Drugs / Ibezapolstat
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07513285 | Aug 2026 → Sep 2027 expected | Clostridium difficile colitis | Acurx Pharmaceuticals Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04247542 | Mar 2020 → Oct 2023 | Clostridium infectious disease | Acurx Pharmaceuticals Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Presentation of a Scientific Poster at the Premier International C. difficile Symposium (ICDS) Demonstrating Superior In Vitro Kill Kinetics of Ibezapolstat vs. Vancomycin and Fidaxomicin (Standards of Care) in Clostridioides difficile and Vancomycin-Resistant Enterococcus Co-Cultures acurxpharma.com ↗
IBZ maintained superior bactericidal activity under co-culture conditions, including further decreasing Clostridioides difficile toxin B (TcdB) expression while simultaneously eradicating vancomycin-resistant bacterial overgrowth |
| 2026-08-17 | Acurx Pharmaceuticals Inc. | Regulatory Acurx Pharmaceuticals Receives FDA Conditional Acceptance and USPTO Trademark Allowance for the Company's Brand Name for Ibezapolstat acurxpharma.com ↗
The proposed proprietary name, or brand name, CIFBEZY has received conditional acceptance from the FDA and also federal trademark allowance from the USPTO |
| 2026-07-14 | Acurx Pharmaceuticals Inc. | Results Acurx Pharmaceuticals Announces Scientific Poster Presentation of Ibezapolstat's Microbiome Preservation Data in Multiply-recurrent C. difficile Infection acurxpharma.com ↗
IBZ and FDX were superior in biofilm experimental models with IBZ significantly more effective at killing C. difficile than VAN and FDX |
| 2025-11-10 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Publication in the Nature Communications Scientific Journal Documenting its Unique Targeting of DNA pol IIIC Gram-positive Priority Pathogens acurxpharma.com ↗ |
| 2025-10-28 | Acurx Pharmaceuticals Inc. | Results Acurx Announces New Data on its DNA pol IIIC Inhibitor Antibiotics Demonstrating a Potential Class Effect of Gut Microbiome Selectivity Presented at IDWeek 2025 Scientific Conference acurxpharma.com ↗
Pioneering data demonstrate that Acurx's U.S. and EU Phase 3-ready DNA pol IIIC inhibitor, ibezapolstat (IBZ), has unique selective antibacterial activity in the gut which spares beneficial bile acid-metabolizing bacteria |
| 2025-09-30 | Acurx Pharmaceuticals Inc. | Regulatory Acurx Announces Positive Opinion from EMA on Pediatric Investigation Plan for Ibezapolstat Use in Children with C. difficile Infection acurxpharma.com ↗
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections announced receipt of a favorable opinion from the PDCO of the EMA on Acurx's Pediatric Investigation Plan (PIP) for ibezapolstat use in children with C. difficile infection (CDI). |
| 2025-06-17 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Publication in Lancet Microbe of Phase 2b Clinical Trial Data for Ibezapolstat in CDI acurxpharma.com ↗
As previously reported, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and all 15 of 15 (100%) remained free of C. difficile infection (CDI) recurrence through one month after EOT |
| 2025-06-09 | Acurx Pharmaceuticals Inc. | Results Acurx Pharmaceuticals Announces Presentation of Results from Leiden University Medical Center Public-Private Partnership for Its DNA pol IIIC Inhibitors at the Federation of American Societies for Experimental Biology Scientific Conference acurxpharma.com ↗
A Unique Inhibitor Conformation Selectively Targets the DNA Polymerase PolC of Gram-Positive Priority Pathogens |
| 2025-03-03 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Publication of Nonclinical In Vivo Data Differentiating Ibezapolstat's Gut Microbiome Effects from Other Anti-CDI Antibiotics acurxpharma.com ↗
Changes in alpha and beta microbiome diversities following IBZ treatment were less pronounced compared to those observed in vancomycin (VAN)-or metronidazole (MET)-treated groups, complementing prior Phase 2 clinical findings showing IBZ's more selective antibacterial activity |
| 2025-02-24 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Publication of Positive Results from an In-Silico Study Predicting the Microbiome-Restorative Potential of Ibezapolstat in the Treatment of CDI acurxpharma.com ↗
IBZ susceptibility of human commensal (nonpathogenic) microbiota was predicted using genomic analysis and a phylogenetic tree construction of the IBZ target enzyme, pol IIIC |
| 2025-01-06 | Acurx Pharmaceuticals Inc. | Regulatory Acurx Receives Positive Regulatory Guidance from EMA for Ibezapolstat Phase 3 Program for C. Difficile Infection (CDI) acurxpharma.com ↗
