Pfizer nash clinical trial Jun 24, 2023 · In a phase 2, randomized clinical trial in patients with severe hypertriglyceridemia, pegozafermin, a long-acting analog of human fibroblast growth factor 21, was safe and met the primary endpoint 3 days ago · Pfizer Inc. Phase 3: Product Enhancement. 13, 16, 17, 18 It entered several phase 2 trials in individuals with NAFLD, NASH, type 2 diabetes, obesity and hereditary fructose intolerance (ClinicalTrials Apr 12, 2019 · FOSTER CITY, Calif. About Pfizer; If endpoints in NASH trials are to be defined histologically, as is currently the case, 2 × 2 factorial designs would be a very high bar to clear in a phase III registrational trial. Pfizer Announces Clinical Development Agreement with Novartis to Advance the Treatment of NASH Sunday, October 28, 2018 - 10:15pm Joint studies will evaluate one or more of Pfizer’s investigational NASH therapies in combination with Novartis’s FXR agonist for the treatment of the progressive liver disease May 1, 2023 · Design, setting, and participants: A phase 2b, double-blind, placebo-controlled, parallel-group, 6-group randomized clinical trial with 16-week double-blind treatment period and 4-week follow-up was conducted from July 7, 2020, to July 7, 2021. 1038/s41591-021-01489-1. Dec 7, 2020 · In collaboration with Pfizer, Novartis is in Phase 1 trials evaluating combining Tropifexor with one or more of Pfizer’s ACC inhibitor (PF-05221304), DGAT2 inhibitor (PF-06865571), and a KHK inhibitor (PF-06835919). The commencement of patient enrollment this early is a good sign for Durect. And NASH treatments can’t come soon enough: By 2020, NASH is expected to be the leading cause of liver transplants in developed countries. Aug 1, 2023 · The U. 92 billion in 2024 and is projected to grow at a CAGR of 6. 12, 2019-- Gilead Sciences, Inc. All Pfizer-sponsored interventional studies must be responsive to the healthcare environment of the country or countries where the research is conducted. Ervogastat i … Nov 27, 2019 · Back in early 2018, Pfizer axed a phase 1 drug in nonalcoholic steatohepatitis (NASH), or fatty liver disease. Reducing the amount of fat in the liver may help control or Mar 14, 2024 · A long-standing challenge for the NASH field is the need to diagnose and track the disease in clinical trials by liver biopsy, an invasive procedure that hampers trial recruitment. Pfizer said the study is expected to be completed in 2024, with results Pfizer’s competitive grant program involves a publicly posted Request for Proposal (RFP) that provides detail regarding a specific area of interest and sets timelines for review and approval. Researchers are looking for treatments for patients with NASH because there are none at the moment. 4 million in 2025 Jan 31, 2023 · 1. May 26, 2022 · Pfizer is currently studying ervogastat/clesacostat in an ongoing Phase 2 clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis (NCT04321031), expected to complete in 2024. Novartis has a May 30, 2022 · 目前， 尚无获美国fda和欧盟ema批准治疗nash的药物。 二酰甘油O-酰基转移酶2（DGAT2）和乙酰辅酶A羧化酶（ACC）是调节脂质代谢的2种关键酶 。 Apr 26, 2025 · NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. S. 2, [iv] Risk factors, such as obesity, type 2 diabetes, insulin resistance, metabolic syndrome, and a genetic predisposition, can lead to metabolic changes in the liver, causing excessive fat accumulation and Apr 13, 2023 · The first pivotal clinical trial, PIVENS, was a phase 3 clinical trial evaluating the efficacy of naturally occurring vitamin E vs pioglitazone vs placebo in the primary outcome of NASH and fibrosis improvement in patients with NASH without type 2 diabetes mellitus (DM2). But the company's scientists remained interested in the drug's mechanism of action that affect millions of people—including diseases like NASH. Pfizer retains ex-US and Japan commercialization rights. Dermatomyositis, Polymyositis (Biologic) (ORPHAN - The NASH Clinical Trial Design International Working Group members disclose the following: Quentin M. 8 This gene gives cells instructions for making adiponutrin, a protein found in liver cells and fat cells. Mar 28, 2019 · An experimental Pfizer drug has scored positive data in a mid-stage clinical trial of patients with fatty liver disease, a precursor condition to the now intensely studied non-alcoholic steatohepatitis, or NASH. have appeared. With a view to expanding the transparency of our pipeline, Pfizer is including new indications or enhancements, which target unmet medical need or represent significant Jan 31, 2024 · JAK3/TEC inhibitor: Vitiligo. (NASDAQ: GILD) and Novo Nordisk A/S (NASDAQ Copenhagen: NOVO B) today announced that the companies intend to collaborate on a clinical trial combining compounds from their respective pipelines in nonalcoholic steatohepatitis (NASH). 