This section highlights FDA-related milestones and regulatory updates for drugs developed by Radiopharm Theranostics (RADX).
Over the past two years, Radiopharm Theranostics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
177Lu-RAD20, 18F-RAD101, RAD, and RV-01. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
177Lu-RAD20 FDA Regulatory Events
177Lu-RAD20 is a drug developed by Radiopharm Theranostics for the following indication: In patients with PD-L1 positive advanced cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 177Lu-RAD20
- Announced Date:
- May 12, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- In patients with PD-L1 positive advanced cancers
Announcement
Radiopharm Theranostics announced that On track to complete the enrollment of the first two cohorts by mid-2025
AI Summary
Radiopharm Theranostics announced a promising update on its Phase 1 clinical trial for the radiotherapeutic asset 177Lu-RAD204, aimed at treating PD-L1 positive advanced cancers. The independent Data and Safety Monitoring Committee confirmed positive safety, pharmacokinetic, and biodistribution data from the first cohort, allowing the trial to proceed without modifications. With this approval, the study will now progress to a higher dose cohort, increasing the starting dose from 40 mCi to 60 mCi for the next group of patients.
The company stated it is on track to complete the enrollment of the first two cohorts by mid-2025. This accelerated timeline, along with the expansion into multiple tumor types, could improve clinical outcomes for patients by offering new treatment options in areas with high unmet medical needs.
Read Announcement- Drug:
- 177Lu-RAD20
- Announced Date:
- May 12, 2025
- Indication:
- In patients with PD-L1 positive advanced cancers
Announcement
Radiopharm Theranostics announced that it has achieved a key milestone in its ongoing clinical development program for its clinical-stage radiotherapeutic asset, 177Lu-RAD204, as the Data and Safety Monitoring Committee (DSMC) has approved to proceed to the next dose in its Phase 1 clinical trial in patients with PD-L1 positive advanced cancers1.
AI Summary
Radiopharm Theranostics has reached a major milestone in the development of its radiotherapeutic asset, 177Lu-RAD204. The company announced that the independent Data and Safety Monitoring Committee (DSMC) approved moving to the next dose level in its Phase 1 clinical trial for patients with PD-L1 positive advanced cancers. After reviewing data from the first cohort of four patients treated at 30mCi, the DSMC found the safety, pharmacokinetics, and biodistribution results positive and recommended continuing the study without any modifications.
With this approval, the trial will progress to a higher dose cohort at 60mCi, replacing the previously assumed 40mCi. This change supports expanding enrollment across various tumor types and additional active centers. Radiopharm Theranostics now expects to complete the enrollment of the next cohort by mid-2025, marking another step forward in potentially offering better treatment outcomes for patients with advanced cancers.
Read Announcement
18F-RAD101 FDA Regulatory Events
18F-RAD101 is a drug developed by Radiopharm Theranostics for the following indication: in suspected recurrent brain metastasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 18F-RAD101
- Announced Date:
- April 28, 2025
- Indication:
- in suspected recurrent brain metastasis.
Announcement
Radiopharm Theranostics nnounced the dosing of the first patient in its U.S. Phase 2b imaging study of 18F-RAD101 in suspected recurrent brain metastasis.
AI Summary
Radiopharm Theranostics has dosed the first patient in its U.S. Phase 2b imaging study of 18F-RAD101, a novel diagnostic agent designed to detect suspected recurrent brain metastases. The multicenter, open-label trial will enroll 30 patients with confirmed recurrent brain metastases from various solid tumors. The study’s primary objective is to compare the detection results of 18F-RAD101 with those of conventional imaging using MRI with gadolinium, aiming to improve diagnostic accuracy. 18F-RAD101 targets fatty acid synthase—an enzyme overexpressed in many tumors—allowing for more precise identification of cancer cells. This early step in clinical testing could lead to a more reliable way to distinguish between tumor recurrence and treatment effects like radiation injury, potentially paving the way for more individualized and effective treatment decisions for patients suffering from brain metastases.
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RAD 101 FDA Regulatory Events
RAD 101 is a drug developed by Radiopharm Theranostics for the following indication: For for successful detection of brain metastases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RAD 101
- Announced Date:
- June 11, 2025
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease.
AI Summary
Radiopharm Theranostics announced that the FDA has granted Fast Track Designation for its novel imaging agent, RAD101. This special status is intended to speed up the development and review of the drug, which is designed to distinguish between recurrent brain metastases and treatment effects, such as those seen from radiation therapy. RAD101 targets fatty acid synthase (FASN), an enzyme often overexpressed in various solid tumors, including those that spread to the brain and cause leptomeningeal disease.
The FDA’s decision recognizes the critical need for improved diagnostic tools to better differentiate true tumor recurrence from treatment-related changes. With over 300,000 patients diagnosed with brain metastases each year in the U.S., RAD101 promises to enhance clinical decision-making and patient outcomes by providing more precise imaging results. The company is advancing Phase 2 clinical trials to further evaluate RAD101’s effectiveness.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- February 10, 2025
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics announce the publication of a novel imaging approach demonstrating proof-of-concept for the use of RAD 101 for successful detection of brain metastases (both treatment-naïve and previously treated) from a variety of primary solid tumors.
AI Summary
Radiopharm Theranostics announced the publication of a novel imaging approach using RAD 101 (18F-Pivalate) to detect brain metastases. The clinical study, published in the European Journal of Nuclear Medicine and Molecular Imaging, demonstrated proof-of-concept for RAD 101’s ability to successfully detect brain metastases. A total of 22 patients were included, with both treatment-naïve and previously treated metastases from a variety of solid tumors being accurately identified. The study showed that RAD 101, used as part of a hybrid PET-mpMRI technique, provided a high tumor-to-background ratio, enhancing the visibility of the metastases. This promising imaging approach leverages the radiotracer's targeting of fatty acid metabolism—a process upregulated in many cancers—and may improve early and precise diagnosis of brain metastases.
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RV-01 FDA Regulatory Events
RV-01 is a drug developed by Radiopharm Theranostics for the following indication: For the 4Ig isoform.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RV-01
- Announced Date:
- July 28, 2025
- Indication:
- For the 4Ig isoform
Announcement
Radiopharm Theranostics announced that the U.S. Food and Drug Administration (FDA) has provided clearance of the Company's Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues.
AI Summary
Radiopharm Theranostics announced that the FDA cleared its IND for Betabart, RV-01, a Lu177-B7H3 monoclonal antibody engineered to bind the 4Ig isoform of B7-H3, which is overexpressed in tumors, sparing healthy tissue.
This first-in-class radiopharmaceutical is set to begin a Phase 1 study in solid tumors in late 2025. CEO Riccardo Canevari called it a major milestone for Radiopharm and MD Anderson and plans to dose patients later this year.
Preclinical data showed RV-01 clears through the liver, giving the isotope time to target tumors while reducing toxicity. Because antibodies are processed by the liver, this route may lower side effects compared to kidney-cleared therapies.
RV-01’s selectivity for the 4Ig B7-H3 helps it ignore the 2Ig version, boosting tumor binding and reducing immune complex formation. Targeting this immune checkpoint, linked to aggressive cancers, may offer an option for resistant tumors.
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