FDA Events for Acurx Pharmaceuticals (ACXP)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Acurx Pharmaceuticals (ACXP).
Over the past two years, Acurx Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ibezapolstat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ibezapolstat - FDA Regulatory Timeline and Events
Ibezapolstat is a drug developed by Acurx Pharmaceuticals for the following indication: Clostridioides difficile Infection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ibezapolstat
- Announced Date:
- June 17, 2025
- Indication:
- Clostridioides difficile Infection
Announcement
Acurx Pharmaceuticals, Inc. announced the publication of results in Lancet Microbe of its Phase 2b clinical study entitled: Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with Clostridioides difficile infection: a phase 2b, randomized, double-blind, active-controlled, multicenter study.
AI Summary
Acurx Pharmaceuticals, Inc. announced the publication of its Phase 2b study results in Lancet Microbe. The study evaluated ibezapolstat for treating Clostridioides difficile infection (CDI) and compared it with standard oral vancomycin. In the Phase 2b trial, 94% of patients treated with ibezapolstat achieved clinical cure, and all patients who were cured remained free of CDI recurrence through one month after treatment. These promising findings were further supported by results from a Phase 2a study, where 100% of ibezapolstat-treated patients maintained cure. Additionally, the study highlighted ibezapolstat’s positive impact on the gut microbiome, showing favorable changes that help protect against CDI recurrence. The publication, with insights from Professor Kevin Garey, builds a strong case for advancing ibezapolstat into international Phase 3 clinical trials as a potentially transformative treatment for CDI.
Read Announcement- Drug:
- Ibezapolstat
- Announced Date:
- June 9, 2025
- Indication:
- Clostridioides difficile Infection
Announcement
- Acurx Pharmaceuticals, Inc. s a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Its lead antibiotic candidate, ibezapolstat (IBZ), is ready to advance to international pivotal Phase 3 clinical trials for treatment of patients with C. difficile infection (CDI).
AI Summary
Acurx Pharmaceuticals, Inc. is advancing a new class of small molecule antibiotics aimed at treating tough bacterial infections. The company’s lead candidate, ibezapolstat (IBZ), has shown promise against Clostridioides difficile infection (CDI) and is now ready to move into international pivotal Phase 3 clinical trials. Ibezapolstat works by targeting the DNA polymerase IIIC enzyme specific to Gram-positive bacteria, potentially offering a more selective treatment that minimizes harm to the healthy gut microbiome.
This late-stage biopharmaceutical effort is part of a broader initiative to tackle antibiotic resistance and improve patient outcomes for CDI, a significant healthcare challenge. The development program is backed by strong scientific research, including collaborations with institutions like Leiden University Medical Center, which have contributed to understanding the drug’s unique mechanism of action.
Read Announcement- Drug:
- Ibezapolstat
- Announced Date:
- March 3, 2025
- Indication:
- Clostridioides difficile Infection
Announcement
Acurx Pharmaceuticals, announced the results of a study in a humanized mouse model and its publication in the Journal of Antimicrobial Agents and Chemotherapeutics entitled: "Microbiome impact of ibezapolstat and other Clostridioides difficile infection-relevant antibiotics using humanized mice".
AI Summary
Acurx Pharmaceuticals recently announced a study published in the Journal of Antimicrobial Agents and Chemotherapeutics titled “Microbiome impact of ibezapolstat and other Clostridioides difficile infection-relevant antibiotics using humanized mice.” The study used a humanized mouse model to directly compare the effects of ibezapolstat on the gut microbiome with those of other antibiotics used to treat C. difficile infections, such as vancomycin, metronidazole, and fidaxomicin.
The results showed that ibezapolstat caused less disturbance in the gut’s alpha and beta microbiome diversity compared to vancomycin and metronidazole. Additionally, while both ibezapolstat and fidaxomicin had a narrower impact on the microbiome, notable differences were observed between them, suggesting future studies could further distinguish these treatments. This research supports ibezapolstat’s more targeted antibacterial approach and lays the groundwork for its upcoming Phase 3 clinical trials.
Read Announcement- Drug:
- Ibezapolstat
- Announced Date:
- January 6, 2025
- Indication:
- Clostridioides difficile Infection
Announcement
Acurx Pharmaceuticals, Inc. 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.