1 Individuals with severe hypertriglyceridemia (SHTG) have triglyceride levels more than three times the normal level. As NASH progresses, it may cause increasing scarring of the liver. Pfizer ran a series of phase 1 and 2 clinical trials of PF-06835919 between 2016 and 2021, and included the asset in Nov 24, 2022 · Discovery efforts leading to the identification of ervogastat (PF-06865571), a systemically acting diacylglycerol acyltransferase (DGAT2) inhibitor that has advanced into clinical trials for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis, are described herein. Jun 26, 2023 · completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to ACC inhibitor alone or co-administered with a DGAT2 inhibitor in patients with non-alcoholic fatty liver disease: two parallel, placebo-controlled, randomized phase 2a trials Nat Med . PF-07853578 is under development for the treatment of non-alcoholic steatohepatitis (NASH). The C C chemokine receptor types 2 (CCR2) and 5 (CCR5) and their respective ligands (CCL2 and CCL3–5) are involved in the pathogenesis of liver inflammation and fibrosis, contributing to the development of NAFLD and NASH [[15], [16], [17]]. It acts by modulating PNPLA3. Here, we investigate DGAT2 as a potential therapeutic target using an orally administered, selective DGAT2 inhibitor, … Jan 9, 2025 · Such a milieu allows for more investments in NASH clinical trials, creating an environment for innovative therapies that can bring treatment solutions for this unmet need one-step closer to full potential. PF-07853578 overview. Jul 24, 2024 · (Clinical Trial Identifier: NCT03248882). Clinical trials for NASH have also likely grown due to newer and better imaging modalities, which can be Oct 29, 2018 · Agreement includes a clinical trial to evaluate a combination of tropifexor (LJN452) and one or more Pfizer compounds for the treatment of non-alcoholic steatohepatitis (NASH) Novartis has a leading development portfolio in non-viral liver diseases, including NASH Mar 30, 2022 · Introduction: Small molecule inhibitors of the terminal step in intrahepatic triglyceride synthesis (diacylglycerol acyltransferase 2 inhibitor (DGAT2i, PF-06865571, ervogastat)) and upstream blockade of de novo lipogenesis via acetyl-coenzyme A carboxylase inhibitor (ACCi, PF-05221304, clesacostat) showed promise in reducing hepatic steatosis in early clinical trials. Search for terms serious type of NAFLD is called non-alcoholic steatohepatitis, or NASH. As research advances and more information about the disease becomes available, more companies will likely begin vying for their spots in the potentially All Pfizer-sponsored interventional studies are conducted in accordance with the principles and procedures described in the Pfizer Human Research Protection Program (HRPP). Key NASH Clinical Trials Market Players and Concentration. The global non-alcoholic steatohepatitis clinical trials market was estimated at USD 2. 26% from 2025 to 2030 The modern prescription medicines and vaccines we have today were studied in hundreds, and often thousands, of people in clinical trials. 1 billion by 2030. The results of this study, which also includes arms investigating ervogastat as monotherapy, will inform a potential Phase The Phase 3 clinical trial was designed to determine if the Pfizer-BioNTech COVID-19 vaccine is safe and effective in preventing COVID-19 disease. NASH . There is a mounting need to develop biomarkers of diagnosis, prognosis and treatment response that can effectively replace curr … no Worsening of NASH at Week 36 Key Secondary Efficacy Endpoints • NASH Resolution • Fibrosis Markers • Lipoproteins • Glycemic Control • Weight Change • Liver Injury Markers EFX 50mg 1 All patients had biopsy -proven compensated cirrhosis (fibrosis stage 4) due to definitive NASH or cryptogenic cirrhosis pres umed secondary to NASH. If you’d like to stay informed about Pfizer clinical trials and other research opportunities, consider joining PfizerConnect. “NASH is a priority therapeutic area for Pfizer due to the substantial global unmet medical need it May 12, 2021 · Diversity in clinical trials is key to equitable health outcomes. Assessments of biop- NASH and Genetics. Pfizer is interested in partnering to develop therapeutics, expand our understanding of disease biology, and identify biomarkers that can help us impact: We would like to show you a description here but the site won’t allow us. Despite its high prevalence, no drugs are currently approved for the treatment of NASH. Jul 24, 2024 · Patient cohort and study design. (NYSE: PFE) today announced results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). Metabolic Interventions to Resolve NASH with fibrosis (MIRNA, NCT04321031) is a phase II, randomised, placebo-controlled, dose-ranging, dose-finding study that assesses the efficacy and safety of an investigational, orally administered DGAT2i and DGAT2i+ACCi in adults with biopsy-confirmed NASH and liver fibrosis stage 2 or 3, as defined using Sep 19, 2018 · Pfizer is now playing catch up with its NASH franchise pipeline with anti-NASH drug candidates, an acetyl-CoA carboxylase inhibitor and a ketohexokinase inhibitor, currently in Phase 2a trials Feb 8, 2022 · In these materials, Pfizer discloses Mechanism of Action (MOA) information for some candidates in Phase 1 and for all candidates from Phase 2 through regulatory approval. 