Investigating the stability and reprocessing of FX-5A injection for drug development.
Official title: DOSAGE FORM REPROCESS AND STABILITY STUDIES OF FX-5A INJECTION UNDER IDIQ CHEMISTRY, MANUFACTURING AND CONTROLS AND RELATED SERVICES FOR DEVELOPMENT OF DRUG PRODUCTS
NIH-11219863 · Data updated 2026-11-12
This study is looking at how the FX-5A injection works over time and under different conditions to make sure it's safe and effective for patients, helping to improve how it's made and ensuring it meets high quality standards.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Project start | September 27, 2024 |
| Project end | May 26, 2026 |
| Funding year | 2024 |
| Award (this year) | $322,928 |
| NIH project number | 75N95024D00036-0-759502400002-1 |
| Project ID | NIH-11219863 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are patients who are prescribed FX-5A injection or similar drug products.
✕Less likely to help
Patients who do not require FX-5A injection or are not involved in drug development processes may not benefit from this research.
What this research studies
This research focuses on the stability and reprocessing of the FX-5A injection, which is essential for ensuring the safety and effectiveness of this drug product. The study will involve rigorous testing and analysis to understand how the drug behaves under various conditions, which is crucial for its manufacturing and quality control. By examining the chemistry and dosage forms, the research aims to optimize the production process and enhance the reliability of the injection for patient use.
Why it matters
Potential benefit: If successful, this research could lead to a more stable and effective FX-5A injection, improving treatment options for patients requiring this medication.
How similar studies have gone: While the specific approach may be novel, similar studies in drug stability and reprocessing have shown promise in improving drug formulations.
Where this research is happening
San Diego, United States
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.