Ecnoglutide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed morbid obesity 1 milestone | |||||
| Filed | China (NMPA) | — | morbid obesity | 2024-12-12 | “Applications of ecnoglutide injection for both treatment of type 2 diabetes and weight management in overweight/obese patients were accepted by China’s NMPA in 2024.” sciwindbio.com ↗ “Marketing Authorization Application for ecnoglutide injection (Class I New Drug) has been accepted by the National Medical products Administration (NMPA) of China” sciwindbio.com ↗ |
| Filed type 2 diabetes mellitus 1 milestone | |||||
| Filed | China (NMPA) | — | type 2 diabetes mellitus | 2024-11-24 | “Applications of ecnoglutide injection for both treatment of type 2 diabetes and weight management in overweight/obese patients were accepted by China’s NMPA in 2024.” sciwindbio.com ↗ “Marketing Authorization Application for ecnoglutide injection (Class I New Drug) has been accepted by the National Medical products Administration (NMPA) of China” sciwindbio.com ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07143227 | Aug 2025 → Apr 2026 | obesity disorder | Hangzhou Sciwind Biosciences Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06335134 | Jul 2023 → Jan 2024 | — | Hangzhou Sciwind Biosciences Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05184322 | Apr 2022 → Jul 2024 | obesity disorder, type 2 diabetes mellitus | Sciwind Biosciences APAC CO Pty. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04389775 | Mar 2020 → Sep 2021 | metabolic dysfunction-associated steatohepatitis, obesity disorder, type 2 diabetes mellitus | Sciwind Biosciences APAC CO Pty. Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07243171 | Nov 2025 → Jan 2027 expected | obesity disorder | Hangzhou Sciwind Biosciences Co., Ltd. | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07073417 | Jul 2025 → Feb 2027 expected | obesity disorder | Hangzhou Sciwind Biosciences Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05111912 | Nov 2021 → Nov 2022 | obesity disorder | Sciwind Biosciences APAC CO Pty. Ltd. | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT07836270 | Oct 2026 → Jun 2028 expected | — | Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07734311 | Aug 2026 → May 2028 expected | obesity disorder, osteoarthritis, knee | Hangzhou Sciwind Biosciences Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07434050 | Mar 2026 → Jun 2028 expected | obesity disorder, obstructive sleep apnea syndrome | Hangzhou Sciwind Biosciences Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07387094 | Feb 2026 → Dec 2027 expected | obesity disorder, obstructive sleep apnea syndrome | Hangzhou Sciwind Biosciences Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05813795 | Apr 2023 → Jun 2024 | — | Hangzhou Sciwind Biosciences Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05680129 | Jan 2023 → Jul 2024 | type 2 diabetes mellitus | Hangzhou Sciwind Biosciences Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05680155 | Dec 2022 → Jun 2024 | type 2 diabetes mellitus | Hangzhou Sciwind Biosciences Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-10-08 | Hangzhou Sciwind Biosciences Co., Ltd. | Results EASD 2026 | Ecnoglutide Demonstrates Favorable Safety Profile in Adolescents with Obesity sciwindbio.com ↗ |
| 2026-06-08 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Head-to-head Study Validates the Clinical Advantage of New-generation Biased GLP-1: Ecnoglutide Delivers 35% Greater Weight Loss than Semaglutide sciwindbio.com ↗ |
| 2026-03-06 | Hangzhou Sciwind Biosciences Co., Ltd. | Regulatory Sciwind Biosciences Announces Ecnoglutide Injection Approved by China’s National Medical Products Administration (NMPA) for Chronic Weight Management sciwindbio.com ↗
March 6, 2026 – Hangzhou Sciwind Biosciences Co., Ltd. ("Sciwind"), a biopharmaceutical company focused on the discovery and development of innovative therapies for metabolic diseases, announced today that China's National Medical Products Administration (NMPA) has approved Ecnoglutide injection for chronic weight management in Chinese adults with overweight or obesity. |
| 2026-01-30 | Hangzhou Sciwind Biosciences Co., Ltd. | Regulatory Sciwind Biosciences Announces Ecnoglutide Injection Approved by China’s National Medical Products Administration (NMPA) for Adult Type 2 Diabetes sciwindbio.com ↗
Ecnoglutide injection represents the world's first approved long-acting cAMP-biased glucagon-like peptide-1 (GLP-1) receptor agonist. |
| 2026-01-28 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences Published T2DM Phase III EECOH-1 Trial Results of Ecnoglutide in Nature Communications sciwindbio.com ↗ |
| 2025-08-23 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences Published T2DM Phase III EECOH-2 Trial Results of Ecnoglutide in Lancet Diabetes & Endocrinology sciwindbio.com ↗
Sciwind Biosciences, a clinical-stage biotech company focusing on metabolic diseases, today announced Phase III EECOH-2 trial results evaluating ecnoglutide injection (XW003) in Chinese adults with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin. |
| 2025-06-21 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences Announces Publication of Phase III SLIMMER Trial Results in The Lancet Diabetes & Endocrinology and Oral Presentation at ADA Scientific Sessions sciwindbio.com ↗
