# 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.

Status checked: 2026-10-25. Last verified: 2026-10-25. Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217806

This page has not been individually reviewed by a clinician.

Information, not medical advice.

| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Mounjaro, Zepbound | legal-analysis | 2026-10-25 | [source](https://www.orrick.com/en/Insights/2026/05/FDA-Moves-to-Shut-the-Door-on-Large-Scale-Compounding-of-GLP1-Drugs) |
| Class | dual-or-triple-agonist | primary | 2026-10-25 | [source](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0) |
| Regulatory status | fda-approved | primary | 2026-10-25 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217806) |
| Status source read | 2026-10-24 | primary | 2026-10-25 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866) |
| Evidence grade | strong-human | our assessment | 2026-10-25 | [source](https://peptideindex.ai/methodology#evidence-grade) |
| 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 | 2026-10-25 | [source](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0) |

## Name

Tirzepatide

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0

## Summary

A prescription drug that acts on the body's receptors for two hormones, GIP and GLP-1. FDA approved it as Mounjaro for diabetes and as Zepbound for weight loss.

Source: https://www.fda.gov/media/184606/download

## 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.

Source: https://peptideindex.ai/methodology#short-answer

## 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].

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0

## 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].

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0

## 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].

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0

## 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].

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866

## What the evidence shows

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].

Source: https://pubmed.ncbi.nlm.nih.gov/35658024/

## 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].

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866

## 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].

Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

## Access routes

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866

### Approved product

Detail: 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.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0

### Approved product

Detail: 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.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b

### Lawful compounding

Detail: 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.

Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

## Unofficial channels

Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

### Compounding outside the rules

What it is: Copies of the approved shots made by pharmacies and outsourcing facilities, often sent in vials that hold several doses.

Legal position: Since 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. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)

Documented risks:

- FDA has more than 730 reports of harm tied to compounded tirzepatide, and says many more likely go unreported. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
- FDA has reports of harm in people given compounded tirzepatide above the approved label. Some sought care for vomiting, diarrhea and belly pain. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
- FDA warns that vials holding several doses carry a higher risk of germs 28 days after first use. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)

Enforcement:

- 2024-12-19: FDA said again that the tirzepatide shortage was over, and set end dates in 2025 for pharmacies and outsourcing facilities making copies. (source: https://www.fda.gov/media/184606/download)
- 2026-04-30: FDA proposed keeping tirzepatide off the list of bulk ingredients outsourcing facilities may use. The proposal is not final. (source: https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list)

Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

### Telehealth

What it is: Websites that offer compounded tirzepatide straight to consumers.

Legal position: FDA says a site may not suggest a compounded copy is FDA-approved or has been checked for safety and effectiveness. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fitish-728280-06082026)

Documented risks:

- FDA warns of sites that claim a copy is the same as the approved drug, or send medicine that looks different or lacks instructions. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
- FDA has complaints that compounded GLP-1 drugs arrived warm, which can harm their quality. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)

Enforcement:

- 2026-06-08: FDA warning letter to a website offering compounded tirzepatide, for claims that suggested the copies were approved. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fitish-728280-06082026)

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fitish-728280-06082026

### Counterfeit or diverted

What it is: Fake compounded tirzepatide whose label names a pharmacy that does not exist or did not make it.

Legal position: FDA calls these drugs illegally marketed and has sent warning letters to stop their sale. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)

Documented risks:

- FDA has one report of redness, swelling and pain where a person injected a product with a false pharmacy label. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
- Drugs sold illegally online may hold the wrong ingredient, too much or too little drug, or none at all, FDA warns. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)

Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

### Research use seller

What it is: Sold online with a label saying it is for research use or not for people.

Legal position: FDA treats these as unapproved new drugs when the seller's site shows they are meant for people, whatever the label says. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026)

Documented risks:

- FDA says nobody can be sure of the quality of these products, and they may harm health. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
- FDA warns that injected products skip some of the body's defenses, so toxins or germs in them can cause life-threatening illness. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026)

Enforcement:

- 2026-03-31: FDA warning letter to an online seller of research-use peptides, including tirzepatide. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026)

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026

## Recruiting trials

Snapshot date: 2026-10-25.

