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Peptides Explained

Mitochondrial

SS-31 (elamipretide)

A US medicine for one rare muscle disease. Online vials sold as SS-31 are a different product.

Authorised outside the EU

Short page. This is a short page. A full page with the complete evidence review is planned for version 1.1. The grades and regulatory status below are complete and sourced.

At a glance

Is it an approved medicine?
Not in the EU Approved only in some countries outside the EU.
Has it been tested in people?
Some Approved on a 12-patient trial that missed its main goals. Bigger trials in other diseases found no benefit.8,7,14,12,15
Is it allowed in sport?
Unclear Not named on the anti-doping list. Ask your anti-doping organisation before using it in sport. Regulatory status
What is the biggest risk?
Sore, red skin where you inject. Some had serious allergic reactions. More about the risks

Status checked on . The details and sources are further down this page.

Stop and get help if you notice

  • Swollen face or throat, or trouble breathing3,51
  • Hot, red, swollen or painful injection site49
  • Fever or chills after you inject it50

If it is severe, call your local emergency number.

All warning signs, further down this page Warning signs for any peptide

The 30-second version

About 5 minutes for the short version; 11 with every detail open.

  • SS-31 is a lab-made chain of four amino acids. Its medicine name is elamipretide.
  • Since 2025 it is a US prescription medicine for Barth syndrome, a rare muscle and heart disease.
  • The approval is conditional. It rests on 12 patients, and a new trial must confirm the benefit.
  • In bigger trials for other diseases it did not help. It is not approved in the EU.
  • A vial sold online as 'SS-31' is not the approved medicine. No regulator has checked it.
Class
Mitochondrial
How it is taken
Injection under the skin, once a day
Approved for
Barth syndrome, in the US, since 2025
Type of approval
Accelerated: the benefit still has to be confirmed
Most common side effect
Redness, pain or itching where it is injected
Status in the EU
Not authorised
Tested in people
Some

Label facts, not dosing advice. Sources are in the sections below.

Last reviewed
Muscle fibres under a microscope: long pink strands with fine cross-stripes and dark nuclei along their edges.
Muscle under the microscope. A US approval covers muscle strength in one rare disease. Photo: Berkshire Community College Bioscience Image Library, Muscle Tissue: Skeletal Muscle Fibers (Wikimedia Commons) CC0 1.0 Image details

Each section starts with the short answer. The rest is folded under “In detail”.

Evidence profile

Four separate questions. Not a score.

Human clinical evidence How far has it been tested in people?
Authorised by a regulator
Preclinical volume How much laboratory and animal research exists?
Extensive
Source independence How many independent groups produced it?
Broadly replicated
Safety characterisation How well do we know the harms in humans?
Partial
In detail Why these grades: the reason for each step
Human clinical evidence
Authorised under our rubric: the FDA approved it as Forzinity in September 2025. The approval rests on a 12-patient crossover trial that missed both main goals and on open-label follow-up of 8 to 10 of those patients; a phase 3 trial in 218 adults with another mitochondrial disease found no benefit.
Preclinical volume
Extensive. On 23 October 2026 PubMed held 258 non-review records on elamipretide or SS-31 that mention rats or mice.
Source independence
Broadly replicated in animals: only 32 of those 258 records include the originating Szeto group. In people it is different: every clinical trial we found was funded by the developer, Stealth BioTherapeutics.
Safety characterisation
Partial. A few hundred people received it in trials lasting weeks to months, and 3 patients with Barth syndrome for 192 weeks. No cancer studies in animals had been done at approval (the FDA has required them), and experience after approval is short.

We never add these up. A compound can have a large animal literature from one laboratory and no human data at all — that is a specific situation, and a single number would hide it. How we grade evidence

In detail The molecule: amino-acid sequence and technical details
Amino-acid sequence4 amino acids

H–D-Arg-Dmt-Lys-Phe-NH2

Read from the N-terminus (start) to the C-terminus (end).

