Inventera succeeds in phase 3 trial of MRA contrast agent; plans to apply for marketing approval

Inventera announced on the 21st that it achieved the primary efficacy endpoint in a domestic phase 3 clinical trial of INV-002 (NEMO-103 injection), a contrast agent specialized for magnetic resonance arthrography (MRA).

Inventera said that it had received the final clinical study report (CSR) for the phase 3 clinical trial, which was conducted with approval from the Ministry of Food and Drug Safety, from the contract research organization through the electronic disclosure system (DART) that day.

The clinical trial compared the quality of images obtained after administration of NEMO-103 injection with that of noncontrast MRI in patients with known or suspected shoulder joint disease who required MR arthrography. The trial was conducted in 85 patients at eight institutions, including Seoul National University Bundang Hospital.

The primary endpoint comprised three quality measures—joint distention, contrast and sharpness—assessed by independent central readers. The analysis showed that MR arthrography performed 30 to 60 minutes after administration of NEMO-103 injection demonstrated statistically significant improvement in all measures compared with noncontrast MRI.

Specifically, the change in joint distention was 1.6±0.67 points, while contrast and sharpness were 1.1±0.26 points and 1.1±0.50 points, respectively. The p value was less than 0.0001 for all three measures.

Based on the results, the company plans to apply to the Ministry of Food and Drug Safety for marketing approval (NDA). The clinical trial period was from September 23, 2025, to April 21, 2026.