Ecnoglutide
Evidence: B+ — Meaningful Human EvidenceEvidence: CGrade B+ — Human clinical evidence for SC ecnoglutide/XW003 -- three Phase 2/3 RCTs including two pivotal Phase 3 trials underlying China approval. Oral XW004/VRB-101 evidence is Phase 1/early Phase 2b only and does not share this grade..
Grade C — Oral ecnoglutide (XW004/VRB-101 clinical program).
Phase 1 safety/PK complete for the oral tablet formulation; a Phase 2b trial (EVOLVE-2, sponsor Verdiva Bio) has completed enrollment with results not yet published. This program is not the basis for ecnoglutide's China approval, which rests on the SC (XW003) trials.
Metabolic / Weight Management
Evidence Snapshot
What this grade covers
Human clinical evidence for SC ecnoglutide/XW003 -- three Phase 2/3 RCTs including two pivotal Phase 3 trials underlying China approval. Oral XW004/VRB-101 evidence is Phase 1/early Phase 2b only and does not share this grade.
Regulatory Context
Ecnoglutide (XW003, injection) received China NMPA approval for type 2 diabetes (January 2026) and chronic weight management (March 6, 2026); this is a high-confidence finding independently corroborated by multiple trade-press sources, though a primary NMPA/CDE regulator record was not directly obtained for this review. No approval was identified in the verified searches used for this review for the United States or European Union. An oral tablet formulation (XW004, licensed outside Greater China/South Korea as VRB-101) remains investigational worldwide.
Research Takeaway
Ecnoglutide (XW003) is a long-acting GLP-1 receptor agonist peptide; an oral tablet formulation (XW004, licensed outside Greater China/South Korea as VRB-101) is described by the sponsor as the same molecule in a different formulation.
Evidence boundary: The XW003-XW004 relationship is a sponsor technical statement, not an independently verified peptide-sequence or patent disclosure. Do not describe it as independently chemically confirmed.
See all 6 evidence claims →Quick Summary
Ecnoglutide (XW003) is a long-acting GLP-1 receptor agonist peptide that received China NMPA approval for type 2 diabetes in January 2026 and for chronic weight management in March 2026, based on Phase 2 and Phase 3 trials showing significant HbA1c reduction and up to 13.2% body-weight loss. An oral tablet formulation (XW004, licensed outside Greater China/South Korea as VRB-101) remains investigational, with Phase 1 safety data published and a Phase 2b trial completed but not yet reported. Ecnoglutide is not approved in the United States or European Union.
Mechanism & Research Overview
Ecnoglutide (XW003) is a long-acting GLP-1 receptor agonist peptide. An oral tablet formulation (XW004, licensed outside Greater China/South Korea as VRB-101) is described by the sponsor as the same molecule in a different formulation; this relationship is sponsor-confirmed but has not been independently verified at the peptide-sequence level for this review.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Ecnoglutide (XW003) is a long-acting GLP-1 receptor agonist peptide; an oral tablet formulation (XW004, licensed outside Greater China/South Korea as VRB-101) is described by the sponsor as the same molecule in a different formulation.
Does not establish
Evidence boundary: The XW003-XW004 relationship is a sponsor technical statement, not an independently verified peptide-sequence or patent disclosure. Do not describe it as independently chemically confirmed.
Sources: Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial; Sciwind Biosciences "About Ecnoglutide" technical statement on XW003/XW004 formulation identity
Supported
In a 20-week Phase 2 RCT, SC ecnoglutide (XW003) 0.4-1.2mg reduced HbA1c by a mean of 1.81-2.39 percentage points vs 0.55 with placebo (p<0.0001); a subsequent 24-week Phase 3 RCT (EECOH-1) confirmed HbA1c reductions vs placebo at 0.6mg and 1.2mg doses in adults with type 2 diabetes.
Does not establish
Evidence boundary: Both trial populations were China-only; do not generalize to other regions without caveat.
Sources: Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial; Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial
Supported
In a 48-week Phase 3 RCT (SLIMMER), SC ecnoglutide at low/medium/high doses produced up to 13.2% mean body-weight loss at week 40 vs placebo in non-diabetic adults with overweight or obesity.
Does not establish
Evidence boundary: China-only population; this is the pivotal trial underlying China's obesity approval, not a claim of efficacy in other populations.
Supported
Across three published SC ecnoglutide trials, gastrointestinal adverse events (diarrhea, nausea, vomiting, constipation) were the most common treatment-emergent adverse events, generally mild-to-moderate; discontinuation due to adverse events ranged from 0.6% (GI-specific) to 2.8%; no Grade 3 or higher events, serious adverse events, or deaths were attributed to ecnoglutide across these trials.
Does not establish
Evidence boundary: Route-specific to SC/XW003; oral/XW004 safety is a separate, formulation-specific dataset.
Sources: Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial; Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial; Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (SLIMMER)
Supported
Ecnoglutide (XW003, injection) received China NMPA approval for type 2 diabetes in January 2026 and for chronic weight management on March 6, 2026, independently corroborated by multiple trade-press outlets; a primary NMPA/CDE database record was not directly obtained for this review. No approval was identified in the verified searches used for this review for the United States or European Union.
Does not establish
Evidence boundary: Do not write "globally approved" or "FDA-approved."
Sources: Ecnoglutide (XW003) approved by China's NMPA for type 2 diabetes; Ecnoglutide (XW003) approved by China's NMPA for chronic weight management
Supported
An oral tablet formulation of ecnoglutide (XW004) has completed Phase 1 safety/tolerability/PK testing in healthy adults; a separate licensee-run Phase 2b trial (VRB-101, Verdiva Bio) has completed enrollment with results not yet published as of this review.
