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Peptides Explained

Timeline: a hundred years of peptide medicines and their rules

In short

About 2 minutes for the short version; 5 with every detail open.

  • It starts with the first insulin in 1922 and ends with a US vote in July 2026.
  • It shows new science, new laws, new medicines, bans in sport and safety alerts.
  • Each event has a date and a source you can check.
  • Laws often changed after people were harmed.
Last reviewed
A man in a white shirt reaches up to a lamp in a laboratory full of glass flasks, bottles and racks of test tubes.
An FDA scientist checks for impurities in the 1960s. The FDA is the US medicines regulator. Photo: The U.S. Food and Drug Administration, U.S. Food and Drug Administration (Wikimedia Commons) Public domain Image details

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

What does the timeline show?

Four threads: new science, new rules, new medicines, and what went wrong.
The timeline follows four threads. Each one has its own filter button.
ThreadFilterExamples
ScienceDiscovery, ChemistryInsulin (1922), the first synthetic peptide hormone (1953), GLP-1 releases insulin (1987)
RulesRegulation, SportProof that a medicine works (US, 1962), a licence before sale (European Community, 1965), BPC-157 banned in sport (2022)
MedicinesApprovalsRecombinant insulin (1982), exenatide (2005), semaglutide (2017), tirzepatide (2022)
ProblemsSafety, MarketThalidomide (1961), GLP-1 shortages (2022), fake Ozempic pens (2023)

Sources 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13

Peptide medicines are about a century old. Insulin, one of the first, lowered blood sugar in people with diabetes in 1922, and more than 80 peptide medicines have reached the market since.14,15 The rules that decide which medicines reach patients are younger: the US began to require proof that a medicine works in 1962, and Europe a licence before sale in 1965.4,5

In detail How to read the dates
  • Approvals give the first approval of a product in that jurisdiction: the FDA’s first approval date from Drugs@FDA, and the date the European Commission granted the EU marketing authorisation.9,16 Later approvals for new uses are not listed.
  • Laws give the date the act was adopted, unless the event says it came into force.
  • Events without a day are known to the year only.
  • Regulatory status changes. Each event describes the situation on the date shown. For the status today, see the compound pages and what’s changing. We last checked every date on 22 October 2026.
In detail What this timeline leaves out

It is a selection, not a complete history. It leaves out most peptide medicines that are not discussed on this site, most national laws outside the Netherlands, the EU and the US, and most later approvals of the same molecule for new uses. A medicine that appears here is not recommended by this site, and a peptide that does not appear here is not safe or unsafe because of that.

The timeline

How do I use it?

Use the buttons to show one kind of event. Each event links to its sources.

  1. Discovery

    Insulin is first used to treat diabetes

    In Toronto, Frederick Banting and Charles Best, with James Collip and John Macleod, made an extract of the pancreas containing insulin, a peptide hormone. Clinical tests by January 1922 showed that it lowered blood sugar in people with diabetes, and the team published its first clinical report in March 1922.

    Banting et al. 1922U.S. Food and Drug Administration (FDA History Office) 2022

  2. Discovery

    Nobel Prize for the discovery of insulin

    Frederick Banting and John Macleod received the Nobel Prize in Physiology or Medicine 1923 'for the discovery of insulin'.

    Nobel Prize Outreach 1923

  3. Regulation

    US law starts to require proof of safety

    In 1937 a medicine called Elixir of Sulfanilamide, dissolved in the toxic solvent diethylene glycol, killed 107 people, many of them children. The US Food, Drug, and Cosmetic Act, approved on 25 June 1938, then required new drugs to be shown safe before marketing. It did not yet require proof that they work.

    United States Congress 1938U.S. Food and Drug Administration 2023Meadows M (FDA Consumer magazine) 2006

  4. Chemistry

    The first peptide hormone made in a laboratory

    Vincent du Vigneaud's group made oxytocin from its building blocks and showed that the synthetic version acted like the natural hormone. He received the Nobel Prize in Chemistry 1955 for 'the first synthesis of a polypeptide hormone'.

    du Vigneaud et al. 1953Nobel Prize Outreach 1955

  5. Chemistry

    Sanger works out the structure of insulin

    Frederick Sanger's group worked out the order of the amino acids in insulin's two chains, and in 1955 reported how the chains are joined by disulphide bonds. Sanger received the Nobel Prize in Chemistry 1958 for this work.