AI Summary
Acurx Pharmaceuticals announced that it received positive written guidance from the European Medicines Agency (EMA) during its Scientific Advice Procedure. The EMA confirmed that the clinical, non-clinical, and Chemistry, Manufacturing and Controls (CMC) package submitted by Acurx supports advancing the Phase 3 program for ibezapolstat, a promising treatment for Clostridioides difficile Infection (CDI).
The guidance also outlined the regulatory pathway for a Marketing Authorization Application for ibezapolstat in the European Union. With this favorable advice from the EMA, the company is well positioned to move forward with its international Phase 3 registration program, which includes non-inferiority trials comparing ibezapolstat to vancomycin. Acurx plans to incorporate the EMA’s constructive suggestions into its global registration strategy as it prepares for upcoming international clinical trials.
Read Announcement- Drug:
- Ibezapolstat
- Announced Date:
- December 9, 2024
- Indication:
- Clostridioides difficile Infection
Announcement
Acurx Pharmaceuticals, Inc. announced updates on Phase 3 Readiness for Ibezapolstat in C. difficile Infection based on recent FDA and EMA Communications.
AI Summary
Acurx Pharmaceuticals, Inc. has shared promising updates regarding the Phase 3 readiness of its lead candidate, ibezapolstat, for treating Clostridioides difficile infection (CDI). Recent written feedback from the FDA confirmed the acceptability of the company’s Chemistry, Manufacturing, and Controls (CMC) plan and supporting data package for the upcoming Phase 3 clinical program. Additionally, Acurx has initiated a Scientific Advice procedure with the European Medicines Agency (EMA) to discuss starting Phase 3 trials in the European Union, with a final written advice letter expected in the coming weeks.
The company is also in discussions with both FDA and EMA authorities about pediatric development plans to meet regulatory requirements. Meanwhile, international Phase 3 trial planning is advancing, with the use of artificial intelligence and modern methods to identify high-potential clinical trial sites. Acurx is preparing to request further guidance to begin trials in Japan, Canada, and the United Kingdom.
Read Announcement- Drug:
- Ibezapolstat
- Announced Date:
- November 18, 2024
- Indication:
- Clostridioides difficile Infection
Announcement
Acurx Pharmaceuticals, Inc. announced its support and participation in the Inaugural Peggy Lillis Foundation (virtual) Scientific Symposium, held on Friday, November 15, 2024.
AI Summary
Acurx Pharmaceuticals announced its support and participation in the inaugural Peggy Lillis Foundation virtual Scientific Symposium held on November 15, 2024. During the symposium, Acurx’s Executive Chairman, Bob DeLuccia, delivered the opening remarks, setting the stage for a day of expert presentations and discussions focused on Clostridioides difficile (C. diff). The event brought together leading experts, clinicians, and patient advocates to share the latest insights on C. diff epidemiology, bacterial behavior, and emerging therapeutic strategies. Participants discussed how innovative treatments, including Acurx’s lead antibiotic candidate, ibezapolstat, could improve patient outcomes and potentially reduce the recurrence of C. diff infections. The symposium underscored Acurx’s commitment to advancing research and raising awareness during C. diff Awareness Month, while fostering collaboration among the global medical community.
Read Announcement- Drug:
- Ibezapolstat
- Announced Date:
- July 17, 2024
- Indication:
- Clostridioides difficile Infection
Announcement
Acurx Pharmaceuticals, Inc. announced that a new patent has been granted by the United States Patent and Trademark Office (USPTO) on July 16, 2024.
AI Summary
Acurx Pharmaceuticals, Inc. announced that the United States Patent and Trademark Office granted a new patent on July 16, 2024. This patent covers the use of its lead antibiotic candidate, ibezapolstat, for treating Clostridioides difficile Infection (CDI) while reducing the risk of recurrence. The patent highlights ibezapolstat’s unique ability to fight CDI and protect the beneficial gut microbiome, setting it apart from other treatments. Company leaders emphasize that this protection is timely and important as ibezapolstat continues to show unexpected positive effects on gut health. The achievement is expected to strengthen the company’s competitive position, improve patient outcomes, and potentially lower overall healthcare costs related to recurrent infections. This patent adds to Acurx’s growing portfolio of innovative approaches in the development of small molecule antibiotics for challenging bacterial infections.