Modifications
position 1: D-Arg: the mirror-image form of arginine
position 2: Dmt: 2′,6′-dimethyltyrosine, a tyrosine with two extra methyl groups
D-form (mirror-image) amino acid
D-Arg (1)
non-standard amino acid
Dmt (2)
Full name
Elamipretide (D-Arg-Dmt-Lys-Phe-NH2)
International non-proprietary name
elamipretide
Also called
MTP-131, Bendavia, elamipretide hydrochloride, Szeto-Schiller peptide 31
Authorised products
Forzinity
Class
Mitochondrial
Body systems
Muscles, tendons, bones, Heart and blood vessels, Cells and mitochondria
Formula
C32H49N9O5
Molecular mass
639.8 Da

What it actually is

What is SS-31?

A tiny lab-made peptide aimed at mitochondria. In the US it is a medicine for one rare disease.
The US medicine and an online 'SS-31' vial share a name, not a guarantee. What is known about each, from the FDA label and FDA enforcement letters, checked on 23 October 2026.
Forzinity (elamipretide), US prescription medicineVial sold online as “SS-31”
Checked by a regulator?Yes Approved by the FDA in 2025, under accelerated approval.1No The FDA has warned sellers offering SS-31 “for research” that these are unapproved drugs.2
Contents and strength stated and checked?Yes The label states what each vial contains.3Unknown No regulator has checked it.2
Made sterile?Yes A sterile liquid with a preservative.3Unknown Not known.
Approved for any use in the EU?No No EU authorisation.4No No.

SS stands for Szeto-Schiller, after the two researchers who designed this family of peptides.5,6 Barth syndrome is a rare inherited disease, mostly of boys and men, that can weaken the heart and muscles.7,8

In detail The molecule, and how it was approved

SS-31 is D-Arg-Dmt-Lys-Phe-NH2: four building blocks, two of them changed in the lab. The first is the mirror-image form of arginine; the second, Dmt, is tyrosine with two extra methyl groups. The formula of the free peptide is C32H49N9O5, mass 639.8 g/mol.3,5 The design alternates ring-shaped and positively charged building blocks, which lets it slip into cells.6

The developer, Stealth BioTherapeutics, applied to the FDA in January 2024. On 10 October 2024 an FDA advisory committee voted 10 to 6 that it is effective for Barth syndrome, while noting “significant uncertainty”.9 The FDA did not approve it at first: on 15 May 2025 it sent a letter that did not approve it. The company replied in full in August, and the FDA granted accelerated approval on 19 September 2025.10 Accelerated approval is based on a measure “reasonably likely to predict” benefit, here the strength of the muscle that straightens the knee, not on proof that patients feel or function better.7

How it works

How does it work?

It sticks to cardiolipin, a fat in the inner wall of mitochondria. How this helps patients is unclear.
The proposed causal chain, step by step

Each step is labelled with how well the link from the previous step is established.

  1. Step 1 Binding In cells

    Enters cells and gathers in mitochondria

    In cell studies by the inventors, the peptide crossed cell membranes and became about 1000 times more concentrated in the inner membrane of mitochondria than outside.

  2. Step 2 Cell response In animals

    Binds cardiolipin in the inner membrane

    It binds cardiolipin, a fat molecule that the energy-making machinery needs. In rats whose kidneys had lost blood flow, it protected mitochondria and kidney function (originating group). The US label calls it a cardiolipin binder.

  3. Step 3 Effect on the body In humans

    Stronger leg muscles in Barth syndrome: not yet confirmed

    Knee strength rose only in the open-label part of the Barth syndrome trial, without a comparison group; the randomised part showed no difference. Trials in heart attack, heart failure and mitochondrial myopathy found no benefit.

In detail What each step rests on

The first two steps come from cell, isolated-organ and rat studies, mostly by the inventors.6,11 In Barth syndrome, a faulty gene changes cardiolipin itself, which is why this disease was a logical target.8 That a molecule binds the right fat does not show that patients get stronger: the trials below are the test of that.

What the evidence actually shows

Does it work?

The proof is weak and comes from a few patients. Bigger trials in other diseases showed no benefit.

