Peptide · substance profile

Tirzepatide

Dual GIP / GLP-1 receptor agonist Developer: Eli Lilly Approved by the FDA and EMA (Mounjaro, Zepbound) First approval: 2022

Unlike most substances on this site, tirzepatide is an approved medicine with official prescribing information and trials involving tens of thousands of people. But all of this applies to the approved products. “Tirzepatide” vials from the internet, including “research” ones, are different products, and Lilly’s data do not directly apply to them.

What is it?
At a glance

What it is: an Eli Lilly medicine for type 2 diabetes and obesity — a 39-amino-acid peptide that acts on two hormone receptors at once, GIP and GLP-1. It is called a “dual agonist”, sometimes a “twincretin”.

Status: a prescription medicine in the USA, the EU, the UK and many other countries (Mounjaro, Zepbound).[1][8]

When it appeared: developed at Lilly in the mid-2010s; first paper in 2018; first approval by the FDA on 13 May 2022.[13]

Sport: not on WADA’s 2026 Prohibited List, but included in the Monitoring Program — anti-doping laboratories track how often athletes use it.[12]

After a meal, the gut releases hormones called incretins: they help the pancreas release insulin when blood sugar rises and tell the brain that a person is full. Tirzepatide mimics two of them:

  • GLP-1 reduces appetite, slows stomach emptying and boosts insulin release after meals. This is how semaglutide (Ozempic, Wegovy) works.
  • GIP also boosts insulin release and, according to current data, affects fat tissue and appetite centres.
DrugReceptorsStatus
SemaglutideGLP-1approved
TirzepatideGIP + GLP-1approved
RetatrutideGIP + GLP-1 + glucagonunder investigation, not approved

Tirzepatide is a single molecule, not a mixture of two drugs. And “dual” does not mean “50/50”: it “sticks” to the GIP receptor about as well as the natural hormone, but acts on GLP-1 more weakly and slightly differently.[14] Scientists have not fully explained why adding GIP strengthens the effect: for a long time it was thought that in obesity GIP should rather be blocked. Tirzepatide became an argument for stimulating it, but the debate continues.

For those who want more detail: the structure of the molecule

Development code: LY3298176. A peptide based on the GIP sequence: positions 2 and 13 hold non-standard amino acids (Aib) that protect the chain from enzymes; a fatty acid (C20 diacid) is attached via a linker to the lysine at position 20, binding the molecule to blood albumin, so the drug lasts about a week. Formula C₂₂₅H₃₄₈N₄₈O₆₈, mass ≈ 4813 g/mol; CAS 2023788-19-2; UNII OYN3CCI6QE; DrugBank DB15171; ATC A10BX16.[7][1]

When did it appear?
2016
Lilly files a patent on the molecule: GLP-1 activity is “built into” the GIP sequence.[30]
2018
First data: animal experiments, first human studies, phase 2 in diabetes.[13]
2019–2022
Final trials: SURPASS (type 2 diabetes) and SURMOUNT (obesity).
13.05.2022
The FDA approves Mounjaro for type 2 diabetes; EU approval follows in September.
Dec 2022
Tirzepatide goes on the FDA drug shortage list — US pharmacies start compounding “copies” on a mass scale.
08.11.2023
The FDA approves Zepbound — the same tirzepatide for treating obesity.
19.12.2024
The FDA declares the shortage resolved; the transition period for pharmacies runs to February–March 2025.[4]
20.12.2024
Zepbound is approved for sleep apnoea in people with obesity — the first FDA-approved drug for this condition.
Dec 2025
In the USA, Mounjaro is approved for children aged 10 and over with type 2 diabetes.
28.08.2026
The FDA approves Mounjaro to reduce the risk of heart attack, stroke and cardiovascular death in type 2 diabetes.[28]

Patents and copies

Lilly’s main US patent on the molecule runs until January 2036; additional patents (formulation, the pen, methods of use) may extend protection to roughly 2039–2041. In 2026 the FDA accepted Sandoz’s applications for a copy of tirzepatide, but there are no approved copies in the USA or EU yet.[29] For scale: Mounjaro and Zepbound earned Lilly 36.5 billion dollars in 2025 — tirzepatide became the world’s best-selling drug.[31]

What is it used for?

