This section highlights FDA-related milestones and regulatory updates for drugs developed by IMMURON (IMRN).
Over the past two years, IMMURON has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IMM-529, Travelan, and Campylobacter. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
IMM-529 FDA Regulatory Timeline and Events
IMM-529 is a drug developed by IMMURON for the following indication: Oral polyclonal antibody, targeting toxin B in the human gut and neutralises main virulence factors of Clostridium 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:
- IMM-529
- Announced Date:
- October 8, 2025
- Indication:
- Oral polyclonal antibody, targeting toxin B in the human gut and neutralises main virulence factors of Clostridium infection
Announcement
Immuron Limited announce that it has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for clinical development of IMM-529.
AI Summary
Immuron Limited announced it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for IMM-529, an oral antibody therapy designed to treat Clostridioides difficile infection (CDI) and prevent its recurrence.
Under the new IND, Immuron plans to start a Phase 2 clinical trial in the first half of 2026, enrolling both first-episode and recurrent CDI patients. Independent market analysis estimates roughly 98,000 U.S. patients could be eligible at the first recurrence stage. Pending efficacy results, IMM-529 could be positioned early in the treatment algorithm under payer guidelines, with base-case annual revenue projected at about US$400 million. Infectious disease specialists have rated the oral delivery route as highly appealing.
IMM-529 is built on bovine-derived polyclonal antibodies that target C. difficile toxin B, spores and surface proteins. Its mechanism aims to accelerate pathogen clearance and support rapid restoration of healthy gut microbiota, meeting a critical unmet need in CDI management.
Read Announcement- Drug:
- IMM-529
- Announced Date:
- September 5, 2024
- Indication:
- Oral polyclonal antibody, targeting toxin B in the human gut and neutralises main virulence factors of Clostridium infection
Announcement
Immuron Limited announce that it has received favourable feedback from the United States Food and Drug Administration (FDA) on the pre-IND (investigational new drug) information package to support the clinical development of IMM-529.
Read Announcement- Drug:
- IMM-529
- Announced Date:
- July 2, 2024
- Indication:
- Oral polyclonal antibody, targeting toxin B in the human gut and neutralises main virulence factors of Clostridium infection
Announcement
Immuron Limited announce that it has filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for IMM-529.
AI Summary
Immuron Limited, an Australian biopharmaceutical company, has taken a significant step in developing its new therapy, IMM-529, by filing a pre-IND (investigational new drug) application with the US Food and Drug Administration. This move marks the company’s progress toward advancing IMM-529 into later clinical studies.
IMM-529 is designed as an adjunct therapy to be used with standard antibiotics to prevent and treat recurrent Clostridioides difficile infections (CDI). The treatment works by using antibodies produced from hyperimmune bovine colostrum to target key elements of C. diff. This innovative approach may help clear the infection while supporting the re-establishment of the normal gut flora, addressing the challenge posed by recurrent CDI. Immuron’s pre-IND filing demonstrates its commitment to offering new strategies against bacterial infections and tackling the issue of antibiotic resistance.
Read Announcement
Travelan FDA Regulatory Events
Travelan is a drug developed by IMMURON for the following indication: To prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Travelan
- Announced Date:
- October 2, 2025
- Indication:
- To prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).
Announcement
Immuron Limited is pleased to provide shareholders with a brief update on progress with a number of projects.
AI Summary
Immuron Limited gave shareholders an update on its projects. It expects no material impact from new US tariffs on pharmaceutical products. Topline results for the Travelan® clinical study are due in October 2025, following its final participant visit.
We plan to submit an IND application for IMM-529 to the US FDA in mid-October 2025. Approval will allow a Phase 2 clinical program to treat Clostridioides difficile infection and prevent recurrence. Market estimates suggest IMM-529 could reach peak US revenues of around US$400 million.
Immuron will launch ProIBS® in Australia in Q4 2025, ahead of a full rollout in Q1 2026. This product targets IBS symptoms like abdominal pain, bloating, and bowel changes. Initial pre-clinical studies for IMM-986, aimed at vancomycin-resistant enterococci, are expected to finish by year-end 2025, with results released after ethics approval.
Read Announcement- Drug:
- Travelan
- Announced Date:
- January 14, 2025
- Indication:
- To prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).
Announcement
Immuron Limited announce that it has submitted the Clinical Study Report to the U.S. Food and Drug Administration (FDA) for the recently completed Phase 2 study and will soon request an end of Phase 2 meeting which is a pre-cursor to proceeding to Phase 3.
AI Summary
Immuron Limited recently submitted the Clinical Study Report for its Phase 2 study of Travelan® (IMM-124E) to the U.S. Food and Drug Administration. The company will soon request an end-of-Phase 2 meeting, an important precursor before advancing to Phase 3. This meeting will help guide the next steps in the clinical development process.
During the Phase 2 study, significant immunology and microbiome results were observed. Subjects treated with Travelan® showed statistically lower levels of IgA and IgG compared to those receiving a placebo, and they experienced fewer colony forming units (CFUs) in their stools, indicating faster clearance of harmful bacteria. Additionally, the Travelan® group maintained a more stable gut microbiome with increased beneficial bacteria, supporting quicker recovery from gastrointestinal challenges. This progress marks a key milestone in Travelan®’s development for preventing travelers’ diarrhea.
Read Announcement
Campylobacter ETEC Therapeutic (ETEC) FDA Regulatory Events
Campylobacter ETEC Therapeutic (ETEC) is a drug developed by IMMURON for the following indication: ETEC infections.
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:
- Campylobacter ETEC Therapeutic (ETEC)
- Announced Date:
- October 4, 2024
- Indication:
- ETEC infections
Announcement
Immuron Limited announce that the NMRC has completed the interim analysis for the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC).
AI Summary
Immuron Limited announced that the U.S. Naval Medical Research Command (NMRC) completed its interim analysis of a clinical trial testing a new oral therapeutic targeting Campylobacter and Enterotoxigenic E. coli (ETEC). The therapeutic, made using a hyperimmune bovine colostrum product produced with a conjugated vaccine, is designed to boost the body’s defense against these bacteria that cause diarrheal disease. In the study, 27 volunteers participated in a controlled human infection trial where interim results showed a 10.4% protective efficacy against moderate to severe campylobacteriosis compared to a placebo. Data analysis is still ongoing, and further insights from secondary and exploratory endpoints are expected. The findings will be presented at an upcoming international workshop, which could help further refine this approach in preventing these common gastrointestinal infections.
Read Announcement
