Shorla Oncology Receives FDA Orphan Drug Designation for SH-110 to Treat Glioma

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Sharon Cunningham

CAMBRIDGE– Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced that the U.S. Food and Drug Administration has granted orphan drug designation for SH-110, a liquid oral treatment designed for patients with glioma, a rare and aggressive brain cancer.

SH-110 is a palatable oral suspension aimed at patients who struggle with dysphagia, or difficulty swallowing—an issue that affects many individuals with glioma. Until now, patients often had to rely on compounded formulations or manually open capsules, exposing themselves and caregivers to unnecessary risk and inconvenience. SH-110 offers a safer, more convenient alternative in a ready-to-use liquid form.

“For too long, many patients with Glioma and their pharmacists and caregivers had no other choice but to break open capsules and expose themselves to unnecessary hazards,” said Sharon Cunningham, CEO of Shorla Oncology. “SH-110 is a proprietary product that offers them a safer and more convenient formulation to treat this rare brain cancer.”

The new formulation also offers greater flexibility in dosage preparation and administration settings, potentially improving adherence and outcomes for patients who might otherwise face barriers to treatment. SH-110 is expected to be especially impactful in hospitals, long-term care facilities, and home care environments.

“This is a difference maker in the lives of those who suffer from Glioma,” said Orlaith Ryan, chief technical officer and co-founder of Shorla. “SH-110 complements our other Shorla treatments that are designed to be easier for patients to use, and for caregivers and providers to administer.”

According to the National Brain Tumor Society, approximately 13,000 adults and 2,000 children in the United States are diagnosed each year with glioma. The FDA’s orphan drug designation is intended to support the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S.

SH-110 joins a growing portfolio of patient-centric oncology treatments developed by Shorla, which focuses on creating accessible, practical therapies for underserved cancer populations.