    Ryle et al. 1955Nobel Prize Outreach 1958Tiselius A (Nobel Committee for Chemistry, Royal Swedish Academy of Sciences) 1958

  6. Regulation

    Dutch medicines law sets up a register

    The Wet op de Geneesmiddelenvoorziening of 28 July 1958 set up a board to register packaged medicines in the Netherlands. A product could be registered if it could reasonably be assumed to have the claimed effect and not to harm health when used as directed. Selling unregistered packaged medicines was forbidden.

    Koninkrijk der Nederlanden 1958

  7. Safety

    Thalidomide is withdrawn after severe birth defects

    Thalidomide, a sedative sold in 46 countries and given for morning sickness, caused severe birth defects in more than 10,000 children between 1957 and 1962. Doctors in Germany and Australia linked it to the defects in 1961, and withdrawals began in November 1961. In the US, the FDA reviewer Frances Kelsey had refused to approve it because the evidence was inadequate.

    Vargesson N 2015Kim & Scialli 2011U.S. Food and Drug Administration 2018

  8. Regulation

    US law starts to require proof that a medicine works

    On 10 October 1962 the Kefauver-Harris Drug Amendments became US law. Companies now had to provide substantial evidence of effectiveness from adequate and well-controlled studies before approval. Trial participants had to be told and asked for consent, with some exceptions.

    United States Congress 1962Meadows M (FDA Consumer magazine) 2006U.S. Food and Drug Administration 2023

  9. Chemistry

    A faster way to build peptides

    Bruce Merrifield described solid-phase peptide synthesis: the first amino acid is anchored to a solid support, the chain is built one amino acid at a time, and by-products are washed away after each step. He received the Nobel Prize in Chemistry 1984.

    Merrifield RB 1963The Royal Swedish Academy of Sciences 1984

  10. Regulation

    Europe's first medicines law

    Council Directive 65/65/EEC of 26 January 1965 said that no ready-made medicine may be placed on the market in a member state of the European Economic Community without an authorisation. Applicants had to submit test results, including clinical trials, and a licence was refused if the medicine was harmful or its effect was lacking or not properly shown. The European Commission says the thalidomide disaster was much of the impetus.

    Council of the European Economic Community 1965European Commission, Directorate-General for Health and Food Safety 2026European Commission, Directorate-General for Health and Food Safety 2015

  11. Discovery

    The structure of a brain peptide that controls fertility

    Andrew Schally's group proposed the amino-acid sequence of a hormone from the pig hypothalamus that releases LH and FSH from the pituitary gland, known today as GnRH. Leuprolide, approved in 1985, is a lab-made analogue of this hormone.

    Matsuo et al. 1971The Nobel Assembly at the Karolinska Institute 1977U.S. National Library of Medicine (DailyMed) 2026

  12. Discovery

    Somatostatin is discovered

    Roger Guillemin's group isolated a 14-amino-acid peptide from sheep hypothalamus that blocked the release of growth hormone in lab tests and in rats, and showed that a synthetic copy works too. It became known as somatostatin.

    Brazeau et al. 1973The Nobel Assembly at the Karolinska Institute 1977

  13. Discovery

    Nobel Prize for peptide hormones of the brain

    Roger Guillemin and Andrew Schally shared half of the Nobel Prize in Physiology or Medicine 1977 for discoveries about the peptide hormones made by the brain. Rosalyn Yalow received the other half for radioimmunoassays, tests that could measure peptide hormones in blood.

    Nobel Prize Outreach 1977

  14. Approvals

    First medicine made with recombinant DNA

    On 28 October 1982, after five months of review, the FDA approved Humulin, human insulin made by bacteria that had been given the genetic code for its two chains. It was the first approved medical product of any kind made with this technology.