Does not establish
Evidence boundary: Cannot support any efficacy claim for the oral form; Phase 1 was safety/PK only, Phase 2b results are not yet public.
Sources: A Phase 1, Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ecnoglutide Tablet in Healthy Adult Participants; A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (EVOLVE-2)
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
Gastrointestinal adverse events (diarrhea, nausea, vomiting, constipation) are the most common reported side effects of SC ecnoglutide, generally mild-to-moderate. Rates vary by dose and trial -- see individual studies for exact figures; do not average across trials into one number.Safety Consideration
As with other GLP-1 receptor agonists, class-associated concerns (e.g., gallbladder disorders, pancreatitis) have been raised for this drug class broadly. No severe hypoglycemia, pancreatitis, or gallbladder disorders were reported in ecnoglutide's own published trials, but absence of a finding in these specific, limited-duration trials is not proof of long-term absence.Safety Consideration
Oral ecnoglutide (XW004/VRB-101) safety in its Phase 1 study was consistent with typical GLP-1 receptor agonist tolerability; no efficacy-linked safety conclusions can be drawn since Phase 1 was a safety/PK study only, in a small, short trial.
Research Areas Being Studied
Research areas discussed on this page reflect the Metabolic / Weight Management category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial (2026):
- Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (SLIMMER) (2025):
- Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial (2024):
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial | 2026 | 211 adults with type 2 diabetes inadequately controlled by diet/exercise, 32 centers in China | This is the pivotal trial underlying ecnoglutide's January 2026 China NMPA approval for type 2 diabetes. Significant HbA1c reduction from baseline vs placebo at both doses.
| Nausea 7.2%/12.7% (0.6/1.2mg) vs 9.9% placebo; diarrhea 24.6%/11.3% vs 5.6%; abdominal distension 4.3%/8.5% vs 1.4%; decreased appetite 21.7%/26.8% vs 4.2%; overall TEAE 78.3%/77.5% vs 63.4%; discontinuation-for-adverse-event 1.4% in each arm; no severe hypoglycemia, pancreatitis, or gallbladder disorders reported. | |
| Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (SLIMMER) | 2025 | 664 adults with overweight (BMI>=28, or >=24 with comorbidity) or obesity, non-diabetic, 36 centers in China | Up to 13.2% mean body-weight loss at week 40 vs placebo. This is the pivotal trial underlying ecnoglutide's March 6, 2026 China NMPA approval for chronic weight management.
| Mild-to-moderate gastrointestinal adverse events predominant; 10 participants discontinued for adverse events. | |
| Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial | 2024 | 145 adults with type 2 diabetes, China | HbA1c reductions of -1.81% to -2.39% vs -0.55% with placebo (p<0.0001); 33.3% of the 1.2mg group achieved >=5% body-weight reduction vs 3.0% with placebo.
| Diarrhea 14.7% vs 2.8% placebo; nausea 11.9% vs 2.8%; vomiting 2.8% vs 0%; constipation 7.3% vs 5.6%; discontinuation-for-adverse-event 2.8% (1 participant, 1.2mg group only); no Grade >=3 events, serious adverse events, or deaths. |
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (EVOLVE-2) | 2026 | 206 adults with obesity or overweight and weight-related comorbidities | Development-status only: enrollment complete, results not yet published as of this review. Sponsor: Verdiva Bio Dev Limited (licensee of oral ecnoglutide/XW004 outside Greater China/South Korea, referred to as VRB-101). No efficacy claim can currently be supported from this trial.
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| Ecnoglutide (XW003) approved by China's NMPA for chronic weight management | 2026 | Sciwind Biosciences announced NMPA approval of ecnoglutide injection (XW003) for chronic weight management, March 6, 2026, alongside a February 2026 exclusive China commercialization agreement with Pfizer (Sciwind remains marketing authorization holder). Independently corroborated by multiple trade-press outlets. A primary NMPA/CDE database record was not directly obtained for this review -- classified as high-confidence secondary regulatory confirmation, not primary-regulator-confirmed. No approval was identified in the verified searches used for this review for the United States or European Union. | No source link available | ||
| Ecnoglutide (XW003) approved by China's NMPA for type 2 diabetes | 2026 | Sciwind Biosciences announced NMPA approval of ecnoglutide injection (XW003) for type 2 diabetes, January 2026. Independently corroborated by multiple trade-press outlets (BioPharm International, Bioworld, Pharmaceutical Technology). A primary NMPA/CDE database record was not directly obtained for this review -- classified as high-confidence secondary regulatory confirmation, not primary-regulator-confirmed. | No source link available | ||
| A Phase 1, Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ecnoglutide Tablet in Healthy Adult Participants | 2025 | 87 healthy adults 18-55 (later cohorts BMI 30-<40), single Australian site | Registry-confirmed Phase 1 safety/tolerability/PK/PD study of the oral tablet formulation (XW004). This is a safety/PK study only; no efficacy endpoint. Sponsor technical materials describe XW004 as an oral tablet formulation of the same molecule as SC ecnoglutide (XW003), a sponsor-confirmed statement not independently verified at the peptide-sequence level for this review.
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Review Articles / Secondary Sources
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Sciwind Biosciences "About Ecnoglutide" technical statement on XW003/XW004 formulation identity | 2026 | Sponsor technical description states: "Ecnoglutide (XW003) is a novel long-acting GLP-1 analogue... XW004 is an oral tablet formulation of ecnoglutide." This is a sponsor technical statement, not an independently verified peptide-sequence or patent disclosure -- classified as FORM_SPECIFIC_EXACT_SEQUENCE, sponsor-confirmed only. | No source link available |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published research and regulatory announcements and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
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