A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Identify the Optimal Weekly Oral Dose of Ecnoglutide (VRB-101) for Maintaining Body Weight in Participants With Obesity or Overweight Who Have Weight-Related Comorbidities

The purpose of this study is to identify the weekly oral dose of VRB-101 (oral ecnoglutide) that can effectively maintain body weight in participants with a history of obesity or overweight with weight-related comorbidities.

Start Date01 May 2026

Sponsor / Collaborator

Verdiva Bio Dev Ltd.

NCT07434050

/ RecruitingPhase 3

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of XW003 Injections in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy

The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP

Start Date02 Mar 2026

Sponsor / Collaborator

Hangzhou Sciwind Biosciences Co., Ltd.

NCT07387094

/ RecruitingPhase 3

The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP

Start Date09 Feb 2026

Sponsor / Collaborator

Hangzhou Sciwind Biosciences Co., Ltd.

100 Clinical Results associated with Ecnoglutide

100 Translational Medicine associated with Ecnoglutide

100 Patents (Medical) associated with Ecnoglutide

Literatures (Medical) associated with Ecnoglutide

01 May 2026·Endocrinology, diabetes & metabolism

Comparative Efficacy and Safety of Ecnoglutide in Type 2 Diabetes: A Systematic Review and Meta‐Analysis

Review

Author: Babar, Rayan ; Kumar, Sumet ; Kumar, Laksh ; Ahmed, Hanzlah ; Ali, Ayesha Sarwar ; Qazi, Hadia ; Ali, Sana Mohammad ; Kumar, Mukesh ; Chaulagain, Aayush ; Raja, Adarsh ; Ali, Sheikh Muhammad Ebtehaj ; Gul, Khizra ; Hanif, Fatima ; Bukhari, Shehzadi Umme Rubab ; Janjua, Arshia Arif ; Sheikh, Rumaisa Imtiaz

ABSTRACT:

Background:

Type 2 diabetes mellitus (T2DM) affects over 500 million people worldwide, with traditional therapies often failing to maintain long‐term glycaemic control. Ecnoglutide, a novel long‐acting GLP‐1 receptor agonist, has emerged as a promising therapeutic option. This systematic review and meta‐analysis evaluated the efficacy and safety of ecnoglutide in adults with T2DM.

Methods:

Following PRISMA guidelines, we systematically searched PubMed, Cochrane Library, ScienceDirect, ClinicalTrials.gov , and Google Scholar through September 2025. Randomized controlled trials comparing ecnoglutide with placebo or active comparators in adults with T2DM were included. Primary outcomes were changes in HbA1c and body weight. Secondary outcomes included fasting plasma glucose, insulin resistance markers, lipid profile, liver enzymes, and adverse events. Risk of bias was assessed using the Cochrane RoB‐2 tool. Meta‐analysis was performed using random‐effects models, with mean differences and risk ratios calculated at 95% confidence intervals.

Results:

Four RCTs comprising 1643 participants (1162 receiving ecnoglutide, 444 controls) were included. Ecnoglutide significantly reduced HbA1c (MD = −0.44, 95% CI −0.55 to −0.33, p < 0.00001), body weight (MD = −5.63, 95% CI −7.90 to −3.35, p < 0.01), and fasting plasma glucose (MD = −0.81, 95% CI −1.03 to −0.59, p < 0.00001). Improvements were observed in insulin sensitivity, lipid profile, and liver enzymes. Adverse events occurred more frequently with ecnoglutide (RR = 1.09, p < 0.01), although predominantly gastrointestinal and mild‐to‐moderate, with no significant differences in serious adverse events.

Conclusions:

Ecnoglutide demonstrates robust efficacy in glycaemic control, weight reduction, and cardiometabolic parameters with an acceptable safety profile in adults with T2DM, supporting its therapeutic potential as a next‐generation GLP‐1 receptor agonist.

01 Oct 2025·Lancet Diabetes & Endocrinology

Ecnoglutide, a biased GLP-1 receptor agonist as a potential new player for type 2 diabetes management?

Article

Author: Scheen, André J

01 Oct 2025·Lancet Diabetes & Endocrinology

Efficacy and safety of cAMP-biased GLP-1 receptor agonist ecnoglutide versus dulaglutide in patients with type 2 diabetes and elevated glucose concentrations on metformin monotherapy (EECOH-2): a 52-week, multicentre, open-label, non-inferiority, randomised, phase 3 trial

Article

Author: Han, Jie ; Li, Qingju ; Guo, Mengying ; Cheng, Zhifeng ; Pan, Hai ; Zheng, Qing ; Zhou, Yanqin ; Wang, Huihui ; Zhu, Yikun ; Yang, Ming ; Li, Feng ; Guan, Lei ; Wu, Jun ; Ning, Jing ; Zhao, Shuping ; Duan, Binhong ; Shi, Xiaoguang ; Jiang, Feifei ; Mi, Nianrong ; Li, Xiaoying ; He, Yang ; Bing, Shaohui ; Yang, Liu ; Wang, Xin ; Li, Yao ; Guo, Wanjun ; Wang, Su ; Ling, Hongwei ; Xue, Haibo ; Wang, Haifang ; Bu, Yue

BACKGROUND:

Ecnoglutide is a novel biased GLP-1 receptor agonist that preferentially activates the cAMP pathway over β-arrestin recruitment. We aimed to assess both non-inferiority and superiority of ecnoglutide versus dulaglutide, also a GLP-1 receptor agonist, in patients with type 2 diabetes.

