[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of eletogliflozin tablets (5 mg) in healthy Chinese participants under fasting administration conditions.

主要研究目的：按有关生物等效性试验的规定，选择Merck Sharp & Dohme B.V.为持证商的艾托格列净片（商品名：捷诺妥，规格：5mg）为参比制剂，对宜昌东阳光长江药业股份有限公司生产并提供的受试制剂艾托格列净片（规格：5mg）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康试验参与者口服受试制剂艾托格列净片（规格：5mg）和参比制剂艾托格列净片（商品名：捷诺妥，规格：5mg）的安全性

[Translation]

Primary Objective: In accordance with relevant bioequivalence testing regulations, eltogliflozin tablets (trade name: GenoLactone, strength: 5mg), manufactured by Merck Sharp & Dohme B.V., was selected as the reference formulation. A fasting-administered human bioequivalence study was conducted on the test formulation eltogliflozin tablets (strength: 5mg) produced and supplied by Yichang Dongyangguang Changjiang Pharmaceutical Co., Ltd. The study compared the absorption rate and extent of absorption of the drug in the test formulation with those in the reference formulation to determine if the differences were within acceptable limits, thus evaluating the bioequivalence of the two formulations under fasting administration conditions. Secondary Objective: To observe the safety of oral administration of the test formulation eltogliflozin tablets (strength: 5mg) and the reference formulation eltogliflozin tablets (trade name: GenoLactone, strength: 5mg) to healthy participants.

Start Date25 Jul 2026

Sponsor / Collaborator

YiChang HEC ChangJiang Pharmaceutical Co., Ltd.

NCT07621380

/ Not yet recruitingPhase 4IIT

Effect of Ertugliflozin on NT-proBNP and Cardiac Function After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded Endpoint (PROBE) Trial

This prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluates the efficacy of early ertugliflozin initiation (10 mg daily) compared to standard care alone on cardiac function in 476 adult patients with type 2 diabetes mellitus (T2DM) following a first acute myocardial infarction (AMI). The study is supported by scientific rationale suggesting potential effects of ertugliflozin on cardiac resident macrophages in the heart after myocardial infarction.The primary objective is to assess the change in NT-proBNP levels from baseline to 26 weeks, while secondary endpoints explore echocardiographic parameters (such as LVEF and LAVi) and metabolic indices including blood ketone levels, HbA1c, and body weight. Eligible participants are randomized in a 1:1 ratio within 72 hours of AMI onset and followed for a total of 30 weeks to monitor both efficacy outcomes and safety events, with a specific focus on serious adverse events like severe hypoglycemia, genital infections, and ketoacidosis.

Start Date01 Jul 2026

Sponsor / Collaborator-

CTR20261904

/ Active, not recruitingNot Applicable

艾托格列净片（规格：5mg）在中国健康试验参与者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of eletoggliflozin tablets (5 mg) in healthy Chinese participants under fasting and postprandial dosing conditions.

主要研究目的：按有关生物等效性试验的规定，选择Merck Sharp&Dohme B.V为持证商，Pfizer Manufacturing Deutschland GmbH 生产的艾托格列净片（商品名：捷诺妥®，规格：5mg）为参比制剂，对兰西哈三联制药有限公司生产、安徽万邦医药科技股份有限公司提供的受试制剂艾托格列净片（规格：5mg）进行空腹和餐后给药条件下的人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康试验参与者口服受试制剂艾托格列净片（规格：5mg）和参比制剂艾托格列净片（商品名：捷诺妥®，规格：5mg）的安全性。

[Translation]

Primary Objective: In accordance with relevant bioequivalence testing regulations, eltogliflozin tablets (trade name: Genogliflozin®, strength: 5mg), manufactured by Pfizer Manufacturing Deutschland GmbH and licensed by Merck Sharp & Dohme B.V., were selected as the reference formulation. Human bioequivalence studies were conducted on the test formulation eltogliflozin tablets (strength: 5mg), manufactured by Lanxi Ha Sanlian Pharmaceutical Co., Ltd. and provided by Anhui Wanbang Pharmaceutical Technology Co., Ltd., under both fasting and postprandial administration conditions. The study compared the absorption rate and extent of absorption of the drug in the test formulation with those in the reference formulation to determine if the differences were within acceptable limits, thus evaluating the bioequivalence of the two formulations under fasting and postprandial administration conditions. Secondary Objective: To observe the safety of oral administration of the test formulation eltogliflozin tablets (strength: 5mg) and the reference formulation eltogliflozin tablets (trade name: Genogliflozin®, strength: 5mg) to healthy participants.