1 billion by 2030, likely due to rising healthcare expenditure, cases of obesity and the prevalence of NASH in the population. The trial will measure Metabolic Interventions to Resolve NASH with fibrosis (MIRNA, NCT04321031) is a phase II, randomised, placebo-controlled, dose-ranging, dose-finding study that assesses the efficacy and safety of an investigational, orally administered DGAT2i and DGAT2i+ACCi in adults with biopsy-confirmed NASH and liver fibrosis stage 2 or 3, as defined using For more information about participation in a Pfizer clinical trial, please email or call the Pfizer Clinical Trial Contact Center at 1-800-887-7002. Mar 25, 2025 · The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). Elsewhere in its quarterly update, Pfizer shared details of the progress of the protease inhibitors under development for COVID-19. (NCT04321031) May 26, 2022 · Pfizer is currently studying ervogastat/clesacostat in an ongoing Phase 2 clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis (NCT04321031), expected to complete in 2024. , research, quality improvement, or education) to improve patient outcomes in areas of unmet medical need that are aligned with Pfizer’s medical and/or scientific strategies. The results of this study, which also includes arms investigating ervogastat as monotherapy, will inform a potential Phase See full list on clinicaltrialsarena. Hypertriglyceridemia is a common condition characterized by high levels of triglycerides, a type of fat, in the bloodstream. The drug development pipeline in NASH is very active, yet most FDA Efficacy Endpoints for Phase 3 Trials: Liver Histologic Improvement NASH Resolution • Resolution of steatohepatitis on overall histopathologic reading and • No worsening of liver fibrosis Fibrosis Improvement Improvement ≥ 1 fibrosis stage and No worsening of steatohepatitis US FDA. Jul 24, 2024 · Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH) are major metabolic diseases with increasing global prevalence and no approved therapies. M. The results of this study, which also In these materials, Pfizer discloses Mechanism of Action (MOA) information for some candidates in Phase 1 and for all candidates from Phase 2 through regulatory approval. With a vie w to expanding the transparency of our pipeline, Pfizer is including new indications or enhancements, which target unmet medical need or represent significant Objective: Recent studies suggest that excess dietary fructose contributes to metabolic dysfunction by promoting insulin resistance, de novo lipogenesis (DNL), and hepatic steatosis, thereby increasing the risk of obesity, type 2 diabetes (T2D), non-alcoholic steatohepatitis (NASH), and related comorbidities. H. (FLINT and PIVENS trials) cohorts of biopsy-proven NASH patients 11. Web of Science May 26, 2022 · A recent report by Vision Research Reports states that the NASH clinical trials market size is predicted to hit $4. (NYSE: PFE) today announced it has entered into an exclusive global, ex-China, licensing agreement with 3SBio, Inc. As of January 2024, Table 1 summarizes the clinical trials and non-clinical trials registered in Clinical Trials gov. Go to PfizerClinicalTrials. Etrasimod in Crohn’s disease is a Ph2/3 clinical trial Oct 31, 2023 · S1P inhibitor: Atopic Dermatitis. Jul 26, 2024 · Pfizer Inc. com Jul 28, 2021 · Pfizer expects to move an intravenous drug, PF-07304814, into a phase 2/3 clinical trial in hospitalized patients in the third quarter. Clinical trial to be conducted by Philogen S. Learn more about the process of joining a clinical trial and find a trial near you. Dermatomyositis, Polymyositis (Biologic) (ORPHAN - Feb 2, 2025 · Liraglutide, the first GLP-1 agonist in Japan, was launched on the market in 2010, and since then Exenatide, Lixisenatide, etc. Medicine(s) Studied:PF-06835919 Protocol Number:C1061011 Dates of Study: 18 July 2019 to 30 March 2021 Title of this Study:A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type2Diabetes Mellitus [A Phase 2a, Randomized, Double-Blind, May 23, 2023 · In March 2023, PathAI announced its partnership with GSK (LSE/NYSE: GSK) on HORIZON, a randomized Phase 2b non-alcoholic steatohepatitis (NASH) clinical trial (NCT05583344). 