Alpha Tau Medical (DRTS) FDA Approvals

Alpha Tau Medical's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Alpha Tau Medical (DRTS). Over the past two years, Alpha Tau Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Alpha. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Alpha DaRT FDA Regulatory Timeline and Events

Alpha DaRT is a drug developed by Alpha Tau Medical for the following indication: Prostate cancer. 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.

Groundbreaking update - May 11,2026

• Drug: Alpha DaRT
• Announced Date: May 11, 2026
• Indication: Prostate cancer

Alpha Tau Medical Ltd. announced groundbreaking interim data from its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM), also known as the REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial.

Alpha Tau Medical announced interim results from the REGAIN U.S. trial of Alpha DaRT for recurrent glioblastoma. In the first three patients treated at The Ohio State University Comprehensive Cancer Center, two achieved complete responses with total disappearance of all enhancing tumor lesions on multiple MRI scans. One grade 3 serious adverse event was reported but has since resolved. The procedures were performed by a multidisciplinary team led by principal investigator Joshua D. Palmer, MD, with medical physicist Michael Degnan, MS, DABR, and neurosurgeon J. Bradley Elder, MD, using a novel intracranial delivery approach designed by Alpha Tau.

The REGAIN study is a prospective, open-label, single-arm trial evaluating the feasibility and safety of Alpha DaRT for recurrent GBM. The company noted that glioblastoma is highly aggressive and treatment-resistant, with an average survival of about eight months per the National Brain Tumor Society. Alpha Tau will hold a conference call with Dr. Palmer and management on May 11, 2026, at 8:30 am ET to discuss the data.

Enrollment Update - May 8,2026

• Drug: Alpha DaRT
• Announced Date: May 8, 2026
• Indication: Prostate cancer

Alpha Tau Medical Ltd. announced the completion of enrollment in its ReSTART pivotal trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), a U.S. multicenter study evaluating the efficacy and safety of intratumoral Alpha DaRT for the treatment of patients with recurrent cutaneous squamous cell carcinoma (cSCC).

Alpha Tau Medical Ltd. completed enrollment of 88 patients in ReSTART, a U.S. multicenter pivotal trial testing intratumoral Alpha DaRT for recurrent cutaneous squamous cell carcinoma (cSCC). Completion shifts the study from recruitment to patient follow-up and data maturation, a key step toward assessing safety and effectiveness.

Alpha DaRT inserts short-lived alpha-emitting sources directly into tumors. The particles act over very short distances, aiming to destroy cancer cells while sparing nearby healthy tissue. A pivotal trial is designed to provide the definitive clinical evidence regulators rely on.

ReSTART builds on earlier skin cancer studies in Israel, Italy, France and the U.S. cSCC is the second most common skin cancer and is harder to treat when surgery and standard therapies fail. Alpha Tau, founded in 2016, focuses on developing Alpha DaRT for solid tumors and will now follow patients and analyze outcomes.

Presentation - May 4,2026

• Drug: Alpha DaRT
• Announced Date: May 4, 2026
• Indication: Prostate cancer

Alpha Tau Medical Ltd. announced the presentation of updated pooled results from two first-in-human clinical trials of Alpha DaRT in pancreatic ductal adenocarcinoma (PDAC) at Digestive Disease Week (DDW) 2026, the world's premier international gastroenterology conference.

Alpha Tau Medical Ltd. presented pooled results from two first-in-human trials of Alpha DaRT in pancreatic ductal adenocarcinoma (PDAC) at Digestive Disease Week (DDW) 2026. The oral presentation marked the therapy’s first showing at a leading international gastroenterology conference.

The pooled analysis showed a 100% local disease control rate in evaluable patients. Safety was favorable: among 26 treated subjects there were eight device-related adverse events in seven patients (27%), and all but one case (lingering fatigue) resolved within two weeks. Patients were highly heterogeneous and heavily pre-treated, including some ineligible for chemotherapy and others who had received up to four prior lines.