In the only randomised part, the main goals were not met

0 of 2

main goals improved after 12 weeks on the drug against 12 weeks on placebo

Who took part TAZPOWER part 1: 12 males with Barth syndrome, crossover trial Source Reid Thompson et al. (2021)8 Evidence Human trials

Knee strength rose later, with no comparison group

+63 N

median rise in knee strength by week 168, from 124 N at the start

Who took part TAZPOWER open-label extension: 8 patients with Barth syndrome Source FORZINITY (elamipretide) injection, for subcutaneous use3 Evidence Humans, limited

In another muscle disease it did not help

−3.2 m

difference from placebo in distance walked in six minutes, after 24 weeks

Who took part MMPOWER-3: 218 adults with primary mitochondrial myopathy Source Karaa et al. (2023)12 Evidence Human trials

The FDA used its accelerated route, meant for serious diseases without good treatment, and accepted a measure that may predict benefit. A new randomised trial in 48 patients started in 2026.7,13

In detail Every study in one table

7 studies: 5 in humans, 1 in animals, 1 in cells, 0 reviews or other.

Studies discussed on this page
Study Species n Design Funding Research group What it found What it did not show
Zhao et al. 2004 6 Mixed not reported Laboratory (cells) (controlled) Government Originating group Peptides of this design entered cells, gathered about 1000-fold in the inner mitochondrial membrane, reduced damaging oxygen molecules and cell death in cultured cells, and improved contraction of an isolated heart after blood flow returned. Cells, isolated mitochondria and isolated hearts from the inventors' laboratory; no living patient.
Birk et al. 2013 11 Mixed not reported Animal experiment (controlled) Government Originating group SS-31 bound cardiolipin and protected mitochondria and kidney function in rats after the kidneys' blood flow was stopped and restarted. Rat model from the originating group; a short, acute injury, not a chronic disease.
Gibson et al. 2016 14 Humans 300 Phase II trial (controlled, blinded) Industry Originating group In people with a first heart attack treated with a stent, a one-hour drip did not make the heart damage smaller and did not improve any scan, ECG or clinical result. One short drip in hospital; enrolment of 300 is from the trial registry; developer-funded.
Butler et al. 2020 15 Humans 71 Phase II trial (controlled, blinded) Industry Originating group In 71 people with weak heart pumping, 4 weeks of daily injections were well tolerated but did not improve the size or pumping of the heart compared with placebo. Short and small; heart failure is not the approved use.
Reid Thompson et al. 2021 8 Humans 12 Randomised controlled trial (controlled, blinded) Industry Originating group In 12 males with Barth syndrome, 12 weeks on elamipretide and 12 weeks on placebo in random order: neither main goal (walking distance, tiredness score) improved. Very small; short; developer-funded and co-analysed. This is the only randomised evidence for the approved use.
Karaa et al. 2023 12 Humans 218 Phase III trial (controlled, blinded) Industry Originating group In 218 adults with primary mitochondrial myopathy, 24 weeks of daily injections did not improve walking distance (difference −3.2 m) or tiredness compared with placebo; it was mostly well tolerated. A different disease from Barth syndrome; developer-funded.
Thompson et al. 2024 52 Humans 10 Open-label study (uncontrolled) Industry Originating group Of 10 patients who continued on open-label elamipretide, 8 reached week 168. Walking distance and knee strength improved compared with the start of the extension; skin reactions where injected were the most common side effect. No comparison group, so improvement from growing up, practice or natural ups and downs cannot be ruled out; developer-funded.

Trials in other conditions were negative: one hour of the drug during a stent procedure for a heart attack did not reduce heart damage, and 4 weeks in 71 people with heart failure did not improve the heart’s pumping.14,15 A phase 3 trial in dry age-related macular degeneration, an eye disease, is still running.16

In detail Who paid for the evidence

Every clinical trial we found was funded by Stealth BioTherapeutics; in the Barth syndrome trial the company helped design it and analyse the data.8,12,17 The animal research is broader: most of it comes from groups other than the inventors.17

Regulatory status

Is it legal?

A prescription medicine in the US since 2025. Not approved in the EU or the Netherlands.
The FDA said not yet in May 2025, then yes in September. Proof of benefit is still due. The US approval of Forzinity, from application to the required confirmatory trial.

