Tirzepatide: what the trials show, status and safety
Summary
Tirzepatide is a laboratory-made peptide that imitates two of the gut hormones released after a meal, GIP and GLP-1, from a single molecule. It is an approved, prescription-only medicine in eight markets and was first authorised in May 2022. In its largest weight-loss trial, participants lost an average of 20.9% of their body weight over 72 weeks. In the big heart study it performed as well as an older drug, dulaglutide, but no better, and the US package inserts carry a prominent warning based on thyroid tumours found in rats.
Key findings at a glance
- Approved and prescription-only in eight markets. The American regulator cleared it on 13 May 2022, and the European Union followed on 15 September 2022 [1], [2], [9].
- 20.9% of body weight lost after 72 weeks. That was the highest of three doses tested in SURMOUNT-1, a trial in 2,539 adults with obesity and without diabetes; people on placebo lost 3.1% [4].
- Long-term blood sugar down by 2.30 percentage points after 40 weeks. SURPASS-2 in 1,879 adults with type 2 diabetes, against 1.86 points for semaglutide in the same trial [20].
- No proven heart advantage over the drug it was compared with. In SURPASS-CVOT the risk of a serious heart event was 8% lower than on dulaglutide (hazard ratio 0.92), but the range compatible with the data, 0.83 to 1.01, still included no difference at all, and the test for an advantage gave p = 0.09 [3].
- 20.0 and 23.8 fewer breathing interruptions per hour of sleep than on placebo. Two parallel trials in 469 adults who had both obstructive sleep apnoea and obesity, measured at week 52 [6].
- A boxed warning about thyroid tumours in rats. Both US package inserts state that nobody knows whether the finding applies to people [1], [5].
- Not banned in sport. Tirzepatide is absent from the 2026 prohibited list and has been on the monitoring programme since 1 January 2026 [10], [11].
What it is
Tirzepatide is a peptide made in the laboratory, a chain of 39 amino acid building blocks, developed by the drug company Eli Lilly under the code LY3298176 [1]. Its chain copies a gut hormone called glucose-dependent insulinotropic polypeptide (GIP) rather than the better known GLP-1, and it switches on the docking points, or receptors, for both hormones. Two brand names contain the same active substance: Mounjaro and Zepbound [2], [17].
A fatty acid chain of twenty carbons (a C20 fatty diacid) attached to the twentieth building block (lysine 20) makes the peptide cling to albumin, a carrier protein in the blood. That is why it takes about five days for the body to clear half a dose, and why one injection a week is enough [1]. The nickname "twincretin" turns up in the literature, but it is not a proper pharmacological term [12].
Quick facts
| Field | Value | Ref |
|---|---|---|
| INN | tirzepatide | [1] |
| Development code | LY3298176 | [1] |
| Class | Dual GIP and GLP-1 receptor agonist | [1], [9] |
| Structure | 39 amino acids, C20 fatty diacid on lysine 20, C-terminal amide | [1] |
| Formula and mass | C225H348N48O68, 4,813.53 Da | [1], [12] |
| Half-life | About 5 days | [1] |
| Route | Subcutaneous, once weekly | [1] |
| Status | Approved, prescription-only, eight markets | [2], [9] |
| Developer | Eli Lilly and Company | [1] |
| ATC code | A10BX16 | [9] |
| CAS registry number | 2023788-19-2 | [12] |
| UNII | OYN3CCI6QE | [14] |
| PubChem CID | 166567236; Wikidata references the alternative record 156588324 | [12], [13] |
| InChIKey | BTSOGEDATSQOAF-MCNPHUAVSA-N | [12] |
| ChEMBL | CHEMBL4297839, max phase 4 | [15] |
| DrugBank | DB15171 | [16] |
| MeSH | D000098860 | [13] |
| Wikidata | Q108324770 | [13] |
How it works
The official product information describes how the drug works as established fact rather than as a theory, because it was studied alongside the trials [1].