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

- nct NCT07265752, url https://clinicaltrials.gov/study/NCT07265752, phase Phase 2, title Tirzepatide for the Treatment of Cannabis Use Disorder, status not-yet-recruiting, sponsor Brigham and Women's Hospital, countries none listed, us states none listed
- nct NCT07847515, url https://clinicaltrials.gov/study/NCT07847515, phase Not stated, title Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients, status not-yet-recruiting, sponsor Nanjing First Hospital, Nanjing Medical University, countries China, us states none listed
- nct NCT07078838, url https://clinicaltrials.gov/study/NCT07078838, phase Phase 2, title Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer, status not-yet-recruiting, sponsor UNC Lineberger Comprehensive Cancer Center, countries United States, us states North Carolina
- nct NCT07622992, url https://clinicaltrials.gov/study/NCT07622992, phase Not stated, title Preoperative Optimization With Tirzepatide, Ketogenic Diet, or Standard Care Before One Anastomosis Gastric Bypass Surgery, status not-yet-recruiting, sponsor Mario Musella MD, countries Italy, us states none listed
- nct NCT07829198, url https://clinicaltrials.gov/study/NCT07829198, phase Phase 3, title Efficacy of Tirzepatide for Weight Management in Patients With Suboptimal Weight Loss After Bariatric Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial, status not-yet-recruiting, sponsor Universidade do Porto, countries Portugal, us states none listed
- nct NCT07787936, url https://clinicaltrials.gov/study/NCT07787936, phase Not stated, title GLP-1/GIP Receptor Agonists in Obesity-Related HFpEF: The GLIDE-HF Registry, status not-yet-recruiting, sponsor Miedziowe Centrum Zdrowia SA, countries Poland, us states none listed
- nct NCT07881432, url https://clinicaltrials.gov/study/NCT07881432, phase Phase 3, title A Study of EloraTZP in Adult Participants With Obesity Without Type 2 Diabetes, status not-yet-recruiting, sponsor Eli Lilly and Company, 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
- nct NCT06180616, url https://clinicaltrials.gov/study/NCT06180616, phase Phase 2, title Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity, status not-yet-recruiting, sponsor Royal North Shore Hospital, countries none listed, us states none listed
- nct NCT07889648, url https://clinicaltrials.gov/study/NCT07889648, phase Phase 3, title 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, status not-yet-recruiting, sponsor Hoffmann-La Roche, countries none listed, us states none listed
- nct NCT07468552, url https://clinicaltrials.gov/study/NCT07468552, phase Phase 2, title Trial of Tirzepatide for the Treatment of Cannabis Use Disorder, status not-yet-recruiting, sponsor National Institute on Drug Abuse (NIDA), countries none listed, us states none listed
- nct NCT07855900, url https://clinicaltrials.gov/study/NCT07855900, phase Phase 3, title SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight, status not-yet-recruiting, sponsor Boehringer Ingelheim, countries United States, us states Florida
- nct NCT07796477, url https://clinicaltrials.gov/study/NCT07796477, phase Phase 2, title A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin, status not-yet-recruiting, sponsor CSPC Ouyi Pharmaceutical Co., Ltd., countries China, us states none listed
- nct NCT07099742, url https://clinicaltrials.gov/study/NCT07099742, phase Not stated, title Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM), status not-yet-recruiting, sponsor Dr. Md. Alimur Reza, countries Bangladesh, us states none listed
- nct NCT07881458, url https://clinicaltrials.gov/study/NCT07881458, phase Phase 3, title A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes, status not-yet-recruiting, sponsor Eli Lilly and Company, 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
- nct NCT07878494, url https://clinicaltrials.gov/study/NCT07878494, phase Not applicable, title Dietary, Medication, and Endoscopic Interventions for Post-Bariatric Hypoglycemia, status not-yet-recruiting, sponsor Stanford University, countries United States, us states California
- nct NCT07349641, url https://clinicaltrials.gov/study/NCT07349641, phase Phase 2, title A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer, status not-yet-recruiting, sponsor National Cancer Institute (NCI), countries United States, us states Illinois, Texas
