CRS3123 / Crestone, National Institute of Allergy and Infectious Diseases - LARVOL DELTA

New investigational agents for the treatment of clostridioides difficile infections. (PubMed, Expert Opin Investig Drugs) - "Ibezapolstat, CRS3123, and ridinilazole were identified with unique mechanisms of action and narrow spectrums of activity that result in gut microbiome preservation and reduced recurrent CDI (rCDI) rates...Some have the ability to restore the microbiome (VE303) or preserve intestinal integrity (e.g. REC-3964, LMN-201, AQ)...CDI is a significant burden to the healthcare system and the quality of life for patients who suffer from CDI and rCDI. Further development of these investigational agents to prevent this cycle are of upmost importance."

Journal • Review • Infectious Disease

Microbiome Analysis of Fecal Samples Collected in a Phase 2 Clinical Trial Comparing CRS3123 vs. Vancomycin to Treat C. difficile Infection (ASM Microbe 2025) - "These findings suggest that CRS3123 exerts a more microbiome-sparing effect compared to vancomycin, particularly in preserving microbial diversity and protecting beneficial taxa. Ongoing and future analyses will integrate metagenomics, short-chain fatty acid (SCFA) profiling, bile acid quantification, and immune marker data to further elucidate the clinical implications of these microbial shifts."

Clinical • Late-breaking abstract • P2 data • Infectious Disease

Evaluation of the Potential Impact of a High-fat Meal on the Pharmacokinetics of CRS3123 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Crestone, Inc | Active, not recruiting ➔ Completed

Trial completion

Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection (clinicaltrials.gov) - P2 | N=43 | Completed | Sponsor: Crestone, Inc | Active, not recruiting ➔ Completed | N=108 ➔ 43

Enrollment change • Trial completion • Infectious Disease

A Phase 1, Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Potential Impact of High-fat Meal on the Pharmacokinetics of CRS3123 200 mg Capsule in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Crestone, Inc

New P1 trial

Evaluation of CRS3123 compared to vancomycin for the treatment of Clostridioides difficile infection (CDI) (ESCMID Global 2025) - No abstract available

Infectious Disease

Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection (clinicaltrials.gov) - P2 | N=108 | Active, not recruiting | Sponsor: Crestone, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

Novel drug candidates against antibiotic-resistant microorganisms: A review. (PubMed, Iran J Basic Med Sci) - "This review focuses on the resistance mechanisms of the top five threatening pathogens identified by the World Health Organization's global priority pathogens list: carbapenem-resistant Acinetobacter baumannii, carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant, extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae, vancomycin-resistant Enterococcus faecium and methicillin, vancomycin-resistant Staphylococcus aureus...The novel drugs against carbapenem-resistant bacteria include LCB10-0200, apramycin, and eravacycline, while for Enterobacteriaceae, the drug candidates are LysSAP-26, DDS-04, SPR-206, nitroxoline, cefiderocol, and plazomicin. TNP-209, KBP-7072, and CRS3123 are agents against E. faecium, while Debio 1450, gepotidacin, delafloxacin, and dalbavancin are drugs against antibiotic-resistant S. aureus. In addition to these identified drug candidates, continued in vitro and in vivo studies are required to investigate small..."

Journal • Review

Antibiotics with novel mode of action as new weapons to fight antimicrobial resistance. (PubMed, Eur J Med Chem) - "Today, the pipeline of potential new treatments with these characteristics includes promising compounds such as gepotidacin, zoliflodacin, ibezapolstat, MGB-BP-3, CRS-3123, afabicin and TXA-709, which are currently in clinical trials, and lefamulin, which has been recently approved by FDA and EMA. In this review, we report the chemical synthesis, mode of action, structure-activity relationships, in vitro and in vivo activities as well as clinical data of these eight small molecules listed above."

Journal • Review • Oncology

The Urgent Threat of Clostridioides difficile Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects. (PubMed, Biomedicines) - "Many possible drugs of the future for CDI, with diverse mechanisms of action, are in development in the form of microbiota-modulating agents (e.g., ADS024, CP101, RBX2660, RBX7455, SYN-004, SER-109, VE303, DAV132, MET-2, and BB128), small molecules (e.g., ridinilazole, ibezapolstat, CRS3123, DNV3837, MGB-BP-3, alanyl-L-glutamine, and TNP-2198), antibodies (e.g., IM-01 and LMN-201), and non-toxic strains of CD (e.g., NTCD-M3). The development of some therapeutic agents (e.g., DS-2969b, OPS-2071, cadazolid, misoprostol, ramoplanin, KB109, LFF571, and Ramizol) stopped due to failed clinical trials or unknown reasons...The current pipeline of anti-CDI medications appears promising. However, it will be fascinating to see how many of the cited are successful in gaining approval from drug regulators such as the US FDA and becoming medicines for CDI and r-CDI."

Journal • Review • Developmental Disorders • Infectious Disease