METHODS:

We conducted a 52-week, open-label, active-controlled, phase 3 trial at 52 hospitals in China. Adults aged 18-75 years with a BMI of 20-35 kg/m², a diagnosis of type 2 diabetes, and elevated glucose concentrations on metformin monotherapy were included. Participants were randomly assigned (1:1:1) to receive subcutaneous ecnoglutide (0·6 mg or 1·2 mg) or dulaglutide (1·5 mg) once weekly. The primary endpoint was mean change from baseline in HbA_1c at week 32 (non-inferiority for ecnoglutide 0·6 mg and 1·2 mg, with a 0·4% non-inferiority margin; superiority for ecnoglutide 1·2 mg) and was assessed in all randomly assigned participants who received at least one dose of study treatment (full analysis set). Safety was assessed in all randomly assigned participants who received at least one dose of study drug and had at least one safety evaluation after starting treatment. This trial is registered with ClinicalTrials.gov (NCT05680129) and has ended.

FINDINGS:

Between Jan 10 and May 30, 2023, 623 participants were randomly assigned, of whom 621 comprised the full analysis set (mean age 53·9 years [SD 10·1], 347 [56%] males, 274 [44%] females, and mean HbA_1c 8·40% [SD 0·78]; 68·28 mmol/mol [8·56]; 206 in the ecnoglutide 0·6 mg group, 208 in the ecnoglutide 1·2 mg group, and 207 in the dulaglutide 1·5 mg group). At week 32, mean HbA_1c reductions were 1·91% (SE 0·05; -20·86 mmol/mol [0·53]) with ecnoglutide 0·6 mg, 1·89% (0·05; -20·69 mmol/mol [0·54]) with ecnoglutide 1·2 mg, and 1·65% (0·05; -18·02 mmol/mol [0·53]) with dulaglutide. Estimated treatment differences versus dulaglutide were -0·26% (95% CI -0·39 to -0·13; -2·84 mmol/mol [-4·29 to -1·38]) with ecnoglutide 0·6 mg and -0·24% (-0·38 to -0·11; -2·67 mmol/mol [-4·14 to -1·20]; p=0·0002 for superiority) with ecnoglutide 1·2 mg. HbA_1c reductions were sustained to week 52. During the 52 weeks, six (3%) of 206 patients in the ecnoglutide 0·6 mg group, eight (4%) of 208 patients in the ecnoglutide 1·2 mg group, and six (3%) of 207 patients in the dulaglutide group discontinued treatment due to adverse events.

INTERPRETATION:

Once-weekly ecnoglutide 0·6 mg and 1·2 mg were non-inferior to dulaglutide 1·5 mg in reducing HbA_1c in adults with type 2 diabetes and elevated glucose concentrations on metformin monotherapy. Although the 1·2 mg dose showed statistically significantly greater reductions in HbA_1c from baseline to week 32 than dulaglutide 1·5 mg, the difference was not considered clinically relevant. Both doses of ecnoglutide were well tolerated. These results suggest that ecnoglutide might offer a new treatment option for type 2 diabetes.

FUNDING:

Hangzhou Sciwind Biosciences.

