Clinical Trials
545
159 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1958
Active, not recruiting
50
9.2%
Completed
202
37.1%
Enrolling By Invitation
1
0.2%
Not yet recruiting
108
19.8%
Recruiting
142
26.1%
Suspended
1
0.2%
Terminated
28
5.1%
Unknown
4
0.7%
Withdrawn
9
1.6%
No approval data available
- A University of Sydney-led analysis of more than 64,000 middle-aged adults found that varied step counts and walking intensities were each linked to lower mortality risk. - Walking fewer than 5,000 steps daily at a brisk pace of about 80 steps per minute produced mortality reductions comparable to 5,000-7,500 slower steps. - A peak 30-minute cadence of roughly 90-100 steps per minute emerged as a potential target, while 7,500-10,000 daily steps tracked with the lowest mortality risk. - Researchers caution the observational design cannot prove causation, and independent experts note step-intensity evidence remains inconsistent across studies.
- A Monash University-led expert panel of 24 clinicians, bioengineers, bioethicists and governance professionals has issued recommendations on post-trial responsibilities for neural implant participants in Australia. - Participants in implantable neural device trials may face device removal when studies end if sponsors funded by grants or venture capital cannot cover lifelong support costs. - Australia currently has no rules requiring trial organizers to support participants long term or when trials are suspended or devices discontinued. - The panel recommends transparent disclosure of continued-use costs, regulatory status updates, and engagement of participants' primary physicians to reduce travel and geographic barriers.
- The STAREE trial showed atorvastatin 40 mg daily reduced major cardiovascular events by 30% versus placebo in adults aged 70 and older without known cardiovascular disease, diabetes, or dementia. - Over a median 5.9-year follow-up, major cardiovascular events occurred in 6.0% of the atorvastatin group versus 8.3% of the placebo group (HR 0.70; 95% CI 0.61–0.82; p<0.001). - Atorvastatin did not significantly improve disability-free survival (12.8% vs. 13.6%; HR 0.94; 95% CI 0.84–1.05; p=0.25), and no significant difference in dementia rates was observed. - Researchers call for updated treatment guidelines to support primary prevention of cardiovascular events in older adults.
- Researchers from the University of Warwick and Monash University found that the bacterial antibiotic gladiolin can switch Candida albicans from its invasive hyphae form back to a harmless yeast state. - Gladiolin works by altering fungal metabolism, causing the pathogen to burn through glucose faster and depriving hyphae of the fuel needed to sustain tissue invasion. - The study, published in Current Biology, builds on a 2024 discovery showing gladiolin also boosts the effectiveness of the antifungal drug amphotericin B. - The findings suggest a "disarm rather than kill" strategy that could help existing drugs defeat drug-resistant biofilms while enabling lower, less toxic antifungal doses.
- Researchers from Monash University and the Hudson Institute of Medical Research have created the first organoid models combining a patient's intestinal lining with their own gut bacteria to study inflammation. - The 'mini guts' allow scientists to test how individual patients' bacteria drive inflammation, moving beyond a 'one-size-fits-all' approach toward personalised IBD treatment. - The team has built a living biobank of matched organoids and bacterial collections from paediatric Australian patients, laying groundwork for testing tailored interventions before they reach the bedside. - IBD affects an estimated 180,000 Australians, with prevalence projected to reach 1 per cent of the population by about 2030, underscoring the urgent need for more precise therapies.
- CREATE Medicines secured worldwide exclusive rights to Monash University's TP1107 antibody-capture LNP system, which demonstrated an 8-fold increase in mRNA delivery to target cells in a 2025 Nature Nanotechnology study. - The deal arrives one day after CREATE received Australian ethics approval for its first-in-human Phase 1/2 trial of CRT-402, an in vivo CAR-T candidate targeting CD19 for autoimmune diseases. - The Monash technology orients antibodies on LNP surfaces via their Fc regions, ensuring optimal Fab exposure and enabling cell-type-specific delivery across T cells, NK cells, and myeloid cells. - CREATE has dosed over 50 patients across its clinical programs, representing the largest clinical dataset in the in vivo CAR therapy field, and now gains a proprietary targeting toolkit its competitors lack.
- A Monash University review found that medicinal cannabis products prescribed in Australia contain up to 88% THC, yet randomized controlled trials have only tested products up to 22% THC. - Category 5 products account for nearly half of all unapproved medicinal cannabis applications, with adverse events including psychosis, suicidal behavior, and cannabis hyperemesis syndrome. - AHPRA identified practitioners issuing over 10,000 high-THC prescriptions in six months, with some consultations lasting only seconds, raising concerns that profits are prioritized over patient safety. - The TGA is reviewing the unapproved medicinal cannabis framework, while medical bodies including the RACGP and AMA Queensland call for THC concentration limits and stricter prescribing regulations.
- Immuron has engaged Pullan Consulting to identify a strategic partner for Phase 2 development of IMM-529, an orally delivered polyclonal antibody targeting C. difficile infection. - IMM-529 is the only investigational drug to date demonstrating therapeutic potential across all three disease phases: primary prevention (80%, P=0.0052), recurrence protection (67%, P<0.01), and primary treatment (78.6%, P<0.0001). - A planned randomized, double-blind, placebo-controlled Phase 2 trial will enroll up to 60 subjects with first-episode or recurrent CDI, with base case yearly revenue projected at US$400M. - CDI affects over 400,000 people annually in the US and contributes to over 30,000 deaths, underscoring the urgent need for non-antibiotic therapeutic alternatives.
- Researchers at the University of Warwick and Monash University have revealed how bacterial enzymes use 'docking domains' to assemble multiple variants of powerful anti-cancer compounds through a combinatorial biosynthesis mechanism. - The study, published in Nature Communications, identifies a conserved connection point that allows different enzyme partners to mix and match, explaining how bacteria generate structural diversity in HDAC inhibitors like Romidepsin. - The team also identified the previously mysterious biosynthetic pathway for FR-901375, a chemically related depsipeptide HDAC inhibitor, by locating its gene cluster in Pseudomonas chlororaphis subsp. piscium. - Prof. Greg Challis states the discovery provides a blueprint to design synthetic pathways for new anti-cancer drug candidates with superior potency, improved selectivity, and fewer side effects.
- Professor Robyn Jamieson's team received $200,000 from the NSW Government's NAT-Net scheme to advance lab-grown retina research for inherited blindness over two years. - The project uses non-animal technologies to identify which patients with inherited blindness are most likely to respond to gene therapy, enabling access to previously unavailable treatments. - Two additional grants were awarded for programmable microbeads to grow human tissue and a computer model predicting side effects of medicines for spinal muscular atrophy and Huntington's disease. - The funding is part of a $4.5 million NSW Government investment to reduce animal use in medical research and accelerate human-relevant therapeutic discovery.
