Nuvation Bio Expands Safusidenib Trial to Europe
The phase 3 SIGMA study of the brain cancer drug adds study sites in six European countries.
Updated on Nov. 2, 2026 in Cancer
Nuvation Bio is expanding its phase 3 SIGMA study of safusidenib, an investigational oral therapy for IDH1-mutant glioma, to six European countries. The expansion follows the drug's FDA Fast Track Designation granted in August 2026.
Why it matters
Gliomas are the most common type of adult brain cancer worldwide and are not currently curable, so access to new clinical trial options matters for patients. Adding European sites extends the study beyond its existing footprint to reach more patients with IDH1-mutant disease.
The pivotal SIGMA study enrolls approximately 300 patients in a randomized, placebo-controlled design, with an exploratory cohort of approximately 40 patients with grade 3 IDH1-mutant oligodendroglioma. Efficacy outcomes have not yet been reported.
The players
Nuvation Bio
Nuvation Bio is a clinical-stage biopharmaceutical company developing oncology therapies, including safusidenib.
U.S. Food and Drug Administration (FDA)
The FDA is the U.S. federal agency responsible for regulating drugs and granting expedited review designations such as Fast Track.
The details
Study sites are being added in the United Kingdom, France, Sweden, Germany, Italy and Spain, joining existing locations in the US, Australia, China, Canada and Japan. Safusidenib is an oral, brain-penetrant, selective inhibitor of mutant IDH1, evaluated as maintenance therapy after radiotherapy or chemoradiotherapy and adjuvant temozolomide.
Timeline
August 2026: FDA granted Fast Track Designation to safusidenib for IDH1-mutant glioma.
November 2, 2026: Expansion of the SIGMA study to six European countries was announced.
Health Landscape
The FDA's Fast Track Designation program is intended to speed development of drugs for serious conditions with unmet need, and safusidenib's designation for IDH1-mutant glioma places it within that pathway. The European expansion extends the drug's trial footprint as oral, targeted therapies for brain tumors remain an active area of clinical research.
For patients with IDH1-mutant glioma in the participating countries, the expansion may create new clinical trial enrollment options. Participation would depend on eligibility criteria and availability at specific study sites.
The takeaway
Clinical trial expansion can widen access to investigational therapies for patients with rare or incurable cancers. Readers facing a glioma diagnosis can ask their oncology teams whether trials such as SIGMA are an option.
Further reading
For more on the disease at the center of this trial, see our Cancer coverage.