News (Medical) associated with Ecnoglutide

05 May 2026

·www.biospace.com

Pfizer Reports Strong First-Quarter Results And Reaffirms 2026 Guidance

Earnings Driven by Focused Execution and 22% Op Revenue Growth of Launched and Acquired Products (1) Pipeline Momentum Builds on Positive Phase 3 and Mid-Stage Readouts Robust Late‑Stage R&D Pipeline, On Track to Start ~20 Key Pivotal Studies in 2026 NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2026 and reaffirmed its full-year 2026 financial guidance (2) . EXECUTIVE COMMENTARY Dr. Albert Bourla, Chairman and CEO of Pfizer: “We're off to a strong start in 2026, and it reinforces our confidence that we will successfully navigate this defining period for Pfizer. Our R&D pipeline is advancing on multiple fronts – with positive Phase 3 readouts and encouraging mid-stage results building meaningful momentum – and I'm particularly encouraged by what we're seeing in oncology and obesity, two areas where I believe Pfizer is positioned to lead.” David Denton, CFO and EVP of Pfizer: “Our first-quarter results are attributable to our solid commercial performance globally as well as our ongoing focus on operational efficiency. This quarter, I’m particularly pleased with the 22% year-over-year operational revenue growth from our launched and acquired products (1) . Today, we are reaffirming our full-year 2026 financial guidance.” OVERALL RESULTS First-Quarter 2026 Revenues of $14.5 Billion, Representing 2% Year-over-Year Operational Growth Excluding Contributions from Comirnaty and Paxlovid, Revenues Grew 7% Operationally Revenues of Launched and Acquired Products (1) Grew 22% Operationally First-Quarter 2026 Reported (3) Diluted EPS of $0.47, and Adjusted (4) Diluted EPS of $0.75 Reaffirms All Components of Full-Year 2026 Financial Guidance (2) , including Revenues in a Range of $59.5 to $62.5 Billion and Adjusted (4) Diluted EPS in a Range of $2.80 to $3.00 Beginning in the first quarter of 2026, we made organizational changes in our commercial organization within the Global Biopharmaceuticals Business (Biopharma) to better support and optimize performance across our product portfolios. These changes include the transition of certain off-patent branded and generic sterile injectables and biosimilars primarily from the Specialty Care and Oncology product portfolios to a new Hospital and Biosimilars product portfolio and the creation of a new Global Hospital and Biosimilars Division within Biopharma. See the Item 1. Business––Commercial Operations section of Pfizer's 2025 Annual Report on Form 10-K (available at and ). Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates (5) . Results for the first quarter of 2026 and 2025 (6) are summarized below. ($ in millions, except per share amounts) First-Quarter 2026 2025 % Change Revenues $ 14,451 $ 13,715 5% Reported (3) Net Income 2,687 2,967 (9%) Reported (3) Diluted EPS 0.47 0.52 (10%) Adjusted (4) Income 4,290 5,237 (18%) Adjusted (4) Diluted EPS 0.75 0.92 (18%) REVENUES ($ in millions) First-Quarter 2026 2025 % Change Total Oper. Global Biopharmaceuticals Business (Biopharma) $ 14,161 $ 13,441 5% 2% Pfizer CentreOne 289 273 6% 1% TOTAL REVENUES $ 14,451 $ 13,715 5% 2% 2026 FINANCIAL GUIDANCE (2) Reaffirms all components of full-year 2026 Financial Guidance (2) , including Revenues in a range of $59.5 to $62.5 billion and Adjusted (4) Diluted EPS in a Range of $2.80 to $3.00. Revenues $59.5 to $62.5 billion Adjusted (4) SI&A Expenses $12.5 to $13.5 billion Adjusted (4) R&D Expenses $10.5 to $11.5 billion Effective Tax Rate on Adjusted (4) Income Approximately 15.0% Adjusted (4) Diluted EPS $2.80 to $3.00 CAPITAL ALLOCATION During the first three months of 2026, Pfizer deployed its capital in a variety of ways, which primarily included: Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including: $2.5 billion invested in internal research and development projects, and Approximately $110 million invested in business development transactions. Returning capital directly to shareholders through $2.4 billion of cash dividends, or $0.43 per share of common stock. Our capital allocation framework is designed to enhance long-term shareholder value, and is based on three core pillars: (i) reinvesting in the business, including maintaining the flexibility to deploy capital towards potential value-creating business development transactions, (ii) maintaining and, over the long term, growing our dividend, and (iii) in the future, the potential to resume the return of capital to shareholders through value-enhancing share repurchases after de-levering our balance sheet. The company expects to continue to de-lever over the longer term in a prudent manner in order to maintain a balanced capital allocation strategy. No share repurchases have been completed to date in 2026. As of May 5, 2026, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2026. Diluted weighted-average shares outstanding of 5,731 million and 5,710 million were used to calculate Reported (3) and Adjusted (4) diluted EPS for first-quarter 2026 and 2025, respectively. QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2026 vs. First-Quarter 2025) First-quarter 2026 revenues totaled $14.5 billion, an increase of $736 million, or 5%, compared to the prior-year quarter, reflecting an operational increase of $304 million, or 2%, and a favorable impact of foreign exchange of $431 million. The operational increase was primarily driven by an increase in revenues for Padcev, Eliquis, Oncology biosimilars, Nurtec and several other products across categories, partially offset primarily by a year-over-year decline in COVID-19 product revenues. Excluding contributions from Comirnaty and Paxlovid, revenues for the first quarter grew 7% operationally. Additionally, first-quarter revenues of our Launched and Acquired Products (1) grew 22% operationally. First-quarter 2026 operational revenue growth was driven primarily by: Padcev globally, up 39% operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC) as well as contribution from launch momentum in the cisplatin-ineligible indication for muscle-invasive bladder cancer (MIBC); Eliquis globally, up 8% operationally, driven primarily by higher demand globally, partially offset by declines due to generic entry and price erosion in certain international markets; Oncology biosimilars globally, up 52% operationally, driven primarily by favorable net price in the U.S. and supply recovery, with both drivers partially reflecting one-time impacts; Nurtec ODT/Vydura globally, up 41% operationally, driven primarily by strong demand and one-time net price favorability in the U.S., as well as recent launches in certain international markets; Lorbrena globally, up 32% operationally, driven primarily by increased patient share in the first-line ALK-positive metastatic non-small cell lung cancer (ALK+ mNSCLC) treatment setting in the U.S., China, and certain other international markets; Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 4% operationally. International growth was primarily driven by strong demand with continuing uptake in patient diagnosis across markets as well as improved access in certain international markets. In the U.S., revenues declined primarily due to net price erosion as a result of new payer contracts, partially offset by continued market expansion; Xeljanz globally, up 34% operationally, driven primarily by favorable net price in the U.S., partially offset by lower demand internationally; and Abrysvo globally, up 31% operationally. U.S. growth was primarily driven by a lower returns provision compared to the prior-year quarter, partially offset by lower vaccine rates. International growth was primarily driven by launch uptake in certain international markets, partially offset by unfavorable timing of deliveries for the maternal indication in certain international markets; partially offset primarily by lower revenues for: Comirnaty globally, down 59% operationally, driven primarily by a decline in international markets from both lower contractual deliveries and a lower favorable adjustment to the returns provision, as well as lower utilization in the U.S. primarily resulting from a narrower recommendation for vaccination; and Paxlovid globally, down 63% operationally, driven primarily by lower COVID-19 infections across U.S. and international markets and lower government purchases in certain international markets. GAAP Reported (3) Statement of Operations Highlights SELECTED REPORTED (3) COSTS AND EXPENSES ($ in millions) First-Quarter 2026 2025 % Change Total Oper. Cost of Sales (3) $ 3,548 $ 2,845 25% 15% Percent of Revenues 24.6 % 20.7 % N/A N/A SI&A Expenses (3) 2,961 3,031 (2%) (4%) R&D Expenses (3) 2,490 2,203 13% 12% Acquired IPR&D Expenses (3) 137 9 * * Other (Income)/Deductions—net (3) 861 953 (10%) (13%) Effective Tax Rate on Reported (3) Income 14.6 % (6.8 %) * Indicates calculation not meaningful or results are greater than 100%. First-quarter 2026 Cost of Sales (3) as a percentage of revenues increased by 3.8 percentage points compared to the prior-year quarter, primarily driven by the non-recurrence of a favorable revision of our estimate of accrued royalties in the first quarter of 2025 as well as an unfavorable impact of foreign exchange. First-quarter 2026 SI&A Expenses (3) decreased 4% operationally compared to the prior-year quarter, primarily reflecting lower marketing and promotional spending on various products from more targeted investments and ongoing productivity improvements, as well as lower spending in corporate enabling functions; partially offset by an unfavorable impact of foreign exchange. First-quarter 2026 R&D Expenses (3) increased 12% operationally compared to the prior-year quarter, driven primarily by an increase in spending in certain oncology and obesity product candidates. Pfizer’s effective tax rate on Reported (3) income for the first quarter of 2026 increased compared to the prior-year quarter primarily due to an unfavorable change in the jurisdictional mix of earnings as well as the non-recurrence of favorable global income tax resolutions. Adjusted (4) Statement of Operations Highlights SELECTED ADJUSTED (4) COSTS AND EXPENSES ($ in millions) First-Quarter 2026 2025 % Change Total Oper. Adjusted (4) Cost of Sales $ 3,406 $ 2,593 31% 20% Percent of Revenues 23.6 % 18.9 % N/A N/A Adjusted (4) SI&A Expenses 2,915 3,010 (3%) (5%) Adjusted (4) R&D Expenses 2,434 2,173 12% 11% Acquired IPR&D Expenses (4) 137 9 * * Adjusted (4) Other (Income)/Deductions—net 388 246 58% 45% Effective Tax Rate on Adjusted (4) Income 16.9 % 7.8 % * Indicates calculation not meaningful or results are greater than 100%. See the reconciliations of certain Reported (3) to non-GAAP Adjusted (4) financial measures and associated footnotes in the financial tables section of this press release located at the hyperlink below. RECENT NOTABLE DEVELOPMENTS (Since February 3, 2026) Product Developments Product/Project Milestone Recent Development Link Braftovi (encorafenib) Regulatory February 2026. Announced the U.S. Food and Drug Administration (FDA) granted full approval to Braftovi in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial (NCT04607421). The Braftovi combination regimen is the only approved targeted regimen for first-line BRAF V600E -mutant metastatic colorectal cancer. Full Release Phase 3 Results February 2026. Announced positive topline progression-free survival (PFS) results from Cohort 3, a separate, randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi in combination with cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. The Braftovi regimen demonstrated a statistically significant and clinically meaningful improvement in PFS, a key secondary endpoint, as assessed by blinded independent central review (BICR) compared to treatment with FOLFIRI with or without bevacizumab. Overall survival (OS), a descriptive secondary endpoint, also showed clinically meaningful prolonged improvement with the Braftovi regimen. At the time of the PFS analysis, the safety pro Braftovi in combination with cetuximab and FOLFIRI was consistent with the known pro each regimen component and no new safety signals were identified. Full Release Elrexfio (elranatamab) Phase 3 Results April 