Official indications

IndicationUSA (FDA)EU (EMA)
Type 2 diabetes in adults✅ Mounjaro, 2022✅ Mounjaro, 2022
Type 2 diabetes in children aged 10+✅ 2025✅
Obesity, and overweight with related conditions✅ Zepbound, 2023✅ Mounjaro, 2023
Sleep apnoea with obesity✅ Zepbound, 2024—
Reducing the risk of heart attack, stroke and cardiovascular death in type 2 diabetes✅ Mounjaro, 2026no separate indication granted; data added to the product information
Heart failure with preserved ejection fraction in obesity—no separate indication granted; data added to the product information

Regulators assess the same data differently. On heart failure, the EMA concluded that it was unclear whether there was any benefit beyond weight loss, and that treating obesity in these patients is already covered by the indications.[9] On cardiovascular risk, the FDA approved the indication and the EMA did not.[8]

In Russia the original Lilly product is not sold. In 2022, after the start of the war in Ukraine, Lilly suspended operations in Russia, then left the market, and in November 2024 it terminated its own Eurasian patent on tirzepatide.[27][32] After that, Russian pharmaceutical companies registered their own tirzepatide products (for example, “Tirzetta” and “Sejaro”); they are prescription-only.[33] Data from Lilly’s trials apply to Lilly’s product; the Russian products have their own registration data.

Under investigation (not yet indications): heart protection in people with obesity without diabetes (SURMOUNT-MMO, about 15,000 participants, ongoing), fatty liver disease, kidney disease, obesity in adolescents.

Unofficially: weight loss without a medical indication, “cutting” in bodybuilding, and “microdosing” — doses below those studied, to make a calorie deficit easier to maintain. There are no scientific data on “microdosing”.

The different kinds of “tirzepatide”

Lilly originalCompounded “copies” in the USA“Research” vials (e.g. ZPHC)
Approvalyes: FDA, EMA, etc.no; permitted during the shortage, now only in narrow casesno
What has been studiedthousands of people in trialsthe product itself has not been studiedthe product itself has not been studied
Who checks qualityregulatorsthe pharmacy’s licence; the FDA has found sterility violationsonly the manufacturer — a matter of trusting it
Additivesnoneoften B12, niacinamide — such combinations have not been studiedas labelled
Doctorrequired (prescription)on prescription, often onlinenone

The FDA’s position: the only approved tirzepatide products in the USA are Mounjaro and Zepbound.[5] The regulator does not regard a “research use only” label as a defence if the product is in effect sold to people; in 2026 the FDA sent warnings to telehealth services and pharmacies selling tirzepatide “copies”.[34][35]

If there is an approved drug, why buy vials?

The main reasons are price (in the USA about a thousand dollars a month without insurance, and insurance often does not cover obesity treatment) and the prescription: people without an indication, for example those who want it “for definition”, will not be prescribed it. A vial wins on price and availability but loses on the main point: what is inside has to be taken on trust, and there is no medical supervision.

What people expect from it and why it is popular
ExpectationWhere it comes fromWhat the data say
Lose 15–20% of body weightLilly’s trials, mediaon average ~20% over 72 weeks — while the drug is being taken
“Stronger than Ozempic”head-to-head comparison, social mediain a head-to-head trial weight loss was greater than on semaglutide; this is one trial with specific conditions
“Quiet in the head”patients, social mediamany describe it this way, but it is not a measured trial outcome
Lose weight once and for allexpectation of a “course”not supported: after stopping, most of the weight usually comes back
Protect the heart2026 FDA approvalshown in diabetes with heart disease; in obesity without diabetes a trial is ongoing
“Burn fat while keeping muscle”fitness bloggersboth fat and lean mass are lost

Its popularity rests on the largest weight-loss figures among approved drugs, one injection a week and a constant presence in the news. The 2022–2024 shortage and the high price created a huge market for “copies” and “research” vials.

What has research shown?

All the trials below were sponsored by Lilly. The figures apply to the original product.

