Oral version of elraglusib for pancreatic cancer to be evaluated in early trial
FDA green lights clinical testing of drug for those with advanced cancer
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The U.S. Food and Drug Administration (FDA) has given Actuate Therapeutics the green light to begin a clinical trial testing an oral formulation of elraglusib, the company’s experimental anticancer therapy.
The upcoming Phase 1/2 trial will enroll patients with advanced pancreatic cancer, as well as several other forms of advanced cancer. All participants will receive oral elraglusib as monotherapy (that is, on its own), with the main goals of assessing its safety and identifying the optimal dose for further clinical testing. The study, which will also preliminarily evaluate the oral therapy’s antitumor activity, is expected to launch later this year, according to a press release from Actuate.
“Advancing the elraglusib oral tablet is an important element to the success of our overall development strategy … With the [FDA’s okay] for the oral program authorized, we are planning to advance into clinical development in the second half of 2026 with a clear focus on optimizing exposure, dose, and response,” said Daniel Schmitt, Actuate’s president and CEO.
The company stated that the new formulation is expected to “drive next-phase clinical development and broader clinical use” of elraglusib.
Elraglusib is designed to block the activity of a protein called GSK-3 beta, which normally promotes the growth and survival of cancer cells. By blocking this protein, the therapy aims to limit tumor growth through multiple interconnecting mechanisms, including making chemotherapy more effective and activating the body’s immune system to attack the tumor.
Transitioning elraglusib from intravenous to oral use
Actuate has been developing a formulation of elraglusib that’s administered via the intravenous (IV) route, or by infusion directly into the bloodstream. In a previous Phase 1/2 clinical trial (NCT03678883), adding the IV version of elraglusib to standard chemotherapy significantly improved survival in people with an advanced form of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (mPDAC).
The company is now also developing an oral version of the therapy, aiming to increase convenience for patients and also maximize the amount of active medication delivered into the body.
“Transitioning from an IV to an oral formulation of elraglusib, which better positions the program by improving patient convenience and broadening clinical and potential commercial utility, is supported by an analysis of the completed Phase 2 data of elraglusib in mPDAC, showing higher exposures are associated with improved clinical activity,” Schmitt said.
Schmitt added that Actuate is also planning tests of elraglusib in patients with cancer driven by a protein called RAS. He said that preclinical data suggest that elraglusib may act in synergy with RAS-inhibiting medications in such patients.
“With a strong mechanistic rationale targeting key survival and resistance pathways, we believe … oral elraglusib has the potential to enhance the activity of RAS-targeted therapies and address adaptive resistance, positioning it as a potential backbone agent in combination regimens. We look forward to further maturing this data, with additional updates expected in mid-2026,” Schmitt said.