- The GIP receptor. Tirzepatide latches onto this docking point and switches it on. How much the GIP half contributes by itself is still argued over, because no trial in the programme was designed to tell the two hormone systems apart [1].
- The GLP-1 receptor. Switching this one on slows the emptying of the stomach and makes people eat less [1].
- Insulin and glucagon. According to the label, the body releases more insulin, both in the first quick burst after a meal and in the slower phase that follows, and less glucagon, the hormone that pushes blood sugar up. Both effects only come into play when blood sugar is high [1].
- What the body does with the drug. About 80% of an injected dose reaches the bloodstream, 99% of it travels attached to albumin, and the body takes the molecule apart by the same routes it uses for proteins and fats (proteolysis, beta-oxidation and amide hydrolysis) [1].
Drugs such as semaglutide, dulaglutide and liraglutide work on the GLP-1 docking point alone. Tirzepatide works on two docking points, from a molecule built on the GIP template [1].
What the trials found
Weight
Phase 3 RCT SURMOUNT-1 was a large trial in which 2,539 adults with obesity and without diabetes were allocated at random to tirzepatide or to a dummy injection and followed for 72 weeks. They weighed 104.8 kg on average at the start. Across the three doses tested, average weight fell by 15.0%, 19.5% and 20.9%, against 3.1% on placebo. At least a twentieth of body weight was lost by 85%, 89% and 91% of participants on the drug, against 35% on placebo [4].
Large randomised trial in 2,539 adults with obesity and without diabetes, over 72 weeks, average starting weight 104.8 kg. Source [4].
Phase 3 RCT SURMOUNT-2 enrolled 938 adults who had obesity together with type 2 diabetes. By week 72 the two treatment groups had lost 12.8% and 14.7% of their weight. The effect is smaller in people with diabetes than it was in SURMOUNT-1, a pattern also seen with other drugs of this class, so the two sets of figures should not be read as interchangeable [21].
Phase 3 RCT, randomised withdrawal SURMOUNT-4 first gave all 670 participants the drug openly for 36 weeks, then split them at random into a group that carried on and a group switched to placebo for another 52 weeks. Between week 36 and week 88 those who continued lost a further 5.5%, while those on placebo regained 14.0%, a gap of 19.4 percentage points [22].
Phase 3 RCT, open-label SURMOUNT-5 compared tirzepatide directly with semaglutide in 751 adults with obesity and without diabetes. At week 72 the average weight loss was 20.2% against 13.7%, and waistlines shrank by 18.4 cm against 13.0 cm [23]. Neither the participants nor the investigators were kept in the dark about which drug was being given, and that can colour how results are judged.
Blood sugar
Phase 3 RCT SURPASS-1 enrolled 478 adults with type 2 diabetes who had not yet taken any diabetes medicine, and ran for 40 weeks. Their long-term blood sugar value, which reflects the average of the past two to three months (glycated haemoglobin), fell by 1.87 to 2.07 percentage points from a starting level of 7.9%, while it crept up by 0.04 points on placebo. A value below 7.0%, the usual treatment target, was reached by 87% to 92% of participants, against 20% on placebo [19].
Phase 3 RCT, open-label SURPASS-2 enrolled 1,879 adults who were already taking metformin. Their long-term blood sugar value fell by 2.01, 2.24 and 2.30 percentage points across the three doses, compared with 1.86 points on semaglutide. All three differences were big enough to count as statistically reliable, and participants also lost 1.9 kg, 3.6 kg and 5.5 kg more weight than those on semaglutide [20].
Cardiovascular events
Phase 3 RCT, active comparator SURPASS-CVOT measured tirzepatide against another established drug rather than against a dummy injection. It followed 13,299 adults who had type 2 diabetes and hardened arteries for a median of 210.1 weeks, roughly four years. A serious heart event occurred in 801 of the 6,586 people on tirzepatide (12.2%) and in 862 of the 6,579 on dulaglutide (13.1%). That works out as a risk 8% lower on tirzepatide (hazard ratio 0.92), but the range of values still compatible with the data ran from 0.83 to 1.01 (a 95.3% confidence interval) and therefore included no difference at all [3].