How many trials in total
Tirzepatide is one of the most studied substances on this site. For the first approval alone, the FDA considered 9 trials with 7,769 participants with type 2 diabetes.[3] Then came the SURMOUNT programme in obesity, trials in sleep apnoea, heart failure, fatty liver disease and children, a head-to-head comparison with semaglutide and the largest of all — SURPASS-CVOT, with 13,299 participants followed for about 4 years. Another (SURMOUNT-MMO, about 15,000 people without diabetes) is ongoing. Animal experiments were conducted mainly before human trials: in rodents, tirzepatide reduced weight and blood sugar but caused thyroid tumours (see “Possible risks”).

Main results

  • Weight loss. In the main obesity trial (2,539 people, 72 weeks), weight fell by an average of 15–21% depending on the dose vs 3% on placebo.[15]
  • Comparison with semaglutide (751 people): −20.2% body weight vs −13.7% over 72 weeks. The trial was open-label and funded by Lilly.[17]
  • What happens after stopping. After 36 weeks of treatment, some participants were switched to placebo under blinded conditions: over the following year they regained an average of 14% of their weight, while those who continued lost another 5.5%. 89.5% of those who continued maintained at least 80% of the weight lost, compared with only 16.6% of those who stopped.[16] Tirzepatide is not a “course” but long-term treatment.
  • What the lost weight consists of. About 75% fat and about 25% lean mass — the same proportions as in people losing weight by diet alone. Lean mass is not only muscle but also water, organs and connective tissue.[18]
  • The heart. In SURPASS-CVOT, tirzepatide was compared with dulaglutide, which already has proven heart protection: heart attack, stroke or cardiovascular death occurred in 12.2% vs 13.1%. Tirzepatide proved non-inferior, but it could not be shown to be superior.[19] An additional analysis of a broader set of outcomes showed a 16% risk reduction, but such analyses are less reliable.[20]
  • Heart failure (731 people with obesity): worsening or cardiovascular death in 9.9% vs 15.3% on placebo; the number of events was small (92).[21]

What the trials have not yet shown

  • heart protection in people with obesity without diabetes (SURMOUNT-MMO is ongoing);
  • safety over decades;
  • safety in pregnancy and breastfeeding;
  • anything at all about “research” vials and compounded “copies”: they have not been studied.
What people who have used it say

Personal experience is not proof. On Reddit almost all the authors say they received the original product prescribed by a doctor; on YouTube it is more often compounded “copies”, or they do not say. Videos were chosen at random (except obviously promotional ones). Doses, regimens and personal details are not given.

Positive experience

More than two years, minus ~63 kg: weight has been maintained for 8 months already. The worst part — a few episodes of nausea and vomiting in the first year, less and less over time. Never once wanted to quit.[37]

Three weeks, a man who trains hard: “food is no longer in my head”, minus ~6 kg. Honestly lists the downsides — bouts of nausea, weakness in the gym, dizziness, difficulty drinking enough water; attributes some of it to a sharp calorie deficit. Does not say which product he took.[44]

Sources: Reddit, YouTube
Mixed experience

Side effects with every dose increase: flu-like feeling, aches, injection-site reactions, constipation. On a lower dose weight did not fall; on a higher one it does, but the side effects return. The author is deciding what to do together with a doctor.[38]

A successful discontinuation: minus 30 kg, then gradual tapering; over several months plus ~3 kg; the “food noise” came back, but it is manageable.[39]

A compounded “copy” after the original: the first week almost without side effects, fewer thoughts about food. The author notes that the reaction may differ on another version of the drug.[45]

Sources: Reddit, YouTube
Negative experience

Stopped because of abdominal pain: minus ~25 kg, then increasing pain with vomiting after injections. The doctor suspected pancreatitis — tests did not confirm it. After stopping the pain went away, but the “food noise” returned, along with a difficult emotional state driven by fear of regaining weight.[40]

Rapid regain after stopping: minus ~20 kg, and ~11 kg came back within 7 weeks of stopping; the “food noise”, the author says, is stronger than before treatment.[41] Similar stories: plus 7–8 kg after stopping because of the price[42] and a gradual gain of ~10 kg over 3 years despite regular running.[43]

A compounded “copy” with vitamin B12, ~90 days: insomnia on injection day, very vivid dreams, reduced libido. The author does not know whether tirzepatide or B12 is to blame (more in “Possible risks”).[46]

Sources: Reddit, YouTube

What specialists say in videos

Personal opinions, not recommendations.

