Ecnoglutide approval status: China, FDA, and current evidence.
Also searched as XW003 · Sciwind ecnoglutide · cAMP-biased GLP-1 receptor agonist · 埃诺格鲁肽
Ecnoglutide, also called XW003, is Sciwind Biosciences' once-weekly cAMP-biased GLP-1 peptide agonist. China's NMPA approved the injection for type 2 diabetes in January 2026 and chronic weight management in March 2026. Those are China-specific product approvals. They do not establish FDA approval, authorization in another country, or the identity and authority of an online seller using the same name.
Is ecnoglutide approved, and where?
Ecnoglutide injection has two NMPA approvals in Mainland China. The type 2 diabetes indication was approved in January 2026, and chronic weight management for defined Chinese adults with overweight or obesity followed in March 2026. Ecnoglutide is not FDA approved. The Chinese approvals do not transfer to another national market, and they do not prove that a particular seller, clinic, importer, marketplace listing, or research-labelled vial is the approved Sciwind product. Country, presentation, authorization holder, and supply records must all match.
Compare Ecnoglutide with Retatrutide, without losing the country context.
Put evidence status, ClinicalTrials.gov coverage, official United States records, and qualified US research prices in one view. Blank fields stay blank when the underlying dataset does not support a number.
China-approved medicine and active development program
Official product and seller records attached
Investigational clinical program
What can you conclude about Ecnoglutide today?
These are dated program facts, not a cross-trial ranking, approval forecast, personal treatment recommendation, or proof that a same-name online product is the sponsor's medicine.
NMPA approval for adult type 2 diabetes came first, followed by chronic weight management in Chinese adults with overweight or obesity.
Mean change with 2.4 mg under the treatment-policy estimand; the placebo-adjusted change was 15.1%.
Sponsor-reported week-20 interim means in a 163-person open-label Phase 2 trial using 2.4 mg maintenance doses.
China approval and a matching ingredient name do not create an approved US application, label, product, or supply route.
Know which molecule the result belongs to.
- Sponsor
- Sciwind Biosciences; Pfizer commercialization partner in Mainland China
- Mechanism
- cAMP-signalling-biased GLP-1 receptor agonist
- Route being studied
- Once-weekly subcutaneous injection
- Current stage
- China approvals active; indication-expansion studies continue
- Featured trial anchors
- NCT05813795 · NCT05680155 · NCT05680129
- Evidence checked
- July 18, 2026
Ecnoglutide weight-loss results, with the trial attached.
This visual shows one selected result, not every dose or endpoint in the program. The percentage remains attached to its duration, population, comparator, analysis method, and source.
Evidence checked July 21, 2026Ecnoglutide reported 15.4% mean reduction at 48 weeks under the treatment-policy estimand. The comparator recorded 0.3% mean reduction.
Bar lengths share a 0 to 30% visual scale. They describe this selected record and do not make separate trials head-to-head.
- Population
- Chinese adults with obesity or overweight
- Participants
- 664 Total randomized trial population
- Dose
- 2.4 mg
- Primary analysis
- Treatment-policy estimand
- Alternate analysis
- Placebo-adjusted difference
- Regulatory status
- Approved in China for chronic weight management; not FDA approved
Ecnoglutide clinical trials by status, phase, and location.
The current exact-intervention snapshot matches 15 unique NCT records. This chart describes registry coverage and current study fields. It does not compare efficacy, safety, approval probability, eligibility, or treatment access.
Snapshot 2026-07-24Counts use individual locations currently marked Recruiting, not every facility listed on an overall-recruiting study. Repeated centers across studies remain repeated site observations.
Ecnoglutide across 42 countries.
This profile establishes the program identity and its cited clinical or regulatory record. It does not turn a same-name seller listing into the sponsor’s asset or prove authorization, availability, or lawful supply in another destination.
Compare Ecnoglutide by country →Compare Ecnoglutide by US state →Browse the global peptide country dataset →Is Ecnoglutide approved or available in your country?
Start with the United States FDA record, then check the destination that matters to you. Each country page separates drug identity, authorization, product records, seller claims, and supply rules. Directory checked July 20, 2026.
What the record shows - and what it doesn’t.