20 It may be that a longer duration of The U. announced additional follow -up results from the Phase 3 EV -302 clinical trial (also known as KEY NOTE-A39) evaluating the efficacy and safety of PADCEV ® (enfortumab vedotin-ejfv), a Nectin -4 directed antibody -drug conjugate, plus KEYTRUDA® (pembrolizumab), a PD -1 inhibitor, in patients with previously Mar 25, 2025 · And while there are no approved drug regimens to treat NASH, the clinical trial pipeline is very active, with several agents in phase 3 trials. Patients who have NASH have an increased risk of severe liver damage and death. , Vice President of Discovery & Development, Internal Medicine Research Unit, Pfizer, who is expected to join Akero’s newly formed Scientific Advisory Board. The drugmaker tested single and repeat doses of the DGAT2 inhibitor in 12 healthy volunteers last year, enrolling far Jun 16, 2022 · In fact, analysts predict that the clinical trials market in NASH will be valued at $4. Disease Education Information. This transcript may contain forward-looking statements about, among other things, our anticipated operating and financial performance, business plans and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, post-approval clinical Mar 29, 2019 · Last year, Pfizer and Novartis announced their collaboration on a combo therapy for NASH, using Novartis’ tropifexor and Pfizer inhibitors. Although the authors comprehensively assessed the current knowledge and evidence about the impact of NASH on PROs and highlighted the importance of developing and implementing NASH-specific PRO instruments in research Oct 29, 2018 · Agreement includes a clinical trial to evaluate a combination of tropifexor (LJN452) and one or more Pfizer compounds for the treatment of non-alcoholic steatohepatitis (NASH). 2 and Pfizer Global Medical Grants (GMG) supports the global healthcare community’s independent initiatives (e. Jul 19, 2022 · In most clinical trials focusing on precirrhotic nonalcoholic steatohepatitis (NASH), a liver biopsy is required for confirmation of diagnosis, staging fibrosis, and grading steatohepat Best Practices in Liver Biopsy Histologic Assessment for Nonalcoholic Steatohepatitis Clinical Trials: Expert Opinion - Filozof - 2022 - GastroHep - Wiley The Next Era of Decentralized Clinical Trials: The Clinical Trial Anywhere Model About Pfizer's initiative to make clinical trials more participant-friendly through the decentralized "Clinical Trial Anywhere" model; a suite of solutions like remote sample collection, alternative study conduct locations, home health, and mobile units to reduce the need for in-person visits. (01530. Jul 26, 2024 · Pfizer will layoff about 210 workers in eastern North Carolina where it has two large facilities that employ thousands of people, according to paperwork filed with the state. Jun 24, 2023 · The 24-week, randomized clinical trial involved 222 participants with NASH assigned to either receive the drug or a placebo. Mar 28, 2025 · Forward-Looking Statements of Pfizer Inc. Given the high prevalence and deadly Jun 24, 2023 · Sanyal AJ, Loomba R, Anstee QM, et al. Tier 1 companies are the industry leaders with 56. Dec 1, 2023 · This release contains forward-looking information about topline data from the Phase 2b clinical trial investigating Pfizer’s oral Glucagon-like peptide-1 receptor agonist candidate, danuglipron, in adults with obesity and without Type 2 diabetes, Pfizer’s plans to not advance the twice-daily danuglipron formulation into Phase 3 studies at Oct 11, 2021 · Data may be requested from Pfizer trials 24 months after study completion. With a view to expanding the transparency of our pipeline, Pfizer is including new indications or enhancements, which target unmet medical need or represent significant Aug 5, 2021 · Both projects originated at Pfizer and were scheduled to finish this year. & BAGSVÆRD, Denmark--(BUSINESS WIRE)--Apr. May 26, 2022. Clinical trials for NASH have also likely grown due to newer and better imaging modalities, which can be become a clinical trial site with pfizer Clinical trials depend on the experience of healthcare professionals who have dedicated themselves to clinical research. Sponsor: Pfizer, Inc. Jul 1, 2023 · With an estimated worldwide prevalence of at least 25%, nonalcoholic fatty liver disease (NAFLD) is a fast-growing epidemic and public health concern, highly associated with the obesity and diabetes epidemics. “EFX has quickly emerged as a promising potential NASH therapy, with a strong record of clinical trial data,” said Jeff Pfefferkorn, Ph. It is administered by oral route in the form of solution or suspension. , vice president of discovery and development in the internal medicine research unit at Pfizer, noted that efruxifermin (EFX) has emerged as a promising potential NASH therapy based on its clinical trial data. ), the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne (Q. & Loomba, R. . 