Alpha DaRT is delivered via a streamlined outpatient endoscopic ultrasound (EUS)-guided procedure designed to fit standard GI endoscopy workflows. These initial human results suggest potential for patients with limited options and support further clinical study.

Provided Update - April 27,2026

• Drug: Alpha DaRT
• Announced Date: April 27, 2026
• Indication: Prostate cancer

Alpha Tau Medical Ltd announced that an abstract entitled "Combined Safety and Efficacy Results from Three Clinical Studies Evaluating Alpha Radiotherapy for Advanced Pancreatic Cancer" has been accepted at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 - June 2, 2026. .

Alpha Tau Medical Ltd. announced that an abstract titled "Combined Safety and Efficacy Results from Three Clinical Studies Evaluating Alpha Radiotherapy for Advanced Pancreatic Cancer" was accepted for presentation at the 2026 ASCO Annual Meeting, May 29–June 2, 2026. The pooled analysis reports safety and efficacy data from 58 patients enrolled in three prospective clinical studies conducted at centers in Canada and Israel. The abstract will be posted on the ASCO conference website on May 21, 2026 at 5:00 PM ET.

The acceptance follows Alpha Tau presentations this year at the ASCO Gastrointestinal Cancers Symposium and Digestive Disease Week, signaling growing scientific interest in the company’s pancreatic cancer data. Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is an intratumoral alpha-emitter approach designed to deliver highly localized radiation to tumors while sparing nearby healthy tissue. Alpha Tau is developing this technology for the treatment of solid tumors.

Provided Update - April 23,2026

• Drug: Alpha DaRT
• Announced Date: April 23, 2026
• Indication: Prostate cancer

Alpha Tau Medical Ltd announced the successful treatment of the first patient in ACAPELLA (Alpha DaRT for CAncer of the PancrEas in Locally advanced Adenocarcinoma), the Company's European multicenter clinical trial evaluating Alpha DaRT combined with capecitabine for patients with inoperable locally advanced pancreatic ductal adenocarcinoma (LAPC) who have completed first-line mFOLFIRINOX chemotherapy..

Alpha Tau Medical Ltd announced the successful treatment of the first patient in ACAPELLA, its European multicenter trial testing Alpha DaRT combined with capecitabine for people with inoperable, locally advanced pancreatic ductal adenocarcinoma (LAPC) who have completed first-line mFOLFIRINOX chemotherapy. Alpha DaRT delivers short-range alpha radiation from tiny radioactive sources implanted directly into the tumor using a minimally invasive technique. In ACAPELLA, Alpha DaRT is being given alongside oral capecitabine to see if the combination can better control tumors that cannot be removed by surgery.

This first treatment marks the start of enrollment activity in the trial and is an early step toward evaluating safety, tolerability, and initial signals of effectiveness. The study is part of Alpha Tau’s broader effort to develop new local therapies for pancreatic cancer, a disease with limited treatment options and high unmet need. Follow-up will monitor tumor response and side effects over time.

Abstract - March 31,2026

• Drug: Alpha DaRT
• Announced Date: March 31, 2026
• Indication: Prostate cancer

Alpha Tau Medical Ltd. announced that an abstract presenting results of two clinical trials in Jerusalem in patients with pancreatic cancer has been accepted for an oral presentation at Digestive Disease Week (DDW) 2026, the world's premier international gastroenterology conference.

Alpha Tau Medical Ltd. announced that an abstract reporting results from two clinical trials in Jerusalem in patients with pancreatic cancer has been accepted for an oral presentation at Digestive Disease Week (DDW) 2026. The acceptance means the company's data will be shared in a main session at the global gastroenterology meeting May 2–5, 2026. The trials evaluated Alpha DaRT, Alpha Tau's targeted radiotherapy technology for solid tumors, and the oral slot suggests the findings are notable for clinicians and researchers.

