Fidaxomicin
CAS: 873857-62-6
Appearance: White Powder
Qualifications: ISO9001:2015; GMP
Specifications: USP-40
Overview
Fidaxomicin is a macrolide antibiotic with a novel mechanism of action, primarily used to treat diarrhea caused by Clostridioides difficile infections (CDI). It works by inhibiting bacterial RNA polymerase, providing rapid and effective treatment for CDI. Clinical studies have demonstrated its superiority over existing therapies in treating CDI. Fidaxomicin's safety and efficacy have been validated through two large-scale, multicenter, randomized, double-blind, active-controlled clinical trials.
Adverse Reactions
Common side effects include nausea, vomiting, headache, abdominal pain, and diarrhea.
Chemical Properties
Fidaxomicin is a fermentation product derived from Actinoplanes deccanensis or Dactylosporangium aurantiacum, classified as a new 18-membered macrolide compound. It has a molecular formula of C32H74Cl2O18 and a molecular weight of 1058.04. In vivo, it produces an active metabolite known as OP-1118.
Mechanism of Action
Fidaxomicin inhibits bacterial growth by binding to RNA polymerase. Most RNA polymerases consist of five subunits (α2ββ'ω), forming the core catalytic enzyme, with an additional σ subunit responsible for promoter recognition. The σ subunit in C. difficile is distinct from other bacterial strains, and no cross-resistance with other antibiotics has been observed in in vitro studies.
Production Advancements
Our research team utilized synthetic biology techniques to reconstruct production strains and optimize fermentation processes, achieving high-yield and stable production. This significantly reduced homologous impurities. The project has been granted a Chinese invention patent, securing independent intellectual property rights.
China