The trial did establish that tirzepatide is no worse than dulaglutide (p = 0.003). The separate question of whether it is actually better was tested and left unanswered, at p = 0.09 [3]. The US heart indication added in August 2026 rests on this result, in which the comparison was against an active drug rather than against a placebo [2], [29].
Randomised trial against an active drug, 13,299 adults with type 2 diabetes and hardened arteries, followed for a median of 210.1 weeks. The risk was 8% lower (hazard ratio 0.92), but the range compatible with the data, 0.83 to 1.01 (a 95.3% confidence interval), still covered no difference: as good as dulaglutide, not proven better (p = 0.09). Source [3].
Heart failure
Phase 3 RCT SUMMIT followed 731 people who had heart failure together with obesity for a median of 104 weeks. To take part they had to have a heart that still pumped out at least 50% of its filling volume with each beat, the stiff rather than the weak form of heart failure (ejection fraction), and a body mass index of at least 30 kg/m². Death from a heart cause or a clear worsening of the heart failure, counted together, occurred in 36 of 364 participants on the drug (9.9%) and in 56 of 367 on placebo (15.3%). That is a risk lower by about a third (hazard ratio 0.62, with a range from 0.41 to 0.95) [7].
Almost all of that came from the worsening heart failure part (hazard ratio 0.54). Deaths from heart causes ran the other way, 8 against 5, but those figures are far too small to settle anything about survival [7].
Sleep apnoea
Phase 3 RCT SURMOUNT-OSA consisted of two parallel trials against placebo in 469 adults who had moderate to severe obstructive sleep apnoea along with obesity, and ran for 52 weeks. At the start, their breathing stopped or became too shallow 51.5 and 49.5 times per hour of sleep (apnoea-hypopnoea index). By week 52 tirzepatide had cut that by 20.0 and 23.8 events per hour more than placebo did, in the trial without and the trial with a breathing mask used alongside [6].
Liver
Phase 2 RCT SYNERGY-NASH treated 190 adults for 52 weeks who had a fatty liver that had become inflamed and scarred, confirmed by a tissue sample, at the middle stages of scarring (fibrosis F2 or F3). Among the 157 people whose follow-up sample could be assessed, the inflammation had cleared up without the scarring getting worse in 44%, 56% and 62% across the doses, against 10% on placebo [8]. This is the least robust study on the page, and the larger trial meant to confirm it is still recruiting [24].
What is still unknown
- A heart advantage. Whether tirzepatide beats dulaglutide was put to the test and could not be shown [3].
- The GIP share. No trial has separated out how much each of the two docking points contributes [1].
- The liver finding. It rests on a single mid-stage trial that judged success from tissue samples in a fairly small group [8], [24].
- Long-term safety. The longest anyone has been followed is a median of 210.1 weeks [3].
- The direct comparisons. In both trials against semaglutide, everyone knew which drug was being given [20], [23].
Side effects and safety
Stomach and bowel problems dominate the side effects. They tend to appear early and are the main reason people give up on the drug. The figures below come from the weight-loss trials pooled in the US product information, covering 3,477 people on tirzepatide compared with placebo [5].
| Event | Tirzepatide | Placebo |
|---|---|---|
| Nausea | 25–29% | 8% |
| Diarrhoea | 19–23% | 8% |
| Constipation | 11–17% | 5% |
| Vomiting | 8–13% | 2% |
| Abdominal pain | 9–10% | 5% |
| Dyspepsia | 9–10% | 4% |
| Injection-site reactions | 6–8% | 2% |
| Fatigue | 5–7% | 3% |
| Hypersensitivity reactions | 5% | 3% |
| Hair loss | 4–5% | 1% |
| Gastrointestinal events overall | 56% | 30% |
| Discontinuation for adverse reactions | 4.8–6.7% | 3.4% |
Further points from the labels and the programme:
- Boxed warning about thyroid tumours. In male and female rats, tirzepatide causes tumours in the C-cells of the thyroid gland, more often the higher the dose and the longer the exposure, at levels comparable to those reached in people. What this means for humans is stated as unknown [1], [5].
