Dual or triple agonist
Tirzepatide
Tirzepatide is FDA-approved as Mounjaro and Zepbound, with a prescription. The evidence grade is strong-human for blood sugar, weight and sleep apnea. Copies made by pharmacies or sold for research use are not approved, and FDA has not checked them.
This page has not been individually reviewed by a clinician.
Fact sheet · 6 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Mounjaro, Zepbound | legal-analysis | orrick.com | |
| Class | dual-or-triple-agonist | primary | dailymed.nlm.nih.gov | |
| Regulatory status | fda-approved | primary | accessdata.fda.gov | |
| Status source read | 2026-10-24 | primary | accessdata.fda.gov | |
| Evidence grade | strong-human | our assessment | peptideindex.ai | |
| Label dosing | From the Mounjaro and Zepbound labels. Both are shots under the skin once a week. Both start at 2.5 mg a week and go up by 2.5 mg after at least 4 weeks. Mounjaro: the most is 15 mg a week for adults and 10 mg a week for children 10 and older. Zepbound: the dose to stay on is 5 mg, 10 mg or 15 mg a week for weight, or 10 mg or 15 mg for sleep apnea, and the most is 15 mg. The prescriber sets the dose. | primary | dailymed.nlm.nih.gov |
Short answer
Tirzepatide is FDA-approved as Mounjaro and Zepbound, with a prescription. The evidence grade is strong-human for blood sugar, weight and sleep apnea. Copies made by pharmacies or sold for research use are not approved, and FDA has not checked them.
Our assessment, drawn from the sources below.
What it is
Tirzepatide is a prescription drug. It copies two hormones, GIP and GLP-1, that the gut makes after you eat [3]. They help control blood sugar, and tirzepatide also cuts how much people eat [3]. FDA first approved it in 2022 [1]. One company makes it and sells it under two brand names [1] [2].
Mounjaro is a weekly shot for type 2 diabetes [3]. Zepbound is a weekly shot for weight loss. It is also for sleep apnea, where breathing stops and starts during sleep, in adults with obesity [4]. The body clears half of a dose in about 5 days [3]. That is why the shots are taken once a week.
Some pharmacies and online sellers offer their own copies of it. Those copies are not the approved drug [9].
Where it stands legally
Tirzepatide is FDA-approved: FDA approved it as Mounjaro in May 2022 and as Zepbound in November 2023 [1] [2]. That covers the brand drugs, with a prescription, for the uses on their labels. It does not make copies from pharmacies or online sellers approved [9]. Checked 24 October 2026.
Mounjaro is approved for type 2 diabetes, not for weight loss. Zepbound is the brand approved for weight loss [3] [4]. Many copies are sold for weight loss [9] [11].
In December 2022 the shots went on FDA's drug shortage list [6]. During a shortage, pharmacies may make copies of a drug. FDA said the shortage was over in October 2024. A trade group sued, and FDA looked at it again [6] [23]. On 19 December 2024, FDA said again that the shortage was over [5] [6] [7]. Pharmacies had until 18 February 2025 to stop making copies. Larger outsourcing facilities had until 19 March 2025 [6] [8] [14]. A court upheld FDA's decision in May 2025 [13].
Today a pharmacy may not make copies of the approved drug as a regular practice [8]. It may make a different version for one patient. The prescriber has to write down why that patient needs the change [8] [15]. FDA says it will not act on four or fewer copy prescriptions a month [8]. In April 2026, FDA proposed keeping outsourcing facilities from making it from raw powder. The proposal is not final [10] [15]. Selling it with a research-use label is illegal [12].
What the evidence shows
Evidence grade: strong-human · our assessment
The evidence grade is strong-human: several large trials in people agree that it lowers blood sugar and weight [16] [17] [18]. In a 40-week trial of 478 adults with type 2 diabetes, it lowered blood sugar far more than a dummy shot [16]. In a 40-week trial of 1,879 adults with type 2 diabetes, it lowered blood sugar and weight more than semaglutide [17]. In a 72-week trial of 2,539 adults with obesity and no diabetes, people on it lost 15% to 21% of their weight. People on the dummy shot lost about 3% [18]. In two 52-week trials of adults with obesity and sleep apnea, it cut breathing pauses during sleep far more than a dummy shot [19]. A 2023 review of trials with 5,800 people found that most lost at least 5% of their weight [21].