  • FDA review until the first answer (not approved yet)

    29 January 2024 to 15 May 2025

  • Approved, under accelerated approval

    since 19 September 2025

  • Confirmatory trial (48 patients)

    recruiting since July 2026

    Not known: the outcome; main results planned for late 2029

Sources NDA 215244 Accelerated Approval letter; Drugs@FDA; U.S. National Library of Medicine, ClinicalTrials.gov (2026)10,1,13 Checked

In detail Status in each country, and in sport
Regulatory status by jurisdiction
Jurisdiction Status Note Checked
European Union Not authorised Not authorised. EU orphan designations only (2021, 2022); no application under evaluation in October 2026. 4,19,18
Netherlands Not authorised Not authorised. Supplying a medicine without a marketing authorisation is prohibited, with narrow exceptions. 20,21
United States Authorised Since FDA accelerated approval as Forzinity on 19 September 2025, for Barth syndrome (30 kg or more). A confirmatory trial is required. 1,10,3
Sport (WADA) Unclear (not named) Unclear: not named on the 2026 or 2027 List. As an FDA-approved medicine it falls outside S0, but other classes may apply. No ruling found. 22,23,24,25,26

Statuses were checked on 23 October 2026. In the EU, elamipretide has orphan designations for Barth syndrome (2021) and a mitochondrial DNA disease (2022). That status supports development; it is not permission to sell.18 No EU application was under evaluation in October 2026.19 The Dutch medicines database lists no product, and Dutch law forbids supplying a medicine without a marketing authorisation, with narrow exceptions.20,21

In sport, elamipretide is not named on the 2026 or 2027 Prohibited List or the Monitoring Program. The S0 class covers only substances that no government health authority has approved, and the FDA has now approved it. But WADA says an unnamed peptide may also fall under other classes, and no anti-doping body has ruled on elamipretide. Athletes should ask their anti-doping organisation.22,23,24,25,26

Risk profile

What are the risks?

Red, sore skin where it is injected is very common. Some people had a bad allergic reaction.
In the Barth syndrome trial, skin reactions where it was injected were very common. Out of 12 patients who each had 12 weeks on the drug and 12 weeks on placebo, shown as people in 100. Very small numbers.

  • Redness where injected

    100 in 100 Elamipretide

    25 in 100 Placebo

  • Pain where injected

    75 in 100 Elamipretide

    42 in 100 Placebo

  • Hard skin where injected

    67 in 100 Elamipretide

    17 in 100 Placebo

  • Itching where injected

    67 in 100 Elamipretide

    17 in 100 Placebo

Each square is one person in 100. Source FORZINITY (elamipretide) injection, for subcutaneous use3 Evidence Human trials

In detail What the US label warns about
  • Allergic reactions. Serious reactions needing emergency treatment have been reported, with rash, bumps, eczema-like skin or cough, from minutes to months after starting. After a serious reaction it must not be used again.3
  • White blood cells. Eosinophils, white cells involved in allergy, often rose, peaking around 90 days, without symptoms.3
  • Kidneys. The body clears the drug through the urine, so blood levels are higher when the kidneys work poorly. The label lowers the dose for severe kidney disease.3
  • Newborn babies. The preservative, benzyl alcohol, can harm newborns; the medicine is not approved for them.3
  • Unknowns. No cancer studies in animals had been done when it was approved; the FDA requires them now.3,10 There are no data in pregnancy, and the longest use in the trials was 192 weeks, in 3 patients.3

A product bought as a research chemical adds risks the label does not cover: unknown content, strength and sterility.2 See product risk.

Using it safely and legally

How can someone lower the risk?

The US medicine has the fewest unknowns. Check any other product first, and know when to stop.

If your product did not come from a pharmacy: check before you use it

These checks can show that something is wrong. None of them can show that a product is good or free of germs.27,28,29

Tick each box when you have checked it.