Read Announcement- Drug:
- Ibezapolstat
- Announced Date:
- July 15, 2024
- Indication:
- Clostridioides difficile Infection
Announcement
Acurx Pharmaceuticals, Inc. announced that results from the ibezapolstat (IBZ) Phase 2 clinical trial in patients with C. difficile Infection (CDI) were presented at the 17th Biennial Congress of the Anaerobe Society of the Americas on July 11th which was held at the University of Michigan, Ann Arbor, from July 8 to 11, 2024.
AI Summary
Acurx Pharmaceuticals recently presented promising Phase 2 clinical trial results for its antibiotic ibezapolstat in patients with Clostridioides difficile Infection (CDI) at the 17th Biennial Congress of the Anaerobe Society of the Americas. The event was held at the University of Michigan, Ann Arbor, from July 8 to 11, 2024, with an oral presentation delivered on July 11. The trial data revealed that treatment with ibezapolstat led to favorable changes in the gut microbiome, including an increased relative proportion of beneficial Actinobacteria. Additionally, the results confirmed the preservation and even increased concentrations of the Firmicute phylum, which is important for maintaining bile acid balance and short chain fatty acid metabolism. These findings are consistent with earlier human volunteer and Phase 2a studies, reinforcing ibezapolstat’s potential to effectively treat CDI while reducing the risk of recurrence.
Read Announcement- Drug:
- Ibezapolstat
- Announced Date:
- May 15, 2024
- Indication:
- Clostridioides difficile Infection
Announcement
Acurx Pharmaceuticals, Inc. announced the successful outcome of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of ibezapolstat for the treatment of C. difficile Infection into Phase 3 studies based on the recently completed Phase 2 clinical trial results.
AI Summary
Acurx Pharmaceuticals, Inc. recently announced the successful outcome of an End-of-Phase 2 meeting with the FDA regarding its drug candidate ibezapolstat for treating C. difficile infections. During the meeting, the agency reviewed detailed data from the recently completed Phase 2 clinical trial and provided support for the drug’s progression into Phase 3 studies. The favorable feedback from the FDA highlights the potential of ibezapolstat to be both effective and safe for patients suffering from C. difficile, a challenging infection that often requires new treatment strategies. This advancement means that Acurx is now preparing for the next critical phase of testing, which will further assess the drug’s benefits and risks. The upcoming Phase 3 trials will be essential in confirming the candidate’s efficacy and may pave the way for its future approval as an important treatment option for C. difficile infections.
Read Announcement- Drug:
- Ibezapolstat
- Announced Date:
- May 2, 2024
- Indication:
- Clostridioides difficile Infection
Announcement
Acurx Pharmaceuticals, Inc. announced today that results from the ibezapolstat Phase 2 clinical trial in patients with C. difficile Infection (CDI) were presented at the 34th Congress of ESCMID Global (European Society of Clinical Microbiology and Infectious Diseases) on April 30th which was held in Barcelona, Spain, April 27-30, 2024.
AI Summary
Acurx Pharmaceuticals recently presented promising Phase 2 clinical trial results for ibezapolstat, a novel antibiotic targeting Clostridioides difficile infection, at the 34th Congress of ESCMID Global in Barcelona, Spain. Held from April 27 to 30, 2024, the conference featured a detailed oral presentation by Dr. Kevin Garey, who discussed key trial outcomes, including a clinical cure rate comparable to that of vancomycin and the notable absence of recurrence during a 28-day follow-up period. Complementing this, Dr. Eugenie Basseres presented a scientific poster that highlighted ibezapolstat’s efficacy against antimicrobial-resistant C. difficile strains. These findings underline ibezapolstat’s unique mechanism, which involves inhibiting DNA polymerase IIIC, and suggest its potential as an important therapeutic option as resistance issues continue to rise.
Read Announcement
Acurx Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Acurx Pharmaceuticals (ACXP) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Acurx Pharmaceuticals (ACXP) has reported FDA regulatory activity for Ibezapolstat.
The most recent FDA-related event for Acurx Pharmaceuticals occurred on June 17, 2025, involving Ibezapolstat. The update was categorized as "Results," with the company reporting: "Acurx Pharmaceuticals, Inc. announced the publication of results in Lancet Microbe of its Phase 2b clinical study entitled: Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with Clostridioides difficile infection: a phase 2b, randomized, double-blind, active-controlled, multicenter study."
Currently, Acurx Pharmaceuticals has one therapy (Ibezapolstat) targeting the following condition: Clostridioides difficile Infection.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ACXP) was last updated on 7/14/2025 by MarketBeat.com Staff