In a heart trial of 13,299 adults with type 2 diabetes and heart disease, it was compared with dulaglutide, an older drug. Heart attacks, strokes and heart deaths were about as common with both. Tirzepatide was not worse, but it was not shown to be better [20].
These trials tested the approved drug from its maker, and the maker paid for them [16] [17] [18] [19] [20]. They tell us nothing about copies made by pharmacies or sold for research use. FDA has not checked those copies for quality [9].
Known risks
- In rats, tirzepatide caused thyroid tumors. The labels warn people with a rare thyroid cancer in the family not to use it [3] [4].
- The most common problems are nausea, diarrhea, vomiting, constipation and belly pain [3] [4]. In the main weight trial, more people on it than on a dummy shot stopped because of unwanted effects [18].
- The labels warn of a swollen pancreas, gallbladder disease, kidney harm from losing fluids, and bad allergic reactions [3] [4]. A 2023 review of nine trials found more gallbladder and bile duct problems than with a dummy shot or insulin [22].
- Taken with insulin or some other diabetes drugs, it can push blood sugar too low [3] [4].
- It slows how fast the stomach empties, so birth control pills may work less well. The labels advise adding another method for 4 weeks after starting and after each dose increase [3] [4].
- FDA has more than 730 reports of harm tied to compounded tirzepatide. Some people were given more than the label allows [9].
What nobody knows yet
- Nobody knows if it can cause thyroid cancer in people. The rat studies do not tell us [3].
- The main weight trial lasted 72 weeks, so it does not show what many years of use do [18].
- A 2023 review found no clear rise in a swollen pancreas. The range of possible effects was wide, so the question is open [22].
- In a large heart trial, it did about as well as an older drug, dulaglutide. The trial did not show that it lowers heart risk more [20].
- Nobody knows how closely pharmacy copies match the approved drug. FDA does not review them for safety, quality or whether they work [9].
Legitimate ways to get it
The legal way to get tirzepatide is a prescription for Mounjaro or Zepbound, filled at a state-licensed pharmacy [1] [2] [9]. Both are approved by FDA [1] [2]. Each label says who it is for and how it is taken [3] [4].
A copy made by a pharmacy is lawful only in narrow cases. The prescriber has to write down why one patient needs a change from the approved drug, such as an allergy to one of its parts [8] [15]. FDA says pharmacy copies should be used only when an approved drug cannot meet a patient's needs [9]. FDA does not check pharmacy copies for safety, quality or whether they work [9]. Outsourcing facilities may not make it from raw powder, because it is on neither the shortage list nor their list of allowed ingredients [8] [15].
Approved product
Approved by FDA and sold with a prescription as a weekly shot for type 2 diabetes.
Brand names: Mounjaro
Manufacturer: Eli Lilly and Company
Indication: Type 2 diabetes in adults and children 10 and older, and lower heart risk in adults with type 2 diabetes at high risk.
Approved product
Approved by FDA and sold with a prescription as a weekly shot for weight loss, and for sleep apnea in adults with obesity.
Brand names: Zepbound
Manufacturer: Eli Lilly and Company
Indication: Weight loss in adults with obesity, or with overweight and a related health problem, and moderate to severe sleep apnea in adults with obesity.