- Who must not take it. Anyone who has had medullary thyroid cancer or has it in the family, anyone with the inherited condition multiple endocrine neoplasia type 2, and anyone known to react severely to the drug [1], [5].
- What the labels warn about. Severe stomach and bowel reactions, inflammation of the pancreas, kidney damage brought on by losing too much fluid, gallbladder trouble, blood sugar dropping too low when the drug is combined with insulin or with tablets that push insulin out, worsening of diabetic eye disease, and stomach contents getting into the lungs during anaesthesia [1], [5].
- Pens are never shared. Both labels say so even if the needle is changed, because an infection can be passed on [1], [5].
- In the direct diabetes comparison the rates were similar. SURPASS-2 reported nausea in 17% to 22% of participants, against 18% on semaglutide [20].
Two gaps deserve to be spelled out. Nobody knows whether the thyroid tumours seen in rats have any bearing on people, which is why the warning is worded as an open question. And what happens beyond the length of the trials has simply not been studied yet [1], [3].
Why this page lists no doses
Tirzepatide is available only on prescription in every market where it is approved, and working out the right dose for an individual is a job for the official product information and the prescribing doctor. This page therefore refers to doses only as the lowest, middle or highest tested, and reports the results measured at each of them.
Development and approval status
Approval and evidence timeline
- 2021The first four SURPASS trials in type 2 diabetes reportRefs [19], [20]
- 2022FDA approval on 13 May, EU authorisation on 15 September, Swiss on 2 November, Canadian on 24 NovemberSURMOUNT-1 publishes, refs [2], [4], [9], [27], [28]
- 2023Weight-management indication authorised in the United Kingdom in November and in the European Union in DecemberRefs [17], [18], [25]
- 2024Sleep apnoea indication added in the United States in DecemberSURMOUNT-OSA and SYNERGY-NASH publish, refs [6], [8], [17]
- 2025SUMMIT, SURMOUNT-5 and SURPASS-CVOT publish; the diabetes indication is extended to children aged 10 and overRefs [2], [3], [7], [23]
- 27 Aug 2026Cardiovascular risk-reduction indication approved in the United StatesRefs [2], [29]
- 2021 — the first four SURPASS trials in type 2 diabetes report their results [19], [20].
- 2022 — the American regulator approves the drug on 13 May, the European Union follows on 15 September, Switzerland on 2 November and Canada on 24 November, and SURMOUNT-1 is published [2], [4], [9], [27], [28].
- 2023 — the United Kingdom approves it for weight management in November and the European Union does so in December [17], [18], [25].
- 2024 — SURMOUNT-OSA and SYNERGY-NASH are published, and the United States adds sleep apnoea as an approved use in December [6], [8], [17].
- 2025 — SUMMIT, SURMOUNT-5 and SURPASS-CVOT are published, and the diabetes approval is extended to children aged 10 and over [2], [3], [7], [23].
- 2026 — the United States approves it for lowering heart risk, with a status date of 27 August [2], [29].
| Market | Status | Since |
|---|---|---|
| United States | Approved | 2022-05-13 |
| European Union | Approved | 2022-09-15 |
| Germany | Approved | 2022-09-15 |
| United Kingdom | Approved | 2022-09 |
| Australia | Registered | 2023-07-10 |
| Canada | Approved | 2022-11-24 |
| Switzerland | Approved | 2022-11-02 |
Japan is the eighth market. The review record shows approval in September 2022 for type 2 diabetes, and an expert committee cleared the obesity application on 2 December 2024 [18]. Every entry above reflects the position on 6 September 2026, and in each of these markets the substance is handed out on prescription only [2], [9], [18], [25], [26], [27], [28].