General practitioner who takes it himself without an indication[47]

Says frankly that no trial has studied people like him — lean and without diabetes — and calls it a personal “bet”, not advice. Carefully analyses SURPASS-CVOT: no superiority on the primary endpoint. Chose tirzepatide over retatrutide because of the smaller increase in heart rate. His “food noise” disappeared; in the first weeks — nausea and fatigue.

Some of his arguments rely on semaglutide data and mouse experiments, which do not apply directly to tirzepatide.
Owner of a clinic that sells tirzepatide[48]

Minus ~3 kg in a month; the main downside is constipation, plus a loss of strength in the gym. Unexpectedly, his nicotine cravings disappeared. He calls buying vials labelled “not for human consumption” dangerous: in his words, there is no way to know whether the product is sterile or whether the dose is too high or too low.

Conflict of interest: the clinic sells the drug, and the author does not hide this.
Not used as a source
“30 days on tirzepatide” — an entertainment video whose author admits some scenes were staged;[49] a “microdosing” video by a fitness blogger who sells tirzepatide through his own clinic.[50]
Takeaway from reviews

The most common plus is that constant thoughts about food disappear. The most common minuses are nausea at the start and with dose increases, constipation and fatigue. The main topic on Reddit is stopping: in three of five stories, weight partly returned after stopping (from 7–8 to ~11 kg), and one author managed to keep the result. This matches the trials: after stopping, part of the lost weight usually returns, but not all of it. There are no reviews of ZPHC vials in this selection.

Possible effects
Weight loss
proven, approved — while the drug is being taken
Lower blood sugar in type 2 diabetes
proven, approved
Fewer breathing pauses during sleep in apnoea with obesity
proven, FDA-approved
Lower risk of heart attack, stroke and cardiovascular death in diabetes
FDA-approved (non-inferior to dulaglutide); the EMA did not grant a separate indication
Fewer heart failure worsening events in obesity
one trial; no indication
Lower blood pressure, improved blood lipids
observed along with weight loss
Reduced liver fat
phase 2; no indication
Fewer cravings for alcohol and nicotine
only individual reports; not proven
“Muscle preservation”
not confirmed
Possible risks

From the official prescribing information

  • Stomach and gut — the most common: in SURMOUNT-1, nausea in 27.5%, diarrhoea in 20.9%, constipation in 13.6%, vomiting in 10.8%, more often during dose increases.[22]
  • Thyroid tumours in rats; whether tirzepatide causes them in humans is unknown. In the US prescribing information this is a boxed warning — the strictest form.[2]
  • Pancreatitis. In January 2026 the MHRA strengthened warnings for the whole class: 1,296 reports of pancreatitis since 2007, 19 of them fatal. The risk is small, but if it is suspected, treatment must be stopped immediately.[10]
  • Gallbladder, dehydration and kidneys, low blood sugar in combination with insulin, diabetic retinopathy, aspiration under anaesthesia, reduced reliability of contraceptive pills, allergy.

What regulators reviewed and dropped

  • Suicidal thoughts. In January 2026 the FDA analysed 91 trials of the class (about 108,000 participants), found no increased risk and requested removal of the warning, including from the Zepbound prescribing information.[6]
  • Optic nerve damage (NAION). The 2026 UK warning concerns semaglutide; no link has been established for tirzepatide.

The original and unapproved versions: what their side effects have in common

Unapproved versions are compounded “copies” and “research” vials. These products themselves have not been studied, so below is a comparison of what is known about the original with what regulators, Lilly and users report.