  • The seal and the vial are whole

    A broken cap or seal, or a cracked vial, can let germs in. Then do not use it.30,31,32

  • The label shows the name, amount, batch number and expiry date

    In the EU, a medicine must show all four, even on a small vial. If one is missing, or the date has passed, that is a warning sign. Take a photo of the label.33,30

  • For SS-31

    A vial sold as 'SS-31' for research is not the US medicine. The FDA has warned sellers of such vials.2,3

  • It looks right

    A liquid, or a powder after mixing, should be clear and colourless, with no bits. Is it cloudy, has it changed colour, or do you see bits? Then do not use it.34,35

  • A lab report proves little if:

    • its batch number is not the one on your vial;
    • it does not name the lab, or has no date or signature;
    • it shows only purity (HPLC), with no test of what it is, such as mass spectrometry;
    • it has no test for germs (sterility) or for toxins from germs (endotoxin).

    Even a full report covers only one sample. A report from the seller comes from someone who gains if it looks good. It cannot show that your vial is clean.36,37,38,39,40

    What a certificate of analysis shows, and what it does not

  • It was kept as the label says

    Heat, freezing and sunlight can damage a peptide. Did it arrive warm, or was it frozen? Then do not use it. Often nobody can tell you how it was kept on the way. If you cannot know, you cannot rule out damage. When in doubt, throw it out.35,41,42,32

    When to throw a vial away

  • Clean steps, and a new sterile needle and syringe every time

    Wash your hands and wipe the rubber top with alcohol. Never share a needle, a syringe or a vial.32,43,41

    Sterile technique, step by step

  • Keep the vial, its label and any papers

    Keep them, even when the vial is empty, until you know you feel well. If you need a doctor, bring them. A lab can test what was inside.44,45

    If something goes wrong

  • Tell a doctor, and agree which checks fit you

    A doctor can help you choose blood tests that fit what you use. In the Netherlands, your doctor must keep what you say private.46,47,48

    Which checks matter, and whyTalking to your doctor

  • Know the warning signs before you start

    Spreading redness, fever, a swollen face or hard breathing need help fast. If it is severe, call your local emergency number.49,50,51

    All warning signs, and how fast to act

When to stop and get help

Sources 3, 51, 49, 50

Stop-now warning signs

Call your local emergency number now

  • Confusion or slurred speech, very fast breathing, or pale, blue or blotchy skin, often with fever or shivering These can be signs of sepsis: the body's reaction to an infection has started to damage its own organs.
  • Fainting and not waking up within a minute, or fainting with chest pain, a racing heart or a fit This can be a dangerous heart rhythm or a severe allergic reaction.
  • Pain at the injection spot that is much worse than it looks, or dark, purple or grey patches or blisters there This can be a rare, fast-spreading infection of the deep layers under the skin (necrotising fasciitis).
  • Swelling of the lips, tongue or throat, trouble breathing or swallowing, wheezing, a hoarse voice, or feeling faint, soon after an injection This can be a severe allergic reaction (anaphylaxis), which is life-threatening and gets worse very quickly.

Get medical help today

  • Fever, shivering or feeling very ill in the days after an injection Germs from the needle, the skin or the product may have reached your blood. If you also have a fast heartbeat or fast breathing, call your local emergency number.
  • Redness, heat, swelling or pain around the injection spot that keeps growing or getting worse This can be a skin infection (cellulitis), which needs antibiotics before it spreads.
  • Red lines that run from the injection spot towards the armpit or groin The infection may be spreading along the lymph vessels, and from there into the blood. If you also have a fever with a fast heartbeat or fast breathing, call your local emergency number.
  • A painful, warm lump that fills with pus This is probably an abscess: it often needs draining by a doctor, so do not squeeze it.
  • You were pricked by a needle that someone else had used Blood on a used needle can pass on HIV and hepatitis B or C, and preventive treatment works best within hours.

Stop and contact a doctor

  • You fainted, but woke up quickly and now feel well Fainting is often harmless, but a doctor should check the cause.
  • A new mole, or a mole that changes size, shape or colour, itches or bleeds A changing mole can be skin cancer, and tanning peptides such as melanotan II have been linked to new and changing moles in case reports.
  • A lump at an injection spot that does not go away, or keeps growing A doctor should check whether it is an abscess, a reaction to the product or something else.
  • An itchy, raised rash, or puffy eyes or lips, while breathing stays normal Your body may be reacting to the product, and using it again can bring the reaction back.
In detail Checks that make sense, and who should be careful

A doctor can help you decide which checks fit you (see talking to your doctor):

  • Kidney function, because the drug leaves the body through the kidneys.3
  • A blood count, because eosinophils often rose on treatment.3
  • Any rash that spreads or does not settle, because allergic reactions can start months later.3

There are no data in pregnancy or breastfeeding.3 For injecting, see sterile technique.