- nct NCT07609160, url https://clinicaltrials.gov/study/NCT07609160, phase Not applicable, title 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, status not-yet-recruiting, sponsor Acibadem University, countries none listed, us states none listed
- nct NCT07832084, url https://clinicaltrials.gov/study/NCT07832084, phase Phase 4, title Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s, status not-yet-recruiting, sponsor Jing Luo, countries United States, us states Pennsylvania
- nct NCT07812636, url https://clinicaltrials.gov/study/NCT07812636, phase Early phase 1, title Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer, status not-yet-recruiting, sponsor Milton S. Hershey Medical Center, countries United States, us states Pennsylvania
- nct NCT07027969, url https://clinicaltrials.gov/study/NCT07027969, phase Phase 4, title Metabolic Surgery for Atrial Fibrillation Elimination, status not-yet-recruiting, sponsor Ali Aminian, countries United States, us states Ohio
- nct NCT07881783, url https://clinicaltrials.gov/study/NCT07881783, phase Not stated, title 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, status not-yet-recruiting, sponsor Novartis Pharmaceuticals, countries none listed, us states none listed
- nct NCT07874828, url https://clinicaltrials.gov/study/NCT07874828, phase Phase 2, title 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, status recruiting, sponsor M.D. Anderson Cancer Center, countries United States, us states Texas
- nct NCT07868354, url https://clinicaltrials.gov/study/NCT07868354, phase Phase 1, title 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, status recruiting, sponsor Novo Nordisk A/S, countries United States, us states California, Maryland
- nct NCT07777575, url https://clinicaltrials.gov/study/NCT07777575, phase Phase 4, title Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide, status recruiting, sponsor Technical University of Munich, countries Germany, us states none listed
- nct NCT07758231, url https://clinicaltrials.gov/study/NCT07758231, phase Phase 1, title Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics, status not-yet-recruiting, sponsor University of Wisconsin, Madison, countries United States, us states Wisconsin
- nct NCT07809568, url https://clinicaltrials.gov/study/NCT07809568, phase Not stated, title Real-World Outcomes of Tirzepatide in Pakistani Adults With Obesity, Prediabetes, and Type 2 Diabetes, status not-yet-recruiting, sponsor Universiti Sains Malaysia, countries Pakistan, us states none listed
- nct NCT07825857, url https://clinicaltrials.gov/study/NCT07825857, phase Phase 2, title Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder, status not-yet-recruiting, sponsor University of Texas Southwestern Medical Center, countries United States, us states California, Oklahoma, Texas
- nct NCT07782359, url https://clinicaltrials.gov/study/NCT07782359, phase Phase 1, title Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib, status not-yet-recruiting, sponsor University of Chicago, countries United States, us states Illinois
- nct NCT07846865, url https://clinicaltrials.gov/study/NCT07846865, phase Phase 2/Phase 3, title Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea: A Randomised Comparative Effectiveness Trial, status not-yet-recruiting, sponsor Woolcock Institute of Medical Research, countries Australia, us states none listed
- nct NCT07387796, url https://clinicaltrials.gov/study/NCT07387796, phase Not applicable, title Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation, status recruiting, sponsor The University of Texas at Dallas, countries United States, us states Texas
- nct NCT07845500, url https://clinicaltrials.gov/study/NCT07845500, phase Phase 3, title 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, status recruiting, sponsor Pfizer, countries United States, us states Alabama, California, Florida, Kentucky, Michigan, Mississippi, Missouri, Montana, North Carolina, Ohio, South Carolina
- nct NCT07817875, url https://clinicaltrials.gov/study/NCT07817875, phase Phase 3, title 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), status recruiting, sponsor Eli Lilly and Company, 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
- nct NCT07846956, url https://clinicaltrials.gov/study/NCT07846956, phase Not stated, title NAION in Non-Diabetic Obese Patients Using GLP-1 Receptor Agonists: A Real-World Study, status not-yet-recruiting, sponsor Istanbul Saglik Bilimleri University, countries Turkey (Türkiye), us states none listed
