A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE EXTENT OF EXCRETION, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06865571 USING A 14C-MICROTRACER APPROACH

This study is a Phase 1, open-label, non-randomized, 2-period, fixed-sequence, single-dose study of PF-06865571 in healthy male participants to characterize the ADME properties of [14C]PF-06865571 following oral administration; and to evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-06865571 following oral administration of unlabeled PF-06865571 and IV administration of [14C]PF-06865571.

Start Date11 May 2021

Sponsor / Collaborator

Pfizer Inc.

CTR20210412

/ CompletedPhase 2

一项在经活检证实的非酒精性脂肪性肝炎（NASH）伴2 期或3 期纤维化的成人受试者中评价 PF-06865571（DGAT2I）单药及其与 PF-05221304（ACCI）联合治疗的疗效和安全性的 II 期、随机、双盲、双模拟、安慰剂对照、剂量范围探索、剂量探索、平行组研究

[Translation] A Phase II, randomized, double-blind, double-dummy, placebo-controlled, dose-ranging, dose-finding, parallel-group study to evaluate the efficacy and safety of PF-06865571 (DGAT2I) alone and in combination with PF-05221304 (ACCI) in adult subjects with biopsy-proven nonalcoholic steatohepatitis (NASH) and stage 2 or 3 fibrosis

主要目的：在经活检证实的 NASH 伴肝纤维化的受试者中，评价多个 DGAT2i 剂量单药治疗和 DGAT2i+ACCi 联合治疗对缓解NASH和改善纤维化的作用次要目的：评价多个 DGAT2i 剂量单药治疗和 DGAT2i + ACCi 联合治疗与安慰剂相比，以及 DGAT2i + ACCi 联合治疗与 DGAT2i 单药治疗相比，对肝脂肪含量的影响，符合不同应答者定义的受试者中的作用，及安全性和耐受性第三目的：评价多个 DGAT2i 剂量单药治疗和 DGAT2i+ACCi 联合治疗与安慰剂相比，以及 DGAT2i+ACCi 联合治疗与 DGAT2i 单药治疗相比，在活检终点成分出现恶化的受试者中的作用

[Translation]

Primary Objective: To evaluate the effects of multiple DGAT2i doses as monotherapy and DGAT2i+ACCi combination therapy on NASH remission and improvement in fibrosis in subjects with biopsy-proven NASH and fibrosis Secondary Objectives: To evaluate the effects of multiple DGAT2i doses as monotherapy and DGAT2i + ACCi combination therapy compared with placebo and DGAT2i + ACCi combination therapy compared with DGAT2i monotherapy on liver fat content, effects in subjects meeting different responder definitions, and safety and tolerability Tertiary Objectives: To evaluate the effects of multiple DGAT2i doses as monotherapy and DGAT2i+ACCi combination therapy compared with placebo and DGAT2i+ACCi combination therapy compared with DGAT2i monotherapy in subjects with worsening of biopsy endpoint components

Start Date06 Apr 2021

Sponsor / Collaborator

Pfizer Inc.

[+1]

NCT04839393

/ CompletedPhase 1

A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETIC INTERACTIONS BETWEEN PF-06882961 AND PF-06865571 IN HEALTHY ADULT PARTICIPANTS (PART A) AND OVERWEIGHT ADULTS OR ADULTS WITH OBESITY WHO ARE OTHERWISE HEALTHY (PART B)

This study will be conducted in 2 parts. Part A will investigate the potential effect of PF-06865571 on the pharmacokinetics (PK) of PF-06882961 in healthy adult participants. Part B will evaluate the effect of PF-06882961 on the PK of PF-06865571, as well as the effect of PF-06865571 on the PK of PF-06882961 in overweight adults or adults with obesity who are otherwise healthy.

Start Date05 Apr 2021

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Ervogastat

100 Translational Medicine associated with Ervogastat

100 Patents (Medical) associated with Ervogastat

Literatures (Medical) associated with Ervogastat

01 Feb 2025·CPT-Pharmacometrics & Systems Pharmacology

Exposure–response modeling of liver fat imaging endpoints in non‐alcoholic fatty liver disease populations administered ervogastat alone and co‐administered with clesacostat

Article

Author: Wojciechowski, Jessica ; Hughes, Jim H. ; Vourvahis, Manoli ; Amin, Neeta B.

