SPECT/CT Agent Garners FDA Fast Track Designation for Inflammation Assessment in Interstitial Lung Disease

The Food and Drug Administration (FDA) has granted a fast track designation for the SPECT/CT agent^99mTc-maraciclatide for imaging of inflammation in people with known or suspected interstitial lung disease (ILD).

Noting the challenges with ILD, which is associated with well over 100 different disorders, Serac Healthcare, the developer of ^99mTc-maraciclatide, said the agent may improve early differentiation between inflammation and fibrosis, facilitating more effective management of the disease.

In preliminary study findings presented at the European Respiratory Society conference in September 2025, researchers found that ^99mTc-maraciclatide offered higher SUVmean and target to background ratios for patients with idiopathic pulmonary fibrosis (IPF) and fibrotic hypersensitivity pneumonitis (FHP) in comparison to healthy controls.

“These initial findings demonstrate great promise for maraciclatide in this new patient population. The ability to image angiogenesis, which is a key feature of inflammation,could help physicians to distinguish between early-stage inflammation and the ensuing fibrosis in order to determine the most appropriate treatment for each individual,” said Michael Gibbons, M.D., a professor and senior investigator fellow at the NIHR Exeter Biomedical Research Center in Exeter, England, and a consultant respiratory physician at the Royal Devon University Healthcare NHS Foundation Trust.

“The FDA's fast track designation of maraciclatide signals the imperative for improved ILD diagnosis, assessment, and monitoring. … A non-invasive imaging solution capable of distinguishing inflammation and fibrosis predominant ILD has the potential to meaningfully advance early diagnosis, change the treatment paradigm and improve patient outcomes,” noted David Hail, the chief executive officer of Serac Healthcare.

(Editor’s note: For related content, see “Emerging SPECT/CT Agent Gets FDA Fast Track Designation for Superficial Peritoneal Endometriosis,” “What New Lung MRI Research Reveals About Post-COVID-19 Conditions in Children” and “FDA Clears CT-Based AI Software for Enhanced Detection of Usual Interstitial Pneumonia.”)