Developing and testing a new medication formulation for clinical trials.
Official title: THIS TASK ORDER (TO) IS TO PROVIDE DOSAGE FORM DEVELOPMENT, MANUFACTURE AND STABILITY STUDIES OF ORC-13661 FOR PHASE II CLINICAL TRIAL
Funded at Irisys, INC. · NIH-11221085 · Data updated 2026-11-12
This study is working on a new way to deliver a medication called ORC-13661, which could help patients by making the treatment more effective, and it will be tested in a clinical trial to ensure it's safe and works well.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Irisys, INC. NIH-funded |
| Lab location | 1 site (San Diego, United States) |
| Project start | September 28, 2022 |
| Project end | July 31, 2027 |
| Funding year | 2024 |
| Award (this year) | $180,000 |
| NIH project number | 271201700020I-P00001-759502200001-1 |
| Project ID | NIH-11221085 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research would be individuals who are eligible for participation in Phase II clinical trials of ORC-13661.
✕Less likely to help
Patients who do not meet the eligibility criteria for the Phase II clinical trial may not receive any benefit from this research.
What this research studies
This research focuses on creating and testing a new dosage form of the medication ORC-13661, which is intended for use in a Phase II clinical trial. The project involves developing the formulation, manufacturing it, and conducting stability studies to ensure the medication remains effective over time. Patients may benefit from this research as it aims to improve the delivery and effectiveness of a new treatment option. The research will follow strict protocols to ensure safety and efficacy during the trial phase.
Why it matters
Potential benefit: If successful, this research could lead to a more effective medication formulation that improves patient outcomes.
How similar studies have gone: Similar research efforts in dosage form development have shown promise in improving medication efficacy and patient outcomes.
Where this research is happening
-
Irisys, INC.
San Diego, United States Active
Researchers
- Principal investigator: Bourque, Tim — Irisys, INC.
- Study coordinator: Bourque, Tim
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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.