- nct NCT07734792, url https://clinicaltrials.gov/study/NCT07734792, phase Phase 2/Phase 3, title Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial, status not-yet-recruiting, sponsor yifang zhu, countries China, us states none listed
- nct NCT07734870, url https://clinicaltrials.gov/study/NCT07734870, phase Phase 2, title Tirzepatide for Treatment of CCCA, status recruiting, sponsor Johns Hopkins University, countries United States, us states Maryland
- nct NCT07803744, url https://clinicaltrials.gov/study/NCT07803744, phase Phase 1, title A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity, status recruiting, sponsor Eli Lilly and Company, countries United States, us states Florida
- nct NCT07715929, url https://clinicaltrials.gov/study/NCT07715929, phase Phase 4, title Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients, status not-yet-recruiting, sponsor Yunlong Wang, countries none listed, us states none listed
- nct NCT07728812, url https://clinicaltrials.gov/study/NCT07728812, phase Not applicable, title Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy, status not-yet-recruiting, sponsor Phenomix Sciences, countries none listed, us states none listed
- nct NCT07811895, url https://clinicaltrials.gov/study/NCT07811895, phase Not applicable, title Dual GIP/GLP-1 Receptor Agonist in Obese Women Before Frozen Embryo Transfer, status not-yet-recruiting, sponsor RenJi Hospital, countries China, us states none listed
- nct NCT07756359, url https://clinicaltrials.gov/study/NCT07756359, phase Phase 4, title Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008), status not-yet-recruiting, sponsor University of North Carolina, Chapel Hill, countries United States, us states California, Minnesota, Missouri, North Carolina, Utah
- nct NCT07747805, url https://clinicaltrials.gov/study/NCT07747805, phase Phase 2, title GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD, status not-yet-recruiting, sponsor The Cleveland Clinic, countries United States, us states Ohio
- nct NCT07842640, url https://clinicaltrials.gov/study/NCT07842640, phase Phase 1, title A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight, status recruiting, sponsor Ascletis Pharma (China) Co., Limited, countries United States, us states Maryland
- nct NCT07191873, url https://clinicaltrials.gov/study/NCT07191873, phase Phase 4, title Tirzepatide in Idiopathic Intracranial Hypertension Trial, status recruiting, sponsor Duke University, countries United States, us states North Carolina
- nct NCT07720466, url https://clinicaltrials.gov/study/NCT07720466, phase Not stated, title Salivary Function and Dental Changes During GLP-1 Therapy, status not-yet-recruiting, sponsor Bilecik Seyh Edebali Universitesi, countries Turkey (Türkiye), us states none listed
- nct NCT06732245, url https://clinicaltrials.gov/study/NCT06732245, phase Phase 2, title Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese, status not-yet-recruiting, sponsor Biomed Industries, Inc., countries United States, Australia, New Zealand, us states California, Florida, New York, Texas
- nct NCT07728318, url https://clinicaltrials.gov/study/NCT07728318, phase Not applicable, title Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients, status not-yet-recruiting, sponsor Akhtar Saeed Medical and Dental College, countries none listed, us states none listed
- nct NCT07760532, url https://clinicaltrials.gov/study/NCT07760532, phase Not stated, title Comparing Facial Aging Between Identical Twins With 3D Imaging, status not-yet-recruiting, sponsor Ponsky Facial Aesthetics And Plastic Surgery, Llc, countries United States, us states Ohio
- nct NCT07554638, url https://clinicaltrials.gov/study/NCT07554638, phase Phase 4, title Incretin Therapies in Obesity-related HFpEF, status recruiting, sponsor Columbia University, countries United States, us states New York
- nct NCT07213323, url https://clinicaltrials.gov/study/NCT07213323, phase Not applicable, title Probiotic Intervention for Digestive Health in Obese Patients Initiating GLP-RA Treatment, status recruiting, sponsor Hospices Civils de Lyon, countries France, us states none listed
- nct NCT07671248, url https://clinicaltrials.gov/study/NCT07671248, phase Phase 3, title Tirzepatide in the Treatment of Cannabis Use Disorder, status not-yet-recruiting, sponsor McMaster University, countries Canada, us states none listed

