Initiation of API and Drug Product NDA Registration Path and Manufacturing for an Arenavirus Therapy
Official title: Initiation of ARN-75039 API and Drug Product NDA Registration Path and Manufacturing of Phase 3 final Drug Product
Funded at Arisan Therapeutics, INC. · NIH-11283988 · Data updated 2026-11-12
A new antiviral drug for arenavirus infections is being prepared for potential regulatory approval and manufacturing at scale.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Arisan Therapeutics, INC. NIH-funded |
| Lab location | 1 site (Carlsbad, UNITED STATES) |
| Project start | February 10, 2014 |
| Project end | February 28, 2027 |
| Funding year | 2026 |
| Award (this year) | $1,000,000 |
| NIH project number | 5SB1AI112097-10 |
| Project ID | NIH-11283988 on NIH RePORTER |
Who could benefit from this research
✓Could help
Patients with arenavirus infections or those at high risk of exposure in affected regions may ultimately benefit if the therapy reaches the market.
✕Less likely to help
Patients without arenavirus infection or exposure may not directly benefit unless the drug is later approved for broader use.
What this research studies
This grant focuses on moving a promising antiviral compound through the early steps of drug registration and large-scale production. It covers validating manufacturing processes, ensuring consistent quality, and producing the initial drug substance and final product for potential regulatory submission. The work aims to enable reliable, scalable access to an inhaled/tablet-formulated treatment that could help patients facing arenavirus infections in regions with high burden. Collaboration with ARISAN THERAPEUTICS, INC. will drive practical steps toward making the medicine available if trials and approvals proceed.
Why it matters
Potential benefit: If successful, patients could gain access to a validated antiviral therapy with a clear path toward regulatory approval and dependable manufacturing.
How similar studies have gone: Prior antivirals with clear manufacturing paths have advanced to registration; this project pursues a parallel early registration strategy for a category A arenavirus drug.
Where this research is happening
-
Arisan Therapeutics, INC.
Carlsbad, United States Active
Researchers
- Principal investigator: Sokolova, Nadezda V — Arisan Therapeutics, INC.
- Study coordinator: Sokolova, Nadezda V
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.