Start Date28 Jun 2026

Sponsor / Collaborator

Anhui Wanbang Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Ertugliflozin pidolate

100 Translational Medicine associated with Ertugliflozin pidolate

100 Patents (Medical) associated with Ertugliflozin pidolate

409

Literatures (Medical) associated with Ertugliflozin pidolate

24 Jul 2026·TOXICOLOGY MECHANISMS AND METHODS

Ertugliflozin ameliorates thioacetamide-induced renal injury by modulating Nrf2-mediated oxidative stress, TLR4/STAT3 inflammatory signaling, and YAP/TAZ fibrotic pathways

Article

Author: Moustafa, Passant E. ; Alsugoor, Mahdi H. ; Fayed, Hany M. ; Elmadani, Mevidette ; Hussien, Yosra Assem ; Abdel-Rahman, Rehab F. ; ALSuhaymi, Naif

Kidney damage, often caused by oxidative stress and inflammation, can lead to renal failure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, including Ertugliflozin (Ertu), demonstrate renoprotective effects that may extend beyond glucose control. Our research studied the therapeutic potential and underlying mechanisms of Ertu against subchronic kidney injury in rats induced by TAA, focusing on the integrative crosstalk between oxidative stress, TLR4/STAT3 inflammation, and the YAP/TAZ fibrotic pathway, a previously unexplored axis for SGLT2 inhibitors in nephroprotection. Rats were divided into four groups: control, TAA-induced renal damage, and TAA-induced damage treated with Ertu (5 or 10 mg/kg). We assessed renal function (creatinine, urea), oxidative stress (GSH, MDA, Nrf2), inflammation (IL-1β, TNF-α, TLR4, STAT3/p-STAT3), and fibrosis (YAP1, TAZ, TGF-β1) in serum and renal tissue. Immunohistochemistry was performed to quantify TLR4 and Caspase-1 expression. TAA administration significantly induced renal dysfunction, oxidative stress, and inflammation, evidenced by elevated creatinine, urea, MDA, IL-1β, TNF-α, TLR4, and p-STAT3/STAT3 ratio, alongside depleted GSH and Nrf2. Fibrotic markers (YAP1, TAZ, TGF-β1) were also markedly upregulated. Ertu treatment, particularly at the 10 mg/kg dose, effectively reversed these alterations. It restored antioxidant defenses (GSH, Nrf2), suppressed inflammatory signaling (TLR4/IL-1β/TNF-α), normalized STAT3 activation, and downregulated profibrotic pathways. Histological improvements corroborated these biochemical findings. Ertugliflozin confers significant protection against renal damage caused by TAA by concurrently modulating oxidative stress, inflammation, and fibrotic signaling. These mechanistic findings underscore its potential as a repurposed therapeutic agent for subchronic kidney injury.

01 Jul 2026·AMERICAN JOURNAL OF KIDNEY DISEASES

Association of Ertugliflozin on Kidney Outcomes in People After and Without an Interval Cardiovascular Event: Observations From the VERTIS CV Trial

Article

Author: Pratley, Richard E ; Frederich, Robert ; Cannon, Christopher P ; Masiukiewicz, Urszula ; Cosentino, Francesco ; Cherney, David Z I ; Gantz, Ira ; Cater, Nilo B ; Odutayo, Ayodele ; Liu, Chih-Chin

01 Jul 2026·DIABETES OBESITY & METABOLISM

Drug‐Associated Ketoacidosis: A Comprehensive Disproportionality Analysis Based on the FAERS Database

Article

Author: Chen, Xiaoyu ; Xu, Yinpeng ; Gao, Hongli ; Zhou, Yujie ; Du, Pengqiang

ABSTRACT:

Objective:

Ketoacidosis is a critical adverse event requiring close clinical monitoring. Based on the Adverse Event Reporting System (FAERS) database of the U.S. Food and Drug Administration (FDA), this study aimed to identify the drugs with the closest association and the highest signal strength with the risk of drug‐induced ketoacidosis by performing disproportionality analysis, thereby providing a reference for clinical medication safety.