Lawful compounding
FDA said the shortage ended on 19 December 2024. A pharmacy may make a version for one patient only when the prescriber writes down why that patient needs a change from the approved drug. Regular copies of the approved drug are not allowed.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
Snapshot of .clinicaltrials.gov
NCT07265752
Tirzepatide for the Treatment of Cannabis Use Disorder
Phase: Phase 2 · Sponsor: Brigham and Women's Hospital · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07847515
Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients
Phase: Not stated · Sponsor: Nanjing First Hospital, Nanjing Medical University · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07078838
Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer
Phase: Phase 2 · Sponsor: UNC Lineberger Comprehensive Cancer Center · Status: Not yet recruiting
Countries: United States
US states: North Carolina
NCT07622992
Preoperative Optimization With Tirzepatide, Ketogenic Diet, or Standard Care Before One Anastomosis Gastric Bypass Surgery
Phase: Not stated · Sponsor: Mario Musella MD · Status: Not yet recruiting
Countries: Italy
US states: none listed
NCT07829198
Efficacy of Tirzepatide for Weight Management in Patients With Suboptimal Weight Loss After Bariatric Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Phase: Phase 3 · Sponsor: Universidade do Porto · Status: Not yet recruiting
Countries: Portugal
US states: none listed
NCT07787936
GLP-1/GIP Receptor Agonists in Obesity-Related HFpEF: The GLIDE-HF Registry
Phase: Not stated · Sponsor: Miedziowe Centrum Zdrowia SA · Status: Not yet recruiting
Countries: Poland
US states: none listed
NCT07881432
A Study of EloraTZP in Adult Participants With Obesity Without Type 2 Diabetes
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Not yet recruiting
Countries: United States, Argentina, China, Germany, India, Japan, Puerto Rico, South Korea, United Kingdom
US states: Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Mississippi, Nevada, New Mexico, New York, North Carolina, Pennsylvania, Tennessee, Texas, Utah, Virginia
NCT06180616
Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity
Phase: Phase 2 · Sponsor: Royal North Shore Hospital · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07889648
A Clinical Study to Evaluate the Effects of Enicepatide Versus Tirzepatide in Participants With Type 2 Diabetes and Inadequate Blood Sugar Control on Oral Glucose-Lowering Medications
Phase: Phase 3 · Sponsor: Hoffmann-La Roche · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07468552
Trial of Tirzepatide for the Treatment of Cannabis Use Disorder
Phase: Phase 2 · Sponsor: National Institute on Drug Abuse (NIDA) · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07855900
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Phase: Phase 3 · Sponsor: Boehringer Ingelheim · Status: Not yet recruiting
Countries: United States
US states: Florida
NCT07796477
A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin
Phase: Phase 2 · Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07099742
Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)
Phase: Not stated · Sponsor: Dr. Md. Alimur Reza · Status: Not yet recruiting
Countries: Bangladesh
US states: none listed
NCT07881458
A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Not yet recruiting
Countries: United States, Brazil, China, Germany, Japan, Puerto Rico, Romania, South Korea, Spain, Taiwan
US states: Arizona, California, Colorado, Florida, Georgia, Hawaii, Indiana, Louisiana, Missouri, New Jersey, New York, Texas, Virginia, Washington
NCT07878494
Dietary, Medication, and Endoscopic Interventions for Post-Bariatric Hypoglycemia
Phase: Not applicable · Sponsor: Stanford University · Status: Not yet recruiting
Countries: United States
US states: California
NCT07349641
A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer
Phase: Phase 2 · Sponsor: National Cancer Institute (NCI) · Status: Not yet recruiting
Countries: United States
US states: Illinois, Texas
NCT07609160
Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals
Phase: Not applicable · Sponsor: Acibadem University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07832084
Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s
Phase: Phase 4 · Sponsor: Jing Luo · Status: Not yet recruiting
Countries: United States
US states: Pennsylvania
NCT07812636
Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer
Phase: Early phase 1 · Sponsor: Milton S. Hershey Medical Center · Status: Not yet recruiting
Countries: United States
US states: Pennsylvania
NCT07027969
Metabolic Surgery for Atrial Fibrillation Elimination
Phase: Phase 4 · Sponsor: Ali Aminian · Status: Not yet recruiting