    U.S. Food and Drug Administration (FDA History Office) 2022U.S. Food and Drug Administration 2026Johnson IS 1983

  15. Approvals

    A GnRH analogue is approved

    On 9 April 1985 the FDA approved Lupron (leuprolide), a lab-made analogue of GnRH. Given continuously, it first raises the sex hormones and then lowers them.

    U.S. Food and Drug Administration 2026U.S. National Library of Medicine (DailyMed) 2026

  16. Discovery

    GLP-1 is shown to release insulin

    Three groups showed that a fragment of proglucagon made in the gut, GLP-1, releases insulin: in pig pancreas, in rat pancreas, and in seven human volunteers. This hormone is the basis of medicines such as semaglutide and tirzepatide.

    semaglutidetirzepatide Holst et al. 1987Mojsov et al. 1987Kreymann et al. 1987

  17. Approvals

    A long-acting somatostatin analogue is approved

    On 21 October 1988 the FDA approved Sandostatin (octreotide), an eight-amino-acid analogue of somatostatin. In lab tests it resisted breakdown, and in rats and monkeys it acted much longer than the natural hormone.

    U.S. Food and Drug Administration 2026Bauer et al. 1982

  18. Discovery

    A peptide is found in lizard venom

    John Eng's group isolated exendin-4 from the venom of the Gila monster. A synthetic version, exenatide, later became a medicine that acts on the GLP-1 receptor.

    semaglutide Eng et al. 1992U.S. National Library of Medicine (DailyMed) 2025

  19. Regulation

    US accelerated approval and user fees

    In 1992 the FDA formalised accelerated approval: a medicine for a serious disease can be approved on an early sign of benefit, such as tumour shrinkage, if the company later confirms a real clinical benefit. The same year a new law required companies to pay user fees, so the FDA could hire more reviewers and speed up reviews.

    Meadows M (FDA Consumer magazine) 2006Junod SW (FDA History Office) 2008

  20. Regulation

    A European medicines agency is founded

    Regulation 2309/93 created the European Agency for the Evaluation of Medicinal Products, now the European Medicines Agency (EMA), and a single EU-wide authorisation route. Its procedures started on 1 January 1995.

    European Medicines Agency 2026Council of the European Communities 1993

  21. Regulation

    One EU code for medicines

    Directive 2001/83/EC of 6 November 2001 brought the EU's medicines laws together in one code and repealed Directive 65/65/EEC. Its core rule is unchanged: no medicine on the market without a marketing authorisation.

    European Parliament and Council of the European Union 2001European Parliament and Council of the European Union 2001

  22. Approvals

    Exenatide, a GLP-1 receptor medicine, is approved

    On 28 April 2005 the FDA approved Byetta (exenatide), a synthetic peptide first identified in Gila monster venom. The EU authorised it on 20 November 2006; that authorisation was withdrawn at the company's request on 1 January 2026.

    semaglutide U.S. Food and Drug Administration 2026U.S. National Library of Medicine (DailyMed) 2025European Medicines Agency 2026

  23. Regulation

    EU conditional marketing authorisation

    From 2006 the EU could grant a conditional marketing authorisation for medicines that meet an unmet need, on less complete data than normal. It lasts one year at a time and the company must deliver the missing studies.

    European Medicines Agency 2026

  24. Regulation

    The Dutch Geneesmiddelenwet comes into force

    On 1 July 2007 the Geneesmiddelenwet, the Dutch Medicines Act of 8 February 2007, came into force. It replaced the Wet op de Geneesmiddelenvoorziening of 1958 and sets out the EU rules in Dutch law.

    Staten-Generaal / Koninkrijk der Nederlanden 2007Staten-Generaal / Koninkrijk der Nederlanden 2007

  25. Approvals

    Liraglutide: a once-daily GLP-1 medicine

    The EU authorised Victoza (liraglutide) on 30 June 2009 and the FDA approved it on 25 January 2010. It binds to albumin in the blood and resists breakdown, so one injection a day is enough.

    semaglutide European Medicines Agency 2026U.S. Food and Drug Administration 2026

  26. Approvals

    Tesamorelin is approved in the US

    On 10 November 2010 the FDA approved Egrifta (tesamorelin), an analogue of growth-hormone-releasing factor, to reduce excess belly fat in adults with HIV and lipodystrophy. An EU application was withdrawn in 2012, and it is not authorised in the EU.

