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# Orphan Status for Rafael’s Burkitt Lymphoma Drug
- URL: https://www.fdaweb.com/orphan-status-for-rafaels-burkitt-lymphoma-drug/
- Published: 2018-06-28T12:00:00.000Z
- Updated: 2026-09-15T00:16:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141791

FDA has granted Rafael Pharmaceuticals an orphan drug designation for CPI-613, an altered energy metabolism-directed drug candidate for treating Burkitt Lymphoma. The highly aggressive hematologic B-cell malignancy is characterized by the overexpression of c-Myc, the company says. CPI-613 is a novel lipoic acid analog with an anticancer activity that inhibits multiple enzyme targets within the tricarboxylic acid cycle, it says. A Phase 2 study is planned in patients with relapsed/refractory Burkitt Lymphoma who do not have any viable treatment options.