ARK001 topical treatment for infantile hemangioma
Official title: Clinical Development of ARK001 Formulation as a Targeted Therapeutic for InfantileHemangioma
Funded at Arkayli Biopharma, INC. · NIH-11314245 · Data updated 2026-11-12
A new skin gel called ARK001 is being tested to safely treat infantile hemangioma in babies by delivering medicine directly to the skin.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Arkayli Biopharma, INC. NIH-funded |
| Lab location | 1 site (Tracys Landing, UNITED STATES) |
| Project start | September 20, 2026 |
| Project end | July 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $999,904 |
| NIH project number | 1R44HL184627-01 |
| Project ID | NIH-11314245 on NIH RePORTER |
Who could benefit from this research
✓Could help
Infants diagnosed with infantile hemangioma, including preterm infants, who require treatment.
✕Less likely to help
Infants with IH not requiring therapy or those who cannot tolerate topical medications may not benefit.
What this research studies
Infantile hemangioma is a common skin tumor in babies that can scar the skin. This project tests a topical gel version of esmolol to limit systemic side effects while aiming to shrink the lesion locally. The plan includes early-stage safety testing and brief look at preliminary signs of effectiveness in infants, with preclinical work supporting safety. If successful, this could provide a safer local treatment to reduce skin damage without widespread drug exposure.
Why it matters
Potential benefit: If successful, ARK001 could offer a safer, effective option to treat infantile hemangioma with fewer systemic side effects.
How similar studies have gone: Previous beta-blocker therapies for IH have systemic risks, and topical approaches like ARK001 aim to reduce these risks while preserving effectiveness.
Where this research is happening
-
Arkayli Biopharma, INC.
Tracys Landing, United States Active
Researchers
- Principal investigator: Macfarlane, Kathryn — Arkayli Biopharma, INC.
- Study coordinator: Macfarlane, Kathryn
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.