Syntro Health engaged to advance Stabl-Im clinical trial formulation
TrivarX Limited (ASX: TRI) has entered into an agreement with Australian pharmaceutical manufacturing specialist Syntro Health to undertake laboratory formulation activities for its Stabl-Im imaging platform. The company described the engagement as a further milestone in preparations for its planned clinical trial.
The agreement follows the company’s clinical development update of 23 September 2026. That update outlined progress across key workstreams required to advance Stabl-Im into clinical evaluation.
Under the agreement, Syntro Health will undertake laboratory formulation activities to support development of the Stabl-Im investigational product for clinical use. First patient enrolment is currently scheduled for Q1 2027. The announcement does not disclose the contract value, fees or the timeline for completing formulation.
Dr Danielle Meyrick, CEO
“Ensuring a suitable formulation for clinical use is an important component of our preparations, and Syntro brings specialist pharmaceutical manufacturing expertise and established infrastructure to support this work.”
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Why Syntro Health matters for the trial pathway
Who is Syntro Health
Syntro Health is an Australian specialist in investigational medicinal product (IMP) manufacturing and management. An IMP is the drug or compound being tested in a clinical trial.
Its services cover pharmaceutical development, manufacturing, packaging, storage and distribution for clinical trials. The company operates Therapeutic Goods Administration (TGA)-licensed current Good Manufacturing Practice (cGMP) facilities and supports pharmaceutical and biotechnology companies undertaking Phase 1 through Phase 4 clinical studies.
Workstreams now running in parallel
The September update identified several workstreams needed to move Stabl-Im into clinical evaluation. The Syntro Health work is expected to complement activities already under way:
- Investigational product formulation
- Analytical method work-up
- Dosing protocols
- Clinical study site selection
According to the announcement, the engagement gives TrivarX access to established pharmaceutical formulation expertise and infrastructure as it progresses the technical and operational requirements for its planned clinical trial. For investors, this means formulation work draws on existing facilities rather than requiring in-house capability to be built.
Understanding Stabl-Im and stable isotope MRI imaging
Stabl-Im is an imaging platform with potential to combine stable isotope technology with magnetic resonance imaging (MRI) to provide insights into cellular activity and metabolism. MRI is a scan that produces detailed images of the body’s internal structures.
A stable isotope is a form of an element that is not radioactive. The company’s profile states that Stabl-Im uses stable isotope labelling combined with MRI to enable non-invasive imaging of cellular proliferation.
The technology has the potential to enable non-invasive assessment of disease activity and response to therapy. Formulation matters because the investigational product must be prepared for clinical administration before it can be given to patients in a study.
Formulation follows earlier progress on investigational product supply, which TrivarX secured in July 2026 as a mandatory prerequisite before the trial could advance.
Stabl-Im sits within TrivarX’s focus on diagnostic and imaging solutions across mental health and neuro-oncology.
| Fact | Why it matters |
|---|---|
| Syntro Health operates TGA-licensed cGMP facilities | Specialist investigational medicinal product manufacturing and clinical trial supply services |
| Laboratory formulation activities under the agreement | Supports preparation of Stabl-Im for clinical administration |
| First patient enrolment currently scheduled for Q1 2027 | Marks the planned start of the clinical feasibility study |
Feasibility study objectives and next steps
The planned clinical feasibility study will evaluate:
- Safety
- Feasibility
- Pharmacokinetics
- Reproducibility of systemic deuterium enrichment
Pharmacokinetics refers to how a substance moves through the body over time. Results are intended to inform subsequent clinical development and the potential expansion of the platform into broader applications.
The announcement describes formulation, analytical method work-up, site selection and clinical study preparation as ongoing, complementary activities. Each completed workstream moves the company closer to first patient enrolment.
The specialist CRO engagement announced in May 2026 covers protocol completion, regulatory documentation and clinical site selection, which sit alongside the formulation work now being handled by Syntro Health.
Dr Meyrick said the company continues to make progress across the technical, clinical and operational activities required to commence the study. She stated that its focus remains on “…systematically completing these activities to ensure Stabl-Im is appropriately evaluated in the clinic and to establish a strong foundation for the platform’s longer-term development.”
Investors may watch for further announcements on formulation, site selection and enrolment timing. The announcement does not address funding or cash, and does not discuss expected study outcomes.
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