EffectOriginalUnapproved versionsWhat they share
Nausea, vomiting, diarrhoea, constipationthe most commonthe same complaints; the FDA notes that many reactions resemble those to the original[5]shared — an effect of the molecule
Pancreatitis, gallbladder, dehydrationrare, listed in the prescribing informationno separate statisticsshared — expected whenever the product actually contains tirzepatide
Serious reactions, hospitalisationsraremore than 730 reports to the FDA; some are dosing errors[5]shared in nature, higher risk: the dose is not controlled
Injection-site reactionsusually mildplus a risk of infection: Lilly found bacteria, the FDA found sterility violations[25]partly; contamination only in unapproved versions
Impurities, a different substance, wrong doseruled out by manufacturing controlsimpurities, an altered structure, in one case only a sugar alcohol (according to Lilly)[25]only in unapproved versions
Additives (B12, etc.)no additivesin 2026 Lilly found an impurity of unknown toxicity in all 10 samples of “tirzepatide with B12”[26]only in unapproved versions
Unusual complaints from social medianot among the common onesvivid dreams, “vibration”, a burning sensation in the skinunknown
Conclusion
If the vial really contains tirzepatide in the stated amount, most of the expected side effects are the same as with the original: they are caused by the molecule itself. Unapproved versions add an inaccurate dose, contamination and impurities, and unstudied additives — plus the absence of a doctor who would spot a complication in time. Almost all the data concern US compounded “copies”; for “research” vials, including ZPHC, there are even fewer independent data.

Counterfeits of the original

In February 2026 the UK regulator found counterfeit Mounjaro pens at an online pharmacy.[11] The name on the packaging does not by itself prove authenticity.

Contraindications / who should be especially cautious

Contraindications in the FDA prescribing information and EMA product information

  • personal or family history of medullary thyroid cancer, MEN 2 syndrome;
  • allergy to tirzepatide or any component of the product.

Special caution

  • pregnancy, planning a pregnancy, breastfeeding — there are no safety data;
  • past pancreatitis, severe gastrointestinal disease, diabetic retinopathy;
  • use of insulin or sulfonylureas, surgery under anaesthesia;
  • children under 10 — not studied;
  • eating disorders and older people with low muscle mass — expert opinion, not an item in the prescribing information;
  • people without a medical indication — they did not take part in the trials.
Individual clinical cases
Positive

A young woman with type 2 diabetes and very high blood lipid levels had four attacks of acute pancreatitis over two years. After tirzepatide was prescribed, her metabolic markers improved, and there were no attacks over 12 months. The authors stress that this is a single-case observation, not proof.[23]

Negative

A 64-year-old woman with no history of pancreatitis was admitted a few days after a routine injection of tirzepatide, started for weight loss, with acute pancreatitis that progressed to a severe necrotising form and ended in death. This is the first fatal case of tirzepatide-associated pancreatitis described in the literature.[24][36]

Both cases involve the pancreas — but from opposite sides. That is why no general conclusions can be drawn from individual cases.

ZPHC products: what we could verify
Authenticity check

Using the unique code on the packaging, you can confirm on the ZPHC website that the vial was made by ZPHC and is not a counterfeit of the brand. This protects against fakes but does not replace testing of the contents.

What sellers claim

Third-party shops advertise the product for weight loss and bodybuilding — these are the sellers’ words, not the manufacturer’s.

Key point
We could not find independent tests of ZPHC tirzepatide — quality is confirmed only by the manufacturer’s own data, which is a matter of trusting it. And even tirzepatide of the stated purity is not Mounjaro: the product has not been approved, has not been studied in humans and is used without medical supervision. The expected side effects are the same as with the original, plus the risks described in “Possible risks”.
Sources

Regulators and official documents

  1. FDA — Mounjaro prescribing information (2026): accessdata.fda.gov
  2. FDA — Zepbound prescribing information (2026): accessdata.fda.gov
  3. FDA — Drug Trials Snapshots: Mounjaro: fda.gov
  4. FDA — end of the shortage and compounding policy: fda.gov
  5. FDA — concerns about unapproved GLP-1 drugs: fda.gov
  6. FDA — removal of the suicidal ideation warning, 13.01.2026: fda.gov
  7. FDA — GSRS substance database: tirzepatide: precision.fda.gov
  8. EMA — Mounjaro, assessment documents: ema.europa.eu
  9. EMA — CHMP meeting, January 2026: ema.europa.eu
  10. MHRA — pancreatitis warning, 29.01.2026: gov.uk
  11. MHRA — falsified Mounjaro KwikPen, 24.02.2026: gov.uk
  12. NADA — WADA 2026 list and Monitoring Program: nada.de