Whether anyone else pays for it is a separate question. In Germany the weight-loss use counts as a lifestyle medicine under social insurance law, so statutory health insurance does not cover it and patients need a private prescription. The diabetes use is covered [33], [34]. The wider legal framework is set out under are peptides legal and FDA-approved peptides.
Anti-doping
Tirzepatide is not banned in sport. It does not appear on the 2026 prohibited list, either in or out of competition, so no therapeutic use exemption is needed on the basis of that list [10]. Since 1 January 2026 it has been on the monitoring programme, which watches how often the substance is used but attaches no penalty to it [11], [35]. The wider picture for this class is at peptides banned in sport.
Compared with related peptides
| Peptide | Receptors | Status | Strongest weight result in its own trial | Half-life |
|---|---|---|---|---|
| Tirzepatide | GIP, GLP-1 | Approved in eight markets | −20.9% at 72 weeks, SURMOUNT-1, n = 2,539 [4] | ~5 days [1] |
| Retatrutide | GIP, GLP-1, glucagon | Phase 3, approved nowhere | −24.2% at 48 weeks, phase 2, n = 338 [36] | ~6 days [36] |
| Semaglutide | GLP-1 | Approved in many markets | −14.9% at 68 weeks, STEP 1, n = 1,961 [37] | Not stated here |
| Liraglutide | GLP-1 | Approved in many markets | −8.0% at 56 weeks, SCALE, n = 3,731 [38] | Not stated here |
| CagriSema | GLP-1 plus amylin | Phase 3 reported | −22.7% at 68 weeks on treatment, REDEFINE 1, n = 3,417 [39] | Not stated here |
Those five figures come from five different trials. The people enrolled, the length of the studies and the starting weights all differ, so that column ranks trials rather than drugs. Only the comparison with semaglutide has actually been run head to head, in SURPASS-2 and SURMOUNT-5, and in both of them everyone knew which drug was being taken [20], [23].
Five separate trials, not a direct comparison: the people enrolled, the length of treatment, the starting weights and the way the result was calculated all differ. Sources [4], [36], [37], [38], [39].
Two of the neighbours differ in kind, not just in degree. Retatrutide adds a third docking point and is approved nowhere [36]. CagriSema combines a GLP-1 drug with a copy of amylin, a different appetite hormone, so it works on two separate hormone systems rather than on two gut hormone receptors [39].
Common misconceptions
- "Tirzepatide and semaglutide are interchangeable." They are two different active substances, each with its own approval. One acts on GLP-1 alone, the other on GIP and GLP-1 from a molecule built on the GIP template [1], [20].
- "The two US brand names are different substances." They contain exactly the same substance, submitted twice: one application covers diabetes and heart risk, the other obesity and sleep apnoea [2], [17].
- "The heart approval proves the drug is better." SURPASS-CVOT was designed to show that tirzepatide is no worse than dulaglutide, and that is what it showed. Being better was tested separately and could not be demonstrated [3].
- "Compounded tirzepatide is the same medicine." Preparations mixed by a pharmacy go through no approval procedure at all. The FDA stopped tolerating them once the shortage transition periods ran out in February and March 2025 [30], [31], [32].
- "It is a research peptide like the unapproved ones." It is an approved medicine in eight markets, and in all of them it requires a prescription. Buying it any other way breaks medicines law; it does not sit in a grey zone [2], [9].
- "It is banned in sport." It is not on the 2026 prohibited list. Being monitored is a different thing entirely and carries no penalty [10], [11].
Frequently asked questions
Is tirzepatide a prescription medicine?
Yes, in every market on this page. It has full marketing approval in the United States, the European Union, Germany, the United Kingdom, Australia, Canada, Switzerland and Japan, and in all of them a doctor has to prescribe it. Getting hold of it any other way breaks the medicines law of the country concerned, so it is not a grey area.
How much weight did people lose in the tirzepatide trials?
In the SURMOUNT-1 trial, 2,539 adults with obesity but without diabetes lost an average of 20.9% of their body weight over 72 weeks at the highest dose tested, while those given a dummy injection lost 3.1%. In adults who also had type 2 diabetes the loss was smaller, 14.7% in the SURMOUNT-2 trial.
