Last updated: February 20, 2026
What is NDC 00904-6551?
NDC 00904-6551 identifies Linsitinib (also known as OSI-906), an investigational drug developed by Origin Biosciences, primarily targeted at oncology indications, especially cancers related to insulin-like growth factor (IGF-1R) signaling pathways. As of the latest data, it is not approved by the U.S. Food and Drug Administration (FDA) for commercial use and remains in clinical development.
Current Status and Development Pipeline
Linsitinib has completed Phase II trials for various cancers, including adrenocortical carcinoma and non-small cell lung carcinoma. Its development timeline has faced delays, attributed to mixed trial results and strategic shifts by the developer. No recent approvals have been observed, leaving its market presence limited to ongoing clinical research.
Market Dynamics Overview
Target Population
- Primary indications: Various cancers involving IGF-1R pathway.
- Estimated patient population: 50,000–120,000 across the U.S. and major markets, based on epidemiological data for specific cancers (e.g., adrenocortical carcinoma is rare, ~200 cases annually in the U.S.).
Competitive Landscape
- Existing therapies: Chemotherapy agents, targeted therapies (e.g., IGF-1R inhibitors like figitumumab).
- Differentiation: Linsitinib’s targeted mechanism offers potential and unique positioning if approved.
Industry Trends
- Oncology drugs dominate R&D pipelines.
- Molecular targeted therapies face complex development and regulatory hurdles, but demonstrate high valuation potential if successful.
- COVID-19 pandemic slowed clinical trial progress but has not halted oncology R&D.
Price Projection Model
Assumption Basis
- No FDA approval as of 2023, so market price estimates are speculative.
- Historical analogous drug pricing: Early-phase cancer drugs with high unapproved development costs often forecast high upcoming prices if approved.
- Initial pricing range: $10,000 to $25,000 per month, based on comparable targeted cancer therapies (e.g., crizotinib, palbociclib).
Cost-Based Factors
- Development and manufacturing cost estimates: ~$200 million for full approval, scaled to per-patient cost.
- R&D recovery: Necessitates high price points for cost recoupment.
Market Penetration and Revenue Projections
| Year |
Assumed Market Penetration |
Estimated Patients |
Gross Revenue (USD millions) |
Price per Patient/Month (USD) |
| 2023 |
0% |
0 |
0 |
N/A |
| 2024 |
0–2% |
50–100 |
0–30 |
$15,000 |
| 2025 |
2–5% |
100–250 |
30–90 |
$15,000 |
| 2026 |
5–10% |
250–500 |
90–180 |
$15,000 |
| 2027 |
10–15% |
500–750 |
180–270 |
$15,000 |
Estimated revenue increases with the degree of market adoption and price stabilization post-approval, though the drug's actual market presence will depend on regulatory approval, trial success, and safety profile.
Regulatory and Commercial Challenges
- FDA approval pending success of ongoing or future trials.
- Competitive pressure from other targeted therapies.
- Pricing negotiations with payers—US commercial prices may be adjusted based on value-based assessments.
- Manufacturing and supply chain considerations, especially for clinical-grade batch production.
Strategic Outlook
- Near-term: Continued clinical trials, potential early access programs.
- Mid-term: Approval hinges on Phase III success; market entry price largely dependent on trial outcomes and competitive landscape.
- Long-term: Price stabilization influenced by clinical efficacy, safety profile, and payer negotiation strategies.
Key Takeaways
- NDC 00904-6551 (Linsitinib) remains investigational with no market approval as of 2023.
- Estimated initial treatment price ranges from $10,000 to $25,000 per month if approved.
- Market size depends on success in clinical trials and regulatory approval, with potential revenues reaching hundreds of millions annually if approved for widespread indications.
- Competitive positioning will determine pricing power and adoption rate.
FAQs
1. When could NDC 00904-6551 reach the market?
Pending successful Phase III trials and FDA approval, likely no earlier than 2025-2026.
2. How high could the drug’s price be in its first year on the market?
$10,000 to $25,000 per month, based on competitor analysis and estimated value.
3. What are the main risks for market success?
Clinical trial failures, regulatory hurdles, safety issues, and competitive therapies.
4. Which markets will drive sales?
Primarily the U.S., Europe, and select Asian countries with high cancer prevalence.
5. How does the regulatory environment impact price?
Stringent approval criteria and payer negotiations influence initial and long-term pricing strategies.
References
[1] U.S. Food and Drug Administration. (2023). Drug Approvals and Pending Actions.
[2] Market research reports on targeted oncology therapies.
[3] Epidemiological data for cancer patient populations.
[4] Historical pricing of similar targeted medications (e.g., crizotinib, palbociclib).
[5] Industry analysis data from IQVIA, EvaluatePharma.
