenolanib targets specific subsets of patients with limited therapeutic options. The primary approved or investigational indications include:
- GIST with PDGFRA mutations
- AML with FLT3 mutations
Competitive Environment
The drug faces competition from existing FLT3 inhibitors such as:
- Midostaurin (PKC412)
- Gilteritinib (ASP2215)
- Quizartinib (AC220)
These drugs are approved or in advanced development stages. The market share of crenolanib will depend on clinical efficacy, safety profile, and regulatory approval.
Regulatory Status
As of the latest data, crenolanib remains in clinical trials without full FDA approval. It has completed Phase II trials for AML but has not received marketing authorization.
Market Penetration Factors
- Clinical efficacy: Demonstrated benefits over comparator therapies
- Safety profile: Few severe adverse events
- Pricing strategy: Competitive pricing against existing therapies
- Regulatory pathway: Approval status influences market access
Price Projections
Current Pricing Trends
Since crenolanib is not yet commercially available, price estimates base on comparable kinase inhibitors:
| Therapy |
Approximate Price per Month |
Notes |
| Midostaurin |
$10,000 - $15,000 |
Approved for AML, first-line therapy |
| Gilteritinib |
$12,000 - $16,000 |
Approved for relapsed/refractory AML |
| Quizartinib |
Not commercially available |
Phase III, pricing not established |
Projected Price Range
Considering the competitive landscape and clinical positioning, crenolanib could be priced within this range:
- Initial launch: $10,000 - $15,000 per month
- Premium positioning: Up to $20,000 per month if superior efficacy or safety is demonstrated
- Cost reductions: Possible if generic or biosimilar competitors emerge or if reimbursement negotiations favor lower prices
Factors Influencing Price
- Orphan drug designation: Potential for premium pricing due to rare disease focus
- Manufacturing costs: May influence initial pricing
- Pricing regulations: Health authorities and payers' policies could impact price ceilings
- Reimbursement landscape: Negotiations with insurers will shape real-world costs
Revenue Projections
Assuming market penetration of 10-20% among eligible patients in the US and EU over the next 5 years, revenues could range substantially. For example:
- Market size estimate: 2,000-3,000 AML and GIST patients annually
- Share assumption: 10-20%
- Average annual revenue: $120 million to $360 million
These figures depend on regulatory approval, clinical efficacy, competitive positioning, and reimbursement policies.
Key Challenges to Revenue Growth
- Gaining FDA and EMA approval
- Demonstrating superiority over existing therapies
- Securing favorable insurance reimbursement terms
- Managing manufacturing and distribution costs
Summary
| Aspect |
Details |
| Lead indication |
AML with FLT3 mutations; GIST with PDGFRA mutations |
| Regulatory status |
Clinical trials ongoing; no final approval yet |
| Competitive landscape |
Midostaurin, Gilteritinib, Quizartinib |
| Estimated launch price |
$10,000 - $15,000/month |
| Market potential (US/EU) |
$120M - $360M annually (with 10-20% market share) |
| Challenges |
Regulatory approval, clinical validation, reimbursement hurdles |
Key Takeaways
- Crenolanib is an investigational drug in clinical trials, targeting AML and GIST with focused mutations.
- The market faces competition from established kinase inhibitors, influencing pricing strategies.
- Launch pricing is estimated between $10,000 and $15,000 per month, subject to regulatory and market dynamics.
- Revenue depends on approval, clinical success, reimbursement negotiations, and market penetration.
- Opportunities exist in rare disease segments, but challenges include competitive and regulatory uncertainty.
FAQs
Q1: When is crenolanib expected to gain regulatory approval?
A1: No definitive timeline; clinical trial results and regulatory reviews are ongoing.
Q2: How does crenolanib compare to existing FLT3 inhibitors?
A2: Pending clinical data; potential advantages include activity against resistant mutations and favorable safety profile.
Q3: What are the primary markets for crenolanib?
A3: United States, European Union, and other regions with advanced oncology markets.
Q4: What risks could impact price and revenue?
A4: Delays in approval, clinical failure, regulatory restrictions, or aggressive competitor pricing.
Q5: How might pricing strategies evolve upon approval?
A5: Initial premium pricing may shift as market competition intensifies and biosimilars or generics enter.
References
[1] U.S. Food and Drug Administration. (2022). Approved Drugs. Retrieved from https://www.fda.gov/drugs
[2] IQVIA. (2022). Global Oncology Market Reports.
[3] EvaluatePharma. (2022). Oncology drug forecast.