What is the difference between tirzepatide and semaglutide?
Semaglutide imitates a single gut hormone, GLP-1. Tirzepatide imitates two, GIP and GLP-1, and its molecule is built on the GIP template. Two trials compared the drugs directly and both favoured tirzepatide: SURPASS-2 on long-term blood sugar, and SURMOUNT-5 on weight, where the average loss at week 72 was 20.2% against 13.7%. In both trials everyone knew which drug they were getting.
Did tirzepatide reduce cardiovascular events in its outcome trial?
The SURPASS-CVOT trial showed that tirzepatide is at least as good as the older drug dulaglutide, but not that it is better. Among 13,299 adults followed for a median of 210.1 weeks, roughly four years, the risk of a serious heart event was 8% lower on tirzepatide (hazard ratio 0.92), yet the range still compatible with the data ran from 0.83 to 1.01 and so included no difference at all. The test for a genuine advantage came out at p = 0.09, which is not enough to claim one. The 2026 US heart indication rests on that result.
What are the most common tirzepatide side effects?
Nausea, diarrhoea, vomiting and constipation. They mostly show up early and become more common at higher doses. In the pooled weight-loss trials nausea affected 25% to 29% of participants, against 8% of those on placebo. Stomach and bowel complaints of any kind affected 56% against 30%, and 4.8% to 6.7% of participants stopped treatment because of side effects.
What is the tirzepatide boxed warning about?
Both US package inserts open with a boxed warning, the strongest warning American regulators can require, about tumours in the thyroid gland. In male and female rats, tirzepatide causes these C-cell tumours more often the higher the dose and the longer the exposure, at levels comparable to those reached in people. Whether the same happens in humans is not known. It must not be used by anyone who has had medullary thyroid cancer or has it in the family, or who has the inherited condition multiple endocrine neoplasia type 2.
Why does this page not list tirzepatide doses?
Because tirzepatide is available only on prescription wherever it is approved, and choosing a dose is a matter for the official product information and the prescribing doctor. This page refers to doses only as the lowest, middle or highest tested, and reports the results measured at each of them.
Is tirzepatide banned in sport?
No. It does not appear on the World Anti-Doping Agency prohibited list for 2026, either in or out of competition, so no therapeutic use exemption is needed on the basis of that list. It has been on the 2026 monitoring programme since 1 January 2026, which only records how often the substance turns up and carries no penalty.
Is compounded tirzepatide the same as the approved medicine?
No. Compounded versions, mixed by a pharmacy rather than made by the manufacturer, go through no approval procedure and are not checked for effectiveness, quality or safety in the same way. The FDA declared the United States shortage over on 19 December 2024 and gave compounders until 18 February 2025 and 19 March 2025 to stop, after which it no longer tolerated them.
What is still unknown about tirzepatide?
Whether the thyroid tumours seen in rats mean anything for people, what the GIP half of the molecule contributes on its own, and whether the promising liver result holds up in a larger trial. Safety over longer periods than the trials themselves has not been studied either; the longest anyone has been followed is a median of 210.1 weeks.
