This section highlights FDA-related milestones and regulatory updates for drugs developed by Actuate Therapeutics (ACTU).
Over the past two years, Actuate Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
elraglusib and FOLFIRINOX. 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.
Elraglusib FDA Regulatory Timeline and Events
Elraglusib is a drug developed by Actuate Therapeutics for the following indication: In relapsed/refractory Ewing Sarcoma (r/r EWS).
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:
- elraglusib
- Announced Date:
- June 24, 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc today highlighted results from a pre-specified subgroup analysis of its Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first-line metastatic pancreatic adenocarcinoma (mPDAC).
AI Summary
Actuate Therapeutics, Inc. recently shared promising results from a pre-specified subgroup analysis of its Phase 2 trial (Actuate-1801 Part 3B) testing elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) for first-line treatment of metastatic pancreatic adenocarcinoma (mPDAC). Patients who completed at least one full cycle (four weeks) of the combination therapy experienced a median overall survival of 12.5 months compared to 8.5 months with GnP alone—a 43% reduction in the risk of death and nearly doubled one-year overall survival rate. Notably, in patients with liver metastases, the combination therapy achieved a 2.5-fold improvement in one-year survival and a 38% reduction in the risk of death compared to GnP alone. These findings suggest that early disease control with elraglusib may offer significant benefits for high-risk mPDAC patients.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- June 20, 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc. announced biomarker data from a recent poster presentation at the American Society of Clinical Oncology (ASCO) annual meeting from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first-line metastatic pancreatic adenocarcinoma (mPDAC).
AI Summary
Actuate Therapeutics recently shared promising biomarker data at the ASCO annual meeting from its Phase 2 Actuate-1801 Part 3B trial. The trial explored elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) as a first-line treatment for metastatic pancreatic adenocarcinoma. Researchers analyzed 40 different plasma biomarkers, including cytokines, chemokines, soluble receptors, and growth factors, collected before treatment. They identified 7 key biomarkers that were significant predictors of enhanced overall survival in patients treated with elraglusib. In particular, a unique finding was that higher levels of CXCL2, which were usually linked to poorer outcomes in the control arm, were actually associated with improved survival when patients received elraglusib. This non-invasive blood test approach using machine learning models shows promise for better predicting which patients may benefit most from this treatment.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- June 2, 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc. announced key takeaways from its Key Opinion Leader (KOL) event held on May 31, 2025 discussing the positive topline results from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
AI Summary
Actuate Therapeutics recently shared key takeaways at its Key Opinion Leader event held on May 31, 2025, highlighting the positive topline results from its Phase 2 Actuate-1801 Part 3B trial. In this study, elraglusib was combined with gemcitabine/nab-paclitaxel (GnP) for previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial met its primary endpoint by increasing median overall survival from 7.2 months to 10.1 months, representing a 37% reduction in the risk of death. Additionally, the 12-month survival rate nearly doubled to 44.1% compared to 22.3% in the GnP alone group. Experts noted elraglusib’s unique immune-modulating mechanism and its favorable safety profile, emphasizing its potential to transform mPDAC treatment and address a significant unmet need in oncology.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- May 31, 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc today presented topline results from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) at the American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Actuate Therapeutics, Inc. announced promising topline results from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial met its primary endpoint by showing a statistically significant increase in median overall survival from 7.2 months with GnP alone to 10.1 months with the elraglusib/GnP combination, marking a 37% reduction in the risk of death (log-rank p=0.01). Additionally, patients receiving the combination treatment achieved a 12-month survival rate of 44.1% compared to 22.3% for GnP alone.
These encouraging results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. The company plans to engage with the FDA in the second half of 2025 to discuss the next steps towards product registration, further supporting the potential of elraglusib as a significant advancement for treating mPDAC.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- May 22, 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc announced the online publication of the abstract accepted as an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to take place May 30-June 3, in Chicago, Illinois.
AI Summary
Actuate Therapeutics, Inc. announced that the abstract for its oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting has been published online. The presentation will be held in Chicago, Illinois from May 30 to June 3, 2025. It will showcase topline data from the Phase 2 Actuate-1801 Part 3B trial, which studied the effects of combining elraglusib with gemcitabine/nab-paclitaxel (GnP) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The data underline statistically significant improvements in median overall survival and a higher 1-year survival rate when compared to GnP alone. Devalingam Mahalingam, MD, PhD, from Northwestern University Feinberg School of Medicine, will present the findings, and the Company will also host a KOL event on May 31, 2025, to further review and discuss the promising results.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- May 7, 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc. announced that it will host an in-person key opinion leader (KOL) event, during the 2025 American Society of Clinical Oncology (ASCO) annual meeting, to discuss the elraglusib topline clinical data from the randomized Phase 2 study (Actuate-1801 Part 3B).