Alpha Tau, founded in 2016 in Israel, develops Alpha DaRT, which uses radioactive sources to treat tumors. Presenting at DDW gives the company exposure to specialists in gastroenterology, oncology and surgery and may help inform clinical practice and future research for pancreatic cancer — a disease with limited treatment options. Details of the trial outcomes will be revealed at the DDW presentation.

Results - January 6,2026

• Drug: Alpha DaRT
• Announced Date: January 6, 2026
• Indication: Prostate cancer

Alpha Tau Medical Ltd announced the release of final results from its first-in-human pancreatic cancer study in Montreal, Canada exploring the use of Alpha DaRT in treating pancreatic ductal adenocarcinoma (PDAC).

Alpha Tau Medical released final results from its first-in-human pancreatic cancer study in Montreal testing Alpha DaRT for pancreatic ductal adenocarcinoma (PDAC). In 32 patients (stage II–IV, many previously treated), Alpha DaRT delivered by endoscopic ultrasound was feasible and well tolerated. The trial showed a 22% objective response rate (ORR) and an 81% disease control rate (DCR); excluding the first two low-dose safety patients, ORR was 23% and DCR 87%. Results are published as abstracts and will be presented at the 2026 ASCO Gastrointestinal Cancers Symposium.

In 23 patients with complete lab data, investigators saw no significant change one month after treatment in neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, CD4/CD8 T-cell ratio, or C-reactive protein, suggesting immune preservation versus typical radiation. IL-6 levels dropped dramatically (p<0.000001), indicating a possible anti-inflammatory effect. Alpha DaRT is now being studied with first-line chemotherapy in the U.S. multi-center IMPACT pilot trial (NCT06698458) for newly diagnosed unresectable or metastatic pancreatic cancer.

Provided Update - January 5,2026

• Drug: Alpha DaRT
• Announced Date: January 5, 2026
• Indication: Prostate cancer

Alpha Tau Medical Ltd. announced the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA's previous decision to allow the Company to use the more flexible modular approach.

Alpha Tau Medical announced it submitted the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration for Alpha DaRT, its alpha-radiation therapy. The application seeks approval for treating recurrent cutaneous squamous cell carcinoma in patients who cannot have surgery or standard radiation and who have no curative systemic options. This initial module focuses on the required non-clinical study documentation.

The FDA allowed Alpha Tau to use a modular PMA framework, which lets the company submit sections of the application over time. Alpha Tau says this flexible approach can enable ongoing FDA review and earlier feedback on each module, potentially speeding and clarifying the path toward authorization.

The module was filed while Alpha Tau is running its ReSTART pivotal trial for recurrent cSCC. The company expects to finish recruiting patients for that study in the first quarter of 2026.

FDA approved - December 2,2025

• Drug: Alpha DaRT
• Announced Date: December 2, 2025
• Indication: Prostate cancer

Alpha Tau Medical Ltd. announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with locally recurrent prostate cancer using the Company's Alpha DaRT technology.

Alpha Tau Medical announced that the FDA has approved an Investigational Device Exemption (IDE) to start a U.S. pilot study using its Alpha DaRT technology to treat patients with locally recurrent prostate cancer. The company said the study will test Alpha DaRT as a focused local salvage therapy that could be an alternative to systemic androgen deprivation therapy.

The trial plans to enroll up to 12 U.S. patients who have biochemical recurrence by the Phoenix definition (a PSA rise of 2 ng/mL from the PSA nadir). The primary goal is to evaluate safety, and secondary goals include assessing efficacy by biochemical and clinical measures of disease progression and overall survival.

Alpha DaRT delivers radium-224–impregnated sources directly into tumors. Short-lived decay products emit high-energy alpha particles over very short distances, aiming to destroy tumor cells while limiting damage to nearby healthy tissue.

FDA Approval - April 2,2025

• Drug: Alpha DaRT
• Announced Date: April 2, 2025
• Indication: Prostate cancer

Alpha Tau Medical Ltd. announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with recurrent glioblastoma (GBM) using the Alpha DaRT technology.

