Metabolic
Elamipretide
SS-31 ยท Forzinity
Approved in the United States for one ultra-rare inherited condition, and nothing else. The trial programme behind it involved a handful of patients, and the approval was granted on the accelerated route, meaning confirmatory evidence is still required. Marketing that presents it as an anti-ageing or energy compound is going far beyond what was actually tested.
Mitochondria-targeting granted US FDA accelerated approval on 19 September 2025, solely to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg. No UK marketing authorisation was identified.
How well studied
Tier Guide: A = Well studied, B = Some good studies, C = Early evidence & D = Barely studied
Tested in people, but in smaller or fewer studies. A decent picture, just less certain.
UK status
How you could legitimately come across it here, if at all
No authorised UK medicine contains this, and we have no record of a routine UK clinic route. Material sold online is unregulated.
Evidence strength and UK regulatory status answer different questions.
Heightened caution: this compound carries unresolved regulatory, safety or supply-chain concerns in the UK. Nothing here is a recommendation to use it.
Overview
How it works
It binds cardiolipin, a fat found only in the inner membrane of mitochondria, and is proposed to help that membrane hold its shape so energy production works better. In people, this has only been tested where that membrane is known to be faulty.
Binds cardiolipin in the inner mitochondrial membrane and is proposed to stabilise cristae architecture and improve mitochondrial bioenergetics. Human testing has been confined to conditions with defined mitochondrial pathology, principally Barth syndrome.
Reported benefits
- US FDA accelerated approval covers one outcome only: improving muscle strength in adults and children with Barth syndrome weighing at least 30 kg
- The supporting human evidence base is very small, and confirmatory evidence is still required under the accelerated approval route
- Longevity, general energy, mitochondrial optimisation and wellness claims are not established by this approval
Who it's typically used for
Timeline to results
Safety & UK access
Dosage
Licensed in the United States for Barth syndrome only, where it is given under specialist medical supervision. That regimen is deliberately not reproduced here: it is a supervised treatment protocol for one diagnosed condition, not a self-administration dose. No UK-authorised product exists and no dose is established for any other purpose.
Side effects
- Injection site reactions, described in FDA information as mild to moderatevery common in the reported trial information
- Serious reactions have been reported in the FDA information; no reliable frequency is published for this app to quotereported
- Safety outside Barth syndrome, and at any other route or purposeinsufficient human data
Getting it in the UK
No authorised UK medicine contains this, and we have no record of a routine UK clinic route. Material sold online is unregulated.
Where it turns up
- Clinical trials only
- Not routinely available in the UK
- Unregulated online market
No UK marketing authorisation for elamipretide was identified in this audit. The current MHRA record is a paediatric investigation plan (MHRA-101705-PIP01-24-0) for Barth syndrome by the subcutaneous route, with the invented name recorded as "Not available at present" and a compliance opinion dated 24 July 2026. A paediatric investigation plan is an agreed plan for studying a medicine in children; it is not a marketing authorisation and does not make a product available in the UK. US approval does not create a UK licence.
No UK marketing authorisation identified; the MHRA record is a paediatric investigation plan, which is not an authorisation
MHRA: the UK regulator that assesses whether a medicine is safe and works before it can be authorised for use here. Something not being MHRA-licensed does not automatically mean it is illegal, and it does not mean it is safe.
This is background information about UK regulation, not advice about what you can or should obtain.
Evidence & sources
Why this rating?
The A to D rating shown above comes from our earlier editorial review and is still waiting to be migrated into the structured review record below. That is a gap in our record-keeping, not a sign the rating is wrong.
Evidence fingerprint
No route and indication scope has been published for this profile yet, so no fingerprint is shown.
Sources
Structured source audit not yet published for this profile. The references behind this page are being catalogued one compound at a time, and this one has not been through that process yet.
Content freshness
- Last reviewed
- 24 Sept 2026
- Regulatory status last checked
- 21 Aug 2026