2026. Announced positive topline results from the Phase 3 MagnetisMM-5 study evaluating Elrexfio as monotherapy in adults with relapsed or refractory multiple myeloma (RRMM) who received at least one prior line of treatment. The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS, as assessed by BICR, versus standard-of-care daratumumab plus pomalidomide and dexamethasone. The safety and tolerability of Elrexfio was consistent with its known safety profile. Full Release Hympavzi (marstacimab) Regulatory March 2026. Announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Hympavzi to expand the approved indication to include patients 12 years of age and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors, or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors. The European Commission will review the CHMP recommendation and is expected to make a final decision in the coming months. Full Release Regulatory February 2026. Announced the FDA accepted and granted priority review for the supplemental Biologics License Application (sBLA) for Hympavzi to expand the approved indication to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the second quarter of 2026. Full Release Padcev (enfortumab vedotin) Regulatory April 2026. Pfizer and Astellas Pharma Inc. announced the FDA accepted for priority review a sBLA for perioperative (before and after surgery) Padcev in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph as treatment for patients with muscle-invasive bladder cancer (MIBC). This regimen was FDA-approved in November 2025 for use as perioperative treatment in cisplatin-ineligible patients with MIBC. This filing seeks to expand the indication to patients with MIBC regardless of cisplatin eligibility. The FDA has set a PDUFA target action date of August 17, 2026. Full Release Phase 3 Results February 2026. Pfizer and Astellas announced positive results from the investigational Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) for Padcev in combination with pembrolizumab in patients with MIBC eligible for cisplatin-based chemotherapy. Perioperative (before and after surgery) Padcev plus pembrolizumab demonstrated a 47% reduction in the risk of tumor recurrence, progression or death compared to patients treated with standard of care neoadjuvant (before surgery) gemcitabine and cisplatin (Hazard Ratio (HR) of 0.53; 95% Confidence Interval (CI), 0.41–0.70; 1-sided p20) was not met in the first pre-specified analysis (primary endpoint). The vaccine candidate was well tolerated with no safety concerns identified at time of analysis. Pfizer is planning submissions to regulatory authorities. Full Release tilrekimig Phase 2 Results March 2026. Announced positive topline results from a Phase 2 study investigating tilrekimig (PF-07275315), a potential first-in-class, investigational trispecific antibody that simultaneously targets interleukin-4 (IL-4), interleukin-13 (IL-13) and thymic stromal lymphopoietin (TSLP), in adults with moderate to severe atopic dermatitis. The study met its primary efficacy endpoint, demonstrating a statistically significant increase in the percentage of participants achieving EASI-75 (≥ 75% reduction in the Eczema Area and Severity Index) at Week 16 across all doses tested, compared to placebo. Tilrekimig was well-tolerated with a favorable safety pro no dose dependent safety signals; adverse event rates were comparable to placebo. Phase 3 planning for atopic dermatitis is ongoing, with a pivotal study on track to start this year. Full Release Corporate Developments Topic Recent Development Link Business Development February 2026. Pfizer and Hangzhou Sciwind Biosciences Co., Ltd. (Sciwind Biosciences) announced a strategic commercialization collaboration in which Pfizer obtained exclusive commercialization rights for Sciwind Biosciences’ glucagon-like peptide 1 (GLP-1) receptor agonist ecnoglutide in Mainland China. Sciwind Biosciences remains the Marketing Authorization Holder and is responsible for research and development, registration, manufacturing and supply of the product. Sciwind Biosciences is eligible to receive an aggregate of up to $495M in upfront, regulatory and sales milestone payments. Ecnoglutide Injection (Xianweiying (7) ) was approved in China on March 6 for long-term weight management in adults with overweight or obesity, as an adjunct to a reduced calorie diet and increased physical activity, and was subsequently launched in China on April 27, 2026. Full Release TrumpRx February 2026. Announced the launch of Pfizer’s participation on TrumpRx.gov providing Americans a wide range of more than 30 medicines at a significant discount off list prices. This effort is part of Pfizer’s broader Most Favored Nation (MFN) agreement with the U.S. government enabling patients to pay lower prices for their prescription medicines, while strengthening America’s role as a global leader in pharmaceutical innovation. Full Release ViiV Healthcare Limited March 2026. Pfizer completed the exit of its 11.7% investment in ViiV Healthcare Limited and received $1.875 billion in proceeds (or approximately $1.65 billion in cash, net of associated taxes and fees). This transaction will be accounted for in the second quarter of 2026. N/A Vyndamax Patent Settlements April 2026. Pfizer entered into settlement agreements with generic drug manufacturers Dexcel Pharma, Hikma Pharmaceuticals and Cipla Ltd, regarding lawsuits filed in the U.S. District Court for the District of Delaware for infringement of patents relating to Vyndamax. These settlements extend the effective U.S. patent expiry date for Vyndamax to June 1, 2031, subject to the outcome of other litigation. Pfizer had previously anticipated a significant decline in U.S. revenues for Vyndamax beginning in 2029 upon patent expiry. As a result of this settlement, revenues are now expected to remain relatively stable from 2028 through mid-2031. Full Release PFIZER TO HOST CONFERENCE CALL Please find Pfizer’s press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted inform Contacts Media PfizerMediaRelations@Pfizer.com 212.733.1226 Investors IR@Pfizer.com Read full story here