AI Summary
Actuate Therapeutics, Inc. announced it will host an in-person key opinion leader (KOL) event during the 2025 American Society of Clinical Oncology (ASCO) annual meeting. During this fireside discussion, moderated by CEO Daniel Schmitt, four distinguished experts will discuss the topline clinical data from the randomized Phase 2 Actuate-1801 Part 3B trial.
The study focuses on the new drug elraglusib used in combination with gemcitabine/nab-paclitaxel (GnP) for treating first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Experts will share insights into the clinical impact of these findings and explore their potential to change current treatment strategies for pancreatic cancer patients. The event, taking place on Saturday, May 31, 2025 at 6:30 pm CDT in Chicago and Fort Worth, Texas, aims to provide a clearer understanding of how elraglusib may benefit future therapeutic approaches.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- May 6, 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc announced that elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met the primary endpoints and achieved statistical significance in topline results from its ongoing Phase 2 (Actuate-1801 Part 3B) trial in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).
AI Summary
Actuate Therapeutics, Inc. announced promising topline results from its ongoing Phase 2 Actuate-1801 Part 3B trial for metastatic pancreatic ductal adenocarcinoma (mPDAC). The study evaluated elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) as a first-line treatment for mPDAC. The combination treatment met its primary endpoint by showing statistically significant improvements in overall survival compared to the GnP control arm. Notably, patients receiving elraglusib plus GnP experienced a marked boost in median overall survival as well as a higher percentage reaching one-year survival. The trial also demonstrated a favorable risk-benefit profile, indicating the potential of elraglusib to change the treatment landscape for this aggressive cancer. Actuate plans to present the data at the upcoming ASCO Annual Meeting and work with regulators to move the drug forward rapidly toward commercialization.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- April 17, 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc announced that data on elraglusib in advanced salivary gland carcinoma will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL.
AI Summary
Actuate Therapeutics, Inc. announced that new data on its drug elraglusib will be highlighted at the upcoming AACR Annual Meeting 2025. The poster session, focusing on advanced salivary gland carcinoma, will take place at the McCormick Place Convention Center in Chicago, IL, from April 25th to April 30th, 2025. The poster, scheduled for display on April 29th, presents findings on the use of elraglusib—a glycogen synthase kinase 3 beta (GSK-3β) inhibitor—in combination with chemotherapy, with or without immunotherapy, for treating this challenging cancer type. The study focuses on the potential benefits for patients with non-Adenoid Cystic Carcinoma who show nuclear GSK-3β overexpression. This data presentation at AACR underscores ongoing efforts to explore innovative treatments for difficult-to-treat cancers and may offer a new hope for advanced salivary gland carcinoma patients.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- January 7, 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc announced that the European Medicines Agency (EMA) has granted Orphan Medicinal Product Designation (OMPD) to elraglusib, a novel GSK-3β inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC).
AI Summary
Actuate Therapeutics, Inc. announced that the European Medicines Agency (EMA) has granted Orphan Medicinal Product Designation (OMPD) to its new drug candidate, elraglusib. This designation is aimed at treating pancreatic ductal adenocarcinoma (PDAC), a notably aggressive cancer with limited treatment options and a poor prognosis. As a novel inhibitor of glycogen synthase kinase-3 beta (GSK-3β), elraglusib is designed to target pathways that help tumors grow and resist conventional therapies. The orphan designation provides important benefits, such as up to 10 years of market exclusivity in the European Union, a reduction in regulatory fees, and a centralized approval process. Actuate Therapeutics views this milestone as a crucial step in advancing elraglusib through its clinical trials and toward providing a new therapy option for patients battling metastatic pancreatic cancer.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- December 17, 2024
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc announced new positive data from its ongoing and fully enrolled randomized Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) (Actuate-1801 Part 3B).
AI Summary
Actuate Therapeutics announced positive new results from its fully enrolled Phase 2 trial, Actuate-1801 Part 3B, testing elraglusib combined with gemcitabine/nab-paclitaxel (GnP) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). The study reached its primary endpoints with statistically significant improvements in the 1-year survival rate and median overall survival. Specifically, patients receiving the elraglusib/GnP combination saw a 43.6% 1-year survival rate compared to 22.5% with GnP alone, and a 37% reduction in the risk of death, with median overall survival increasing to 9.3 months versus 7.2 months in the control arm.
The favorable risk-benefit profile, higher objective response and disease control rates, and early signs of complete responses in some patients highlight elraglusib’s potential to improve outcomes in mPDAC. Topline data from the trial is expected in the first half of 2025, with plans to engage the FDA regarding next steps including a proposed Phase 3 registration trial.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- September 16, 2024
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc announced data from the safety cohort of an ongoing Phase 2 trial of FOLFIRINOX in combination with elraglusib and losartan for untreated metastatic pancreatic adenocarcinoma at the American Association for Cancer Research (AACR) Special Conference on Advances in Pancreatic Cancer Research taking place on September 15-18, 2024, in Boston, Massachusetts.
