Visit statistics

May our host count your visit? It then sets a cookie and notes the pages you read, your device and your country. We see only totals. The site works the same either way. What is recorded

Peptides Explained

Mitochondrial

MOTS-c

A peptide our cells make. In mice it changed sugar and fat use. No results in people yet.

Not an authorised medicine

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?
No Not approved as a medicine in the EU, the UK or the US.
Has it been tested in people?
No No studies in people have been published.
Is it allowed in sport?
No Banned in sport at all times. Anti-doping list (WADA), section S4
What is the biggest risk?
Effects in people unknown. Vials may hold germs or the wrong substance. More about the risks

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

Stop and get help if you notice

  • Hot, red, swollen or painful injection site51,2
  • Shaky, sweaty, confused: blood sugar may be low54,2
  • Swollen face or throat, or trouble breathing53,2

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; 12 with every detail open.

  • MOTS-c is a small peptide made inside our cells. It is not an approved medicine.
  • In mice it lowered blood sugar and weight gain. No study in people has been published.
  • A company tested a changed version in people. It stopped the work and began to close in 2023.
  • It is banned in sport at all times.
  • In July 2026, US advisers backed letting pharmacies make it. It was only advice; the law is unchanged.
Class
Mitochondrial
Made of
16 amino acids, coded by mitochondrial DNA
First described
2015, in mice and cells, in Los Angeles
In human blood
Cut into pieces quickly in lab tests
Trial in people
One placebo-controlled trial recruiting in China since 2026
Status in the EU
Not authorised
Tested in people
No

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

Last reviewed
Black-and-white electron microscope image of two oval mitochondria with folded inner walls, inside a lung cell.
Two mitochondria, the energy parts of a cell. MOTS-c is made from their own small set of genes. Photo: Louisa Howard (Wikimedia Commons) Public domain 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?
None published
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?
Uncharacterised
In detail Why these grades: the reason for each step
Human clinical evidence
None. No published study has given MOTS-c itself to people, and the FDA found no human data in its 2026 review. A company tested an altered version, CB4211, in 88 people from 2018 to 2021, but released the results only as a press release and slides. A placebo-controlled phase 2a trial of MOTS-c itself began recruiting in China in February 2026.
Preclinical volume
Extensive. On 22 October 2026 PubMed held 193 records on MOTS-c that are not reviews or comments; about 90 to 105 of them, depending on the search terms, involve mice or rats, well above the threshold of 50. Many of the others measure the body's own MOTS-c in people.
Source independence
Broadly replicated, for the animal work only. The Los Angeles group that discovered MOTS-c wrote a minority of the papers, and laboratories in China and elsewhere have reported similar effects on sugar and fat in mice. None of this has been repeated in people.
Safety characterisation
Uncharacterised. The FDA found no toxicity studies of any kind and no human exposure data. The only human safety information is the company's own summary of the CB4211 study, which reported injection-site reactions in most participants.

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 sequence16 amino acids

H–Met-Arg-Trp-Gln-Glu-Met-Gly-Tyr-Ile-Phe-Tyr-Pro-Arg-Lys-Leu-Arg–OH

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

Full name
Mitochondrial open reading frame of the 12S rRNA-c
Also called
MOTs-C
Class
Mitochondrial
Body systems
Metabolism, Muscles, tendons, bones, Cells and mitochondria
Formula
C101H152N28O22S2
Molecular mass
2,174.6 Da

What it actually is

What is MOTS-c?

A small peptide made inside our cells. It is not an approved medicine.
MOTS-c is made by the body, sold as a lab-made powder, and approved nowhere. What is known about the substance sold under this name, checked on 22 October 2026.
MOTS-c
Made by the body?Yes Its recipe sits in the DNA of mitochondria, the energy parts of cells.1
Lab-made for sale?Yes As a free base or an acetate salt. The FDA calls neither well characterised.2
Approved as a medicine anywhere?No EMA lists no product, and it is not FDA-approved.2,3
Given to people in a published study?No The FDA found no human data.2

A group at the University of Southern California described MOTS-c in 2015.1 It is promoted online as an injection for weight loss, blood sugar and exercise.2 None of these uses has been tested in people.

In detail The molecule, and the company version

MOTS-c is a chain of 16 amino acids, Met-Arg-Trp-Gln-Glu-Met-Gly-Tyr-Ile-Phe-Tyr-Pro-Arg-Lys-Leu-Arg, with formula C101H152N28O22S2 and mass 2174.6 g/mol.2,4 Its recipe is a short stretch inside a mitochondrial gene, which is why it is called a mitochondrial-derived peptide.1

A company, CohBar, developed an altered version, CB4211, and tested it in a phase 1a/1b study from 2018 to 2021.5,6 In 2023 it said the formulation was not suitable for further development. It announced that it would liquidate and dissolve the company.7,8

Proposed mechanism

How does it work?