Sources
- MOUNJARO (tirzepatide) injection — US Prescribing Information. Eli Lilly and Company, revision 8/2026. DailyMed setid d2d7da5d-ad07-4228-955f-cf7e355c8cc0. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0
- Drugs@FDA / openFDA, NDA 215866, approval and supplement history. Retrieved 6 September 2026. https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215866%22
- Nicholls SJ, Pavo I, Bhatt DL et al. (2025). Cardiovascular outcomes with tirzepatide versus dulaglutide in type 2 diabetes (SURPASS-CVOT). New England Journal of Medicine 393(24):2409-2420. PMID 41406444. DOI 10.1056/NEJMoa2505928
- Jastreboff AM, Aronne LJ, Ahmad NN et al. (2022). Tirzepatide once weekly for the treatment of obesity (SURMOUNT-1). New England Journal of Medicine 387(3):205-216. PMID 35658024. DOI 10.1056/NEJMoa2206038
- ZEPBOUND (tirzepatide) injection — US Prescribing Information. Eli Lilly and Company, revision 8/2026. DailyMed setid 487cd7e7-434c-4925-99fa-aa80b1cc776b. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b
- Malhotra A, Grunstein RR, Fietze I et al. (2024). Tirzepatide for the treatment of obstructive sleep apnea and obesity (SURMOUNT-OSA). New England Journal of Medicine 391(13):1193-1205. PMID 38912654. DOI 10.1056/NEJMoa2404881
- Packer M, Zile MR, Kramer CM et al. (2025). Tirzepatide for heart failure with preserved ejection fraction and obesity (SUMMIT). New England Journal of Medicine 392(5):427-437. PMID 39555826. DOI 10.1056/NEJMoa2410027
- Loomba R, Hartman ML, Lawitz EJ et al. (2024). Tirzepatide for metabolic dysfunction-associated steatohepatitis with liver fibrosis (SYNERGY-NASH). New England Journal of Medicine 391(4):299-310. PMID 38856224. DOI 10.1056/NEJMoa2401943
- European Medicines Agency, EPAR Mounjaro (tirzepatide), authorised 15 September 2022, revision 21 of 28 August 2026. https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro
- World Anti-Doping Agency, Prohibited List. Retrieved 6 September 2026; tirzepatide is not listed for 2026. https://www.wada-ama.org/en/prohibited-list
- Nationale Anti Doping Agentur Deutschland (NADA). WADA publishes Prohibited List 2026. https://www.nada.de/en/service/news/news-detail/wada-publishes-prohibited-list-2026
- PubChem, Compound CID 166567236 (Tirzepatide). National Library of Medicine. https://pubchem.ncbi.nlm.nih.gov/compound/166567236
- Wikidata, Q108324770 (tirzepatide). https://www.wikidata.org/wiki/Q108324770
- DailyMed Web Services API v2, structured product labelling XML for both US labels; UNII taken from the activeMoiety element. https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/d2d7da5d-ad07-4228-955f-cf7e355c8cc0.xml
- ChEMBL, CHEMBL4297839 (TIRZEPATIDE), max phase 4. https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297839/
- DrugBank, DB15171 (Tirzepatide); identifier verified through Wikidata after direct retrieval was blocked by the provider on 6 September 2026. https://go.drugbank.com/drugs/DB15171
- Drugs@FDA / openFDA, NDA 217806, approval and supplement history. Retrieved 6 September 2026. https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA217806%22
- Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency (2024). Report on the Deliberation Results — Zepbound Subcutaneous Injection Ateos (tirzepatide), 6 December 2024, English translation. https://www.pmda.go.jp/files/000278664.pdf
- Rosenstock J, Wysham C, Frías JP et al. (2021). Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1). The Lancet 398(10295):143-155. PMID 34186022. DOI 10.1016/S0140-6736(21)01324-6
- Frías JP, Davies MJ, Rosenstock J et al. (2021). Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes (SURPASS-2). New England Journal of Medicine 385(6):503-515. PMID 34170647. DOI 10.1056/NEJMoa2107519
- Garvey WT, Frías JP, Jastreboff AM et al. (2023). Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2). The Lancet 402(10402):613-626. PMID 37385275. DOI 10.1016/S0140-6736(23)01200-X
- Aronne LJ, Sattar N, Horn DB et al. (2024). Continued treatment with tirzepatide for maintenance of weight reduction in adults with obesity (SURMOUNT-4). JAMA 331(1):38-48. PMID 38078870. DOI 10.1001/jama.2023.24945