Methods:

Adverse event data from the first quarter of 2004 to the second quarter of 2025 were retrieved from the FAERS database. Preferred Terms (PTs) related to ‘ketoacidosis’ in the Medical Dictionary for Regulatory Activities (MedDRA) were used as outcome indicators. The generic names of drugs were standardized with reference to the DrugBank database. Disproportionality analysis was conducted using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR) and Information Component (IC) of Bayesian Confidence Propagation Neural Network and the time trend of drug‐induced ketoacidosis was analysed by combining the Time‐to‐Onset (TTO) analysis.

Results:

A total of 22 375 298 adverse event reports were included in this study, among which 6977 were related to ketoacidosis. The top 5 drugs with the highest number of reports were metformin, quetiapine, empagliflozin, canagliflozin and dapagliflozin in sequence; whereas the top 5 drugs with the highest ROR values were dapagliflozin, dapagliflozin‐saxagliptin, ipragliflozin, ertugliflozin‐sitagliptin and empagliflozin. Among the top 50 drugs ranked by ROR, 36 (72%) had no mention of ketoacidosis risk in their package inserts. TTO analysis showed that the incidence frequency of ketoacidosis induced by quetiapine, olanzapine, aripiprazole, pembrolizumab, empagliflozin/linagliptin and nivolumab remained stable with the duration of medication; the incidence frequency induced by tirzepatide and alpelisib increased gradually over time; while that induced by empagliflozin, canagliflozin and other drugs decreased gradually with time.

Conclusion:

The high‐risk drugs for inducing ketoacidosis are mainly sodium‐glucose cotransporter 2 (SGLT2) inhibitors (e.g., dapagliflozin and empagliflozin), followed by psychotropic drugs (e.g., quetiapine). Attention should also be paid to the potential risk of ketoacidosis induced by some drugs that do not mention this adverse reaction in their package inserts. The findings of this study can provide data support for clinical medication monitoring and the revision of drug package inserts.

News (Medical) associated with Ertugliflozin pidolate

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

02 Dec 2024

·www.echemi.com

Layoffs in Pharma Giants: Major Executive Changes at BMS, Merck, Johnson & Johnson

In November, the pharmaceutical industry experienced significant changes in executive personnel, with adjustments at several well-known domestic and international enterprises drawing widespread attention. These changes not only reveal internal strategic adjustments but also signal new trends for the industry's future development. Bristol-Myers Squibb (BMS) recently announced further layoffs as part of its cost-saving strategy. According to the New Jersey Worker Adjustment and Retraining Notification (WARN) document, this round of layoffs affects 195 employees. This is part of BMS's layoff plan in the Lawrenceville area, which follows the announcement in May of a reduction of 963 positions, bringing the total layoffs in the area to 1,329. These measures are crucial to BMS's plan to achieve a cost-saving target of $1.5 billion by the end of 2025. BMS emphasizes that through layoffs and process optimization, the company can allocate resources more effectively and focus on investing in innovative drugs and transformative treatment solutions, aiming to create greater value for patients and shareholders. A company spokesperson noted that BMS is committed to optimizing its operational structure and prioritizing funding for innovative drug development that maximizes patient welfare and shareholder returns. At the same time, it was reported that Merck is also laying off employees in its diabetes business division in China to respond flexibly to market fluctuations and business restructuring needs. This move may relate to the increasingly fierce competition in centralized procurement and generic drugs in the Chinese market. Merck's main products in the diabetes market in China include sitagliptin, sitagliptin/metformin, and ertugliflozin. Although the specific scale of the layoffs has not been publicly disclosed, the market generally believes this is related to intensified price competition under centralized procurement policies. Notably, sitagliptin and its combination formulations have been included in the national centralized procurement list, placing significant pressure on Merck's market share in China. Sales data illustrate the pressure Merck faces. In 2022, sitagliptin and its metformin combination formulations contributed $4.513 billion in sales to Merck; however, by 2023, this total had declined to $3.366 billion. For example, sitagliptin tablets have seen over 30 companies participating in the development and production of generics in the Chinese market, resulting in fierce competition. On November 18, reports emerged that Johnson & Johnson China is undergoing layoffs across multiple product lines, with compensation plans offering "N+1," "N+2," and "N+3" based on years of service. Johnson & Johnson China has yet to officially respond to this news. It is reported that the scale of these layoffs could reach 20% of the total workforce, primarily focused on the surgical department. Some affected employees revealed that layoff notifications were sent via private email, with departure dates set for the end of this year. This round of layoffs may be related to pressures from centralized procurement in surgery and the company's strategic adjustments. Notably, Johnson & Johnson Medical Technology recently announced a major organizational restructuring of its surgical division, which will be reorganized into six major departments starting January 1, 2025. Additionally, the departure of the Senior Director of the MONARCH Surgical Division in China, Chen Xiaoming, further confirms the ongoing changes within the company. In addition to BMS, Merck, and Johnson & Johnson, changes in executive personnel at other domestic pharmaceutical companies continue to attract industry attention, including the resignation of the chairman of Tianjin Pharmaceutical Daren Tang, the appointment of a new chairman at Guangyao Group, the appointment of a new vice president at Health元, the replacement of the general manager at Sinopharm Yisheng, the resignation of a vice president at Kanghua Bio, the replacement of the CEO at Saint No Pharmaceuticals, and the resignation of a director at Zhejiang Zhenyuan. These changes will undoubtedly introduce more uncertainties and observation points for the future development of the pharmaceutical industry.

