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]
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| Other names | SMT19969 |
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| Formula | C24H16N6 |
| Molar mass | 388.434 g·mol−1 |
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As of 2019[update], 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
editReferences
edit- ^ a b Cho JC, Crotty MP, Pardo J (March 2019). "Clostridium difficile infection". Annals of Gastroenterology. 32 (2): 134–140. doi:10.20524/aog.2018.0336. PMC 6394264. PMID 30837785.
- ^ a b c d Carlson TJ, Endres BT, Bassères E, Gonzales-Luna AJ, Garey KW (April 2019). "Ridinilazole for the treatment of Clostridioides difficile infection". Expert Opinion on Investigational Drugs. 28 (4): 303–310. doi:10.1080/13543784.2019.1582640. PMID 30767587. S2CID 73422150.
- ^ Bassères E, Endres BT, Dotson KM, Alam MJ, Garey KW (January 2017). "Novel antibiotics in development to treat Clostridium difficile infection". Current Opinion in Gastroenterology. 33 (1): 1–7. doi:10.1097/MOG.0000000000000332. PMID 28134686. S2CID 32454489.
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.
- ^ Vickers RJ, Tillotson G, Goldstein EJ, Citron DM, Garey KW, Wilcox MH (August 2016). "Ridinilazole: a novel therapy for Clostridium difficile infection". International Journal of Antimicrobial Agents. 48 (2): 137–43. 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
- ^ Collins DA, Riley TV (September 2022). "Ridinilazole: a novel, narrow-spectrum antimicrobial agent targeting Clostridium (Clostridioides) difficile". Letters in Applied Microbiology. 75 (3): 526–536. doi:10.1111/lam.13664. PMC 9541751. PMID 35119124.
- ^ "Fast Track". U.S. Food and Drug Administration. 2018-11-03.
- ^ "HHS spurs new antibiotic development for biodefense and common infections". Public Health Emergency. U.S. Department of Health and Human Services. Retrieved 2020-12-04.