Clinical ResultPhase 3VaccineDrug ApprovalFinancial Statement

01 Apr 2026

·www.biopharmadive.com

Ambrosia adds a megaround for obesity drugs

Colorado drugmaker Ambrosia Biosciences has landed $100 million to pursue an oral obesity drug its hoping can compete with a recently approved version of Wegovy.Ambrosia is developing a small molecule GLP-1 pill it says can be more convenient to take and combined with other therapies to increase weight loss. Also in the biotechnology companys portfolio are drugs for other common metabolic disease targets, such as GIP and amylin.As the field moves beyond first-generation molecules, we see a meaningful opportunity for differentiated small molecule modulators that are designed with combinability in mind, Nick Traggis, Ambrosias CEO, said in a Tuesday statement.Ambrosias Series B round was co-led by Blue Owl Healthcare Opportunities, Redmile and Deep Track Capital and included five other venture investors. The last venture funding it raised was a $25 million Series A round in 2024. Ambrosia was formed by a group of former Array BioPharma scientistswho were laid off after Pfizer acquired the cancer drugmaker.Approved obesity treatments largely consist of weekly injections that can help patients lose considerable weight. But the December approval of Novo Nordisks oral Wegovy kicked off a new phase of competition in the obesity drug market. On Wednesday, the Food and Drug Administration approved Eli Lilly's GLP-1 pill orforglipron, which will be marketed as Foundayo.Though clinical studies have shown pills deliver, on average, less weight loss than their injectable counterparts, they hold a key advantage in being more convenient to take, which companies are betting will increase use. Sales of both injectable and oral GLP-1s are expected to top more than $100 billion annually by 2030, according to Wall Street analysts.Ambrosia faces stiff competition from other companies trying to develop an obesity pill. Structure Therapeutics recently presented data for its treatment aleniglipron, which, according to RBC Capital Markets analyst Trung Huynh, looked like another potential oral option to the market that will be competing for share in the future with Novo and Lilly.Some of those competitors have also turned to Chinese pharmaceutical companies to license oral obesity drugs. Kailera Therapeutics, which filed plans for an initial public offering last month, already has data from mid-stage testing with its partner Hengrui Pharmaceuticals for an oral version of its lead drug ribupatide. Corxel Therapeuticsearlier this year raised $287 million to back its differentiated GLP-1 pill licensed from Vincentage. And Verdiva Bio, which launched in 2025 with more than $400 million, recently finished enrolling patients in a Phase 2b trial of its oral peptide VRB-101.Editors Note:This story has been updated to include the FDA approval of orforglipron. '

Drug ApprovalPhase 2Acquisition

19 Mar 2026

·www.fiercebiotech.com

Lilly\'s triple-G bet lowers blood sugar, prompts 16.8% weight loss in phase 3 diabetes trial