Executive Change

15 May 2024

·www.biospace.com

BioAge Labs Announces Inaugural Scientific Advisory Board to Support Advancement of Novel Therapeutics Targeting Metabolic Aging

Newly appointed advisors are world-renowned experts in obesity, diabetes, and cardiometabolic diseases, spanning basic biology to late-stage development RICHMOND, Calif.--(BUSINESS WIRE)-- BioAge Labs, Inc. ("BioAge"), a clinical-stage biotechnology company developing therapeutic candidates for metabolic diseases, such as obesity, by targeting the biology of aging, today announced the formation of its Scientific Advisory Board (SAB). The SAB is composed of world-renowned leaders with expertise spanning metabolic disease biology, obesity medicine, and clinical development of blockbuster therapeutics. The SAB will work closely with BioAge's leadership team to advance the company's pipeline of novel treatments for age-related chronic metabolic diseases into mid- and late-stage clinical development. "We are thrilled to be working with this esteemed group of expert scientists and drug developers as we pioneer new approaches to treating age-related metabolic diseases," said Kristen Fortney, Ph.D., co-founder and Chief Executive Officer of BioAge. "Our advisors' wealth of experience across all phases of drug development, from scientific discovery through approval and commercialization, will be instrumental as we advance our lead product candidate into Phase 2 clinical trials for obesity." BioAge's lead product candidate azelaprag is an orally administered agonist of the apelin receptor APJ that has the potential to mimic the effects of exercise. In preclinical studies, azelaprag has demonstrated the ability to significantly increase weight loss while improving body composition and metabolic parameters when administered in combination with GLP-1 receptor agonists. The company plans to initiate a Phase 2 trial in mid-2024 evaluating azelaprag in combination with tirzepatide (Zepbound®) for the treatment of obesity in older adults (link). The members of the BioAge SAB are: Caroline M. Apovian, MD, FACP, FTOS, DABOM, Professor of Medicine at Harvard Medical School and Co-Director of the Center for Weight Management and Wellness (CWMW) at Brigham and Women’s Hospital. A leading expert in clinical management of obesity, Dr. Apovian has co-authored multiple U.S. and international obesity treatment guidelines. She co-founded the American Board of Obesity Medicine and served as President of the Obesity Society from 2017–2018. Cedric Dray, Ph.D., Associate Professor at INSERM and faculty member at the RESTORE Geroscience Center at Université de Toulouse III-Paul Sabatier. Prof. Dray has published multiple papers describing his pioneering work on apelin and is a world expert on the biology of the apelin pathway in aging, muscle physiology, and metabolic disease. The apelin pathway is the target of BioAge’s lead product candidate, azelaprag, expected to enter a Phase 2 trial for obesity starting in mid-2024. William Evans, Ph.D., Adjunct Professor of Human Nutrition at UC Berkeley and Adjunct Professor of Medicine (Geriatrics) at Duke University. As a former VP at GSK, he led the company's Muscle Metabolism Discovery Performance Unit, and has served as an investigator in multiple clinical trials of muscle aging. Dr. Evans was the first to describe sarcopenia, the age-related loss of muscle mass and strength. His research on muscle metabolism, aging, and functional capacity has resulted in more than 350 publications with more than 80,000 citations. Alexander Fleming, M.D., Founder and Executive Chairman of Kinexum, which provides strategic and operational guidance throughout the process of clinical development and drug commercialization. As a supervisory physician at the US FDA from 1986-98, Dr. Fleming led landmark regulatory reviews for first-in-class drugs for diabetes and other metabolic diseases including metformin, statins and insulin analogs. He also heads the not-for-profit Kitalys Institute, founded to catalyze progress in developing drugs and other ways to increase healthy longevity. Narimon Honarpour, M.D., Ph.D., Senior VP and Head of Global Development at Amgen, where he leads a team responsible for shaping program clinical development strategies through deep disease state knowledge and generating clinical trial evidence to enable pipeline progression. Since joining Amgen in 2011, Dr. Honarpour has held diverse roles across both cardiovascular and inflammation therapeutic areas. In 2019, he became head of Translational Medicine, and in his most recent prior role served as VP-Global Development for the General Medicine Therapeutic Area Head and JAPAC Development Head. Tim Rolph, D.Phil., Chief Scientific Officer and Co-Founder of Akero Therapeutics, a company devoted to developing novel therapies for patients with serious metabolic diseases, including efruxifermin, an FGF21 analog, for metabolic dysfunction–associated steatohepatitis (MASH). Previously, as Chief Scientific Officer of Pfizer's Cardiovascular & Metabolic Disease unit, Dr. Rolph oversaw the development of Steglatro (ertugliflozin) for type 2 diabetes and discovery of oral small-molecule GLP1R agonists and inhibitors of PCSK9 and DGAT2. "We are looking forward to working closely with the renowned experts on our SAB to harness the biology of apelin, an exercise mimetic, to improve the lives of patients living with obesity and other metabolic conditions,” said Eric Morgen, MD, co-founder and Chief Operating Officer of BioAge. “We will also leverage their broad expertise in drug development for metabolic diseases to guide the continued advancement of the other programs in our metabolic disease pipeline.” About BioAge Labs, Inc. BioAge is a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. The company’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that promoted metabolism and prevented muscle atrophy on bed rest in a Phase 1b trial. In mid-2024, BioAge plans to initiate a Phase 2 trial of azelaprag in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has the potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge is also developing BGE-100, a structurally novel NLRP3 inhibitor, with plans to IND by the end of 2024. BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, also address key pathways in metabolic aging.