1, 2 NAFLD may progress to its most advanced form, nonalcoholic steatohepatitis (NASH), which is characterized by inflammation and hepatocellular damage due to the accumulation of Jan 13, 2025 · The global Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Market is set to experience significant growth over the next decade, with an estimated value of USD 2,964. One might do it for science. Noninvasive, quantitative assessment of liver fat by MRI–PDFF as an endpoint in NASH Jun 25, 2018 · RELATED: Regeneron, Alnylam to take on NASH in discovery deal Rolph previously worked on FGF21 at Pfizer. Registration After Phase 3, if the clinical trial data supports it, an extensive data package is submitted to the U. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Minimizing variability and increasing concordance for NASH histological scoring in NASH clinical trials. ), and the National Jan 1, 2023 · Ervogastat (PF-06865571; Pfizer Inc) is a potent and selective oral, small-molecule DGAT2i being developed for the treatment of NASH with liver fibrosis and currently being evaluated in an ongoing Phase II study. plans to lay off at least 210 workers in Lee and Nash counties following a failed clinical trial for a muscular dystrophy treatment that was being developed by the global drugmaker Jan 20, 2025 · Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. 2021 Oct;27(10):1836-1848. No clinically approved drugs are available. May 27, 2022 · Pfizer has obtained Fast Track designation from the US Food and Drug Administration (FDA) for its investigational combination therapy, ervogastat (PF-06865571) and clesacostat (PF-05221304), to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. Serum samples for this retrospective analysis were sourced from a Phase 2a clinical trial investigating liver-directed ACC1 inhibition by QD dosing of PF-05221304 (clesacostat) in adults with NASH and/or NAFLD (NCT03248882) 20. A. g. FDA Efficacy Endpoints for Phase 3 Trials: Liver Histologic Improvement NASH Resolution • Resolution of steatohepatitis on overall histopathologic reading and • No worsening of liver fibrosis Fibrosis Improvement Improvement ≥ 1 fibrosis stage and No worsening of steatohepatitis US FDA. Hepatology 2021;74:968A-968A. Research has identified gene changes that might play a role, including a certain variation in the PNPLA3 gene. Adults with T2D inadequately controlled by diet and exercise, with or without metformin treatment May 26, 2022 · Pfizer granted FDA Fast Track designation for ervogastat/clesacostat combination for the treatment of non-alcoholic steatohepatitis (NASH). If you consider joining a clinical trial, these details will be explained to you as part of the informed consent process. HK), a leading Chinese biopharmaceutical company, for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer There is currently no FDA-approved medicine for NASH, but nearly 50 candidates, including three from Pfizer, are in clinical testing — one or more which will hopefully be the next breakthrough medicine. Drug development status for NASH related to GLP-1 This release contains forward-looking information about Pfizer’s investigational programs in non-alcoholic steatohepatitis (NASH) and a non-exclusive clinical development agreement with Novartis to investigate one or more combination therapies for the treatment of NASH, including their potential benefits, that involves substantial risks and This 2016 “heat map” from the CDC shows the prevalence of obesity across states and territories. ” Pfizer is currently studying ervogastat/clesacostat in an ongoing Phase 2 clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis (NCT04321031), expected to complete in 2024. In this minireview, we discuss the heterogeneous nature of NASH and lack of consensus in outcome measures among clinical trials. Immune Thrombocytopenic Purpura (Biologic) Phase 2. This curriculum will emphasize the importance of risk factor detection and early detection, diagnosis, and treatment -- through either regression or preventing progression of disease -- as means to Jan 30, 2024 · JAK3/TEC inhibitor: Vitiligo. Increasingly, clinicians, researchers and patients are realizing that a lack of diversity in clinical trial participants may contribute to the stubborn persistence of health disparities, such as the fact that Black Americans are 30% more likely than whites to die prematurely of heart disease. The trial tested two doses of the drug. 5 days ago · Inventiva’s lanifibranor has been tipped to become a blockbuster in the fatty liver disease