Drugs / IMM-529
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Clostridium difficile colitis | 2025-10-08 | “submission of an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for the clinical development of IMM-529” immuron.com.au ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03065374 | Sep 2017 → Nov 2019 | Clostridium difficile colitis | Immuron Ltd. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-10-30 | Immuron Ltd. | Regulatory Clinical Trial Update immuron.com.au ↗
Immuron has received formal acknowledgment of its Investigational New Drug (IND) application from the Center for Biologics Evaluation and Research (CBER), including assignment of a biologic product name and IND number. |
| 2024-07-01 | Immuron Ltd. | Regulatory IMM-529 pre-IND FDA filing immuron.com.au ↗ |
| 2016-01-12 | Immuron Ltd. | Results IMC Achieves Outstanding Results in C-Diff Recurrence Study immuron.com.au ↗ |
| 2015-12-21 | Immuron Ltd. | Results IMC Reports Highly Successful C-Diff Pre-Clinical Results immuron.com.au ↗
The results of these pre-clinical studies showed 80 % efficacy in both the treatment and the prevention of C. difficile infections without the use of antibiotics. |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-05 | Immuron Ltd. | IMM-529 CDI Partnering Update immuron.com.au ↗ |
| 2025-10-30 | Immuron Ltd. | Clinical Trial Update immuron.com.au ↗ |
| 2024-09-05 | Immuron Ltd. | Immuron Plans Phase 2 Trial for IMM-529 following FDA review immuron.com.au ↗ |
| 2024-07-01 | Immuron Ltd. | IMM-529 pre-IND FDA filing immuron.com.au ↗ |
| 2016-01-13 | Immuron Ltd. | Analyst Reports on Immuron IMM-529 C. difficile Program immuron.com.au ↗ |
| 2016-01-12 | Immuron Ltd. | IMC Achieves Outstanding Results in C-Diff Recurrence Study immuron.com.au ↗ |
| 2015-12-21 | Immuron Ltd. | IMC Reports Highly Successful C-Diff Pre-Clinical Results immuron.com.au ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMM-529 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03065374 ↗ |
| Route | Oral | “IMM-529, 1000 mg three times daily, orally” NCT03065374 ↗ |