Countries: United States
US states: Ohio
NCT07881783
A Real-world Study of Treatment Retention and Adherence to Secukinumab in Patients With Plaque Psoriasis (PsO) With or Without Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Co-therapy
Phase: Not stated · Sponsor: Novartis Pharmaceuticals · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07874828
PROACT AYA: Preventing Overweight/Obesity-Associated Cardiotoxicity With Tirzepatide In Adolescent And Young Adult Cancer Survivors - A Phase 2 Single-Arm, Single-Center Feasibility Study
Phase: Phase 2 · Sponsor: M.D. Anderson Cancer Center · Status: Recruiting
Countries: United States
US states: Texas
NCT07868354
A Research Study Investigating How Adults With Overweight or Obesity, With or Without Type 2 Diabetes, Tolerate Switching to a New Treatment (Zenagamtide) From Their Current Tirzepatide Medication
Phase: Phase 1 · Sponsor: Novo Nordisk A/S · Status: Recruiting
Countries: United States
US states: California, Maryland
NCT07777575
Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide
Phase: Phase 4 · Sponsor: Technical University of Munich · Status: Recruiting
Countries: Germany
US states: none listed
NCT07758231
Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics
Phase: Phase 1 · Sponsor: University of Wisconsin, Madison · Status: Not yet recruiting
Countries: United States
US states: Wisconsin
NCT07809568
Real-World Outcomes of Tirzepatide in Pakistani Adults With Obesity, Prediabetes, and Type 2 Diabetes
Phase: Not stated · Sponsor: Universiti Sains Malaysia · Status: Not yet recruiting
Countries: Pakistan
US states: none listed
NCT07825857
Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder
Phase: Phase 2 · Sponsor: University of Texas Southwestern Medical Center · Status: Not yet recruiting
Countries: United States
US states: California, Oklahoma, Texas
NCT07782359
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib
Phase: Phase 1 · Sponsor: University of Chicago · Status: Not yet recruiting
Countries: United States
US states: Illinois
NCT07846865
Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea: A Randomised Comparative Effectiveness Trial
Phase: Phase 2/Phase 3 · Sponsor: Woolcock Institute of Medical Research · Status: Not yet recruiting
Countries: Australia
US states: none listed
NCT07387796
Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation
Phase: Not applicable · Sponsor: The University of Texas at Dallas · Status: Recruiting
Countries: United States
US states: Texas
NCT07845500
A Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity
Phase: Phase 3 · Sponsor: Pfizer · Status: Recruiting
Countries: United States
US states: Alabama, California, Florida, Kentucky, Michigan, Mississippi, Missouri, Montana, North Carolina, Ohio, South Carolina
NCT07817875
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Recruiting
Countries: United States, Belgium, Israel, Italy, Mexico, Poland, Portugal, South Korea, Spain, Taiwan
US states: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New York, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Washington
NCT07846956
NAION in Non-Diabetic Obese Patients Using GLP-1 Receptor Agonists: A Real-World Study
Phase: Not stated · Sponsor: Istanbul Saglik Bilimleri University · Status: Not yet recruiting
Countries: Turkey (Türkiye)
US states: none listed
NCT07734792
Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial
Phase: Phase 2/Phase 3 · Sponsor: yifang zhu · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07734870
Tirzepatide for Treatment of CCCA
Phase: Phase 2 · Sponsor: Johns Hopkins University · Status: Recruiting
Countries: United States
US states: Maryland
NCT07803744
A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity
Phase: Phase 1 · Sponsor: Eli Lilly and Company · Status: Recruiting
Countries: United States
US states: Florida
NCT07715929
Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients
Phase: Phase 4 · Sponsor: Yunlong Wang · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07728812
Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy
Phase: Not applicable · Sponsor: Phenomix Sciences · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07811895
Dual GIP/GLP-1 Receptor Agonist in Obese Women Before Frozen Embryo Transfer
Phase: Not applicable · Sponsor: RenJi Hospital · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07756359
Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)
Phase: Phase 4 · Sponsor: University of North Carolina, Chapel Hill · Status: Not yet recruiting
Countries: United States
US states: California, Minnesota, Missouri, North Carolina, Utah
NCT07747805
GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD
Phase: Phase 2 · Sponsor: The Cleveland Clinic · Status: Not yet recruiting
Countries: United States
US states: Ohio
NCT07842640
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight
Phase: Phase 1 · Sponsor: Ascletis Pharma (China) Co., Limited · Status: Recruiting
Countries: United States
US states: Maryland
NCT07191873
Tirzepatide in Idiopathic Intracranial Hypertension Trial
Phase: Phase 4 · Sponsor: Duke University · Status: Recruiting
Countries: United States
US states: North Carolina
NCT07720466
Salivary Function and Dental Changes During GLP-1 Therapy
Phase: Not stated · Sponsor: Bilecik Seyh Edebali Universitesi · Status: Not yet recruiting
Countries: Turkey (Türkiye)
US states: none listed
NCT06732245
Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese
Phase: Phase 2 · Sponsor: Biomed Industries, Inc. · Status: Not yet recruiting
Countries: United States, Australia, New Zealand
US states: California, Florida, New York, Texas
NCT07728318
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Phase: Not applicable · Sponsor: Akhtar Saeed Medical and Dental College · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07760532
Comparing Facial Aging Between Identical Twins With 3D Imaging
Phase: Not stated · Sponsor: Ponsky Facial Aesthetics And Plastic Surgery, Llc · Status: Not yet recruiting
Countries: United States
US states: Ohio
NCT07554638
Incretin Therapies in Obesity-related HFpEF
Phase: Phase 4 · Sponsor: Columbia University · Status: Recruiting
Countries: United States
US states: New York
NCT07213323
Probiotic Intervention for Digestive Health in Obese Patients Initiating GLP-RA Treatment
Phase: Not applicable · Sponsor: Hospices Civils de Lyon · Status: Recruiting
Countries: France
US states: none listed
NCT07671248
Tirzepatide in the Treatment of Cannabis Use Disorder
Phase: Phase 3 · Sponsor: McMaster University · Status: Not yet recruiting
Countries: Canada
US states: none listed
How people are getting it anyway
This section describes what happens and is not a recommendation.
Tirzepatide reaches people outside the approved brands in four main ways [9]. The first is pharmacies that kept making copies after the shortage ended [8] [13]. FDA has more than 730 reports of harm tied to pharmacy copies. It says many more likely go unreported [9]. The second is websites that offer these copies. FDA has warned a site whose claims suggested a copy was approved [11]. The third is fake products. FDA has found copies with labels naming pharmacies that do not exist or did not make them [9]. The fourth is online sellers that label it for research use. FDA has warned such a seller that the label does not make the sale legal [12].
In each case, FDA cannot vouch for what is in the product [9]. Some people were given more than the approved label allows and needed medical care [9]. Shots shipped without enough cold packs may lose quality [9].
Compounding outside the rules
Copies of the approved shots made by pharmacies and outsourcing facilities, often sent in vials that hold several doses.
The lawSince the shortage ended, a pharmacy may not make copies of the approved drug as a regular practice. Outsourcing facilities may not make it from raw powder, since it is on neither the shortage list nor their list of allowed ingredients.fda.gov
Documented riskFDA has more than 730 reports of harm tied to compounded tirzepatide, and says many more likely go unreported.fda.gov
Documented riskFDA has reports of harm in people given compounded tirzepatide above the approved label. Some sought care for vomiting, diarrhea and belly pain.fda.gov
Documented riskFDA warns that vials holding several doses carry a higher risk of germs 28 days after first use.fda.gov
Enforcement FDA said again that the tirzepatide shortage was over, and set end dates in 2025 for pharmacies and outsourcing facilities making copies.fda.gov
Enforcement FDA proposed keeping tirzepatide off the list of bulk ingredients outsourcing facilities may use. The proposal is not final.fda.gov
Telehealth
Websites that offer compounded tirzepatide straight to consumers.
The lawFDA says a site may not suggest a compounded copy is FDA-approved or has been checked for safety and effectiveness.fda.gov
Documented riskFDA warns of sites that claim a copy is the same as the approved drug, or send medicine that looks different or lacks instructions.fda.gov
Documented riskFDA has complaints that compounded GLP-1 drugs arrived warm, which can harm their quality.fda.gov
Enforcement FDA warning letter to a website offering compounded tirzepatide, for claims that suggested the copies were approved.fda.gov
Counterfeit or diverted
Fake compounded tirzepatide whose label names a pharmacy that does not exist or did not make it.