In cells and mice it switches on an energy sensor. Its direct target is unknown.
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 Hypothesised

    Its direct target is not known

    The FDA notes that the molecular target or targets of MOTS-c remain unknown, so it is hard to predict which organs it affects.

  2. Step 2 Signal inside the cell In cells

    The cell's energy sensor, AMPK, switches on

    In human cells in a dish, MOTS-c slowed the folate cycle and the making of purines (DNA building blocks). A molecule called AICAR then built up and switched on AMPK, the cell's energy sensor. Shown by the discovering group.

  3. Step 3 Tissue response In animals

    Muscle takes up more sugar; mice gain less fat

    In mice, muscle responded better to insulin, and animals on a high-fat diet gained less weight; an AMPK blocker weakened the effects. An independent group in China saw similar effects in mice whose ovaries had been removed.

  4. Step 4 Effect on the body Hypothesised

    Benefit in people: not shown

    No published study has given MOTS-c to people. Whether any step above happens in people, and at what amounts, is unknown.

In detail What each step rests on

The energy-sensor link comes from the discovering group’s cell work. MOTS-c slowed two linked processes in cells. AICAR, a natural switch for AMPK, then built up.1 The FDA notes that all studies were in rodents or cells. No dose–response was tested in living animals, and the molecular target is unknown.2 An independent group in China reported less weight gain in mice whose ovaries had been removed, and AMPK again seemed involved.9

What the evidence actually shows

Does it work?

Unknown in people. In mice it lowered blood sugar and weight gain.

Mice on a high-fat diet gained less weight

about 20%

lower body weight than untreated mice after 8 weeks

Who took part Lee 2015: male mice on a high-fat diet, daily injections into the belly (FDA summary) Sources FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (MOTS-c (free base) and MOTS-c acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026; Lee et al. (2015)2,1 Evidence Animals

The first trial of MOTS-c in people is still running

120

adults with slightly high blood sugar, half on a dummy drug; results after early 2027

Who took part MOTS-MET, phase 2a, one site in China, recruiting since February 2026 Source ClinicalTrials.gov (2026)10

The animal work is large and comes from many laboratories.11 In people, studies so far only measure the body’s own MOTS-c. A blood test widely used for that may not be reliable.12

In detail Every study in one table

5 studies: 1 in humans, 3 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
Lee et al. 2015 1 Mixed not reported Animal experiment (controlled) Mixed Originating group Identified MOTS-c, a 16-amino-acid peptide coded in mitochondrial DNA. In cells it switched on AMPK; in mice it prevented insulin resistance with age and on a high-fat diet, and limited weight gain. Mice and cells only; the discovering group, whose two lead authors were consultants for the company developing MOTS-c drugs; no dose–response tested in living animals.
Knoop et al. 2019 12 Cells (lab) 20 Product testing (uncontrolled) Not disclosed Independent group An anti-doping laboratory built a mass-spectrometry test for MOTS-c in blood. MOTS-c was quickly cut into shorter pieces in human blood, and natural levels reported with a commercial ELISA test could not be confirmed. A test-method study, not a study of effects; the ELISA comparison used blood from 20 people.
Lu et al. 2019 9 Mice not reported Animal experiment (controlled) Not disclosed Independent group In mice whose ovaries had been removed, MOTS-c prevented weight gain and insulin resistance and increased brown-fat activity; an AMPK blocker weakened the effect. Mice only; animal numbers and blinding are not given in the abstract; one laboratory.
CohBar, Inc 2021 6 Humans 88 Phase I trial (controlled, blinded) Industry Mixed In a placebo-controlled phase 1a/1b study of the altered version CB4211 (65 healthy adults, then 23 people with fatty liver for four weeks, of whom 20 finished), the company reported no serious adverse events, injection-site reactions in most people, and liver fat falling about equally with drug and placebo. A different molecule from MOTS-c; results only in a company press release and slides, never in a journal; a tiny second stage; the study was paused to change the formulation because the drug stayed at the injection site.
Reynolds et al. 2021 13 Mixed not reported Animal experiment (controlled) Mixed Originating group MOTS-c improved running performance in young, middle-aged and old mice, and started late in life it improved physical capacity. In 10 healthy young men, a session on an exercise bike raised their own MOTS-c in muscle and blood. Every effect of the peptide was seen in mice; the human part only measured natural levels during exercise; same group, with the same company links.

