On July 6, 2023 EpicentRx, Inc., a clinical stage biotechnology company with two therapeutic platforms that address cancer and inflammatory diseases, reported that the United States Adopted Name (USAN) Council in consultation with the World Health Organization’s (WHO) International Nonproprietary Names (INN) Expert Committee has assigned the generic name "nibrozetone", a shortening of the chemical name, alpha-bromodinitroazetidine, for its lead drug candidate, RRx-001 (Press release, EpicentRx, JUL 6, 2023, https://www.epicentrx.com/press-release/united-states-adopted-name-usan-council-and-international-nonproprietary-names-inn-expert-committee-recognizes-new-therapeutic-class-by-granting-nibrozetone-as-new-generic-name-f/ [SID1234633079]).
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This is the first representative of a novel class of hypoxia-activated therapeutics with a chemical scaffold, a dinitroazetidine, that is commonly found only in explosives. RRx-001 is protective under normal oxygen conditions but under low oxygen conditions that are present in tumors the molecule transforms to metabolites that disrupt the tumor microenvironment. RRx-001 is under development for the treatment of small cell lung cancer (SCLC) in a Phase 3 clinical trial, and a soon-to-start late-stage trial for the protection against oral mucositis in first line head and neck cancer, an indication for which RRx-001 has received FDA Fast Track designation. RRx-001 is proprietary to EpicentRx with issued and currently pending patents that are expected to extend coverage until 2042.
"We are pleased but not surprised given its unique aerospace-derived origins and dual mechanism of action that USAN has recognized the first-in-class nature of RRx-001 with a new generic name," stated EpicentRx’s CEO Dr. Tony Reid. "This is on the critical path for bringing a new drug to market and comes at an opportune time for EpicentRx given the late-stage trials with RRx-001 in SCLC, head and neck cancer, and radioprotection."
A nonproprietary name also known as a generic name is necessary and important, according to WHO, for "clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide". To prevent potentially lethal clinical mix-ups, this name must be distinctive enough to clearly differentiate it from other medications. A multisyllabic mouthful, the chemically descriptive—and distinctive— nibrozetone is unlikely to be confused with other drug names. Therefore, and henceforth, EpicentRx will use "nibrozetone" in upcoming publications, press releases, forums, conferences, and other events or activities on the way to commercialization at which time, hopefully, a more mellifluous and shorter proprietary brand name will replace it.