Mazdutide
Approved only in China; product sold online elsewhere is unapproved.
A weekly injection approved in China for weight management in June 2025, and in no region this book covers. A made by Innovent Biologics (licensed from Eli Lilly), also called IBI362 and Xinermei.
What the evidence shows
Side effects and risks
Who should avoid it: Anyone outside China or a clinical trial. Product sold online elsewhere is unapproved.
How it works
- Where it acts
- GLP-1 and glucagon receptors.
- What it changes
- GLP-1 lowers appetite. Glucagon pushes the liver to burn fat.
- What people notice
- Weight loss in trials in China. Stomach side effects are common.
How it has been given in trials
Weekly injection under the skin, at doses set by the Chinese label.
Getting it in the United States
The legal route for Mazdutide
Not approved. The only lawful way to get it is to join a clinical trial.
Routes people use for any peptide in the United States
Telehealth prescribing
Online clinics prescribe after a questionnaire, sometimes with no live doctor visit, and mail the drug. FDA moved in February 2026 to restrict mass-marketed compounded copies and claims that they are generic equivalents.
Risk: Thin medical screening. Compounded versions are not reviewed by FDA for quality.
Covers: Approved GLP-1 drugs, compounded semaglutide and tirzepatide
Source: GZERO Media, Apr 2026
Clinical trial enrolment
The only lawful way to get an unapproved peptide drug with medical monitoring. ClinicalTrials.gov lists eligibility, sites and phone numbers. Researchers note recruitment is hard when people can buy the drug on the gray market instead of risking placebo.
Risk: Possible placebo assignment, strict eligibility and travel to a study site.
Covers: Investigational peptide drugs still in development
Source: NIH, finding a clinical trial
Routes people use for any peptide in the United States
Compounding pharmacy with prescription
A clinician prescribes and a pharmacy compounds. Twelve peptides left the FDA do-not-compound category in April 2026 and a panel backed six in July, but they are not yet formally eligible. Pharmaceutical-grade ingredient is scarce.
Risk: Legal status is unsettled until FDA rulemaking ends. Pharmacies may use research-grade ingredient.
Covers: BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon and similar
Source: Frier Levitt, Apr 2026
Med spas and weight-loss clinics
Very common. Secret shoppers called 75 clinics and med spas in two states after shortages ended. 92 percent offered compounded semaglutide and 87 percent tirzepatide, often mixed with B vitamins to look custom.
Risk: Four of 23 suppliers lacked sterile compounding licenses and four had disciplinary records.
Covers: Compounded semaglutide and tirzepatide
Source: American Med Spa Association on JAMA Health Forum study, Jul 2026
Concierge and longevity doctors
Cash-pay physicians build peptide plans for wealthy clients. Reporting from San Francisco says some source from overseas channels, domestic research-use-only sellers or the few compounding pharmacies that will supply clinicians.
Risk: A doctor's involvement does not guarantee a pharmaceutical-grade product.
Covers: BPC-157, thymosin alpha-1, Selank, Semax, CJC-1295, ipamorelin, retatrutide
Source: San Francisco Standard, Sep 2025
Cross-border purchase or import
FDA says importing drugs for personal use is illegal in most cases but it may not object to small personal quantities in limited situations. Reporting also describes people travelling to Mexico for injections.
Risk: Packages can be seized. Product origin and cold-chain handling are hard to check.
Covers: Approved prescription peptides sold abroad
Source: FDA, personal importation
Online research-chemical sellers
Not approved in the US. FDA warning letters in 2024 and 2026 named it among peptides sold online with research-only labels. FDA says these injectables are unapproved drugs of unverified quality that can cause serious harm.
Source: FDA warning letter, 2024-12
Online sellers with mixing supplies
A 2026 FDA letter described a seller offering it alongside sterile water and a dose calculator, which FDA treated as proof of intended human use. Identity, purity and sterility are unchecked.
Source: FDA warning letter, 2026-08
Routes people use for any peptide in the United States
Research-chemical websites
Sites sell vials marked for research or not for human consumption, with no prescription. FDA says some ship direct to consumers with dosing directions, and it has sent warning letters. Retatrutide exists only through this route or trials.
Risk: Unknown identity, strength and sterility. No pharmacist or prescriber involved.
Covers: Retatrutide, semaglutide, tirzepatide, BPC-157 and most unapproved peptides
Source: FDA, unapproved GLP-1 drugs page
Direct orders from Chinese factories
Buyers message factory sales agents and pay by crypto or payment app. A minimum order of about ten vials pushes people to buy in bulk and share. A blockchain analysis found US buyers were the largest source of funds.
Risk: Many of the same vendors list fentanyl precursors. Lab reports sent by sellers cannot be verified.
Covers: GLP-1 copies, melanotan II, BPC-157, TB-500, GHK-Cu, epitalon
Source: TRM Labs, Oct 2026
Chat groups and social sellers
Dealers are found through Telegram, WhatsApp, Discord and influencer discount codes. In a May 2026 survey of 1,000 US users, 14.5 percent bought this way and three quarters asked an AI chatbot for dosing.
Risk: 45 percent of social media buyers in that survey reported an emergency or urgent care visit for a reaction.
Covers: Retatrutide and other research-use-only peptides
Source: The Ethos, May 2026
This describes what people do. It is not advice. The decision is yours.
