Actuate Therapeutics receives FDA IND clearance for oral elraglusib programme
Tuesday, May 12, 2026
Actuate Therapeutics, Inc. has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for a Phase 1/2 study of the oral formulation of elraglusib.
The clinical-stage biopharmaceutical company is advancing the oral tablet version of elraglusib to improve patient convenience, expand clinical use and enhance drug exposure across several cancer indications.
The company said its strategy is supported by data from a completed Phase 2 trial in metastatic pancreatic ductal adenocarcinoma (mPDAC), which showed a positive link between higher drug exposure and improved clinical outcomes, including better overall survival.
The planned Phase 1/2 study will compare the oral and intravenous (IV) formulations of elraglusib to determine whether the oral version can achieve higher overall drug exposure. The trial will also assess safety and early signs of efficacy in patients with advanced solid tumours, including metastatic melanoma, non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer.
Actuate said previous clinical studies of the IV formulation and machine learning-based therapeutic target analyses supported the selection of these tumour types.
The company has also been working with the European Medicines Agency on guidance for a potential registration study for IV elraglusib in mPDAC. Earlier Phase 2 findings, published in Nature Medicine, showed that IV elraglusib combined with gemcitabine and nab-paclitaxel improved overall survival in patients with mPDAC.
Actuate plans to continue discussions with both the FDA and EMA regarding the design of a future registration study using the oral tablet formulation.
In parallel, the company is exploring the use of oral elraglusib in combination with RAS inhibitors for RAS-driven cancers. Early preclinical findings have suggested possible synergy between the therapies and the potential to overcome treatment resistance pathways.
The Phase 1 portion of the study will focus on determining the maximum tolerated dose, recommended Phase 2 dose, safety profile and pharmacokinetics of oral elraglusib. The Phase 2 stage will enrol patients more likely to benefit from treatment, including those with melanoma, NSCLC, colorectal cancer and pancreatic cancer.
Actuate also announced the appointment of Martin Huber, MD, to its board of directors. Dr Huber previously served as chief executive officer of Mersana Therapeutics and is currently a board member of Syndax Pharmaceuticals.
Source: globenewswire.com
