SS-31 (Elamipretide) in Australia: A Research Overview

Short answer: what is SS-31?

SS-31 is a small synthetic peptide, also known as elamipretide, MTP-131, and historically Bendavia, that research describes as concentrating at the inner mitochondrial membrane. It was developed by Stealth BioTherapeutics and has been investigated in laboratory and clinical studies of mitochondrial function.

In Australia, SS-31 is not approved by the Therapeutic Goods Administration and is not listed on the Australian Register of Therapeutic Goods. NovaPeptides supplies SS-31 strictly for laboratory and scientific research, not for human or veterinary use.

What SS-31 is: identity and chemistry

SS-31 is a small synthetic tetrapeptide, meaning it is built from four amino acid residues. It belongs to a family of aromatic-cationic peptides first described in the scientific literature by Hazel Szeto and Peter Schiller, which is where the SS designation originates.

The reported sequence is D-Arg-2',6'-dimethyltyrosine-Lys-Phe-NH2. The alternating aromatic and basic residues give the molecule its aromatic-cationic character, a feature that research links to how it associates with the inner mitochondrial membrane. The same compound is referred to as elamipretide in clinical development, as MTP-131 and Bendavia in earlier development codes, and as Forzinity under its United States brand name.

Names used for the same molecule

• SS-31, the research designation
• Elamipretide, the generic name used in clinical development
• MTP-131 and Bendavia, earlier development codes
• Forzinity, a United States brand name

The cardiolipin and mitochondria mechanism described in research

Published research describes SS-31 as selectively binding cardiolipin, a phospholipid found almost exclusively in the inner mitochondrial membrane. Through this association the peptide is reported to accumulate many-fold within the inner membrane relative to its surrounding concentration.

In that research setting, the interaction with cardiolipin has been studied in relation to the structure of mitochondrial cristae, the organisation of electron-transport chain components, and the efficiency of energy-related processes. Studies have also examined reactive oxygen species generation in mitochondria. These descriptions reflect laboratory findings and are presented here to explain what the literature investigates, not to claim any human effect.

What the research has investigated and its clinical stage

Elamipretide has been investigated across a range of settings associated with mitochondrial function, including primary mitochondrial myopathy, Barth syndrome, heart failure, ischemia-reperfusion injury, and eye conditions such as geographic atrophy in dry age-related macular degeneration. Results across these programs have been mixed.

In primary mitochondrial myopathy, the phase 3 MMPOWER-3 trial did not meet its co-primary endpoints, which assessed the six-minute walk test and a fatigue symptom score. Investigators reported that elamipretide did not separate from placebo on those measures overall, while later subgroup analyses explored possible genotype-specific differences. These findings are reported neutrally and should not be read as evidence of benefit.

In Barth syndrome, a rare genetic condition, the TAZPOWER program supported a United States regulatory decision. On 19 September 2025 the United States Food and Drug Administration granted accelerated approval to elamipretide hydrochloride, under the brand name Forzinity, for improving muscle strength in adult and paediatric Barth syndrome patients weighing at least 30 kg. Accelerated approval in the United States is based on an intermediate endpoint, and continued approval is described as contingent on confirmatory evidence of clinical benefit.

A United States approval for one rare condition does not constitute approval in Australia, nor does it establish any effect for general research or non-clinical use.

Australian regulatory status

SS-31, also known as elamipretide, is not approved by the Therapeutic Goods Administration for any use in Australia and is not listed on the Australian Register of Therapeutic Goods. A regulatory decision made in another country, such as the United States accelerated approval of Forzinity, does not change this position in Australia.

Because it is not an approved therapeutic good here, SS-31 is handled in Australia as a research chemical. It is not supplied, labelled, or intended for human or veterinary administration. Anyone working with it in a research capacity is responsible for complying with all applicable Australian laws, institutional requirements, and import rules.

What research use only means

Research use only means a material is supplied for laboratory and scientific investigation and is not a medicine, supplement, or consumer product. It is not tested, labelled, or approved for use in humans or animals, and it should be handled only by people with appropriate training in a controlled research environment.

What research use only implies

• No human or veterinary use, and no self-administration
• No dosing guidance, protocols, or therapeutic instructions are provided
• No claims that the compound treats, cures, prevents, or improves any condition
• Handling, storage, and disposal follow standard laboratory safety practice
• The researcher is responsible for compliance with all applicable laws and institutional rules

NovaPeptides does not provide dosing information or usage protocols for SS-31, and nothing on this page should be interpreted as encouraging use in people.

A note on sport and anti-doping

Athletes and sporting bodies operate under the World Anti-Doping Agency framework, and the prohibited list is updated regularly. Based on available information, SS-31, also known as elamipretide, does not appear to be named under an explicit class on the current WADA prohibited list, but this is not clearly settled and lists change over time.

Because anti-doping rules can include broad catch-all categories and are revised each year, anyone subject to testing should not rely on this page. Check the current WADA prohibited list directly and seek guidance from the relevant anti-doping authority before making any decision.

How NovaPeptides supplies SS-31

NovaPeptides supplies SS-31 as a research chemical for laboratory use only. It is not offered for human or veterinary use, and no dosing or treatment guidance is provided with it.

What ships with research orders

• Research-use-only labelling and documentation
• A Novagen certificate of analysis for the relevant batch where available
• Shipping within Australia from an Australian-facing store

A certificate of analysis documents identity and purity testing for a batch and is provided for research record-keeping. It is not a claim of safety or suitability for any use in people. For questions about availability or batch documentation, contact NovaPeptides directly.

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