Abstract:

Non‐alcoholic fatty liver disease and non‐alcoholic steatohepatitis describe a collection of liver conditions characterized by the accumulation of liver fat. Despite biopsy being the reference standard for determining the severity of disease, non‐invasive measures such as magnetic resonance imaging proton density fat fraction (MRI‐PDFF) and FibroScan® controlled attenuation parameter (CAP™) can be used to understand longitudinal changes in steatosis. The aim of this work was to describe the exposure–response relationship of ervogastat with or without clesacostat on steatosis, through population pharmacokinetic/pharmacodynamic (PK/PD) modeling of both liver fat measurements simultaneously. Population pharmacokinetic and exposure–response models using individual predictions of average concentrations were used to describe ervogastat/clesacostat PKPD. Due to both liver fat endpoints being continuous‐bounded outcomes on different scales, a dynamic transform‐both‐sides approach was used to link a common latent factor representing liver fat to each endpoint. Simultaneous modeling of both MRI‐PDFF and CAP™ was successful with both measurements being adequately described by the model. The clinical trial simulation was able to adequately predict the results of a recent Phase 2 study, where subjects given ervogastat/clesacostat 300/10 mg BID for 6 weeks had a LS means and model‐predicted median (95% confidence intervals) percent change from baseline MRI‐PDFF of −45.8% and −45.6% (−61.6% to −31.8%), respectively. Simultaneous modeling of both MRI‐PDFF and CAP™ was successful with both measurements being adequately described. By describing the underlying changes of steatosis with a latent variable, this model may be extended to describe biopsy results from future studies.

01 Oct 2024·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Combined structure-based virtual screening and machine learning approach for the identification of potential dual inhibitors of ACC and DGAT2

Article

Author: Deng, Liangying ; Zhang, Shuran ; Wu, Lixing ; Mi, Nana ; Ding, Feng ; Liu, Yanfeng ; Tong, Huangjin

Acetyl-coenzyme A carboxylase (ACC) and diacylglycerol acyltransferase 2 (DGAT2) are recognized as potential therapeutic targets for nonalcoholic fatty liver disease (NAFLD). Inhibitors targeting ACC and DGAT2 have exhibited the capacity to reduce hepatic fat in individuals afflicted with NAFLD. However, there are no reports of dual inhibitors targeting ACC and DGAT2 for the treatment of NAFLD. Here, we aimed to identify potential dual inhibitors of ACC and DGAT2 using an integrated in silico approach. Machine learning-based virtual screening of commercial molecule databases yielded 395,729 hits, which were subsequently subjected to molecular docking aimed at both the ACC and DGAT2 binding sites. Based on the docking scores, nine compounds exhibited robust interactions with critical residues of both ACC and DGAT2, displaying favorable drug-like features. Molecular dynamics simulations (MDs) unveiled the substantial impact of these compounds on the conformational dynamics of the proteins. Furthermore, binding free energy assessments highlighted the notable binding affinities of specific compounds (V003-8107, G340-0503, Y200-1700, E999-1199, V003-6429, V025-4981, V006-1474, V025-0499, and V021-8916) to ACC and DGAT2. The compounds proposed in this study, identified using a multifaceted computational strategy, warrant experimental validation as potential dual inhibitors of ACC and DGAT2, with implications for the future development of novel drugs targeting NAFLD.

01 Feb 2024·Clinical and translational science

Investigation of pharmacokinetic drug interaction between clesacostat and DGAT2 inhibitor ervogastat in healthy adult participants

Article

Author: Tripathy, Sakambari ; Bergman, Arthur J. ; Gosset, James R. ; Sawant‐Basak, Aarti ; Calle, Roberto A. ; Mancuso, Jessica ; Esler, William P. ; Mendes da Costa, Laure

Abstract:

Co‐administration of clesacostat (acetyl‐CoA carboxylase inhibitor, PF‐05221304) and ervogastat (diacylglycerol O‐acyltransferase inhibitor, PF‐06865571) in laboratory models improved non‐alcoholic fatty liver disease (NAFLD)/non‐alcoholic steatohepatitis (NASH) end points and mitigated clesacostat‐induced elevations in circulating triglycerides. Clesacostat is cleared via organic anion‐transporting polypeptide‐mediated hepatic uptake and cytochrome P450 family 3A (CYP3A); in vitro clesacostat is identified as a potential CYP3A time‐dependent inactivator. In vitro ervogastat is identified as a substrate and potential inducer of CYP3A. Prior to longer‐term efficacy trials in participants with NAFLD, safety and pharmacokinetics (PK) were evaluated in a phase I, non‐randomized, open‐label, fixed‐sequence trial in healthy participants. In Cohort 1, participants (n = 7) received clesacostat 15 mg twice daily (b.i.d.) alone (Days 1–7) and co‐administered with ervogastat 300 mg b.i.d. (Days 8–14). Mean systemic clesacostat exposures, when co‐administered with ervogastat, decreased by 12% and 19%, based on maximum plasma drug concentration and area under the plasma drug concentration–time curve during the dosing interval, respectively. In Cohort 2, participants (n = 9) received ervogastat 300 mg b.i.d. alone (Days 1–7) and co‐administered with clesacostat 15 mg b.i.d. (Days 8–14). There were no meaningful differences in systemic ervogastat exposures when administered alone or with clesacostat. Clesacostat 15 mg b.i.d. and ervogastat 300 mg b.i.d. co‐administration was overall safe and well tolerated in healthy participants. Cumulative safety and no clinically meaningful PK drug interactions observed in this study supported co‐administration of these two novel agents in additional studies exploring efficacy and safety in the management of NAFLD.

News (Medical) associated with Ervogastat

13 Mar 2024

·www.biospace.com

Ionis’ Antisense Molecule Hits Primary Endpoint in Phase II MASH Trial

Pictured: Illustration depicting a damaged liver/iStock, Mohammed Haneefa Nizamudeen A Phase II clinical trial of Ionis Pharmaceuticals’ metabolic dysfunction-associated steatohepatitis drug candidate has hit its primary endpoint, the company said Wednesday. Investigators randomized 160 people with metabolic dysfunction-associated steatohepatitis (MASH), the liver disease formerly known as nonalcoholic steatohepatitis, to receive placebo or one of three doses of ION224 subcutaneously once a month. Ionis designed the ligand-conjugated antisense medicine to cut production of DGAT2, an enzyme that studies have linked to fatty liver disease. After 51 weeks, the proportion of patients who had MASH histologic improvement without worsening of fibrosis was significantly higher in the top two dose cohorts than in the placebo group. The significant differences caused the trial to meet its primary endpoint. Ionis shared the p values for the successful 90-mg and 120-mg doses—0.015 and less than 0.001, respectively—but is yet to provide a closer look at the primary endpoint data. Subgroup analyses found patients with both F2 and F3 fibrosis, the middle scores on a four-point scarring severity scale, improved after taking ION224. The biotech published some secondary endpoint data. ION224 beat placebo on an endpoint that looked at MASH resolution without worsening of fibrosis, as measured by biopsy. At the highest dose, 44% of patients had a 50% or greater relative reduction in liver steatosis, as measured by imaging, while 3% of people on placebo experienced such an improvement. Ionis also saw a trend favoring ION224 for a liver scarring endpoint. In the high-dose arm, 32% of people had at least a one stage improvement in fibrosis without worsening of steatohepatitis as measured by biopsy, compared to 12.5% of their peers in the placebo cohort. The FDA asks sponsors to show a one stage improvement in fibrosis with no worsening of MASH or the resolution of MASH with no worsening of fibrosis in Phase III clinical trials. The first wave of MASH assets failed to clear that bar but recent studies have fared better, with Madrigal Pharmaceuticals hitting both the endpoints in Phase III. The FDA is set to decide whether to approve Madrigal’s resmetirom by Thursday. The success of resmetirom, a THR-β agonist, in clinical trials is part of a series of events that suggest Ionis will face competition if it delivers its own pivotal study victory and brings ION224 to market. Companies are working on MASH molecules against a range of targets, from Boehringer Ingelheim’s glucagon/GLP-1 receptor dual agonist survodutide to Akero Therapeutics’ FGF21 analog efruxifermin. Other companies are interested in Ionis’ MASH target, DGAT2. Pfizer axed one DGAT2 inhibitor after Phase I but still has another candidate, PF-06865571, in mid-stage development. Data from the Phase II clinical trial are imminent, according to ClinicalTrials.gov. Other companies including Sinew Pharma and Viking Therapeutics are working on DGAT1 inhibitors. Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.