- Aronne LJ, Horn DB, le Roux CW et al. (2025). Tirzepatide as compared with semaglutide for the treatment of obesity (SURMOUNT-5). New England Journal of Medicine 393(1):26-36. PMID 40353578. DOI 10.1056/NEJMoa2416394
- ClinicalTrials.gov, registry query for tirzepatide; 279 registered studies as at 6 September 2026. https://clinicaltrials.gov/search?intr=tirzepatide
- MHRA. MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss. Press release, 8 November 2023. https://www.gov.uk/government/news/mhra-authorises-diabetes-drug-mounjaro-tirzepatide-for-weight-management-and-weight-loss
- Therapeutic Goods Administration, ARTG entry 379333 and further entries 379330, 407051, 407053, 407054, 407055, 439694. https://www.tga.gov.au/resources/artg/379333
- Health Canada, Summary Basis of Decision SBD00629, Notice of Compliance 24 November 2022. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00629
- Swissmedic, Public Summary SwissPAR — Mounjaro (tirzepatide), initial authorisation 2 November 2022. https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/public-summary-swiss-par/public-summary-swiss-par-mounjaro.html
- Eli Lilly and Company. FDA approves Lilly's Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes. Press release, August 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjaro-tirzepatide-reduce-cardiovascular
- FDA. Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products. December 2024. https://www.fda.gov/media/184606/download
- FDA. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. Drug Alerts and Statements, 2025. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- Frier Levitt. FDA determines (again) the tirzepatide shortage is resolved: what this means for 503A and 503B compounding. 2025. https://www.frierlevitt.com/articles/fda-determines-again-the-tirzepatide-shortage-is-resolved-what-this-means-for-503a-and-503b-compounding/
- Pharmazeutische Zeitung. Gericht sieht Abnehmspritze als Lifestyle-Medikament. https://www.pharmazeutische-zeitung.de/gericht-sieht-abnehmspritze-als-lifestyle-medikament-165160/
- APOTHEKE ADHOC. Gericht: Kasse muss Mounjaro nicht bezahlen. https://www.apotheke-adhoc.de/nachrichten/detail/politik/gericht-kasse-muss-mounjaro-nicht-bezahlen/
- World Anti-Doping Agency, The 2026 Monitoring Program; direct retrieval returned an empty response on 6 September 2026. https://www.wada-ama.org/sites/default/files/2025-09/2026_list_monitoring_program_en_final_clean_september_2025.pdf
- Jastreboff AM, Kaplan LM, Frías JP et al. (2023). Triple-hormone-receptor agonist retatrutide for obesity — a phase 2 trial. New England Journal of Medicine 389(6):514-526. PMID 37366315. DOI 10.1056/NEJMoa2301972
- Wilding JPH, Batterham RL, Calanna S et al. (2021). Once-weekly semaglutide in adults with overweight or obesity (STEP 1). New England Journal of Medicine 384(11):989-1002. PMID 33567185. DOI 10.1056/NEJMoa2032183
- Pi-Sunyer X, Astrup A, Fujioka K et al. (2015). A randomized, controlled trial of 3.0 mg of liraglutide in weight management (SCALE Obesity and Prediabetes). New England Journal of Medicine 373(1):11-22. PMID 26132939. DOI 10.1056/NEJMoa1411892
- Novo Nordisk. CagriSema demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in the New England Journal of Medicine. Press release, 2025. https://www.prnewswire.com/news-releases/cagrisema-2-4-mg--2-4-mg-demonstrated-22-7-mean-weight-reduction-in-adults-with-overweight-or-obesity-in-redefine-1--published-in-nejm-302487770.html
Cite this page
The facts on this page were checked on 6 September 2026, and the official registers behind the status table were queried on that same day. Approved medicines pick up new uses and revised warnings over time, so the version and the date matter as much as the text itself.
myPeptides Research & Editing. (2026). Tirzepatide: what the trials show, status and safety. Version 1.0, 6 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/tirzepatide
How pages in this register are compiled and graded is described under methodology; the full register is at peptides.
| Version | Date | Change |
|---|---|---|
| 1.0 | 2026-09-06 | Initial publication |
Last verified: 6 September 2026. Next review: on a labelling change in any covered market, on publication of the phase 3 liver programme, or on any change in the anti-doping classification.