Phase 2Executive ChangePhase 1

100 Deals associated with Ertugliflozin pidolate

External Link

KEGG	Wiki	ATC	Drug Bank
D10313 D11043	Ertugliflozin pidolate	A10BK04	DB11827

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	United States	Merck Sharp & Dohme Corp.	19 Dec 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Functional Mitral Regurgitation	Phase 3	South Korea	Merck Sharp & Dohme Corp.	04 Nov 2020
Left ventricular systolic dysfunction	Phase 3	South Korea	Merck Sharp & Dohme Corp.	04 Nov 2020
Mitral Valve Insufficiency	Phase 3	South Korea	Merck Sharp & Dohme Corp.	04 Nov 2020
Heart Failure	Phase 3	South Korea	MSD Korea Co., Ltd.	01 Jun 2019
Vascular Diseases	Phase 3	-	Pfizer Inc.	04 Nov 2013
Vascular Diseases	Phase 3	-	Merck Sharp & Dohme LLC	04 Nov 2013
Chronic heart failure	Phase 2	United States	Merck Sharp & Dohme Corp.	10 Mar 2021
Hypertension	Phase 2	-	Pfizer Inc.	17 May 2010
Hypertension	Phase 2	-	Merck Sharp & Dohme LLC	17 May 2010
Atherosclerosis	Phase 1	United States	Merck Sharp & Dohme Corp.	01 Jul 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04167761 (CTgov)	Early Phase 1	Diabetes Mellitus, Type 2 \| Insulin Resistance \| Atherosclerosis	61	Ertugliflozin	lsxflwdytn(nmvhnnqucm) = vlhvntvspi igvgccbhxe (pbyalugjkr, 10) View more	-	04 Jun 2026
NCT05727579 (DESIGN, CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Diabetic Nephropathies \| Hypertension	41	Salt-Diet and/or Ertugliflozin (High-sodium Diet; Placebo)	bllhohnyhu(jktvohbiyd) = kednbhcmwg rskvcgoqxa (zgqencgxgc, 13) View more	-	15 Apr 2026
				Salt-Diet and/or Ertugliflozin+Ertugliflozin 15 mg (High-sodium Diet; Ertugliflozin 15 mg Once Daily)	bllhohnyhu(jktvohbiyd) = gygwftxswc rskvcgoqxa (zgqencgxgc, 12.3) View more
NCT04029480 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	166	Placebo to ertugliflozin 5 mg+Insulin+Metformin	hcsftzgwex(ovsmnxlutx) = ociurasgwz texhgtwbcn (jfqpaayfjt, yxcedgkjmn - chvhknxocm) View more	-	31 Oct 2025