The lawFDA calls these drugs illegally marketed and has sent warning letters to stop their sale.fda.gov
Documented riskFDA has one report of redness, swelling and pain where a person injected a product with a false pharmacy label.fda.gov
Documented riskDrugs sold illegally online may hold the wrong ingredient, too much or too little drug, or none at all, FDA warns.fda.gov
Research use seller
Sold online with a label saying it is for research use or not for people.
The lawFDA treats these as unapproved new drugs when the seller's site shows they are meant for people, whatever the label says.fda.gov
Documented riskFDA says nobody can be sure of the quality of these products, and they may harm health.fda.gov
Documented riskFDA warns that injected products skip some of the body's defenses, so toxins or germs in them can cause life-threatening illness.fda.gov
Enforcement FDA warning letter to an online seller of research-use peptides, including tirzepatide.fda.gov
Sources
- [1]Drugs@FDA: Mounjaro injection, application 215866Regulatory · primary
- [2]Drugs@FDA: Zepbound injection, application 217806Regulatory · primary
- [3]DailyMed: Mounjaro injection prescribing information, revised August 2026Label · primary
- [4]DailyMed: Zepbound injection prescribing information, revised August 2026Label · primary
- [5]FDA drug shortages: tirzepatide injection, resolvedRegulatory · primary
- [6]FDA order: the tirzepatide injection shortage is resolved, 19 December 2024Regulatory · primary
- [7]FDA memo: resolution of the tirzepatide injection shortage, 19 December 2024Regulatory · primary
- [8]FDA: policies for compounders as GLP-1 supply stabilizes, updated 1 April 2026Regulatory · primary
- [9]FDA: concerns with unapproved GLP-1 drugs used for weight loss, updated 1 October 2026Regulatory · primary
- [10]FDA: proposal to exclude tirzepatide from the 503B bulks list, 30 April 2026Regulatory · primary
- [11]FDA warning letter to a website offering compounded tirzepatide, 8 June 2026Regulatory · primary
- [12]FDA warning letter to an online seller of research-use peptides, 31 March 2026Regulatory · primary
- [13]McDermott Will & Schulte: court backs FDA in the tirzepatide compounding caseLegal analysis · legal-analysis
- [14]Frier Levitt: FDA again finds the tirzepatide shortage resolvedLegal analysis · legal-analysis
- [15]Orrick: FDA moves to end large-scale compounding of GLP-1 drugsLegal analysis · legal-analysis
- [16]SURPASS-1: tirzepatide alone in type 2 diabetes, 2021Rct · peer-reviewed
- [17]SURPASS-2: tirzepatide versus semaglutide in type 2 diabetes, 2021Rct · peer-reviewed
- [18]SURMOUNT-1: weekly tirzepatide in adults with obesity, 2022Rct · peer-reviewed
- [19]SURMOUNT-OSA: tirzepatide for sleep apnea in adults with obesity, 2024Rct · peer-reviewed
- [20]SURPASS-CVOT: tirzepatide versus dulaglutide and heart outcomes, 2025Rct · peer-reviewed
- [21]Review and meta-analysis of tirzepatide for weight loss, 2023Systematic review · peer-reviewed
- [22]Review of pancreas and gallbladder safety with tirzepatide, 2023Systematic review · peer-reviewed
- [23]NBC News: FDA says the tirzepatide shortage is over after a second lookReference · established-news
Last verified · 6 facts · 10 sources
- clinicaltrials.gov
- dailymed.nlm.nih.gov
- peptideindex.ai
- peptideindex.ai
- pubmed.ncbi.nlm.nih.gov
- accessdata.fda.gov
- accessdata.fda.gov
- fda.gov
- fda.gov
- orrick.com
Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217806
Machine readers: JSON · Markdown · Status history: Change log
Information, not medical advice.
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