In mice, MOTS-c improved insulin sensitivity and running performance, and when started late in life it improved physical capacity.1,13 In 10 healthy young men, a session on an exercise bike raised their own MOTS-c; nobody was given the peptide.13 The two lead authors of the discovery work were consultants for CohBar.1,13

In detail The company version, CB4211: what was reported

The company reported its results in a press release and slides, not in a journal. In 65 healthy adults and then 23 people with fatty liver, it reported no serious adverse events. Liver fat fell by about the same amount with CB4211 and with placebo. Some liver enzymes and fasting glucose fell more with the drug.6 The study was paused to change the formulation, because drug stayed at the injection site.14 No results are posted on the trial registry.5

Regulatory status

Is it legal?

It is approved nowhere and banned in sport. The 2026 US vote was only advice.
It is not an approved medicine. The July 2026 US vote did not change that. Status in the Netherlands, the EU and the US, and in sport, checked on 22 October 2026.
Netherlands and the EUUnited States
Approved as a medicine?No No EU or Dutch authorisation.15,16No Not FDA-approved.2
Legal to sell or supply as a medicine?No Dutch law forbids supplying a medicine without a marketing authorisation, with narrow exceptions.17No Not until the FDA makes a rule adding it to the 503A list.18
Allowed in sport?No Banned at all times, named in section S4.19,20No The same worldwide rule.19
In detail Status in each country, and in sport
Regulatory status by jurisdiction
Jurisdiction Status Note Checked
European Union Not authorised No authorised product, and no record in EMA's medicines data (checked 22 October 2026). 3,15,2
Netherlands Not authorised Not authorised; supplying an unauthorised medicine is prohibited by the Geneesmiddelenwet. 16,17
United States Not authorised Not FDA-approved. The July 2026 advisory vote to recommend pharmacy compounding is non-binding; no rule has been made. 2,26,23,22
Sport (WADA) Prohibited in sport · S4, at all times Named in S4.4.1 (activators of AMPK) since the 2025 List; prohibited at all times. 21,19,20

All statuses were checked on 22 October 2026. The CBG database lists no MOTS-c product.16 WADA added MOTS-c by name to section S4.4.1, activators of AMPK, in the 2025 List.21 The FDA had put MOTS-c in category 2 of its interim policy, for substances that may present significant safety risks. The nominations were later withdrawn.22

In detail The July 2026 US vote, point by point
  • On 23 July 2026 the FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted 8–6 with one abstention to recommend BPC-157 for the 503A bulk drug substances list (count as reported from the public meeting).23,24
  • The committee considered seven peptides, including MOTS-c, which the FDA reviewed for obesity and osteoporosis.23,25 As reported from the meeting, it recommended six: BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon; emideltide (DSIP) was not recommended. The FDA asked for separate votes on the free base and the acetate salt of each.24 The FDA had posted no minutes by 23 October 2026, so the counts and outcome above are as reported from the public meeting.
  • The vote is advisory and non-binding, and it went against FDA staff’s own recommendation not to list MOTS-c.26
  • Legal compounding remains prohibited until the FDA formally adopts the recommendation and completes rulemaking.18
  • None of these is an approved medicine in the EU, the UK or the US (Semax is registered as a medicine in Russia). A 503A listing would allow pharmacy compounding on prescription in the US. It is not a marketing authorisation, says nothing about efficacy, and changes nothing in the EU or the Netherlands.27,28,17

Risk profile

What are the risks?

Its effects in people are unknown. The product itself may be the biggest risk.
Several harms are possible. None has been studied properly in people. What the FDA review and the company's own trial summary suggest, as of 22 October 2026.
Possible harmShown in people?
Infection from germs or bacterial toxins in the productUnknown The FDA found no published tests for them.2
An immune reaction to the peptide or its impuritiesUnknown The FDA cannot rule it out for injections.2
Reactions where it is injectedYes Common with the company version, CB4211.14
Blood sugar falling too lowUnknown Blood sugar fell by about half in obese mice.2
Harm from long-term useUnknown No toxicity studies of any kind exist.2
In detail What has been reported, and why the gaps matter

The FDA’s adverse-event database held no reports for MOTS-c up to March 2025. US compounding pharmacies generally do not report adverse events to the FDA, so this says little.2 In the company’s CB4211 study, the company reported injection-site reactions in 79% of people on the drug and 33% on placebo.14 Because the FDA does not know what MOTS-c binds, it cannot predict which organs it affects. No studies have looked at genetic damage, cancer or effects on pregnancy.2

If someone is going to do this anyway

This section exists to reduce harm. It gives no doses, schedules or sourcing advice, and it is not a recommendation to use this compound.