Trial percentages are kept beside the design details that make them interpretable. Unknowns stay visible instead of being filled with launch speculation.
China has two indication-specific approvals
Sciwind announced that the NMPA approved ecnoglutide injection for glycemic control in adults with type 2 diabetes on January 30, 2026 and for chronic weight management in Chinese adults with overweight or obesity on March 6, 2026. The authorization holder, approved presentations, prescription route, current market status, and lawful seller still require exact Chinese records. Neither decision transfers to the United States or another destination.
SLIMMER provides peer-reviewed Phase 3 weight evidence
The completed SLIMMER trial randomized 664 Chinese adults without diabetes to weekly ecnoglutide or placebo. At week 40, mean changes ranged from 9.1% to 13.2% for the active groups versus a 0.1% gain with placebo. The sponsor's week-48 treatment-policy analysis reported 15.4% at 2.4 mg and a 15.1% placebo-adjusted difference. Ten ecnoglutide participants discontinued treatment because of adverse events in the peer-reviewed report.
The semaglutide comparison is direct but still interim
SLIMMER-UP-SWITCH randomized 163 Chinese adults with obesity to open-label weekly ecnoglutide or semaglutide at 2.4 mg maintenance doses for a planned 60 weeks. Sciwind reported interim week-20 mean changes of 12.8% and 9.5%, respectively. This is more informative than a cross-trial comparison, but it remains a sponsor-reported interim analysis from one population and cannot answer every dose, product, duration, indication, or individual-treatment question.
No FDA-approved ecnoglutide product
Ecnoglutide has no FDA-approved indication, US prescribing information, application number, pharmacy presentation, coverage policy, or approved US supply channel. An ingredient page, research listing, clinic advertisement, imported package, or same-name vial cannot inherit the Chinese approvals or Sciwind's clinical evidence.
Worldwide authorization and supply remain country-specific
The cited approvals apply to defined products and indications in Mainland China. They do not establish authorization, launch, price, reimbursement, import status, pharmacy availability, or seller authority in France, Mexico, Canada, Australia, the United Kingdom, the European Union, the United States, or another destination.
The 60-week head-to-head outcome is not yet reported
The June 2026 semaglutide comparison reports a prespecified week-20 interim analysis from an open-label Phase 2 trial. Final 60-week efficacy, discontinuation, adverse-event, missing-data, and durability results still matter. A 35% relative difference headline should not be read as a universal superiority claim across semaglutide products or populations.
The questions behind the search.
Concise answers based on the dated sponsor and trial records below. This is educational reporting, not medical advice.
What is ecnoglutide, and is it the same as XW003?
Yes. Ecnoglutide is the international name for XW003, a long-acting peptide developed by Sciwind Biosciences. It is designed to activate the GLP-1 receptor with a signalling bias toward the cAMP pathway and less beta-arrestin recruitment. The marketed Chinese injection is a specific regulated product, while the ingredient name also appears in trials and online search results. Matching the name connects the evidence trail, but it does not authenticate a seller, an imported presentation, a research vial, or a product offered outside its authorized jurisdiction.
Is ecnoglutide approved, and where?
Ecnoglutide injection has two NMPA approvals in Mainland China. The type 2 diabetes indication was approved in January 2026, and chronic weight management for defined Chinese adults with overweight or obesity followed in March 2026. Ecnoglutide is not FDA approved. The Chinese approvals do not transfer to another national market, and they do not prove that a particular seller, clinic, importer, marketplace listing, or research-labelled vial is the approved Sciwind product. Country, presentation, authorization holder, and supply records must all match.
Did ecnoglutide outperform semaglutide in a head-to-head trial?
Sciwind reported a direct randomized Phase 2 interim comparison in 163 Chinese adults with obesity. At week 20, mean weight change was 12.8% with ecnoglutide and 9.5% with semaglutide, with both groups using a 2.4 mg maintenance dose. That is direct evidence for the studied protocol, unlike a comparison assembled from separate trials. It is still an open-label interim analysis from a planned 60-week study, so final outcomes, tolerability, discontinuations, missing-data handling, and applicability to other semaglutide products and populations remain unresolved.
Do not use an investigational name, trial dose, or online research listing as a substitute for approved care. This page does not recommend treatment, sourcing, or participation in a clinical trial.
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