Sources

Every claim on this page links to one of these sources. Scholarly sources link to their DOI; regulatory sources to the regulator's own page.

In detail All 52 sources, numbered as in the text
  1. U.S. Food and Drug Administration (2026). Drugs@FDA: NDA 215244, Forzinity (elamipretide hydrochloride) injection. Regulator accessdata.fda.gov — accessed 23 October 2026 ↩
  2. U.S. Food and Drug Administration (2026). Warning Letters (searchable database). Regulator fda.gov — accessed 22 October 2026 ↩
  3. U.S. Food and Drug Administration; Stealth BioTherapeutics Inc. (2025). FORZINITY (elamipretide) injection, for subcutaneous use: Prescribing Information (revised 9/2025). Official product information accessdata.fda.gov — accessed 23 October 2026 ↩
  4. European Medicines Agency (2026). Medicines data download (JSON report of all EPARs: authorised, refused, withdrawn and suspended medicines). Dataset ema.europa.eu — accessed 20 October 2026 ↩
  5. National Center for Biotechnology Information (2026). PubChem Compound Summary for CID 11764719, Elamipretide (SS-31). PubChem. Dataset pubchem.ncbi.nlm.nih.gov — accessed 23 October 2026 ↩
  6. Zhao K, Zhao GM, Wu D, Soong Y, Birk AV, Schiller PW, Szeto HH (2004). Cell-permeable peptide antioxidants targeted to inner mitochondrial membrane inhibit mitochondrial swelling, oxidative cell death, and reperfusion injury. The Journal of Biological Chemistry 279:34682-34690. Research article doi:10.1074/jbc.M402999200 ↩
  7. U.S. Food and Drug Administration (2025). FDA Grants Accelerated Approval to First Treatment for Barth Syndrome (press release, 19 September 2025). Regulator fda.gov — accessed 23 October 2026 ↩
  8. Reid Thompson W, Hornby B, Manuel R, Bradley E, Laux J, Carr J, Vernon HJ (2021). A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism. Genetics in Medicine 23:471-478. Clinical trial doi:10.1038/s41436-020-01006-8 ↩
  9. U.S. Food and Drug Administration (2025). Final Summary Minutes of the Cardiovascular and Renal Drugs Advisory Committee Meeting, 10 October 2024 (NDA 215244, elamipretide, Barth syndrome). Regulator fda.gov — accessed 23 October 2026 ↩
  10. U.S. Food and Drug Administration (2025). NDA 215244 Accelerated Approval letter: Forzinity (elamipretide) injection, Stealth BioTherapeutics Inc.. Regulator accessdata.fda.gov — accessed 23 October 2026 ↩
  11. Birk AV, Liu S, Soong Y, Mills W, Singh P, Warren JD, Seshan SV, Pardee JD, Szeto HH (2013). The mitochondrial-targeted compound SS-31 re-energizes ischemic mitochondria by interacting with cardiolipin. Journal of the American Society of Nephrology 24:1250-1261. Research article doi:10.1681/ASN.2012121216 ↩
  12. Karaa A, Bertini E, Carelli V, Cohen BH, Enns GM, Falk MJ, et al. (2023). Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology 101:e238-e252. Clinical trial doi:10.1212/WNL.0000000000207402 ↩
  13. U.S. National Library of Medicine, ClinicalTrials.gov (2026). NCT07531251: Phase 3b/4 randomised, double-blind, placebo-controlled trial of daily subcutaneous elamipretide in genetically confirmed Barth syndrome. Trial registration clinicaltrials.gov — accessed 23 October 2026 ↩
  14. Gibson CM, Giugliano RP, Kloner RA, Bode C, Tendera M, Jánosi A, et al. (2016). EMBRACE STEMI study: a Phase 2a trial to evaluate the safety, tolerability, and efficacy of intravenous MTP-131 on reperfusion injury in patients undergoing primary percutaneous coronary intervention. European Heart Journal 37:1296-1303. Clinical trial doi:10.1093/eurheartj/ehv597 ↩
