Veru Inc. announced on September 8, 2026, a strategic pivot in its drug development pipeline. The company will no longer pursue sabizabulin for treating chronic inflammation related to atherosclerotic cardiovascular disease. Instead, Veru will advance sabizabulin into a planned Phase 2 clinical trial to treat metastatic pancreatic cancer that has developed resistance to daraxonrasib (RASONQUE), a therapy recently approved by the FDA.
The decision is based on new preclinical data demonstrating that sabizabulin can overcome resistance to daraxonrasib. In a study of KRAS-driven pancreatic and colon cancer cell lines, the drug showed potent anticancer efficacy with an IC50 of 18.2 nM. This concentration is reportedly achievable with current human dosing regimens and is associated with a good safety profile.
Veru’s Chief Executive Officer, Mitchell Steiner, M.D., noted that the median time to cancer progression for patients receiving daraxonrasib is 7.2 months. The primary mechanism of resistance identified in the preclinical studies was the reactivation of the KRAS signaling pathway. As sabizabulin targets downstream components of this pathway, the company views it as a rational treatment option for patients who have progressed on daraxonrasib.
The company controls global development and commercialization rights to sabizabulin, with issued patent protection extending until 2043. To initiate this new oncology program, Veru plans to seek regulatory clarity from the FDA through a pre-IND meeting in the fourth quarter of 2026.
In other company news, Veru’s enobosarm program remains on track. The Phase 2b PLATEAU clinical trial, which evaluates enobosarm in combination with semaglutide for older patients with obesity, is fully enrolled with 239 patients. The company expects an interim analysis in the first quarter of 2027.