non-alcoholic steatohepatitis (NASH) after it became the first drug to hit two regulatory goals in a Jun 5, 2023 · Nonalcoholic steatohepatitis (NASH) is a chronic liver disease affecting a large population worldwide. Mar 29, 2019 · Last year, Pfizer and Novartis announced their collaboration on a combo therapy for NASH, using Novartis’ tropifexor and Pfizer inhibitors. Exploring NASH - Nonalcoholic Fatty Liver Disease. A 2. Nonalcoholic steatohepatitis, or NASH,is liver damage caused by inflammation of the liver and the buildup of fat in the liver (“fatty liver disease”). Dazukibart (PF-06823859) interferon, beta 1, fibroblast (IFNB1) blocker. Food and Drug Administration (FDA) approved PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVD -19 in adults who Feb 7, 2024 · From the University of Oxford, Oxford (S. Nov 13, 2020 · The sample size was reduced during the trial on the basis of emerging placebo response data from other NASH trials. B. We compare the efficacy of 33 published clinical trials that . Of the patients who received the drug at a higher dose, approximately 27% showed an improvement in liver fibrosis, relative to 7% of the patients who received the placebo. Because of the connection between excess weight and fatty liver disease, Neeta Amin’s NASH study was centered in the deep south, where 35 percent or more of adults identified themselves as obese. Development of PF -06480605 (now RVT-3101) licensed to subsidiary of Roivant Sciences. Nov 1, 2022 · Pfizer has also given the heave-ho to PF-07202954 in NASH with liver fibrosis. PF-06835919 (1, Figure 1), developed by Pfizer, is the most advanced clinical KHK inhibitor, and was found to be generally safe and well-tolerated at all tested doses. Apr 29, 2025 · Pfizer and Astellas Pharma Inc. Refer to Appendix 1. Food and Drug Administration (FDA) approved PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVD -19 in adults who Nov 27, 2019 · Nonalcoholic steatohepatitis (NASH) is characterized by the accumulation of hepatocyte triglycerides, the synthesis of which is catalyzed by diacylglycerol acyltransferases (DGATs). Jun 24, 2023 · trials involving patients with NASH,20,21 a con-sensus scoring method that involved a central panel of three pathologists replaced the original biopsy-reading approach. , 1 which explored patient-reported outcomes (PROs) in non-alcoholic steatohepatitis (NASH) populations. This scarring of the liveris knownas cirrhosis. D. 3. 21 The Swiss giant is focusing its efforts on the FXR-agonist program and recently made headlines by offloading its FGF21 early-stage trials, but ph2b requires liver biopsy data to progress to ph3. If the current registrational framework persists, phase III combinatorial trials may only become feasible if non-invasive assessment of disease becomes acceptable. Organizations are invited to submit an application addressing the specific gaps in research, practice or care as outlined in the specific RFP. injects $3B-plus into COVID-19 research to Apr 12, 2023 · Nonalcoholic fatty liver disease consists of a spectrum starting from nonalcoholic fatty liver disease that may progress to nonalcoholic steatohepatitis (NASH), which can lead to fibrosis, cirrhosis, hepatocellular carcinoma, or even liver failure. 2 SHTG can lead to multiple serious conditions, including cardiovascular disease (CVD) and acute pancreatitis. 3% of the global industry. Noncirrhotic NASH With Liver Fibrosis. This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on May 26, 2022 · A phase 2 trial of the combo is ongoing to evaluate its effect on the resolution of NASH or improvement in liver fibrosis. 9 Scientists believe that a particular change in the PNPLA3 gene could cause increased fat production and Apr 29, 2025 · This phase usually signifies when an investigational medicine or vaccine may be two to three years from approval, subject to clinical trial and regulatory success. Non-alcoholic steatohepatitis (NASH) is a progressive form of the disease that can lead to severe complications such as cirrhosis and hepatocellular carcinoma. doi: 10. The intended Jun 5, 2023 · Pharma giants like Pfizer and Regeneron get a lot of attention in the space, but other companies, like Intercept Pharmaceuticals and GENFIT, also have drugs in Phase III trials targeting NASH. Another one, for hope. They include: the length of the clinical trial Jul 28, 2022 · In these materials, Pfizer disclose s Mechanism of Action (MOA) information for some candidates in Phase 1 and for all candidates from Phase 2 through regulatory approval. This Clinical Trials Day, we recognize all of the clinical research professionals and trial volunteers — the people who help power scientific breakthroughs & move progress in medicine forward. News release. Draft