    U.S. Food and Drug Administration 2026U.S. Food and Drug Administration / DailyMed (National Library of Medicine) 2026European Medicines Agency 2026

  27. Approvals

    Afamelanotide: authorised under exceptional circumstances

    On 22 December 2014 the EU authorised Scenesse (afamelanotide), an implant for a rare disease that makes light painful, under 'exceptional circumstances' because full data could not be collected. The FDA approved it on 8 October 2019.

    European Medicines Agency 2026U.S. Food and Drug Administration 2026

  28. Regulation

    The EMA starts its PRIME scheme

    In March 2016 the EMA published the guidance for PRIME, a scheme that gives early advice to developers of medicines for unmet needs to speed up development and review.

    European Medicines Agency 2026

  29. Approvals

    Semaglutide is approved

    The FDA approved Ozempic (semaglutide) for type 2 diabetes on 5 December 2017, and the EU authorised it on 8 February 2018.

    semaglutide U.S. Food and Drug Administration 2026European Medicines Agency 2026

  30. Sport

    TB-500 named on the doping list

    From 1 January 2018 the World Anti-Doping Agency named thymosin beta-4 and its derivatives, such as TB-500, as examples of prohibited growth factors.

    tb-500 World Anti-Doping Agency 2017

  31. Approvals

    Bremelanotide is approved in the US

    On 21 June 2019 the FDA approved Vyleesi (bremelanotide), a melanocortin-receptor agonist, for low sexual desire in some premenopausal women. The EMA lists no application for it, and it is not authorised in the EU.

    U.S. Food and Drug Administration 2026U.S. Food and Drug Administration / DailyMed (National Library of Medicine) 2025European Medicines Agency 2026

  32. Approvals

    Semaglutide for weight management

    The FDA approved Wegovy (semaglutide) for weight management on 4 June 2021, and the EU authorised it on 6 January 2022.

    semaglutide U.S. Food and Drug Administration 2026European Medicines Agency 2026

  33. Sport

    BPC-157 banned in sport

    From 1 January 2022 the World Anti-Doping Agency lists BPC-157 by name under S0, non-approved substances, which are prohibited at all times.

    bpc-157 World Anti-Doping Agency 2021World Anti-Doping Agency 2025

  34. Market

    GLP-1 shortages and copies made by US pharmacies

    From 2022 rising demand put semaglutide and tirzepatide injections on the FDA's shortage list. During a shortage, US pharmacies may compound copies, and the FDA later warned of dosing errors with compounded semaglutide.

    semaglutidetirzepatide U.S. Food and Drug Administration 2026U.S. Food and Drug Administration 2024

  35. Approvals

    Tirzepatide is approved

    The FDA approved Mounjaro (tirzepatide) for type 2 diabetes on 13 May 2022, and the EU authorised it on 15 September 2022. It acts on two hormone receptors, for GLP-1 and GIP.

    tirzepatide U.S. Food and Drug Administration 2026European Medicines Agency 2026

  36. Regulation

    FDA lists peptides as possible safety risks for compounding

    On 29 September 2023 the FDA added peptides such as ipamorelin to 'category 2', bulk substances that may present significant safety risks in compounding. BPC-157, TB-500 and KPV were also in category 2 at some point (the FDA gives no date for them) until their nominations were withdrawn.

    bpc-157tb-500kpv U.S. Food and Drug Administration 2026

  37. Safety

    Fake Ozempic pens found in Europe

    On 18 October 2023 the EMA warned of falsified Ozempic pens, and the Dutch and UK regulators followed within days. In Germany, fake pens were found to contain insulin instead of semaglutide; in the UK, people were taken to hospital with very low blood sugar that pointed to insulin.

    semaglutide European Medicines Agency 2023Inspectie Gezondheidszorg en Jeugd (IGJ) 2023Medicines and Healthcare products Regulatory Agency 2023Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) 2024

