TrivarX advances Stabl-Im toward clinical feasibility study
TrivarX Limited (ASX: TRI) has provided a broad development update on its Stabl-Im stable isotope-enhanced MRI platform, with multiple concurrent workstreams advancing in preparation for the company’s planned clinical feasibility study. The update covers both clinical and operational progress, reflecting a coordinated build-out of the infrastructure required to move Stabl-Im into clinical evaluation.
Key activities reported across the program include:
- Clinical feasibility study design requirements: completed
- Pre-clinical studies: underway
- Investigational product: received and in specialist preparation
- Site and Principal Investigator (PI) selection: commenced
- Specialist deuterium analytical vendor: preferred vendor identified, with discussions advancing
- Clinical trial manager: added to the team to support trial start-up and ongoing execution
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What is Stabl-Im and why does it matter?
Stabl-Im is TrivarX’s proprietary stable isotope-enhanced MRI platform. It works by using deuterium oxide (D2O) labelling to enable non-invasive imaging of cellular proliferation, meaning it can show how quickly cells are dividing inside the body without requiring invasive procedures such as biopsies.
This capability has potential clinical significance across TrivarX’s focus areas of mental health and neuro-oncology diagnostics, where monitoring cellular activity can be informative for diagnosis and treatment monitoring. Because deuterium measurement in biological samples is a specialised technique not available through conventional clinical trial laboratories, the company must work with purpose-built analytical vendors to generate reliable study data. Establishing this analytical infrastructure is therefore a foundational step, not a peripheral one, in the broader clinical development program.
Progress across the development program
The table below outlines the current status and indicative timing for each activity within the Stabl-Im development program, as reported in the 23 September 2026 ASX announcement.
| Activity | Status | Timing |
|---|---|---|
| Preclinical study design and testing requirements finalised | Completed | Q2 CY26 |
| Preclinical studies commenced | Underway | Q3 CY26 |
| Preclinical studies finalised | Pending | Nov CY26 |
| Clinical feasibility/plasma enrichment study trial design and requirements finalised | Underway | Q4 CY26 |
| Site and Principal Investigator selection | Underway | Q4 CY26 |
| Ethics submission for clinical feasibility study | In preparation | Jan CY27 |
| Anticipated ethics committee determination for clinical feasibility study | Pending | Q1 CY27 |
| First participant enrolled | Pending | Q2 CY27 |
| Recruitment completed/last participant enrolled | Pending | Q2 CY27 |
| Data analysis and initial clinical study results available | Pending | H1 CY27 |
| Assessment of next stage regulatory and clinical development pathway | Planned | — |
The company notes that this timeline is indicative and subject to the usual clinical development considerations.
Three workstreams advancing in parallel
Clinical site and Principal Investigator selection
The formal selection process for the clinical site and PI is underway. TrivarX is seeking a site with demonstrated capability in conducting healthy-volunteer studies. The company is prioritising a clinical team that can work collaboratively with management and its existing clinical development partners to support streamlined study initiation and efficient participant recruitment.
Specialist CRO Beyond Drug Development was engaged earlier in the program to complete the clinical protocol, prepare regulatory documentation, and identify clinical sites, with the organisation bringing an average team experience of more than 20 years in clinical development.
Specialist deuterium analysis
Measuring deuterium in plasma requires a specialised analytical technique that is not routinely available through conventional clinical trial laboratories. TrivarX has identified a preferred specialist technical vendor and is advancing discussions to establish and optimise the analytical methodology. The preferred vendor is expected to draw on published methods and adapt them to the specific requirements of the planned study, with the aim of supporting a reliable, scalable, and cost-effective analytical approach as Stabl-Im progresses through clinical evaluation.
Investigational product preparation
The investigational product supply for the planned clinical feasibility study was received following the 16 July 2026 ASX announcement. The company is currently working alongside a specialist vendor to prepare the investigational product for individual study participants in accordance with applicable Therapeutic Goods Administration (TGA) requirements. This workstream is advancing concurrently with site selection and analytical method development, enabling key study-readiness activities to progress in parallel.
Securing investigational product supply represented a mandatory prerequisite gate for the program, with TrivarX clearing that milestone in July 2026 and keeping the overall clinical commencement timeline on track.
Expanding Stabl-Im’s potential applications
Beyond its lead clinical program, TrivarX has commenced the pre-clinical animal studies contemplated within its broader development program. Building on a scientific review of historical D2O-associated data, management has also initiated a series of additional non-clinical studies to investigate further potential clinical applications for the platform. Results from this initiative are expected to materialise in Q4 CY26.
This work is intended to deepen the company’s understanding of Stabl-Im and may inform development opportunities complementary to the lead clinical program, broadening the platform’s future pipeline without diverting focus from the primary feasibility study.
CEO Dr Danielle Meyrick
“Our focus is on establishing the right foundations to give the Stabl-Im clinical program the best opportunity for success. We are applying a ‘measure twice, cut once’ philosophy – making considered decisions now about preclinical and clinical study designs, clinical partners, analytical methodology and vendor selection so that we are well positioned to execute efficiently and build sustainable value once our first clinical trial commences.
“That is particularly important for Stabl-Im, which does not follow a conventional device study pathway. We are bringing together an investigational product, a specialised deuterium analysis methodology and MRI within a clinical setting. The careful integration of all operational components is central to generating high-quality, informative data as we begin recruiting participants.
“We have made meaningful progress across these foundations in recent months. The clinical and pre-clinical study design work has been completed, our pre-clinical studies are underway, investigational product has been received, and we are now advancing site and Principal Investigator selection, product preparation and the specialist analytical work required for the clinical study.
“Completing the work thoroughly at the outset is expected to support efficient study execution and strengthen the quality and utility of the data generated. Our objective is to establish a clinical program that evaluates Stabl-Im in its initial application while also creating a strong foundation from which to explore the platform’s broader potential over time.”
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