Guidance. May 26, 2022 · A recent report by Vision Research Reports states that the NASH clinical trials market size is predicted to hit $4. ’ A protocol is a detailed plan that explains the purpose of the clinical trial and how it will be run. May 26, 2022 · Pfizer is currently studying ervogastat/clesacostat in an ongoing Phase 2 clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis as assessed by liver biopsy and expects the study to be complete in 2024, the Pfizer statement says. Long-term clinical outcomes needed for full approval • Placebo response: Unusually high, variable placebo response observed in NASH trials, obscuring observed effect of therapeutic interventions • Trial duration: Must consider drug’s MoA, chosen endpoints 4 days ago · The Next Era of Decentralized Clinical Trials: The Clinical Trial Anywhere Model About Pfizer's initiative to make clinical trials more participant-friendly through the decentralized "Clinical Trial Anywhere" model; a suite of solutions like remote sample collection, alternative study conduct locations, home health, and mobile units to reduce Oct 22, 2024 · Pfizer scientists are eager to work with world-class partners who share our mission to develop novel and differentiated medicines to improve the lives of patients suffering from CVD. Phase 2: Product Enhancement. Matthew Hoare, University of Cambridge ; Laura Calabresi, Università degli Studi di Milano Non-Alcoholic Steatohepatitis (NASH) with Liver Fibrosis Phase 2 New Molecular Entity PF-05221304 + PF-06865571 Acetyl CoA-Carboxylase (ACC) Inhibitor; Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor Combination for Non-Alcoholic Steatohepatitis (NASH) with Liver Fibrosis Phase 2 New Molecular Entity PF-06865571 Mar 16, 2023 · The treatment duration of 48 weeks used in the current study is in line with other phase 2b and 3 trials in patients with NASH and compensated cirrhosis. abstract. The first pivotal clinical trial, PIVENS, was a phase 3 clinical trial evaluating the efficacy of naturally occurring vitamin E vs pioglitazone vs placebo in the primary outcome of NASH and fibrosis improvement in patients with NASH without type 2 diabetes mellitus (DM2). This trial began July 27, 2020, and completed enrollment of 46,331 participants in January 2021. The final sample size was based on the assumption that 14% of the patients in NASH develops in about 20% of NAFLD patients when excess of liver fat is accompanied by cell ballooning, inflammation and cell damage. A common complication of cirrhosis is hepatocellular carcinoma orliver cancer. Pfizer is proud to partner with over 6,000 investigators and site staff to conduct our clinical trials around the world. Pfizer expects to move an intravenous drug, PF-07304814, into a phase 2/3 clinical trial in hospitalized patients in the third quarter. 29,30 However, this is a shorter duration than the 72-week treatment period used in the phase 2 trial of semaglutide in patients with NASH and F1–3. Genetics seem to contribute to NAFLD and NASH. Pfizer’s Jeff Pfefferkorn, Ph. Whatever your reason, we want to make it easy for you to get connected with Pfizer. Nov 1, 2024 · Three compounds that target KHK have entered clinical trials to date. Sep 15, 2020 · Company has 89 pipeline projects spread across 6 targeted therapeutic areas with 4 programs in registration and 23 in Phase 3 27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame Pipeline contributes to the Company’s expectation of at least 6% revenue CAGR over the next five years – and delivery of longer Clinical Trials Your participation in a clinical trial can make a world of difference. New Molecular Entity Nov 25, 2020 · Increased fructose consumption and its subsequent metabolism have been implicated in metabolic disorders such as nonalcoholic fatty liver disease and steatohepatitis (NAFLD/NASH) and insulin resistance. com Details We would like to show you a description here but the site won’t allow us. What is NASH?Did you know that you can get liver disease even if you don’t drink alcohol? Nonalcoholic fatty liver disease (or NAFLD) is a condition in which fat builds up in the liver. What happens in a clinical trial depends on the ‘protocol. PF-06835375: anti-CXCR5. The manufacturing operation closures have already Glossary. Ketohexokinase (KHK) converts fructose to fructose-1-phosphate (F1P) in the first step of the met … Jul 28, 2022 · It’s not the first NASH drug to be culled from Pfizer’s pipeline, either. Some might do it for their families, or for the next generation. Pfizer will layoff 60 workers at its Rocky Mount facility in Nash County and 150 at its Sanford facility in Lee County. 