SYDNEY, April 16, 2026

Radiopharmaceutical innovation continues to reshape oncology diagnostics as Radiopharm Theranostics announced completion of enrollment in its U.S. Phase 2b clinical trial of RAD101, a novel imaging agent designed to improve detection of brain metastases. The milestone marks a significant step toward addressing a major unmet need in cancer diagnostics, with primary endpoint data expected in June 2026 and plans already underway for a pivotal Phase 3 trial.

Clinical Milestone Strengthens Diagnostic Pipeline

The completion of patient enrollment represents a critical advancement in the company’s clinical-stage radiopharmaceutical pipeline, particularly in the field of oncology imaging. The Phase 2b trial is a multicenter, open-label study evaluating the diagnostic performance of 18F-RAD101 in patients with confirmed recurrent brain metastases originating from various solid tumors.

Interim findings have already demonstrated approximately 90% concordance with MRI, the current gold standard for detecting brain metastases. This high level of agreement highlights the potential of RAD101 to serve as a complementary or superior diagnostic tool, especially in complex clinical scenarios where MRI results may be ambiguous.

Importantly, the trial focuses on distinguishing between tumor recurrence and treatment-related effects, a long-standing challenge in neuro-oncology. Accurate differentiation is essential for guiding treatment decisions and avoiding unnecessary interventions. The company has emphasized that successful completion of this study could significantly enhance clinical decision-making and patient management.

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Innovative Mechanism Targets Tumor Metabolism

RAD101 is a first-in-class radiopharmaceutical imaging agent that targets fatty acid synthase (FASN), an enzyme overexpressed in many solid tumors, including brain metastases. By leveraging tumor metabolism, RAD101 enables highly specific visualization of cancer cells, offering a novel approach beyond traditional anatomical imaging.

This mechanism provides a functional imaging advantage, allowing clinicians to detect active tumor biology rather than relying solely on structural changes. Such capability is particularly valuable in cases where standard imaging techniques, including contrast-enhanced MRI, may struggle to differentiate between viable tumor tissue and post-treatment changes.

The agent has also received FDA Fast Track designation, underscoring its potential to address a critical unmet medical need. This designation facilitates closer regulatory interaction and may accelerate development timelines, positioning RAD101 as a promising candidate in the evolving field of precision oncology diagnostics.

Addressing a Growing Clinical Burden

Brain metastases remain a significant global health challenge, with over 300,000 cases diagnosed annually in the United States alone. Advances in systemic cancer therapies have extended patient survival,but have also increased the incidence of intracranial metastatic disease, creating a growing demand for more accurate diagnostic tools.

Current imaging modalities, while effective, have limitations in follow-up surveillance and treatment monitoring, often leading to uncertainty in clinical interpretation. RAD101 aims to overcome these limitations by providing enhanced sensitivity and specificity, enabling earlier detection and more precise assessment of disease progression.

The successful completion of this trial positions Radiopharm Theranostics to engage with regulators and define the optimal pathway toward commercialization. With a pipeline that includes multiple Phase 1 and Phase 2 programs across solid tumors, the company continues to expand its role in advancing radiopharmaceutical innovation.

The RAD101 Phase 2b trial milestone highlights the growing importance of radiopharmaceutical diagnostics in oncology, combining molecular targeting with clinical precision. As the healthcare industry moves toward personalized medicine and advanced imaging technologies, innovations like RAD101 are expected to play a crucial role in improving outcomes for patients with complex cancers such as brain metastases.

Source: Radiopharmaceuticals press release