  38. Approvals

    Tirzepatide for weight management in the US

    On 8 November 2023 the FDA approved Zepbound (tirzepatide) for weight management.

    tirzepatide U.S. Food and Drug Administration 2026

  39. Safety

    WHO warns about falsified semaglutide

    On 20 June 2024 the World Health Organization warned about falsified medicines used for diabetes and weight loss, after falsified Ozempic batches were found in Brazil, the UK and the US.

    semaglutide World Health Organization 2024

  40. Discovery

    Lasker Award for the GLP-1 story

    The 2024 Lasker-DeBakey Clinical Medical Research Award went to Joel Habener and Svetlana Mojsov for the discovery of GLP-1(7-37), and to Lotte Bjerre Knudsen, a Novo Nordisk scientist, for her role in developing long-acting versions to treat obesity.

    semaglutide Friedman JM 2024Knudsen LB 2024

  41. Market

    The US GLP-1 shortages end

    The FDA declared the tirzepatide shortage resolved on 2 October 2024 (confirmed on 19 December 2024) and the semaglutide shortage resolved on 21 February 2025. The temporary room for pharmacies to compound copies then ran out in 2025.

    semaglutidetirzepatide U.S. Food and Drug Administration 2026

  42. Market

    Record seizures of unlicensed weight-loss medicines

    In January 2026 the UK regulator reported almost 20 million doses of illegal medicines seized in 2025, up from 17 million in 2024, including 5,680 GLP-1 pens. In May 2026 it made its largest seizure of unlicensed weight-loss medicines, including retatrutide and tirzepatide. Vials are also sold online 'for research purposes' without a prescription.

    semaglutidetirzepatideretatrutide Medicines and Healthcare products Regulatory Agency 2026Medicines and Healthcare products Regulatory Agency 2026Belcourt et al. 2025

  43. Regulation

    FDA advisers vote on seven peptides

    On 23 July 2026 the FDA's Pharmacy Compounding Advisory Committee voted 8–6, with one abstention, to recommend BPC-157 for the 503A list of substances US pharmacies may compound on prescription; of the seven peptides it considered, it recommended six (BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon, but not emideltide, also called DSIP), as reported from the public meeting. The vote is advisory and non-binding and went against FDA staff's own recommendation, so legal compounding stays prohibited until the FDA formally adopts it and completes rulemaking. None of these peptides is an approved medicine in the EU, the UK or the US (Semax is registered as a medicine in Russia), and a listing would not be a marketing authorisation, would say nothing about whether they work, and would change nothing in the EU or the Netherlands.

    bpc-157kpvtb-500 U.S. Food and Drug Administration 2026U.S. Food and Drug Administration 2026U.S. Food and Drug Administration 2026U.S. Food and Drug Administration 2026U.S. Food and Drug Administration 2026U.S. Food and Drug Administration 2026U.S. Food and Drug Administration 2026U.S. Food and Drug Administration 2026U.S. Food and Drug Administration 2026European Medicines Agency 2026Legal Information Institute, Cornell Law School (text of the United States Code) 2026Staten-Generaal / Koninkrijk der Nederlanden 2007

Patterns worth noticing

What does the timeline teach?

Rules came after harm. Faster routes came after long waits. Copies and fakes came when demand was high.
Three times, a problem led to a change in the rules.
What went wrongWhat changed next
A toxic medicine killed 107 people in the US in 1937Proof of safety before marketing (US, 1938)
Thalidomide harmed more than 10,000 children, 1957–1962Proof that a medicine works (US, 1962); a licence before sale (European Community, 1965)
Seriously ill patients pushed for earlier access, and US reviews were criticised as too slowUser fees to fund faster reviews and accelerated approval (US, 1992); conditional authorisation (EU, 2006)

Sources 17, 11, 4, 18, 19, 20, 21

The pattern runs in both directions. Disasters made the rules stricter; long waits for new treatments made them faster in places. The page how we got here explains both pressures.

