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 and Travelan. 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:
- July 6, 2026
- 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 engaged Pullan Consulting to provide business development services to assist in securing a strategic partnership for IMM-529.
AI Summary
Immuron Limited said it has hired Pullan Consulting to help find a strategic partner for IMM-529, its oral antibody product being developed for Clostridioides difficile infection. The company wants business development support to move the program toward a partnership that could help speed development and future commercialization.
IMM-529 is designed to target three key parts of the C. diff disease process: toxin B, spores, and surface proteins on the bacteria’s active form. Immuron says this broad approach may give the product a unique position in the market. The company also noted that it has already prepared key trial materials, secured a lead investigator and Australian trial sites, and manufactured product for clinical use.
By bringing in Pullan Consulting, Immuron is signaling that it wants outside help to build the right commercial and development deal for IMM-529.
Read Announcement- Drug:
- IMM-529
- Announced Date:
- November 5, 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 the United States Food and Drug Administration (FDA) has approved Immuron's Investigational New Drug application for IMM-529 and the Phase 2 clinical trial may proceed.
AI Summary
Immuron Limited has announced that the U.S. Food and Drug Administration has approved its Investigational New Drug application (IND 032095) for IMM-529. This approval means the company can move forward with a Phase 2 clinical trial to prevent or treat Clostridioides difficile infection (CDI).
The Phase 2 study is set to begin in the first half of 2026. It will be a randomized, double-blind, placebo-controlled trial of up to 60 patients with either a first episode or recurrent CDI. Participants will receive IMM-529 plus standard of care antibiotics or a placebo plus standard care in a 2:1 ratio at multiple sites in Australia. The main goal is to assess safety and tolerability, while efficacy will be measured by comparing mortality rates, disease symptoms and recurrence rates between groups.
IMM-529 is an oral, bovine colostrum–derived antibody therapy that targets three key C. difficile components. Experts have praised its potential to fit early in the treatment pathway. If effective, analysts estimate a yearly market opportunity of about US$400 million.
Read Announcement- 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
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