Source: https://clinicaltrials.gov/api/v2/studies?query.intr=tirzepatide+OR+Mounjaro+OR+Zepbound&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState

## Sources

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0

### 1. Drugs@FDA: Mounjaro injection, application 215866

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866

### 2. Drugs@FDA: Zepbound injection, application 217806

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217806

### 3. DailyMed: Mounjaro injection prescribing information, revised August 2026

Type: label

Tier: primary

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0

### 4. DailyMed: Zepbound injection prescribing information, revised August 2026

Type: label

Tier: primary

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b

### 5. FDA drug shortages: tirzepatide injection, resolved

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Tirzepatide%20Injection&st=r

### 6. FDA order: the tirzepatide injection shortage is resolved, 19 December 2024

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/184606/download

### 7. FDA memo: resolution of the tirzepatide injection shortage, 19 December 2024

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/185577/download

### 8. FDA: policies for compounders as GLP-1 supply stabilizes, updated 1 April 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

### 9. FDA: concerns with unapproved GLP-1 drugs used for weight loss, updated 1 October 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

### 10. FDA: proposal to exclude tirzepatide from the 503B bulks list, 30 April 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list

### 11. FDA warning letter to a website offering compounded tirzepatide, 8 June 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fitish-728280-06082026

### 12. FDA warning letter to an online seller of research-use peptides, 31 March 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026

### 13. McDermott Will & Schulte: court backs FDA in the tirzepatide compounding case

Type: legal-analysis

Tier: legal-analysis

Source: https://www.mcdermottlaw.com/insights/court-backs-fda-in-tirzepatide-compounding-case/

### 14. Frier Levitt: FDA again finds the tirzepatide shortage resolved

Type: legal-analysis

Tier: legal-analysis

Source: https://www.frierlevitt.com/articles/fda-determines-again-the-tirzepatide-shortage-is-resolved-what-this-means-for-503a-and-503b-compounding

### 15. Orrick: FDA moves to end large-scale compounding of GLP-1 drugs

Type: legal-analysis

Tier: legal-analysis

Source: https://www.orrick.com/en/Insights/2026/05/FDA-Moves-to-Shut-the-Door-on-Large-Scale-Compounding-of-GLP1-Drugs

### 16. SURPASS-1: tirzepatide alone in type 2 diabetes, 2021

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/34186022/

### 17. SURPASS-2: tirzepatide versus semaglutide in type 2 diabetes, 2021

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/34170647/

### 18. SURMOUNT-1: weekly tirzepatide in adults with obesity, 2022

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/35658024/

### 19. SURMOUNT-OSA: tirzepatide for sleep apnea in adults with obesity, 2024

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/38912654/

### 20. SURPASS-CVOT: tirzepatide versus dulaglutide and heart outcomes, 2025

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/41406444/

### 21. Review and meta-analysis of tirzepatide for weight loss, 2023

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/37253796/

### 22. Review of pancreas and gallbladder safety with tirzepatide, 2023

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/37908750/

### 23. NBC News: FDA says the tirzepatide shortage is over after a second look

Type: reference

Tier: established-news

Source: https://www.nbcnews.com/health/health-news/fda-says-eli-lilly-weight-loss-drug-shortage-taking-second-look-rcna184842

Last verified: 2026-10-25.