What experts and influencers say
Recorded views, not a survey or scientific consensus. Cautions may concern misuse or unapproved products. Statements are paraphrased; check each source for context.
Supportive expert view
Reported that nearly half of participants in the main China trial lost over 15 percent of body weight, and described the outcomes as promising.
Source: BioSpace, 2025-05
Money: Lead investigator of Innovent-sponsored trials
Cautionary expert view
No sourced expert view in this category yet. See the full list for other perspectives.
See all views 5
Reported that nearly half of participants in the main China trial lost over 15 percent of body weight, and described the outcomes as promising.
Source: BioSpace, 2025-05
Told Reuters that some patients with obesity and fatty liver disease now ask on their own whether they can use the drug.
Source: Reuters via Zawya, 2025
Money: Lead investigator of Innovent-sponsored trials
Said a real success for the drug would affect Western competitors, but questioned whether it can hold up against cheap generic semaglutide.
Source: Reuters via Zawya, 2025
Twice named the drug in warning letters to online research-chemical sellers. It said research-only labels did not hide that the products were unapproved drugs meant for human injection.
Source: FDA warning letter, 2026-08
US Food and Drug AdministrationSourceWarns against
Predicted the drug would become a major blockbuster in China, pointing to plans for obesity, type 2 diabetes and further uses.
Source: Reuters via Zawya, 2025
Enrique ConternoWebsiteRecommends
Photo source: fool.com
Commenting on the main China trial, said obesity treatment in China needs strategies tailored to the local population, with attention to liver health and blood fats.
Source: BioSpace, 2025-05
Vanita Aroda and Leigh PerreaultSourceMixed view
More contextCase reports, watch and read, emerging uses and chemistry
Watch and read
Explainers, reporting and podcasts worth your time. Summaries are ours. No sellers.
Retatrutide = Mazdutide + Tirzepatide? (Ask A Weight Loss Doctor)
Dr Meghan, weight loss doctor
A weight loss doctor compares mazdutide with retatrutide and tirzepatide, explaining how their receptor targets differ and where each stands.
A clinician places mazdutide among its better-known rivals.
When options run out
Uses people turn to when standard treatment has failed.
Adolescents with obesity
- Who
- Teenagers for whom lifestyle programmes alone have failed, treated at specialist children's hospitals in China.
- Evidence
- One 12-week phase 1b trial of 36 adolescents: BMI fell about 9 to 11 percent against under 2 percent on placebo, with no serious adverse events reported. Company-reported, small and short.
- Route
- Planned phase 3 adolescent trial in China
Type 2 diabetes with obesity
- Who
- Adults whose diabetes and weight are not controlled, as an alternative to semaglutide.
- Evidence
- Phase 3 head-to-head trial in 349 Chinese adults: more reached combined blood sugar and weight targets than on semaglutide at 32 weeks. Chinese population only.
Source: HCPLive, 2025-10
Obesity with fatty liver
- Who
- People with excess weight and high liver fat who seek a drug that lowers liver fat.
- Evidence
- In the main phase 3 trial, liver fat fell by well over half in participants who started with raised liver fat. No liver outcome trial result yet.
Source: BioSpace, 2025-05
Legal last-resort routes
Expanded access (compassionate use)
For a serious or life-threatening condition with no comparable alternative and no trial you can join. Your physician asks the company for the drug, then files with FDA and an ethics board. The company can refuse. Costs are often not insured.
Right to Try
For a life-threatening condition after approved options are exhausted and no trial is open to you. The drug must have finished Phase 1 and be in active development. Your doctor asks the manufacturer directly. FDA does not review requests.
Source: FDA, Right to Try
Trial finders
Search ClinicalTrials.gov by condition or drug name, check eligibility and call the listed site. ResearchMatch is a free NIH-funded registry that lets researchers find you. Discuss risks with your own clinician before enrolling.
Source: NIH, finding a clinical trial
Personal import for serious conditions
FDA may not object when a US citizen imports up to about three months of a drug for a serious condition with no effective US treatment, with written personal-use confirmation and a US doctor's details. It is discretion, not a right.
Source: FDA, personal importation
Patient-specific compounding
When the approved product cannot meet a specific need of an identified patient, a prescriber can order a compounded version from a licensed pharmacy. Lower price alone does not qualify. Ingredients must be pharmaceutical grade.
Questions people ask
Where is mazdutide approved?
Only in China, where it was approved for weight management in June 2025. It is not approved in any region this book covers, product sold online elsewhere is unapproved, and FDA named it in warning letters to research-use-only sellers in August 2026.
Is mazdutide better than semaglutide?
In a Chinese trial in people with diabetes and obesity (DREAMS-3), weight fell 10.3% at 32 weeks on mazdutide, against 6.0% on semaglutide at its diabetes dose. Further head-to-head trials are running.
What are the side effects of mazdutide?
Mainly stomach and bowel side effects. The trial data come almost entirely from China.
Who makes mazdutide?
Innovent Biologics, which licensed it from Eli Lilly.
Your notebook
Taking it? A ten-second daily check-in keeps a record of how you feel, to talk through with your clinician.
Sources
- Clinical Trials Arena: DREAMS-3 results (27 Oct 2025)
- ArentFox Schiff: FDA letters to research-use-only vendors (Sep 2026)
Structure: PubChem