Dimerix takes the reins on U.S. IND for renal asset DMX-652
Dimerix (ASX: DXB) has successfully completed the transfer of the U.S. Investigational New Drug (IND) application for DMX-652 from UK-based Mission Therapeutics. The clinical-stage biopharmaceutical company now holds full ownership of the IND and is the trial sponsor for the Phase 2-stage acute kidney injury (AKI) asset.
The move follows Dimerix’s recent acquisition of DMX-652, announced on 17 July 2026, which the company describes as a first and best-in-class asset. The renal candidate is Phase 2-ready under an existing open IND.
Assuming sponsorship gives Dimerix direct control over clinical development activities in the US and the ability to engage directly with the U.S. Food and Drug Administration (FDA).
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What the IND transfer means for Dimerix
The transfer marks an important milestone in the development of DMX-652. According to the company, IND sponsorship delivers three concrete benefits: direct engagement with the FDA, the ability to manage ongoing clinical development activities and timelines, and the ability to maximise the strategic value of the programme for later-stage development.
The DMX-652 acquisition from Mission Therapeutics was structured with a US$5 million upfront payment and total potential milestone payments reaching up to US$287 million, targeting a US$3.5 billion global AKI market that currently has no approved therapies and no known clinical-stage competitors.
On the back of encouraging safety and pharmacokinetic data observed in the extensive Phase 1 trial, together with promising pre-clinical data, Dimerix plans to advance DMX-652 into a Phase 2 clinical trial during the second half of 2026. The initial indication targeted is AKI associated with cardiac surgery.
Dr Nina Webster, CEO & Managing Director, Dimerix
“IND sponsorship enables the Company to engage directly with the FDA, manage ongoing clinical development activities and timelines, as well as maximise the strategic value of the program as we evaluate opportunities to advance DMX-652 into later-stage clinical development. We believe DMX-652 has significant potential across a range of mitochondrial dysfunction diseases, creating the opportunity to explore global commercial pathways and potential partnerships that may generate additional sources of income. Securing IND sponsorship positions Dimerix to drive the development of the asset in alignment with our broader pipeline strategy.”
Understanding acute kidney injury and the DMX-652 opportunity
The clinical problem
Acute kidney injury is a prevalent and severe clinical syndrome marked by a rapid decline in kidney function. It can arise from several high-risk clinical settings, including cardiac surgery and sepsis, and is often associated with high morbidity and mortality.
There are currently no approved therapies for AKI, and the condition is linked to an increased risk of chronic kidney disease and long-term kidney complications.
The current addressable high-risk patient population is estimated at approximately 260,000 per annum across the major markets of the United States, Germany, France, Italy, Spain and the United Kingdom. The company describes this indication as a potential orphan designation opportunity.
How DMX-652 works
DMX-652 is a selective inhibitor of USP30, a mitochondrial enzyme that slows the removal of damaged mitochondria.
The candidate is a small molecule delivered as a once-daily oral capsule, designed to support mitochondrial quality control in injured kidney cells. This mechanism is implicated in the progression of AKI caused by reduced blood flow and oxygen supply (ischaemia), toxins or sepsis, as well as other renal and non-renal indications.
The DMX-652 acquisition includes:
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Composition of matter patent
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An open IND in the US with an FDA-approved Phase 2 clinical trial protocol
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Sufficient GMP-grade drug product for the Phase 2 trial
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All manufacturing methodology
Dimerix’s broader renal pipeline
DMX-652 sits alongside Dimerix’s lead programme, DMX-200, which is in Phase 3 clinical development for focal segmental glomerulosclerosis (FSGS), a serious and life-threatening rare kidney disease with limited treatment options.
ACTION3 Phase 3 trial dosing was completed with 333 patients randomised across 21 countries, exceeding the original target of 286 and strengthening the statistical power of the primary endpoints ahead of the expected March 2028 data readout.
DMX-200 holds Orphan Drug Designation in the United States, Europe, the UK and Japan, and is protected by granted patents until 2032, with global applications that may extend protection to 2042. Dimerix is also supported by a growing network of five commercial partners underpinning global development and future market access.
The addition of DMX-652 brings a second high-need renal indication to the pipeline, broadening the company’s clinical footprint beyond FSGS.
| Program | Indication | Stage | Key point |
|---|---|---|---|
| DMX-200 | FSGS | Phase 3 | Orphan Drug Designation (US/EU/UK/Japan) |
| DMX-652 | Acute Kidney Injury | Phase 2-ready | Open US IND, no approved therapies for AKI |
What comes next
With sponsorship now secured, the focus shifts to progressing DMX-652 toward the clinic. The company has outlined the following forward steps:
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Preparations are underway for the DMX-652 Phase 2 trial in AKI associated with cardiac surgery
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The Phase 2 trial is targeted to commence in the second half of 2026
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Ongoing evaluation of opportunities to advance DMX-652 into later-stage clinical development and explore global commercial pathways and partnerships
Full IND sponsorship gives Dimerix direct control to drive the asset forward in alignment with its broader pipeline strategy.
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