  15. Butler J, Khan MS, Anker SD, Fonarow GC, Kim RJ, Nodari S, et al. (2020). Effects of Elamipretide on Left Ventricular Function in Patients With Heart Failure With Reduced Ejection Fraction: The PROGRESS-HF Phase 2 Trial. Journal of Cardiac Failure 26:429-437. Clinical trial doi:10.1016/j.cardfail.2020.02.001 ↩
  16. U.S. National Library of Medicine, ClinicalTrials.gov (2026). NCT06373731: ReNEW, phase 3 double-masked placebo-controlled trial of subcutaneous elamipretide in dry age-related macular degeneration. Trial registration clinicaltrials.gov — accessed 23 October 2026 ↩
  17. National Library of Medicine (2026). PubMed searches for elamipretide / SS-31, 23 October 2026. PubMed. Dataset pubmed.ncbi.nlm.nih.gov — accessed 23 October 2026 ↩
  18. European Medicines Agency (2024). EU/3/21/2430 – orphan designation for treatment of Barth syndrome (elamipretide). Regulator ema.europa.eu — accessed 23 October 2026 ↩
  19. European Medicines Agency (2026). Applications for new human medicines under evaluation by the CHMP: October 2026. Regulator ema.europa.eu — accessed 22 October 2026 ↩
  20. College ter Beoordeling van Geneesmiddelen (CBG-MEB) (2026). Geneesmiddeleninformatiebank (database of medicines authorised in the Netherlands). Regulator geneesmiddeleninformatiebank.nl — accessed 20 October 2026 ↩
  21. Staten-Generaal / Koninkrijk der Nederlanden (2007). Geneesmiddelenwet, artikel 40 (verbod op geneesmiddelen zonder handelsvergunning, en de uitzonderingen). wetten.overheid.nl (BWBR0021505), version in force from 9 September 2025. Law wetten.overheid.nl — accessed 22 October 2026 ↩
  22. World Anti-Doping Agency (2025). World Anti-Doping Code International Standard: Prohibited List 2026. Regulator wada-ama.org — accessed 20 October 2026 ↩
  23. World Anti-Doping Agency (2026). World Anti-Doping Code International Standard: Prohibited List 2027 (in effect 1 January 2027). Regulator wada-ama.org — accessed 20 October 2026 ↩
  24. World Anti-Doping Agency (2026). Summary of Major Modifications and Explanatory Notes, 2027 Prohibited List. Regulator wada-ama.org — accessed 22 October 2026 ↩
  25. World Anti-Doping Agency (2025). The 2026 Monitoring Program. Regulator wada-ama.org — accessed 20 October 2026 ↩
  26. World Anti-Doping Agency (2026). The 2027 Monitoring Program. Regulator wada-ama.org — accessed 20 October 2026 ↩
  27. Inspectie Gezondheidszorg en Jeugd (IGJ) (2026). Online medicijnen. Regulator igj.nl — accessed 22 October 2026 ↩
  28. Ashraf AR, Mackey TK, Vida RG, Kulcsár G, Schmidt J, Balázs O, Domián BM, Li J, Csákó I, Fittler A (2024). Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study. Journal of Medical Internet Research 26:e65440. Research article doi:10.2196/65440 ↩
  29. Smith RM, Schaefer MK, Kainer MA, Wise M, Finks J, et al. (2013). Fungal infections associated with contaminated methylprednisolone injections. The New England Journal of Medicine 369:1598-1609. Research article doi:10.1056/NEJMoa1213978 ↩
  30. U.S. Food and Drug Administration (2020). BeSafeRx: Considering an Online Pharmacy?. Regulator fda.gov — accessed 22 October 2026 ↩
  31. Hospira, Inc. / DailyMed (National Library of Medicine) (2026). Sterile Water for Injection, USP: prescribing information. Official product information dailymed.nlm.nih.gov — accessed 20 October 2026 ↩
  32. World Health Organization (2010). WHO best practices for injections and related procedures toolkit (WHO/EHT/10.02). World Health Organization, Geneva. Report who.int — accessed 20 October 2026 ↩
  33. European Parliament and Council of the European Union (2001). Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text). Official Journal of the European Communities, L 311. Law eur-lex.europa.eu — accessed 20 October 2026 ↩