Scientific publications

  1. Coskun et al., Molecular Metabolism, 2018 — discovery: doi.org
  2. Willard et al., JCI Insight, 2020 — receptor activity: ncbi.nlm.nih.gov
  3. Jastreboff et al., NEJM, 2022 — SURMOUNT-1: nejm.org
  4. Aronne et al., JAMA, 2024 — SURMOUNT-4, discontinuation: jamanetwork.com
  5. Aronne et al., NEJM, 2025 — SURMOUNT-5 (ACC summary): acc.org
  6. Look et al., Diabetes, Obesity and Metabolism, 2025 — body composition: wiley.com
  7. SURPASS-CVOT — summary of results: diabetesonthenet.com
  8. Nissen et al., JAMA Cardiology, 2026 — additional analysis of SURPASS-CVOT: pubmed.ncbi.nlm.nih.gov
  9. SUMMIT — summary of results: tctmd.com
  10. Problems of Endocrinology, 2026 — expert consensus on safety (in Russian): ncbi.nlm.nih.gov
  11. Case report: tirzepatide in recurrent pancreatitis, 2026: ncbi.nlm.nih.gov
  12. Fatal necrotising pancreatitis after starting tirzepatide, AACE, 2024: sciencedirect.com

Manufacturer materials (according to Eli Lilly)

  1. Lilly — open letter on compounded and counterfeit tirzepatide: lilly.com
  2. PharmExec, 2026 — Lilly’s letter on an impurity in tirzepatide with B12: pharmexec.com
  3. Lilly, 2022 — suspension of operations in Russia: lilly.com

Media and industry sources

  1. Epocrates, 31.08.2026 — approval for cardiovascular risk: epocrates.com
  2. Drug Topics, 2026 — Sandoz applications: drugtopics.com
  3. Parola Analytics — tirzepatide patents: parolaanalytics.com
  4. Drug Discovery Trends — 2025 sales: drugdiscoverytrends.com
  5. Vademecum, 23.12.2024 — the Eurasian patent (in Russian): vademec.ru
  6. Vademecum, 07.08.2026 — Russian products (in Russian): vademec.ru
  7. McDermott, 2026 — FDA warnings to telehealth services: mcdermottlaw.com
  8. Frier Levitt, 25.09.2026 — FDA warning to Empower pharmacy: frierlevitt.com
  9. Medscape, 10.06.2024 — pancreatitis cases: medscape.com

Reviews and videos (personal experience and personal opinion)

  1. Reddit — r/Mounjaro: more than two years: reddit.com
  2. Reddit — r/Mounjaro: side effects with dose increases: reddit.com
  3. Reddit — r/MounjaroMaintenance: a successful discontinuation: reddit.com
  4. Reddit — r/Mounjaro: stopping because of pain: reddit.com
  5. Reddit — r/Mounjaro: weight regain after stopping: reddit.com
  6. Reddit — r/Mounjaro: stopping because of the price: reddit.com
  7. Reddit — r/TirzepatideRX: three years after stopping: reddit.com
  8. YouTube — The Truth About Tirzepatide After 3 Weeks: youtu.be
  9. YouTube — Week 1 on Compounded Tirzepatide: youtu.be
  10. YouTube — The Weirdest Things I've Experienced On Tirzepatide: youtu.be
  11. YouTube — Why I Take Low-Dose Tirzepatide: youtu.be
  12. YouTube — My Experience With Tirzepatide: youtu.be
  13. YouTube — I Took Tirzepatide for 30 Days (not used as a source): youtu.be
  14. YouTube — How I Got Crazy Lean with Low-Dose Tirzepatide (not used as a source): youtu.be

Doses and regimens are deliberately not given.