In detail The pattern, event by event

Harm, then rules. The US Food, Drug, and Cosmetic Act of 1938 came after Elixir of Sulfanilamide killed 107 people, many of them children, in 1937.17 The European Commission writes that much of the impetus behind Europe’s first medicines law, in 1965, was the determination to prevent another thalidomide.18

Delay, then faster routes. During the AIDS epidemic of the 1980s, very ill patients pushed for access to drugs still in development.19 The FDA’s review was long praised for its quality but, in the words of a former head of its drug centre, “criticized … for being too slow”. User fees to pay for more reviewers, and accelerated approval, followed in 1992.20 The EU added conditional marketing authorisation in 2006 and the PRIME scheme in 2016.21,22

Demand, then unlicensed supply. When demand for GLP-1 medicines outran supply in 2022, US pharmacies were allowed to compound copies during the shortage.12 Falsified pens followed in 2023, and by 2025 the UK regulator was seizing GLP-1 pens alongside other illegal medicines.13,23,24

Advice is not approval. The latest event is an FDA advisory vote. On 23 July 2026 the FDA’s Pharmacy Compounding Advisory Committee voted 8–6, with one abstention, to recommend BPC-157 for the list of bulk substances US pharmacies may use in compounding (the 503A list). Over two days it considered seven peptides and, as reported from the public meeting, recommended six: BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon (not emideltide, also called DSIP). No fda.gov page yet gives the vote counts.25,26,27

The vote is advisory and non-binding, and it went against FDA staff’s own recommendation.28 Legal compounding of these peptides remains prohibited until the FDA formally adopts the recommendation and completes rulemaking.29 None of them is an approved medicine in the EU, the UK or the US; Semax is registered as a medicine in Russia, as the FDA’s own briefing notes.30,31,32,33,34 A 503A listing, if it ever happens, would allow pharmacy compounding on prescription in the US. It is not a marketing authorisation, it says nothing about whether a peptide works, and it changes nothing in the EU or the Netherlands.35,36,37