AI Summary
Actuate Therapeutics, Inc. shared promising early results from the safety cohort of its ongoing Phase 2 trial combining FOLFIRINOX with elraglusib and losartan for untreated metastatic pancreatic adenocarcinoma. The data was presented during the AACR Special Conference on Advances in Pancreatic Cancer Research in Boston from September 15-18, 2024. Initial findings suggest that elraglusib, a GSK-3β inhibitor, may help overcome chemoresistance caused by FOLFIRINOX, potentially increasing the overall effectiveness of the treatment. Researchers observed early signs of enhanced clinical activity, with some patients showing deep and durable responses, especially those with extensive liver metastases. The trial’s primary goal is to assess the safety, tolerability, and progression-free survival of this combination therapy, offering hope for new strategies to combat metastatic pancreatic cancer if further findings continue to be positive.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- September 11, 2024
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for elraglusib, a novel GSK-3β inhibitor for treatment of soft tissue sarcoma (STS).
AI Summary
Actuate Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) for its novel drug elraglusib, a leading GSK-3β inhibitor, specifically for the treatment of soft tissue sarcoma (STS). This FDA designation is significant because it provides the company with benefits such as tax credits, fee exemptions, and a period of post-approval marketing exclusivity, which can help speed up the development process. Elraglusib has shown promise in early trials by demonstrating a favorable safety profile and antitumor activity in several solid tumors. With over 70 types of soft tissue sarcomas making treatment challenging, this move underscores the potential of elraglusib to address the high unmet medical needs of patients suffering from this rare form of cancer.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- September 9, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Therapeutics, Inc. announced that Enrollment Ongoing with Topline Data Anticipated in 1H 2025
AI Summary
Actuate Therapeutics, Inc. recently updated on its Phase 1/2 clinical trial testing elraglusib in patients with relapsed or refractory Ewing Sarcoma. The study is showing promising results with early signs of anti-tumor activity, including two patients experiencing ongoing complete responses and stabilization of the disease in others. These early findings are important because Ewing Sarcoma is an aggressive cancer with very limited treatment options for patients who have not responded to standard therapies.
The company announced that patient enrollment is ongoing, and it expects to share topline data in the first half of 2025. Actuate plans to meet with the FDA to discuss the design of a phase 2 trial and explore ways to speed up the development process. This update highlights the potential of elraglusib to offer new hope for patients facing this challenging cancer.
Read Announcement- Drug:
- elraglusib
- Announced Date:
- September 9, 2024
- Indication:
- In relapsed/refractory Ewing Sarcoma (r/r EWS).
Announcement
Actuate Th provided an update on its Phase 1/2 trial of elraglusib in relapsed/refractory Ewing Sarcoma (r/r EWS).
AI Summary
Actuate Therapeutics recently provided an update on its Phase 1/2 trial of elraglusib in relapsed/refractory Ewing Sarcoma. Early results from the trial, which uses elraglusib in combination with cyclophosphamide/topotecan, are promising. Among the initial eight patients treated, two continue to have complete responses while two others have achieved stable disease, resulting in a disease control rate of about 62%. These findings are notable considering the high unmet medical need in pediatric patients with relapsed or refractory Ewing Sarcoma, a condition that typically offers few effective treatment options. The study is open-label and multicenter, specifically targeting children and adolescents with these aggressive tumors. Actuate Therapeutics intends to discuss future trial designs with the FDA and plans to expand the study to provide further evidence for advancing elraglusib’s development in this rare cancer population.
Read Announcement
FOLFIRINOX FDA Regulatory Events
FOLFIRINOX is a drug developed by Actuate Therapeutics for the following indication: In Patients with Previously Untreated Metastatic Pancreatic 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.
- Drug:
- FOLFIRINOX
- Announced Date:
- February 25, 2025
- Indication:
- In Patients with Previously Untreated Metastatic Pancreatic Cancer
Announcement
Actuate Therapeutics, Inc announced the completion of patient enrollment in the ongoing Phase 2 trial of FOLFIRINOX in combination with elraglusib and losartan for untreated metastatic pancreatic adenocarcinoma (mPDAC).
AI Summary
Actuate Therapeutics, Inc. announced that patient enrollment is now complete for its ongoing Phase 2 trial. This study is testing a new treatment combination for patients with untreated metastatic pancreatic adenocarcinoma (mPDAC). The trial uses a mix of FOLFIRINOX, elraglusib (an experimental GSK-3β inhibitor), and losartan, aiming to improve treatment outcomes.
The study enrolled 56 patients who had not received prior treatment and is led by Dr. Colin Weekes at Massachusetts General Hospital, with additional contributions from sites at the University of Colorado and Fred Hutchinson Cancer Center. Early data, presented last September at an AACR conference, suggests that adding elraglusib to the treatment regimen may enhance clinical activity against pancreatic cancer. Final trial results are anticipated in 2026 as researchers continue to explore this promising new combination therapy.
Read Announcement