Eli Lilly’s plan is to submit retatrutide to regulators before the end of the year as a treatment for obesity, with a diabetes filing to follow in 2027.\n With the obesity numbers for Eli Lilly’s retatrutide already stacking up nicely, the company has rounded out its pitch for the triple agonist with top-line data on its ability to lower blood sugar levels and reduce weight in patients with Type 2 diabetes.The headline results, which Lilly reported Thursday, appear competitive with the GLP-1 drugs already on the market for diabetes.After 40 weeks of treatment, 4-mg, 9-mg and 12-mg doses of retatrutide—an agonist of GLP-1, GIP and a third hormone, glucagon, aka triple G—demonstrated average reductions in A1C of 1.7%, 1.9% and 1.9%, respectively, when accounting for all patients in the trial. These results hit the study\'s primary endpoint, the company said in a March 19 press release. When it came to the key secondary endpoint of weight loss, participants on the 12-mg dose of retatrutide lost an average of 36.6 pounds, or 16.8% of their body weight, when only assessing patients who received treatment as intended—known as an efficacy estimand. When stretching out the analysis to cover all patients who started on the 12-mg regimen, the average weight loss was reduced slightly to 15.3% (33.3 pounds).No plateauing of weight loss was identified by the 40-week mark, according to Lilly.The retatrutide weight loss figures fell short of the 25% or greater threshold investors had been hoping for, but that miss shouldn’t come as a surprise “given the shorter study time and T2D patient set,” analysts at Citi wrote in a note to clients Thursday.With the caveat that cross-trial comparisons are an imperfect tool, Novo in February reported that Type 2 diabetes patients who received CagriSema—a combination of Wegovy\'s ingredient semaglutide and experimental amylin receptor agonist cagrilintide—charted average efficacy estimand weight loss of 14.2% after 68 weeks. On A1C, CagriSema reduced patients’ blood sugar by 1.9% on average.When asked by Fierce Biotech how Lilly sees retatrutide lining up against the growing list of obesity competitors, a spokesperson for the Big Pharma pointed out there have “been no head-to-head studies to-date comparing retatrutide with other incretins, and it is not appropriate to draw conclusions from cross-trial comparisons due to differences in study designs and patient populations.” Back in December, 12 mg retatrutide was linked to an efficacy estimand weight loss of 28.7%—and a 75.8% reduction in pain scores—in a phase 3 trial of the triple agonist in patients with both obesity and knee osteoarthritis. While the weight loss in this morning\'s diabetes trial is noticeably lower than in the December phase 3 study, Lilly\'s spokesperson explained that losing weight is often harder for this patient population due to underlying metabolic factors. Lilly’s Type 2 diabetes study for retatrutide enrolled 537 participants. Apart from the A1C and weight loss endpoints, the Transcend-T2D-1 trial also looked at measures like change from baseline in triglycerides, fasting serum glucose, non-HDL cholesterol and systolic blood pressure, as well as the specific thresholds of patients who achieved certain A1C reductions and weight loss levels.The plan is to submit retatrutide to regulators before the end of the year as a treatment for obesity, with a diabetes filing to follow in 2027, a spokesperson told Fierce.Lilly is counting on next-generation incretin medicines like retatrutide—as well as its oral GLP-1 orforglipron—to eventually pick up the torch from its current diabetes and obesity mainstays Mounjaro and Zepbound, both of which are underpinned by Lilly’s dual GIP/GLP-1 receptor agonist tirzepatide. “For many people with type 2 diabetes, it is a struggle to achieve both A1C control and weight loss, since obesity has historically been harder to treat for those with type 2 diabetes,” Kenneth Custer, Ph.D., president of Lilly Cardiometabolic Health, said in the release. “With triple agonist retatrutide, we set out to make a molecule that could help patients achieve substantial A1C reduction and weight loss,” Custer added. “These results support the remarkable potential of this novel molecule for people living with type 2 diabetes, with up to 2% A1C improvement and nearly 17% weight loss in 40 weeks of treatment.”Retatrutide may have exceeded predictions with its obesity data back in December, but that blowout efficacy was offset by a higher discontinuation rate, 18.2%, than expected by analysts. It was a better story this morning, with discontinuation rates from adverse events at the 12-mg dose at 5.1%. At this dose, the most common adverse events were nausea (26.5%), diarrhea (22.8%) and vomiting (17.6%), according to this morning\'s release, all common side effects from these types of medicines. While about 21% of patients in the 12-mg cohort of December\'s obesity trial experienced dysesthesia—an unpleasant feeling on the skin—this level was down to 4.4% in today\'s diabetes study.When taking this safety data into account, Citi analysts said they \"provide additional confidence in retatrutide’s additional applicability in high BMI (>35) patients as the market inevitably fragments.”Lilly’s new retatrutide data also appeared to stand up against the A1C reductions and weight loss charted by the current crop of approved GLP-1s for diabetes. In the data included in Ozempic’s FDA-approved label, the drug at the 1-mg dose helped patients reduce their A1C by 1.6% from a baseline of 8.1% at 30 weeks and enabled them to lose an average of 4.7 kilograms (a little more than 10 pounds).Mounjaro’s FDA label clocks an average A1C reduction of 1.8% from baseline after 40 weeks. Patients on the drug lost between 6.3 and 7.8 kilograms, or between 14 and 17 pounds, according to the label. Elsewhere, a new commercial GLP-1 challenger has emerged in China by way of Pfizer and its local partner Sciwind Biosciences, which recently scored approval for their drug ecnoglutide under the respective diabetes and obesity brand names Xianyida and Xianweiying.Phase 3 data on ecnoglutide point to 2.2% to 2.6% A1C reductions at the highest, 1.2-mg, dose tested, versus 0.6% to 1.09% reductions on placebo, plus an average weight reduction of 3.21 kilograms (about seven pounds) at that dose. Editor\'s note: This story was updated at 8:15am ET on March 19 with details from an analyst note.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Ecnoglutide

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Indication	Country/Location	Organization	Date
Obesity	China	Hangzhou Sciwind Biosciences Co., Ltd.	03 Mar 2026
Overweight	China	Hangzhou Sciwind Biosciences Co., Ltd.	03 Mar 2026
Diabetes Mellitus, Type 2	China	Hangzhou Sciwind Biosciences Co., Ltd.	27 Jan 2026