The Company today announced that it has received positive regulatory guidance from the EMA during its Scientific Advice Procedure that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted supports advancement of the ibezapolstat Phase 3 program. |
| 2024-11-18 | Acurx Pharmaceuticals Inc. | Results Acurx Sponsored and Participated in the Peggy Lillis Foundation Inaugural CDI Scientific Symposium and Presented Ibezapolstat Ph2b Clinical Data Update acurxpharma.com ↗
In contrast to patients dosed with vancomycin, ibezapolstat has consistently shown in the phase 1 and 2 studies that it promotes the growth of beneficial Actinobacteria important for short chain fatty acid production and Clostridiales important for bile acid homeostasis. |
| 2024-10-21 | Acurx Pharmaceuticals Inc. | Results Acurx Announces New Bile Acid and Microbiome Analyses from Ph2b Trial of Ibezapolstat in CDI Patients Presented at IDWeek Scientific Conference acurxpharma.com ↗
The data presented indicate a favorable gut bile acid profile which may contribute to ibezapostat's beneficial anti-recurrence effect in patients with C. difficile Infection (CDI) |
| 2024-09-26 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Additional Ibezapolstat Ph2b Results in CDI as well as Anthrax (B. anthracis) Susceptibility to ACX-375 Analogues acurxpharma.com ↗
The data show an increased proportion of Actinobacteriota and increased quantity of beneficial Bacillota (Firmicutes) leading to reversal of dysbiosis and contributing to the CDI anti-recurrence effect of ibezapolstat. |
| 2024-09-24 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Results of Its Pioneering Research with Ibezapolstat in Collaboration with Leiden University Medical Center at the Premier International C. difficile Symposium acurxpharma.com ↗ |
| 2024-07-15 | Acurx Pharmaceuticals Inc. | Results Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results for CDI at Scientific Conference acurxpharma.com ↗
Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with C. difficile Infection (CDI) |
| 2024-05-02 | Acurx Pharmaceuticals Inc. | Results Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results at ESCMID Global 2024 Scientific Conference acurxpharma.com ↗
These findings show that ibezapolstat's unique mechanism of activity, inhibition of DNA polymerase IIIC, translates into in vitro activity against C. difficile strains with reduced susceptibility to fidaxomicin and vancomycin. |
| 2024-02-27 | Acurx Pharmaceuticals Inc. | Regulatory Acurx Announces FDA Has Granted an End of Phase 2 Meeting for Ibezapolstat for C. difficile Infection and the European Medicines Agency Granted SME Designation for Ibezapolstat EU Development acurxpharma.com ↗
On February 14, 2024, the FDA granted an EOP2 meeting which confirms adequate information was provided to warrant this type of meeting. |
| 2024-01-29 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Positive Extended Clinical Cure Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients acurxpharma.com ↗
This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. |
| 2024-01-17 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients acurxpharma.com ↗
Ibezapolstat outperformed vancomycin showing eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 treated patients (94%), versus vancomycin which had eradication of C. difficile in 10 of 14 treated patients (71%). |
| 2023-12-11 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Positive Phase 2b Results Showing 100% of Patients Who Had Clinical Cure with Ibezapolstat Also Had Sustained Clinical Cure acurxpharma.com ↗
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced positive Phase 2b results showing 100% of CDI patients who had CC with ibezapolstat, the company's late-stage antibiotic candidate, also had SCC. |
| 2023-11-02 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Positive Top-Line Ibezapolstat Phase 2 Efficacy Results with 96% Clinical Cure Rate in Patients with C. difficile Infection acurxpharma.com ↗
In a total of 26 ibezapolstat-treated patients in Phases 2a and 2b, the Clinical Cure rate is 96% |
| 2023-10-19 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Ibezapolstat Scientific Posters and Presentations at ClostPath 2023 and IDWeek 2023 Scientific Conferences acurxpharma.com ↗
Ibezapolstat reduces toxin production by C. difficile |
| 2023-10-02 | Acurx Pharmaceuticals Inc. | Results Acurx Pharmaceuticals Announces Successful Completion and Early Discontinuation of the Ibezapolstat Phase 2b Trial for Treatment of C. difficile Infection acurxpharma.com ↗
Based on observed aggregate blinded data the Company has determined that both treatments, ibezapolstat and the control antibiotic vancomycin, have performed as expected |