Sources:

- https://clinicaltrials.gov/api/v2/studies?query.intr=tirzepatide+OR+Mounjaro+OR+Zepbound&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0
- https://peptideindex.ai/methodology#evidence-grade
- https://peptideindex.ai/methodology#short-answer
- https://pubmed.ncbi.nlm.nih.gov/35658024/
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217806
- https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
- https://www.fda.gov/media/184606/download
- https://www.orrick.com/en/Insights/2026/05/FDA-Moves-to-Shut-the-Door-on-Large-Scale-Compounding-of-GLP1-Drugs

[^1]: Drugs@FDA: Mounjaro injection, application 215866 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866
[^2]: Drugs@FDA: Zepbound injection, application 217806 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217806
[^3]: DailyMed: Mounjaro injection prescribing information, revised August 2026 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0
[^4]: DailyMed: Zepbound injection prescribing information, revised August 2026 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b
[^5]: FDA drug shortages: tirzepatide injection, resolved https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Tirzepatide%20Injection&st=r
[^6]: FDA order: the tirzepatide injection shortage is resolved, 19 December 2024 https://www.fda.gov/media/184606/download
[^7]: FDA memo: resolution of the tirzepatide injection shortage, 19 December 2024 https://www.fda.gov/media/185577/download
[^8]: FDA: policies for compounders as GLP-1 supply stabilizes, updated 1 April 2026 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
[^9]: FDA: concerns with unapproved GLP-1 drugs used for weight loss, updated 1 October 2026 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
[^10]: FDA: proposal to exclude tirzepatide from the 503B bulks list, 30 April 2026 https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
[^11]: FDA warning letter to a website offering compounded tirzepatide, 8 June 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fitish-728280-06082026
[^12]: FDA warning letter to an online seller of research-use peptides, 31 March 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026
[^13]: McDermott Will & Schulte: court backs FDA in the tirzepatide compounding case https://www.mcdermottlaw.com/insights/court-backs-fda-in-tirzepatide-compounding-case/
[^14]: Frier Levitt: FDA again finds the tirzepatide shortage resolved https://www.frierlevitt.com/articles/fda-determines-again-the-tirzepatide-shortage-is-resolved-what-this-means-for-503a-and-503b-compounding
[^15]: Orrick: FDA moves to end large-scale compounding of GLP-1 drugs https://www.orrick.com/en/Insights/2026/05/FDA-Moves-to-Shut-the-Door-on-Large-Scale-Compounding-of-GLP1-Drugs
[^16]: SURPASS-1: tirzepatide alone in type 2 diabetes, 2021 https://pubmed.ncbi.nlm.nih.gov/34186022/
[^17]: SURPASS-2: tirzepatide versus semaglutide in type 2 diabetes, 2021 https://pubmed.ncbi.nlm.nih.gov/34170647/
[^18]: SURMOUNT-1: weekly tirzepatide in adults with obesity, 2022 https://pubmed.ncbi.nlm.nih.gov/35658024/
[^19]: SURMOUNT-OSA: tirzepatide for sleep apnea in adults with obesity, 2024 https://pubmed.ncbi.nlm.nih.gov/38912654/
[^20]: SURPASS-CVOT: tirzepatide versus dulaglutide and heart outcomes, 2025 https://pubmed.ncbi.nlm.nih.gov/41406444/
[^21]: Review and meta-analysis of tirzepatide for weight loss, 2023 https://pubmed.ncbi.nlm.nih.gov/37253796/
[^22]: Review of pancreas and gallbladder safety with tirzepatide, 2023 https://pubmed.ncbi.nlm.nih.gov/37908750/
[^23]: NBC News: FDA says the tirzepatide shortage is over after a second look https://www.nbcnews.com/health/health-news/fda-says-eli-lilly-weight-loss-drug-shortage-taking-second-look-rcna184842