How can someone lower the risk?

Check the vial first, bring a doctor in, 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.29,30,31

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.32,33,34

  • 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.35,32

  • For MOTS-c

    Check which form the label names. MOTS-c is sold as a free base or an acetate salt. The FDA treats them as different substances.2

  • 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.36,37

  • 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.38,39,40,41,42

    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.37,43,44,34

    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.34,45,43

    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.46,47

    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.48,49,50

    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.51,52,53

    All warning signs, and how fast to act

When to stop and get help

Sources 51, 54, 53, 2

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.
  • Shaking, sweating or sudden hunger that turns into confusion or drowsiness Very low blood sugar can cause a fit or loss of consciousness; take something sugary if you can still swallow safely.
  • Severe, constant pain in the upper belly that spreads to the back, often with vomiting This can be an inflamed pancreas (pancreatitis), a known risk of GLP-1 medicines such as semaglutide and tirzepatide.

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.
  • Vomiting so often that you cannot keep fluids down, or passing very little urine Losing too much fluid can damage the kidneys.
  • Yellow skin, or yellow whites of the eyes This can be a sign of a liver problem, gallstones or an inflamed pancreas.
  • Dark, red or cola-coloured urine together with muscle pain, tenderness or weakness Damaged muscle can release a protein that harms the kidneys (rhabdomyolysis).

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 not use it

A doctor can help with these checks (see talking to your doctor):

  • Blood sugar, if you use insulin or diabetes tablets, because MOTS-c lowered blood sugar in mice.2
  • Anti-doping rules, if you compete: MOTS-c is banned at all times, and an anti-doping laboratory has a test for it.19,12