| 2023-04-19 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Ibezapolstat Scientific Poster and Update on its Pol IIIC Pipeline Presented at ECCMID 2023 Scientific Conference acurxpharma.com ↗
C. difficile strains with reduced susceptibility to metronidazole, vancomycin, or fidaxomicin were susceptible to ibezapolstat, confirming its unique mechanism of action. |
| 2023-04-11 | Acurx Pharmaceuticals Inc. | Regulatory FDA Accepts Interim Analysis Plan for Ongoing Phase 2b Ibezapolstat Clinical Trial and Acurx Announces Presentations at ECCMID 2023 Scientific Conference acurxpharma.com ↗
FDA has accepted an Interim Analysis Plan for an IDMC to assess clinical outcome when 36 patients are enrolled in the Company's Ph2b clinical trial of ibezapolstat in patients with CDI |
| 2022-10-26 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Scientific Oral and Poster Presented at IDWeek 2022 acurxpharma.com ↗
Assessed by qPCR and metagenomic sequencing analysis, colonic microbiome Firmicute bacterial populations consistently demonstrated preservation or increased abundance of Lachnospiraceae and Clostridiales throughout the course of ibezapolstat treatment. |
| 2022-08-02 | Acurx Pharmaceuticals Inc. | Results Acurx Announces New Data Presentations from Ongoing Ph2 Clinical Trial Program of Ibezapolstat for CDI at the 16th Biennial Congress of the Anaerobe Society of America acurxpharma.com ↗
New data link beneficial microbiome changes in Ph2a CDI patients to earlier results from Ph1 healthy volunteers to predict potential anti-recurrence properties of ibezapolstat |
| 2022-02-07 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Publication of Positive Phase 2a Clinical Trial Results of Ibezapolstat for CDI in Clinical Infectious Diseases acurxpharma.com ↗
Clinical results of 10 of 10 patients (100%) enrolled met the study's primary and secondary efficacy endpoints of Clinical Cure at end of treatment |
| 2021-11-08 | Acurx Pharmaceuticals Inc. | Results Acurx Announces New Microbiome Data from Its Phase 2a Clinical Trial of Ibezapolstat for CDI at the 9th International C. diff. Conference acurxpharma.com ↗
Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. |
| 2021-10-04 | Acurx Pharmaceuticals Inc. | Results Acurx Presents Positive Ibezapolstat Microbiome Data from Its Phase 2a Trial at IDWeek acurxpharma.com ↗
The Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment as well as the observed overgrowth of healthy gut microbiota Actinobacteria and Firmicute phyla species during and after therapy. |
| 2021-07-01 | Acurx Pharmaceuticals Inc. | Results Acurx Announces New Ibezapolstat Data on Anti-Recurrence Mechanisms in CDI at Prominent International Conference acurxpharma.com ↗
These results were presented by Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiome aspects of the clinical trial program for ibezapolstat. |
| 2020-11-19 | Acurx Pharmaceuticals Inc. | Results Acurx Announces Positive Phase 2A Clinical Trial Results for Ibezapolstat in C. difficile Infection at Prominent International Conference acurxpharma.com ↗
Taken together, the two presentations extend the positive findings from Phase 1 into the Phase 2 program and continue to build the scientific, clinical, and microbiological foundations for ongoing ibezapolstat development. |
| 2020-11-05 | Acurx Pharmaceuticals Inc. | Results Acurx Announces All Patients Demonstrated Clinical and Sustained Cure in Ph2A Open-Label Trial of Ibezapolstat for Treatment of C. difficile Infection (CDI) acurxpharma.com ↗
All 10 patients enrolled in the trial met the study's primary and secondary efficacy endpoints of Clinical Cure at end of treatment and Sustained Clinical Cure of no recurrence of CDI at the 28-day follow-up visit. |
| 2020-07-23 | Acurx Pharmaceuticals Inc. | Results Acurx Actively Enrolling Patients in Ph2 Clinical Trial of its Lead Antibiotic for Treatment of Clostridioides difficile Infection (CDI) acurxpharma.com ↗
All of the first 6 patients enrolled in the trial have met the study's primary endpoint, Clinical Cure at end of treatment. |
All press releases naming this drug 48 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ibezapolstat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07513285 ↗ |
| Known as | ACX-362E | ChEMBL registry synonym — accepted as the source's own label CHEMBL4571518 ↗ |
| Action | Inhibit | “ibezapolstat, an antibiotic that inhibits the PolC-type DNA polymerase III α subunit C” PMID 40516571 ↗ Jun 2025 |
| Modality | Small molecule | — CHEMBL4571518 ↗ |
| Route | Oral | “Patients were treated with 450 mg of oral ibezapolstat twice daily for 10 days.” NCT04247542 ↗ |