Clinical Trials

Clinical trials are structured research studies that investigate how well new or existing medical approaches work in people, including treatments, tests, or preventive strategies for various conditions.​

Before a new treatment becomes widely available, it usually progresses through several trial phases and must be assessed and approved by national regulators, such as the TGA in Australia and the FDA in the United States. In Phase 1, researchers focus mainly on safety and finding an appropriate dose in a small group of participants, while Phase 2 looks more closely at whether the treatment works and what side effects occur in a larger group.​

People who join these studies are known as trial participants or volunteers and may be either healthy individuals or people living with a particular illness.

Syntara’s drug pipeline includes drugs at discovery, pre clinical, clinical phase 1 and phase 2 stage. Syntara has active clinical programs in three therapeutic areas:

The oral pan-LOX inhibitor amsulostat in combination with standard therapy 5-Azacitidine is being evaluated in patients with Myelodysplastic Neoplasms (MDS) or Chronic Myelomonocytic Leukemia (CMML). The study, supported by German Cancer Aid (Deutsche Krebshilfe), is being conducted at nine centres under Heidelberg University sponsorship.

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The MESSAGE trial will evaluate amsulostat, in combination with a hypomethylating agent, for treatment of patients with transfusion dependent, low and intermediate risk MDS. The trial is being led by the Australasian Leukaemia & Lymphoma Group (ALLG) and will recruit up to 30 patients across 10 hospitals in Australia.

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In a trial beginning later in 2026, amsulostat will also be evaluated in combination with standard of care chemotherapy for the treatment of advanced pancreatic cancer. This trial is being run by The Garvan Insitute of Medical Research, supported by funding from the Australian Government’s Medical Research Future Fund.

Syntara is currently evaluating the topical pan-LOX inhibitor, SNT-9465, in a randomised, double-blinded, placebo-controlled split-scar trial in 20 adult participants with hypertrophic sternotomy scars. The trial is being run at clinical sites in Queensland and Western Australia.

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The Fiona Wood Foundation and University of Western Australia are running an exploratory clinical trial in keloid scarring using Syntara-developed drug candidate SNT-6302.

Syntara’s Compassionate Use Policy

If you are not able to participate in a Syntara clinical trial, you may be eligible for compassionate access (also known as early access) to medicine. Please email us for more information about our Compassionate Use policy.

Email: medical.information@syntaratx.com.au

Syntara

Collaborating with scientific and clinical thought leaders worldwide and multiple publications in high-impact scientific journals.