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# Denovo Bio Fast Track for Enzastaurin
- URL: https://www.fdaweb.com/denovo-bio-fast-track-for-enzastaurin/
- Published: 2020-07-17T12:00:00.000Z
- Updated: 2026-09-14T16:21:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147225

FDA has granted Denovo Biopharma a fast track designation for DB102 (enzastaurin) and its use as a potential treatment for patients with newly-diagnosed glioblastoma. Enzastaurin is a serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients across a range of solid and hematological tumor types. It was originally developed by Eli Lilly and Denovo has acquired worldwide rights. Denovo says it plans to conduct a Phase 3 pivotal study of enzastaurin in combination with temozolomide, both during and following radiation therapy, in newly-diagnosed glioblastoma patients.