Hangzhou, China & San Francisco, U.S. – June 21, 2025 – Sciwind Biosciences, a clinical-stage biopharmaceutical company focused on metabolic diseases, today announced Phase III SLIMMER trial results evaluating ecnoglutide (XW003) in Chinese adults with overweight or obesity. |
| 2024-12-12 | Hangzhou Sciwind Biosciences Co., Ltd. | Regulatory Sciwind’s Second Marketing Authorization Application of Ecnoglutide for Chronic Weight Management Has Been Accepted by the NMPA of China sciwindbio.com ↗ |
| 2024-11-24 | Hangzhou Sciwind Biosciences Co., Ltd. | Regulatory Marketing Authorization Application for Ecnoglutide, a First-in-Class Biased GLP-1 Peptide Agonist, has Been Accepted by the NMPA of China sciwindbio.com ↗
Sciwind Biosciences announces today that the Marketing Authorization Application for ecnoglutide injection (Class I New Drug) has been accepted by the National Medical products Administration (NMPA) of China, for the treatment of adults with type 2 diabetes. |
| 2024-01-23 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences Announces Positive Results from Phase 1 Clinical Trial of XW004, an Oral Formulation of Long-acting GLP-1 Analog Ecnoglutide sciwindbio.com ↗
Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic diseases, today announced positive interim results from the first four cohorts of a Phase 1 clinical trial of oral ecnoglutide (XW004). |
| 2024-01-02 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences Announces Positive Topline Results from Phase 3 Clinical Trial of Ecnoglutide (XW003), a Long-acting cAMP Signaling Biased GLP-1 Analog, in Adult Patients with Type 2 Diabetes in China sciwindbio.com ↗
Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic diseases, today announced positive topline results from a Phase 3 clinical trial of ecnoglutide (XW003) in Chinese adults with type 2 diabetes mellitus (T2DM). |
| 2023-07-11 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences Announces Publication of Discovery, Preclinical, and Phase 1 Clinical Trial Results of Ecnoglutide (XW003) in Molecular Metabolism sciwindbio.com ↗
In a Phase 1 clinical study, ecnoglutide was found to be generally safe and well tolerated with pharmacokinetic properties supporting once-weekly subcutaneous injections. |
| 2023-06-23 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences to Highlight Positive Clinical Data for GLP-1 Peptide Agonist Ecnoglutide (XW003) at the American Diabetes Association (ADA) 83rd Annual Conference sciwindbio.com ↗
Results from three clinical studies show ecnoglutide to be safe and well-tolerated, and demonstrate robust therapeutic effects in overweight/obese and type 2 diabetes patients |
| 2022-10-27 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences Announces Positive Interim Results from Ongoing Phase 2b Clinical Trial of XW003 (Ecnoglutide) in Patients with Obesity sciwindbio.com ↗
Sciwind Biosciences, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic disease, announced today positive results from an interim analysis of the on-going Phase 2b clinical trial of XW003 (ecnoglutide) in patients with obesity. |
| 2022-08-08 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences Reports Positive Interim Results from Phase 1c/2a Clinical Trial of XW003 (Ecnoglutide) in Overweight and Obese Adult Volunteers in China sciwindbio.com ↗
Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic disease, today announced positive interim topline results from a 26-week Phase 1c/2a clinical trial of XW003 (Ecnoglutide) in overweight or obese Chinese adult volunteers. |
| 2022-08-02 | Hangzhou Sciwind Biosciences Co., Ltd. | Results Sciwind Biosciences Announces Positive Topline Results from 20-week Phase 2 Clinical Trial of XW003 (Ecnoglutide), a novel long-lasting GLP-1 analogue, in Adult Patients with Type 2 Diabetes in China sciwindbio.com ↗
At week 20, participants receiving 0.4 mg, 0.8 mg, and 1.2 mg XW003 had statistically significant HbA1c reductions from baseline of 1.8%, 1.9% and 2.4%, respectively, compared to 0.5% in participants receiving placebo (P < 0.0001). |
| 2021-02-28 | Hangzhou Sciwind Biosciences Co., Ltd. | Regulatory Sciwind's Investigational New Drug Approved for NASH Trial sciwindbio.com ↗
HANGZHOU, China, Feb. 28, 2021 /PRNewswire/ -- Hangzhou Sciwind Biosciences Co., Ltd., (Sciwind), a clinical-stage, fast-growing biotech focusing on research and development of innovative biologics, today announced that XW003, a potential candidate for the treatment of non-alcoholic steatohepatitis (NASH), has been approved by China NMPA for clinical trial. |
All press releases naming this drug 25 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ecnoglutide | “Here we describe the discovery and characterization of ecnoglutide (XW003), a novel GLP-1 analog.” PMID 37364710 ↗ Jun 2023 |
| Known as | Ecnoglutida | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095115 ↗ |
| Known as | Ecnoglutide component of xw-004 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095115 ↗ |
| Known as | Ecnoglutide component of xw004 xw003 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095115 ↗ |
| Known as | XW003 | “Here we describe the discovery and characterization of ecnoglutide (XW003), a novel GLP-1 analog.” PMID 37364710 ↗ Jun 2023 |
| Action | Activate | “ecnoglutide potently induced cAMP” PMID 37364710 ↗ Jun 2023 |
| Modality | Peptide | “XW003 is an acylated human glucagon-like peptide 1 (GLP-1) analogue” NCT05111912 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL5095115 ↗ |
| Route | Subcutaneous | “subcutaneous ecnoglutide injection” PMID 37364710 ↗ Jun 2023 |