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 37 sources, numbered as in the text
  1. Banting FG, Best CH, Collip JB, Campbell WR, Fletcher AA (1922). Pancreatic Extracts in the Treatment of Diabetes Mellitus. Canadian Medical Association Journal 12:141-146. Research article PMID 20314060 ↩
  2. du Vigneaud V, Ressler C, Swan JM, Roberts CW, Katsoyannis PG, Gordon S (1953). The synthesis of an octapeptide amide with the hormonal activity of oxytocin. Journal of the American Chemical Society 75:4879-4880. Research article doi:10.1021/ja01115a553 ↩
  3. Kreymann B, Williams G, Ghatei MA, Bloom SR (1987). Glucagon-like peptide-1 7-36: a physiological incretin in man. The Lancet 2:1300-1304. Research article doi:10.1016/s0140-6736(87)91194-9 ↩
  4. United States Congress (1962). Public Law 87-781 (Drug Amendments of 1962), 76 Stat. 780, approved 10 October 1962. United States Statutes at Large, volume 76. Law govinfo.gov — accessed 22 October 2026 ↩
  5. Council of the European Economic Community (1965). Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. Official Journal of the European Communities, 022, 9 February 1965, pp. 369-373. Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  6. World Anti-Doping Agency (2021). Summary of Major Modifications and Explanatory Notes, 2022 Prohibited List. Regulator wada-ama.org — accessed 20 October 2026 ↩
  7. U.S. Food and Drug Administration (2026). Drugs@FDA: BLA 018780 (Humulin R, insulin human). Regulator accessdata.fda.gov — accessed 22 October 2026 ↩
  8. U.S. Food and Drug Administration (2026). Drugs@FDA: NDA 021773 (Byetta, exenatide injection). Regulator accessdata.fda.gov — accessed 22 October 2026 ↩
  9. U.S. Food and Drug Administration (2026). Drugs@FDA: NDA 209637 (Ozempic, semaglutide injection). Regulator accessdata.fda.gov — accessed 20 October 2026 ↩
  10. U.S. Food and Drug Administration (2026). Drugs@FDA: NDA 215866 (Mounjaro, tirzepatide injection). Regulator accessdata.fda.gov — accessed 20 October 2026 ↩
  11. Vargesson N (2015). Thalidomide-induced teratogenesis: history and mechanisms. Birth Defects Research. Part C, Embryo Today: Reviews 105:140-156. Review doi:10.1002/bdrc.21096 ↩
  12. U.S. Food and Drug Administration (2026). FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. Regulator fda.gov — accessed 20 October 2026 ↩
  13. European Medicines Agency (2023). EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens. Regulator ema.europa.eu — accessed 20 October 2026 ↩
  14. U.S. Food and Drug Administration (FDA History Office) (2022). 100 Years of Insulin. Regulator fda.gov — accessed 22 October 2026 ↩
  15. Muttenthaler M, King GF, Adams DJ, Alewood PF (2021). Trends in peptide drug discovery. Nature Reviews Drug Discovery 20:309-325. Review doi:10.1038/s41573-020-00135-8 ↩
  16. European Medicines Agency (2026). Ozempic (semaglutide): EPAR — overview and product information. Official product information ema.europa.eu — accessed 20 October 2026 ↩
  17. U.S. Food and Drug Administration (2023). Milestones in U.S. Food and Drug Law. Regulator fda.gov — accessed 22 October 2026 ↩
  18. European Commission, Directorate-General for Health and Food Safety (2026). Legal framework governing medicinal products for human use in the EU. Regulator health.ec.europa.eu — accessed 22 October 2026 ↩
  19. Junod SW (FDA History Office) (2008). FDA and Clinical Drug Trials: A Short History. U.S. Food and Drug Administration; originally published in: A Quick Guide to Clinical Trials (Bioplan, 2008), pp. 25-55. Report fda.gov — accessed 22 October 2026 ↩
  20. Meadows M (FDA Consumer magazine) (2006). Promoting Safe and Effective Drugs for 100 Years. FDA Consumer magazine, Centennial Edition, January–February 2006 (fda.gov). Web page fda.gov — accessed 22 October 2026 ↩
  21. European Medicines Agency (2026). Conditional marketing authorisation. Regulator ema.europa.eu — accessed 22 October 2026 ↩
  22. European Medicines Agency (2026). PRIME: priority medicines. Regulator ema.europa.eu — accessed 22 October 2026 ↩
  23. Medicines and Healthcare products Regulatory Agency (2023). MHRA warns of unsafe fake weight loss pens. GOV.UK. Regulator gov.uk — accessed 20 October 2026 ↩
  24. Medicines and Healthcare products Regulatory Agency (2026). MHRA seizes illegal medicines worth almost £45m in 2025 – disrupting major criminal networks. GOV.UK. Regulator gov.uk — accessed 22 October 2026 ↩
  25. 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 ↩
  26. U.S. Food and Drug Administration (2026). 2026 Meeting Materials, Pharmacy Compounding Advisory Committee. Regulator fda.gov — accessed 20 October 2026 ↩
  27. U.S. Food and Drug Administration (2026). Questions, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  28. 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 ↩
  29. 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 ↩
  30. 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 ↩
  31. 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 ↩
  32. U.S. Food and Drug Administration (2026). FDA Briefing Document for KPV-Related Bulk Drug Substances (KPV (free base) and KPV acetate), Pharmacy Compounding Advisory Committee meeting, 23-24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  33. 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 ↩
  34. European Medicines Agency (2026). Medicines (search of centrally authorised medicines and EPARs). Regulator ema.europa.eu — accessed 20 October 2026 ↩
  35. Legal Information Institute, Cornell Law School (text of the United States Code) (2026). 21 U.S. Code § 353a – Pharmacy compounding (FD&C Act § 503A). United States Code. Law law.cornell.edu — accessed 22 October 2026 ↩
  36. U.S. Food and Drug Administration (2026). FDA Presentations, Pharmacy Compounding Advisory Committee meeting, 23 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  37. Staten-Generaal / Koninkrijk der Nederlanden (2007). Geneesmiddelenwet (BWBR0021505). wetten.overheid.nl. Law wetten.overheid.nl — accessed 20 October 2026 ↩