  34. U.S. Food and Drug Administration / DailyMed (National Library of Medicine) (2026). EGRIFTA SV (tesamorelin for injection): prescribing information and instructions for use. Official product information dailymed.nlm.nih.gov — accessed 20 October 2026 ↩
  35. European Medicines Agency (2026). Wegovy (semaglutide): EPAR — overview and product information. Official product information ema.europa.eu — accessed 20 October 2026 ↩
  36. European Medicines Agency (ICH) (2000). ICH Q7 Good manufacturing practice for active pharmaceutical ingredients (CPMP/ICH/4106/00). European Medicines Agency, scientific guideline. Regulator ema.europa.eu — accessed 22 October 2026 ↩
  37. European Medicines Agency, CHMP and CVMP (2025). Guideline on the Development and Manufacture of Synthetic Peptides (EMA/CHMP/CVMP/QWP/367182/2025). European Medicines Agency. Regulator ema.europa.eu — accessed 22 October 2026 ↩
  38. U.S. Food and Drug Administration (2026). FDA Briefing Document for BPC-157-Related Bulk Drug Substances (BPC-157 (free base) and BPC-157 acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  39. U.S. Food and Drug Administration (2026). FDA Briefing Document for TB-500-Related Bulk Drug Substances (TB-500 (free base) and TB-500 acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  40. Janvier S, Cheyns K, Canfyn M, Goscinny S, De Spiegeleer B, Vanhee C, Deconinck E (2018). Impurity profiling of the most frequently encountered falsified polypeptide drugs on the Belgian market. Talanta 188:795-807. Research article doi:10.1016/j.talanta.2018.06.023 ↩
  41. U.S. Food and Drug Administration (2026). FDA's concerns with unapproved GLP-1 drugs used for weight loss. Regulator fda.gov — accessed 20 October 2026 ↩
  42. Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS (2010). Stability of protein pharmaceuticals: an update. Pharmaceutical Research 27:544-575. Review doi:10.1007/s11095-009-0045-6 ↩
  43. Centers for Disease Control and Prevention (2024). Preventing Unsafe Injection Practices. Regulator cdc.gov — accessed 20 October 2026 ↩
  44. NHS (2025). Poisoning. Web page nhs.uk — accessed 22 October 2026 ↩
  45. Antonacci G, Bortignon E, Bolognesi M, Piano SS, Cadore A, Camuffo L, Venturini F, Faoro S, Favretto D, Romano A, Mengato D (2026). Hypoglycaemic coma induced by a falsified semaglutide product: a case report. European Journal of Hospital Pharmacy 33:486-489. Research article doi:10.1136/ejhpharm-2025-004656 ↩
  46. Thuisarts.nl (Nederlands Huisartsen Genootschap, NHG) (2024). Ik ga naar de huisarts: wat kan ik van tevoren doen en verwachten?. Web page thuisarts.nl — accessed 22 October 2026 ↩
  47. Department of Health, Victoria (Australia), Chief Health Officer (2026). Toxicity linked to unapproved peptide product labelled Retatrutide (health alert). Regulator health.vic.gov.au — accessed 22 October 2026 ↩
  48. KNMG (Royal Dutch Medical Association) (2024). Medisch beroepsgeheim: wat en waarom. Web page knmg.nl — accessed 20 October 2026 ↩
  49. NHS (England) (2024). Cellulitis. Web page nhs.uk — accessed 20 October 2026 ↩
  50. NHS (England) (2026). Sepsis. Web page nhs.uk — accessed 20 October 2026 ↩
  51. NHS (England) (2023). Anaphylaxis. Web page nhs.uk — accessed 20 October 2026 ↩
  52. Thompson WR, Manuel R, Abbruscato A, Carr J, Campbell J, Hornby B, Vaz FM, Vernon HJ (2024). Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER. Genetics in Medicine 26:101138. Clinical trial doi:10.1016/j.gim.2024.101138