Alpha Tau Medical Ltd. announced that the FDA has approved an Investigational Device Exemption (IDE) for a pilot study using its Alpha DaRT technology to treat patients with recurrent glioblastoma, an aggressive type of brain cancer. This new approach is aimed at patients whose tumors are not suitable for surgery and who have already received central nervous system radiation. The IDE approval enables the clinical trial to enroll up to ten U.S. patients and will focus on assessing the feasibility and safety of implanting the Alpha DaRT sources directly into the tumor.

The Alpha DaRT method works by delivering radium-224 inside the tumor, allowing its decay to release high-energy alpha particles that target cancer cells while sparing healthy tissue. This pilot study marks an important step toward offering a new treatment option for patients facing the poor survival outcomes associated with recurrent glioblastoma.

FDA Approval - February 3,2025

IDE Application

• Drug: Alpha DaRT
• Announced Date: February 3, 2025
• Indication: Prostate cancer

Alpha Tau Medical Ltd announced an approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) supplement to the IDE previously announced on Jan 27, 2025, which had approved a clinical study examining the combination of Alpha DaRT and first-line chemotherapy in 12 patients with newly diagnosed metastatic pancreatic cancer, allowing expansion of the clinical trial to a broader group of pancreatic cancer patients.

Alpha Tau Medical Ltd recently announced that the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplement. This supplement allows the company to expand its clinical trial for treating pancreatic cancer by combining its alpha-radiation therapy, Alpha DaRT®, with first-line chemotherapy. Originally, the clinical study focused on 12 patients with newly diagnosed metastatic pancreatic cancer. With the new FDA approval, the trial will now include an additional cohort of patients with locally advanced pancreatic cancer. Each cohort will be increased to 15 patients, resulting in a total of 30 patients across up to 10 U.S. clinical trial sites. This expansion brings Alpha Tau one step closer to studying the potential benefits of its innovative treatment across a broader range of pancreatic cancer patients.

Provided Update - October 10,2024

• Drug: Alpha DaRT
• Announced Date: October 10, 2024
• Indication: Prostate cancer

Alpha Tau Medical Ltd. announced that its first patient with recurrent lung cancer has been treated, in a clinical trial at Hadassah Medical Center in Jerusalem, Israel.

Alpha Tau Medical Ltd. announced a major breakthrough in lung cancer treatment. The company treated its first patient with recurrent lung cancer as part of a clinical trial at Hadassah Medical Center in Jerusalem, Israel. This trial focuses on patients with recurrent tumors in the mediastinum, the area between the lungs. It aims to evaluate the safety and feasibility of using Alpha Tau’s innovative alpha-radiation therapy, Alpha DaRT®, delivered via an endobronchial ultrasound (EBUS) procedure. The study will monitor successful placement of the radioactive sources, track any treatment-related adverse events, and assess tumor response over time. This approach combines precision targeted therapy that may reduce damage to surrounding healthy tissues. Researchers are hopeful that this new method could offer a promising treatment option for lung cancer patients with limited alternatives, paving the way for further exploration of alpha-radiation therapies in challenging cancer cases.

FDA Approval - September 20,2024

IDE Application

• Drug: Alpha DaRT
• Announced Date: September 20, 2024
• Indication: Prostate cancer

Alpha Tau Medical Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application to initiate a multi-center study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients using the Alpha DaRT.

Alpha Tau Medical Ltd. has announced that the FDA has approved an Investigational Device Exemption (IDE) application for a new multi-center study. This study will investigate the use of their innovative Alpha DaRT treatment for recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients. Led by the Winship Cancer Institute of Emory University, the trial plans to enroll up to 28 patients across eight U.S. institutions. The study will focus on patients who have recurrent cSCC and weakened immune systems due to conditions other than diabetes.

The primary goal is to evaluate the treatment’s effectiveness by measuring the objective response rate, while also observing progression-free survival, overall survival, and local tumor control over twelve months. This initiative aims to provide a new treatment option for a vulnerable patient group with limited alternatives.