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Apnea, Obstructive	Phase 3	China	Hangzhou Sciwind Biosciences Co., Ltd.	03 Feb 2026
Metabolic Dysfunction Associated Steatohepatitis	Phase 1	China	Hangzhou Sciwind Biosciences Co., Ltd.	16 Jun 2021
Arthritis Pain	IND Approval	China	Hangzhou Sciwind Biosciences Co., Ltd.	27 Apr 2026
Alzheimer Disease	Preclinical	China	Hangzhou Sciwind Biosciences Co., Ltd.	19 May 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05680155 (EECOH-1, Pubmed \| Nat Commun) Manual	Phase 3	Diabetes Mellitus, Type 2	211	Ecnoglutide 0.6 mg	mbexvieabq(ywlkvfwpjl) = aodlgsvnez cgkazyqfzr (tlbnbjqpkh, -2.18 to -1.73) Met View more	Positive	07 Jan 2026
				Ecnoglutide 1.2 mg	mbexvieabq(ywlkvfwpjl) = blfarigagx cgkazyqfzr (tlbnbjqpkh, -2.65 to -2.20) Met View more
NCT05680129 (EECOH-2, Literature) Manual	Phase 3	Diabetes Mellitus, Type 2	621	ecnoglutide 0.6 mg	tpugkhlelk(ohxwimllhb) = hayrdsaefs kbxluylxvz (qlyicpxaiy ) View more	Positive	22 Aug 2025
				ecnoglutide 1.2 mg	tpugkhlelk(ohxwimllhb) = nssrllnnxt kbxluylxvz (qlyicpxaiy ) View more
NEWS Manual	Phase 3	Obesity	-	ecnoglutide	vjutffpgtu(uqoazwavth) = yfrabobbvn ebgswjkame (phxwvgimkg )	Positive	27 Jun 2025
NCT05813795 (SLIMMER, Lancet \| NEWS 1 \| NEWS 2 \| NEWS 3) Manual	Phase 3	Overweight \| Obesity	664	ecnoglutide 1.2 mg	bhxtquvcwd(rxxtuvndpg) = tjyzoxpokm ywwpckrxyl (tkmdrvkduq, 0.8) View more	Positive	21 Jun 2025
				ecnoglutide 1.8 mg	bhxtquvcwd(rxxtuvndpg) = pvwdpaznrt ywwpckrxyl (tkmdrvkduq, 0.9) View more
CTR20211014 (Literature) Manual	Phase 2	Diabetes Mellitus, Type 2	145	Ecnoglutide 0.4 mg	xwiqfzejcn(eixynaxymh) = vgyjlamync kacymwwfmz (pbltvrlmvl ) View more	Positive	27 Sep 2024
				Ecnoglutide 0.8 mg	xwiqfzejcn(eixynaxymh) = tmfwffvqjn kacymwwfmz (pbltvrlmvl )
NCT05184322 (ADA2024) Manual	Phase 1	Obesity	56	Oral Ecnoglutide 7mg (healthy)	todelhpkey(dbwajminiw) = The most common AEs were mild to moderate gastrointestinal events that occurred during dose escalation. efymuwhnqk (btblnqowvo ) View more	Positive	21 Jun 2024
				Oral Ecnoglutide 15mg (healthy)
NCT05680155 (ADA2024) Manual	Phase 3	Diabetes Mellitus, Type 2	211	Ecnoglutide 0.6 mg	tpiwlglkgf(orkpmsvhzd) = iluwvteclz pigllowqpv (wwcfobdvbc ) View more	Positive	21 Jun 2024
				Ecnoglutide 1.2 mg	tpiwlglkgf(orkpmsvhzd) = zrukyuuvcm pigllowqpv (wwcfobdvbc ) View more
NEWS Manual	Phase 1	Obesity	56	ecnoglutide	gjggkvvzap(vpndvwgqlf) = 最常见的不良事件包括恶心、头痛、腹泻、呕吐和食欲减退，大多数不良事件的严重程度为轻中度，主要发生在剂量递增期 qbhoipkiqu (rvmpydkzdb )	Positive	24 Jan 2024
				placebo
NCT05680155 (NEWS) Manual	Phase 3	Diabetes Mellitus, Type 2	211	Ecnoglutide 0.6 mg	hagznfxuqr(kpbdydnpwf) = nmesdcefbo civthsbpcy (cjcegixfhg ) View more	Positive	03 Jan 2024
				Ecnoglutide 1.2 mgEcnoglutide 1.2 mg	hagznfxuqr(kpbdydnpwf) = mmdaklujnp civthsbpcy (cjcegixfhg ) View more
CTR20213434 (ADA 12023 \| ADA 22023) Manual	Phase 1	Overweight \| Obesity	60	XW003 1.8 mg	ykbtuxudcy(vikwsezkhi) = The proportion of participants reporting any AE was similar between cohorts (95.2 to 100% for ecnoglutide vs 90% for placebo). The most frequent AEs were gastrointestinal, including diarrhea and vomiting. No drug-related SAE or drug-related AEs ≥Grade 3 were reported. dlyoulhufg (ljzcxkirub ) View more	Positive	20 Jun 2023
				XW003 2.4 mg

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