Last updated: March 10, 2026
What is the drug associated with NDC 51672-4052?
NDC 51672-4052 corresponds to BKM120 (Buparlisib), an oral pan-class I PI3K inhibitor developed primarily for oncology indications. It has been investigated in clinical trials for various cancers, including breast cancer, glioblastoma, and lymphoma.
What is the current regulatory status?
BKM120 has completed Phase II trials, with no recent submissions for FDA approval. It remains an investigational drug with no approved indications in the U.S. or major markets. Regulatory agencies have expressed concerns about safety profiles in clinical trials.
What is the current market landscape?
Competitor drugs
BKM120 competes in the PI3K inhibitor class, which includes:
- Alpelisib (PIQRAY): Approved for HR-positive, HER2-negative breast cancer.
- Buparlisib (BKM120): Investigational, with limited clinical success.
- Idelalisib (Zydelig): Approved for hematologic malignancies.
- Copanlisib (Aliqopa): Approved for follicular lymphoma.
Market size
The global cancer drug market reached approximately $150 billion in 2022, with PI3K inhibitors accounting for a significant segment. The specific segment for investigational drugs like BKM120 is smaller, primarily driven by clinical trial activity and early-stage partnerships.
R&D investments
Major pharmaceutical companies have invested heavily in PI3K pathway inhibitors, totaling over $2 billion in R&D since 2015. Clinical trial phases and outcomes influence subsequent market potential.
Patent and exclusivity
As an investigational drug, BKM120 has no market exclusivity. Patent life extensions depend on patent filings and approvals, with primary patents expiring around 2023-2025.
What are the factors influencing future pricing?
- Clinical trial outcomes: Failure to demonstrate superior efficacy or safety concerns decrease valuation.
- Regulatory approval: No approval limits commercialization and pricing.
- Competitive landscape: Established drugs like Alpelisib have set price points, affecting potential pricing.
- Manufacturing and development costs: R&D investments influence baseline valuation.
- Market demand: Limited by clinical trial status and indication specificity.
What are the price projections?
Scenario 1: No FDA approval, continued research
- Pricing: BKM120 remains an investigational agent.
- Market value: Low, primarily for licensing and partnership deals.
- Estimated worth: $50-$100 million based on pathogen licensing rights and pipeline potential.
Scenario 2: FDA approval for specific indications in 2-3 years
- Pricing: Similar to current PI3K inhibitors, $10,000 - $15,000 per month per patient.
- Market size: Approximately 10,000–15,000 eligible patients in the U.S.
- Estimated revenue: $1.2-$2.2 billion annually, subject to pricing strategies and market penetration.
Scenario 3: Accelerated approval due to breakthrough designation
- Pricing: Premium, $15,000 - $20,000 monthly per patient.
- Market share: 20-30%, depending on safety profile and competitor responses.
- Estimated revenue: $1.5-$3 billion annually.
Cost comparison with competitors
| Drug |
Approved Indication |
Monthly Price |
Estimated Market Size |
Market Revenue Potential |
| Alpelisib |
HR-positive breast cancer |
~$11,000 |
15,000 patients |
~$2 billion |
| Idelalisib |
Chronic lymphocytic leukemia |
~$13,000 |
8,000 patients |
~$1 billion |
| Copanlisib |
Follicular lymphoma, relapsed |
~$14,000 |
6,000 patients |
~$1 billion |
| BKM120 (est.) |
Investigational, pending approvals |
$10,000-$15,000 |
Variable |
Up to $3 billion (if approved) |
Key factors that could alter projections:
- Early termination of clinical trials due to safety or lack of efficacy.
- Regulatory hurdles, including safety concerns or insufficient efficacy data.
- Partnership or licensing deals that could de-risk commercialization.
- Pricing negotiations influenced by payer resistance or market dynamics.
Key Takeaways
- BKM120 is an investigational PI3K inhibitor with limited commercialization prospects without regulatory approval.
- Market revenue projections depend heavily on clinical success, approval, and competition.
- In a best-case scenario, revenues could approach $3 billion annually, similar to existing approved agents in the class.
- The current valuation remains speculative until more clinical data and regulatory updates emerge.
- Patent and exclusivity status influences pricing, but so far, no exclusive rights are in place.
FAQs
1. What clinical data supports BKM120’s potential?
Limited Phase II trial data indicated some activity, but safety concerns and lack of clear efficacy hinder progress.
2. When could BKM120 gain regulatory approval?
Likely 2-3 years if ongoing trials demonstrate sufficient safety and efficacy. No FDA submission is currently announced.
3. How does BKM120 compare with approved PI3K inhibitors?
It has similar target pathways but faces competition from drugs like Alpelisib, which have proven efficacy and safety profiles.
4. What are the main risks to price projections?
Clinical trial failure, regulatory setbacks, and market resistance, especially if safety concerns remain.
5. Could licensing or partnership deals impact valuation?
Yes, deals could bring in upfront payments, milestone payments, or licensing fees, increasing immediate valuation, especially pre-approval.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] FDA. (2022). Approved PI3K inhibitors.
[3] GlobalData. (2023). Cancer drug pipeline analysis.
[4] ClinicalTrials.gov. (2022). BKM120 clinical trial registry.
[5] Evaluate Pharma. (2023). Market forecasts for cancer therapeutics.
