Chemistry:Ridinilazole
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| Other names | SMT19969 |
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| Formula | C24H16N6 |
| Molar mass | 388.434 g·mol−1 |
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Ridinilazole (previously known as SMT19969) is an investigational small molecule antibiotic being evaluated for oral administration to treat Clostridioides difficile infection (CDI). In vitro, it is bactericidal against C. difficile and suppresses bacterial toxin production; the mechanism of action is thought to involve inhibition of cell division.[1] It has properties which are desirable for the treatment of CDI, namely that it is a narrow-spectrum antibiotic which exhibits activity against C. difficile while having little impact on other normal intestinal flora and that it is only minimally absorbed systemically after oral administration.[2] At the time ridinilazole was developed, there were only three antibiotics in use for treating CDI: vancomycin, fidaxomicin, and metronidazole.[1][2] The recurrence rate of CDI is high, which has spurred research into other treatment options with the aim to reduce the rate of recurrence.[3][4]
(As of 2019), two phase II trials have been completed and two phase III trials comparing ridinilazole to vancomycin for CDI are expected to be completed in September 2021.[2][5][6] Ridinilazole was designated as a Qualified Infectious Disease Product (QIDP) and was granted Fast Track status by the U.S. FDA.[2] Fast Track status is reserved for drugs designed to treat diseases where there is currently a gap in the treatment, or a complete lack thereof.[7] The QIDP designation adds five more years of exclusivity for ridinazole upon approval.[8]
See also
References
- ↑ 1.0 1.1 "Clostridium difficile infection". Annals of Gastroenterology 32 (2): 134–140. March 2019. doi:10.20524/aog.2018.0336. PMID 30837785.
- ↑ 2.0 2.1 2.2 2.3 "Ridinilazole for the treatment of Clostridioides difficile infection". Expert Opinion on Investigational Drugs 28 (4): 303–310. April 2019. doi:10.1080/13543784.2019.1582640. PMID 30767587.
- ↑ "Novel antibiotics in development to treat Clostridium difficile infection". Current Opinion in Gastroenterology 33 (1): 1–7. January 2017. doi:10.1097/MOG.0000000000000332. PMID 28134686. https://pubmed.ncbi.nlm.nih.gov/28134686/. "These tables highlight the increased drug development directed towards CDI due to the rise in prevalence of infections and to attempt to reduce the number of recurrent infections.".
- ↑ "Ridinilazole: a novel therapy for Clostridium difficile infection". International Journal of Antimicrobial Agents 48 (2): 137–43. August 2016. doi:10.1016/j.ijantimicag.2016.04.026. PMID 27283730. "there exists a significant unmet and increasing medical need for new therapies to treat CDI, specifically those that can reduce the rate of disease recurrence.".
- ↑ Clinical trial number NCT03595553 for "Ri-CoDIFy 1: Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection" at ClinicalTrials.gov
- ↑ "Ridinilazole: a novel, narrow-spectrum antimicrobial agent targeting Clostridium (Clostridioides) difficile". Letters in Applied Microbiology 75 (3): 526–536. September 2022. doi:10.1111/lam.13664. PMID 35119124.
- ↑ "Fast Track". U.S. Food and Drug Administration. 2018-11-03. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
- ↑ "HHS spurs new antibiotic development for biodefense and common infections". Public Health Emergency. U.S. Department of Health and Human Services. https://www.phe.gov/Preparedness/news/Pages/ridinilazole.aspx.
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