63 In biochemical assays, ervogastat inhibited human and rat DGAT2 with a half maximal inhibitory concentration (IC 50) of 17. Nov 22, 2021 · The NASH Clinical Trial Design International Working Group members disclose the following: Quentin M. Pfizer will provide additional data that supports the findings of this study One might do it for science. 1 After all, if a clinical trial for We would like to show you a description here but the site won’t allow us. p. Sirlin, C. Currently, Novartis has two phase II clinical trials recruiting NASH patients: TANDEM and FLIGHT-FXR. RELATED: U. Jun 16, 2022 · “EFX has quickly emerged as a promising potential NASH therapy, with a strong record of clinical trial data,” said Jeff Pfefferkorn, Ph. We summarize NASH therapeutic targets and candidate drugs. Sep 15, 2020 · Company has 89 pipeline projects spread across 6 targeted therapeutic areas with 4 programs in registration and 23 in Phase 3 27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame Pipeline contributes to the Company’s expectation of at least 6% revenue CAGR over the next five years – and delivery of longer Non-alcoholic fatty liver disease is a condition that affects 25% of the population. Feb 2, 2023 · Lilly’s retreat from KHK inhibition leaves the future of the target in doubt. Food and Drug Administration (FDA) and other regulatory Breakthroughs are powered by purpose. Anstee is supported by the Newcastle NIHR Biomedical Research Centre and the Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) consortium, which has received funding from the Innovative Medicines Initiative Program of the European Union under grant agreement 777377; this Jun 16, 2022 · Pfizer’s Jeff Pfefferkorn, Ph. Table 1. The prevalence of NASH has increased in parallel with the rising rate of obesity and type 2 diabetes. 1 Pfizer To the Editor: We read with interest the article by Younossi et al. With a view to expanding the transparency of our pipeline, Pfizer is including new indications or enhancements, which target unmet medical need or represent significant Previous grant recipients and their institutions, highlighted below, are leading innovative projects to uncover insights on the origin and progression of NASH, obesity and cachexia and we’re thrilled to continue to support independent research. We would like to show you a description here but the site won’t allow us. . Anstee is supported by the Newcastle NIHR Biomedical Research Centre and the Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) consortium, which has received funding from the Innovative Medicines Initiative Program of the European Union under grant agreement 777377; this Feb 1, 2020 · Liver inflammation is regulated by chemokines that control the activities and migration of various hepatic and immune cells [15]. A clinical trial is a research study that seeks to understand how potential medicines, vaccines, and other medical interventions work, and also whether they are safe and effective. NASH (or nonalcoholic steatohepatitis) is a type of NAFLD that can damage the liver. The protein plays a key role in regulating metabolism and signaling throughout the body Feb 18, 2019 · All Pfizer’s NASH drug candidates are in early-mid phase clinical trials, a phase that focuses on the clinical evaluation of safety, tolerability, pharmacokinetics and efficacy/biological Jun 26, 2023 · Pfizer is continuing to advance the first full agonist oral GLP-1-RA candidate danuglipron toward late-state development Danuglipron is the largest oral, small molecule GLP-1-RA clinical development program underway with over 1,400 participants enrolled for the treatment of obesity and T2DM Ongoing danuglipron Phase 2b study in obesity is fully enrolled Second GLP-1-RA candidate lotiglipron to Dec 14, 2021 · Final data available from all high-risk patients enrolled in EPIC-HR study (n= 2,246) confirmed prior results of interim analysis showing PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo; no deaths compared to placebo in non May 3, 2022 · In these materials, Pfizer discloses Mechanism of Action (MOA) information for some candidates in Phase 1 and for all candidates from Phase 2 through regulatory approval. The Big Pharma dropped the ketohexokinase inhibitor PF-06835919 after a mid-stage trial a year ago, and had previously May 2, 2023 · 12 programs advanced or are new 6 programs discontinued since last update Included are 70 NMEs, 31 additional indications Discovery Projects May 8, 2024 · Novo Nordisk, Eli Lilly, Pfizer and AstraZeneca have all tried their own MASH drugs against different pathways; some are still in phase 2 and 3 trials 1, but many have been pulled in recent years Jun 16, 2022 · Pfizer has dropped off some cash in the form of an equity investment for Akero Therapeutics, adding $25 million for the biotech's NASH work. yaabcc niflpx zludvrn kjzhg ggg ktrjz pxytfo odqhj elvgwgh zhwe