LONDON, Feb. 12, 2026 /PRNewswire/ — Serac Healthcare Limited, a clinical radiopharmaceutical company developing an innovative molecular imaging agent, announced today that the US Food and Drug Administration (FDA) has granted Fast Track Designation to 99mTc-maraciclatide as a diagnostic SPECT-CT agent for the “visualization of inflammation in the lungs of patients with known and suspected interstitial lung disease (ILD).”
Fast track is a process designed to facilitate the development and expedite the review of drugs to treat (or in our case, diagnose) serious conditions and fill an unmet medical need. Criteria include improving the diagnosis of a serious condition where early diagnosis results in an improved outcome.
ILD is a life-threatening condition encompassing over 200 disorders affecting lung function, characterized by progressive inflammation, fibrosis, and reduced quality of life. Accurate, early differentiation between inflammation and fibrosis is critical to guiding treatment decisions, predicting disease outcomes, and monitoring therapy response, yet this is currently very difficult or impossible to assess.
The benefits of Fast Track designation, which are intended to reduce the time to approval in the US and enable faster access for patients, include:
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
- More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
- More frequent written communication from FDA about such things as the design of the proposed clinical trials
- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.
David Hail, Chief Executive Officer of Serac Healthcare, said:
“The FDA’s Fast Track designation of maraciclatide signals the imperative for improved ILD diagnosis, assessment, and monitoring. ILD symptoms are non-specific and often present late in disease progression, making early detection extremely difficult. While symptom management therapies are available, including powerful anti-inflammatory agents, inappropriate administration can prove more detrimental than beneficial. 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.”
About 99mTc-maraciclatide
99mTc-maraciclatide is a radio-labelled tracer which binds with high affinity to αvβ3 integrin, a cell-adhesion molecule which is up-regulated in vascular endothelial cells during angiogenesis, a key biological process that occurs during inflammation.
Phase II preliminary data from the PRospective Evaluation of Interstitial Lung Disease progression with quantitative CT (PREDICT-ILD)’ trial have demonstrated that visualisation of inflammation in people with fibrotic-ILD could be feasible with 99mTc-maraciclatide. Further clinical results will be published later this year.
Maraciclatide is for investigational use only and is not approved by the FDA or UK and European regulatory authorities.
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SOURCE Serac Healthcare