NCT04600921 (ERASE, CTgov)	Phase 3	Arrhythmias, Cardiac \| Heart failure with reduced ejection fraction \| Heart failure with mid range ejection fraction ... View more	55	Ertugliflozin 5 mg (Ertugliflozin)	kdyxzpvtuh(rxsrnhwjpu) = cppmtdjues zgnyapnybr (gkqqwpbrnw, 6) View more	-	03 Jun 2025
				Placebo 5mg (Placebo)	kdyxzpvtuh(rxsrnhwjpu) = yngkmmyqpl zgnyapnybr (gkqqwpbrnw, 34) View more
NCT03416270 (ERADICATE-HF, CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Heart Failure	34	Ertugliflozin (Ertuglifozin Treatment Arm)	gppwenzcxd(dadfezbapn) = jkajpocscm mjxobcfqcf (pqvgmcevpm, 6.9) View more	-	06 May 2025
				Placebo (Placebo Arm)	gppwenzcxd(dadfezbapn) = zpsljmdpoe mjxobcfqcf (pqvgmcevpm, 16.8) View more
NCT04231331 (EFFORT \| EFFORT Trial, CTgov)	Phase 3	Left ventricular systolic dysfunction \| Functional Mitral Regurgitation \| Mitral Valve Insufficiency	128	Placebo (Placebo)	nzadjlxjxs(azeraqgmry) = krqslxynzh rybypaukrs (zwlsocgqfp, 0.12) View more	-	06 Jan 2025
				Ertugliflozin (Ertugliflozin)	nzadjlxjxs(azeraqgmry) = xmnwjzlybe rybypaukrs (zwlsocgqfp, 0.06) View more
NCT03717194 (ERTU-GLS, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Heart Failure	102	Placebo	kgdrcxacji(fhcohofxdk) = bxuabtykaf xegpbizonj (qpdxbxxaah, 2.6) View more	-	20 Nov 2024
NCT04231331 (EFFORT Trial, Pubmed \| Circulation)	Phase 3	Functional Mitral Regurgitation	128	Ertugliflozin	gwhoyqldtm(cxyciojmvu) = Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group zcgnidppmd (fslllbmqfq )	Positive	11 Jun 2024
				Placebo
NCT04071626 (EMMED-HF, CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Heart Failure, Diastolic	9	Ertugliflozin 5 mg (Ertugliflozin Treatment Arm)	anbyydtazr(hhuarcgvvj) = cugbnjzdty zrqsnckdaa (qsrqixgkky, 1.13) View more	-	13 Dec 2023
				Placebo oral tablet (Placebo)	anbyydtazr(hhuarcgvvj) = bxdvdfsyzj zrqsnckdaa (qsrqixgkky, 1.23) View more
NCT02033889 \| NCT02630706 (8835-012 \| MK-8835-012, Pubmed \| Diabetes Ther)	Phase 3	Overweight \| Obesity	445	Ertugliflozin 5 mg	bbhqubbxnw(twmxpyojmv) = pzwdfpzuth qaxqjgrkti (acertkmbqi ) View more	-	03 Feb 2023
				Ertugliflozin 15 mg	bbhqubbxnw(twmxpyojmv) = oguopripll qaxqjgrkti (acertkmbqi ) View more

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