Pregnancy and breastfeeding are reasons not to use it: there are no studies on effects in pregnancy.2 See product risk and 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 54 sources, numbered as in the text
  1. Lee C, Zeng J, Drew BG, Sallam T, Martin-Montalvo A, Wan J, Kim SJ, Mehta H, Hevener AL, de Cabo R, Cohen P (2015). The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metabolism 21:443-454. Research article doi:10.1016/j.cmet.2015.02.009 ↩
  2. U.S. Food and Drug Administration (2026). FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (MOTS-c (free base) and MOTS-c acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 22 October 2026 ↩
  3. European Medicines Agency (2026). Medicines (search of centrally authorised medicines and EPARs). Regulator ema.europa.eu — accessed 20 October 2026 ↩
  4. National Center for Biotechnology Information (2026). PubChem Compound Summary for CID 146675088, MOTS-c. PubChem. Dataset pubchem.ncbi.nlm.nih.gov — accessed 22 October 2026 ↩
  5. ClinicalTrials.gov (2019). NCT03998514 — A Phase 1a/1b Study of Safety, Tolerability, and Pharmacokinetics of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease. Trial registration clinicaltrials.gov — accessed 22 October 2026 ↩
  6. CohBar, Inc. (2021). Press release dated August 10, 2021: topline results from the Phase 1a/1b study of CB4211 (Exhibit 99.2 to Form 8-K). U.S. Securities and Exchange Commission, EDGAR. Report sec.gov — accessed 22 October 2026 ↩
  7. CohBar, Inc. (2023). Form S-4 Registration Statement, filed 3 July 2023. U.S. Securities and Exchange Commission, EDGAR. Report sec.gov — accessed 22 October 2026 ↩
  8. CohBar, Inc. (2023). Form 8-K Current Report, filed 1 November 2023 (termination of merger agreement; intention to liquidate and dissolve). U.S. Securities and Exchange Commission, EDGAR. Report sec.gov — accessed 22 October 2026 ↩
  9. Lu H, Wei M, Zhai Y, Li Q, Ye Z, Wang L, Luo W, Chen J, Lu Z (2019). MOTS-c peptide regulates adipose homeostasis to prevent ovariectomy-induced metabolic dysfunction. Journal of Molecular Medicine (Berlin) 97:473-485. Research article doi:10.1007/s00109-018-01738-w ↩
  10. ClinicalTrials.gov (2026). NCT07505745 — A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of MOTS-c (a Mitochondrial-Derived Peptide) in Adults With Prediabetes and Overweight/Obesity (MOTS-MET). Trial registration clinicaltrials.gov — accessed 22 October 2026 ↩
  11. National Library of Medicine (2026). PubMed searches for MOTS-c, 22 October 2026 (record counts by type and authorship). PubMed. Dataset pubmed.ncbi.nlm.nih.gov — accessed 22 October 2026 ↩
  12. Knoop A, Thomas A, Thevis M (2019). Development of a mass spectrometry based detection method for the mitochondrion-derived peptide MOTS-c in plasma samples for doping control purposes. Rapid Communications in Mass Spectrometry 33:371-380. Research article doi:10.1002/rcm.8337 ↩
  13. Reynolds JC, Lai RW, Woodhead JST, Joly JH, Mitchell CJ, Cameron-Smith D, Lu R, Cohen P, Graham NA, Benayoun BA, Merry TL, Lee C (2021). MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasis. Nature Communications 12:470. Research article doi:10.1038/s41467-020-20790-0 ↩
  14. CohBar, Inc. (2021). Q2 Investor Presentation, August 2021 (Exhibit 99.3 to Form 8-K). U.S. Securities and Exchange Commission, EDGAR. Report sec.gov — accessed 22 October 2026 ↩
  15. 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 ↩
  16. College ter Beoordeling van Geneesmiddelen (CBG-MEB) (2026). Geneesmiddeleninformatiebank (database of medicines authorised in the Netherlands). Regulator geneesmiddeleninformatiebank.nl — accessed 20 October 2026 ↩
  17. Staten-Generaal / Koninkrijk der Nederlanden (2007). Geneesmiddelenwet (BWBR0021505). wetten.overheid.nl. Law wetten.overheid.nl — accessed 20 October 2026 ↩
  18. U.S. Food and Drug Administration (2026). Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Regulator fda.gov — accessed 20 October 2026 ↩
  19. World Anti-Doping Agency (2025). World Anti-Doping Code International Standard: Prohibited List 2026. Regulator wada-ama.org — accessed 20 October 2026 ↩
  20. 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 ↩
  21. World Anti-Doping Agency (2024). Summary of Major Modifications and Explanatory Notes, 2025 Prohibited List. Regulator wada-ama.org — accessed 22 October 2026 ↩
  22. U.S. Food and Drug Administration (2026). Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Regulator fda.gov — accessed 20 October 2026 ↩
  23. U.S. Food and Drug Administration (2026). July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Regulator fda.gov — accessed 20 October 2026 ↩
  24. U.S. Food and Drug Administration (2026). Questions, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  25. U.S. Food and Drug Administration (2026). Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments — Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List (FR Doc. 2026-07361). Federal Register. Regulator federalregister.gov — accessed 20 October 2026 ↩
  26. U.S. Food and Drug Administration (2026). FDA Briefing Document Introduction, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  27. U.S. Food and Drug Administration (2026). FDA Presentations, Pharmacy Compounding Advisory Committee meeting, 23 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  28. U.S. Food and Drug Administration (2026). FDA Briefing Document for Semax-Related Bulk Drug Substances (Semax (free base) and Semax acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 22 October 2026 ↩
  29. Inspectie Gezondheidszorg en Jeugd (IGJ) (2026). Online medicijnen. Regulator igj.nl — accessed 22 October 2026 ↩
  30. 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 ↩
  31. 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 ↩
  32. U.S. Food and Drug Administration (2020). BeSafeRx: Considering an Online Pharmacy?. Regulator fda.gov — accessed 22 October 2026 ↩
  33. 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 ↩
  34. 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 ↩
  35. 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 ↩
  36. 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 ↩
  37. European Medicines Agency (2026). Wegovy (semaglutide): EPAR — overview and product information. Official product information ema.europa.eu — accessed 20 October 2026 ↩
  38. 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 ↩
  39. 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 ↩
  40. 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 ↩
  41. 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 ↩
  42. 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 ↩
  43. 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 ↩
  44. 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 ↩
  45. Centers for Disease Control and Prevention (2024). Preventing Unsafe Injection Practices. Regulator cdc.gov — accessed 20 October 2026 ↩
  46. NHS (2025). Poisoning. Web page nhs.uk — accessed 22 October 2026 ↩
  47. 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 ↩
  48. 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 ↩
  49. 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 ↩
  50. KNMG (Royal Dutch Medical Association) (2024). Medisch beroepsgeheim: wat en waarom. Web page knmg.nl — accessed 20 October 2026 ↩
  51. NHS (England) (2024). Cellulitis. Web page nhs.uk — accessed 20 October 2026 ↩
  52. NHS (England) (2026). Sepsis. Web page nhs.uk — accessed 20 October 2026 ↩
  53. NHS (England) (2023). Anaphylaxis. Web page nhs.uk — accessed 20 October 2026 ↩
  54. NHS (England) (2023). Low blood sugar (hypoglycaemia). Web page nhs.uk — accessed 20 October 2026 ↩