Phase 2Phase 3Phase 1Clinical Result

13 Mar 2024

·www.biospace.com

Ionis’ Antisense Molecule Hits Primary Endpoint in Phase II MASH Trial

Pictured: 3D illustration of a damaged liver/iStoc The biotech announced Wednesday that patients on ION224 had histologic improvement in the liver disease without worsening of fibrosis. Ionis’ mid-stage win comes as the FDA is set to decide whether to approve rival Madrigal’s resmetirom by Thursday. Pictured: Illustration depicting a damaged liver/iStock, Mohammed Haneefa Nizamudeen A Phase II clinical trial of Ionis Pharmaceuticals ’ metabolic dysfunction-associated steatohepatitis drug candidate has hit its primary endpoint, the company said Wednesday. Investigators randomized 160 people with metabolic dysfunction-associated steatohepatitis (MASH), the liver disease formerly known as nonalcoholic steatohepatitis, to receive placebo or one of three doses of ION224 subcutaneously once a month. Ionis designed the ligand-conjugated antisense medicine to cut production of DGAT2, an enzyme that studies have linked to fatty liver disease. After 51 weeks, the proportion of patients who had MASH histologic improvement without worsening of fibrosis was significantly higher in the top two dose cohorts than in the placebo group. The significant differences caused the trial to meet its primary endpoint. Ionis shared the p values for the successful 90-mg and 120-mg doses—0.015 and less than 0.001, respectively—but is yet to provide a closer look at the primary endpoint data. Subgroup analyses found patients with both F2 and F3 fibrosis, the middle scores on a four-point scarring severity scale, improved after taking ION224. The biotech published some secondary endpoint data. ION224 beat placebo on an endpoint that looked at MASH resolution without worsening of fibrosis, as measured by biopsy. At the highest dose, 44% of patients had a 50% or greater relative reduction in liver steatosis, as measured by imaging, while 3% of people on placebo experienced such an improvement. Ionis also saw a trend favoring ION224 for a liver scarring endpoint. In the high-dose arm, 32% of people had at least a one stage improvement in fibrosis without worsening of steatohepatitis as measured by biopsy, compared to 12.5% of their peers in the placebo cohort. The FDA asks sponsors to show a one stage improvement in fibrosis with no worsening of MASH or the resolution of MASH with no worsening of fibrosis in Phase III clinical trials. The first wave of MASH assets failed to clear that bar but recent studies have fared better, with Madrigal Pharmaceuticals hitting both the endpoints in Phase III. The FDA is set to decide whether to approve Madrigal’s resmetirom by Thursday. The success of resmetirom, a THR-β agonist, in clinical trials is part of a series of events that suggest Ionis will face competition if it delivers its own pivotal study victory and brings ION224 to market. Companies are working on MASH molecules against a range of targets, from Boehringer Ingelheim ’s glucagon/GLP-1 receptor dual agonist survodutide to Akero Therapeutics ’ FGF21 analog efruxifermin. Other companies are interested in Ionis’ MASH target, DGAT2. Pfizer axed one DGAT2 inhibitor after Phase I but still has another candidate, PF-06865571, in mid-stage development. Data from the Phase II clinical trial are imminent, according to ClinicalTrials.gov . Other companies including Sinew Pharma and Viking Therapeutics are working on DGAT1 inhibitors. Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn .

Phase 2Phase 3Phase 1Clinical Result

12 Dec 2022

·www.prnewswire.com

Propulsion of Nonalcoholic Steatohepatitis Pipeline as Novel and Extensive 150+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of nonalcoholic steatohepatitis has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Nonalcoholic Steatohepatitis and the growing research and development activities drive the market. The Companies developing the potential therapies in the last stage of development include Madrigal Pharmaceuticals, Inventiva, Boehringer Ingelheim, and several others. LAS VEGAS, Dec. 12, 2022 /PRNewswire/ -- DelveInsight's ' Nonalcoholic Steatohepatitis Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline nonalcoholic steatohepatitis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the nonalcoholic steatohepatitis pipeline domain. Key Takeaways from the Nonalcoholic Steatohepatitis Pipeline Report DelveInsight's nonalcoholic steatohepatitis pipeline report depicts a robust space with 130+ active players working to develop 150+ pipeline therapies for nonalcoholic steatohepatitis treatment. Key nonalcoholic steatohepatitis companies such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others are evaluating nonalcoholic steatohepatitis drugs to improve the treatment landscape. Promising nonalcoholic steatohepatitis pipeline therapies in various stages of development include TERN-101, SNP-610, LJN452 (tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others. In November 2022, Sagimet Biosciences announced positive interim data from its Phase IIb clinical trial (FASCINATE-2) with denifanstat, a fatty acid synthase (FASN) inhibitor, in non-alcoholic steatohepatitis patients. Data showed statistically significant improvements across key markers of NASH, reinforcing results observed in earlier studies, including statistically significant reductions in markers of liver fat, inflammation, and fibrosis. There were no treatment-related serious adverse events, with the majority of adverse events mild to moderate in nature (Grade 1 and 2). Additional interim data are expected in early 2023. In November 2022, Inventiva announced that the United States Patent and Trademark Office granted a patent (U.S. Patent No. 11,504,380) that protects the use of lanifibranor for the treatment of cirrhotic patients at risk of progressing from compensated stage to decompensated stage. This patent will expire on November 8, 2039. This patent further expands the intellectual property protection of lanifibranor in the United States for use in patients with cirrhotic NASH. In October 2022, Galectin Therapeutics, Inc. reported the positive outcome of its second data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase IIb/III study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The objective of this second independent DSMB was further to review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, the DSMB concluded that NAVIGATE could continue as designed, without modifications. In September 2022, Inventiva and Chia Tai-Tianqing Pharmaceutical Group entered into a licensing and collaboration agreement to develop and commercialize lanifibranor, if approved, for the treatment of nonalcoholic steatohepatitis and potentially other metabolic diseases in mainland China, Hong Kong, Macau, and Taiwan. In June 2022, Poxel SA announced that the U.S. Patent and Trademark Office (PTO) has issued to Poxel US Patent No. 11319313, which represents a new patent for PXL065, a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which is being investigated in Phase II stage of clinical trial evaluation for the treatment of Nonalcoholic steatohepatitis (NASH). In May 2022, Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to Pfizer's investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). In May 2022, Hepion Pharmaceuticals, Inc. announced that it has entered into a clinical collaboration with HepQuant, a Denver-based, privately held company with novel, proprietary investigational technology for evaluating liver function and health in patients with chronic liver diseases. Hepion will incorporate the HepQuant 'SHUNT' test into a dedicated Phase IIb clinical trial in presumed NASH F3 subjects. In February 2022, the US Food and Drug Administration (FDA) granted a Fast-Track Designation to Axcella Therapeutics' AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. In January 2022, LISCure Biosciences announced that it had executed a research collaboration agreement with Mayo Clinic for new drug development for rare liver diseases. LISCure Biosciences Inc. has executed a research collaboration agreement with US based-Mayo Clinic for new drug development for rare liver diseases. Request a sample and discover the nash drugs in development 2022 @ Nonalcoholic Steatohepatitis Pipeline 2022 Report The nonalcoholic steatohepatitis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage nonalcoholic steatohepatitis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the nonalcoholic steatohepatitis clinical trial landscape. Nonalcoholic Steatohepatitis Overview Nonalcoholic steatohepatitis (NASH) is a type of liver inflammation and damage caused by fat buildup. It is one of several conditions known as nonalcoholic fatty liver disease. Nonalcoholic fatty liver disease is classified into two types: isolated fatty liver, in which only fat accumulates, and nonalcoholic steatohepatitis, in which fat, inflammation, and liver cell damage occur. NASH does not usually cause symptoms. Most people with NASH feel fine and are unaware that they have it. As NASH progresses and liver damage worsens, a patient may experience fatigue, weight loss, general weakness, and acne in the upper right part of the belly. Screening for nonalcoholic fatty liver disease in the general population is not advised. It is usually considered after discovering unexplained liver enzyme levels, or imaging reveals hepatic steatosis. A patient's medical history, a physical exam, and tests for nonalcoholic steatohepatitis are used by doctors. Want to discover how the Nash treatment pipeline will look like? Request for sample @ NASH Drug Pipeline 2022 A snapshot of the Nonalcoholic Steatohepatitis Pipeline Drugs mentioned in the report: Want to know how nash dash the pipeline race is for new agents? Download the sample page @ NASH Clinical Trials Nonalcoholic Steatohepatitis Therapeutics Assessment The nonalcoholic steatohepatitis pipeline report proffers an integral view of nonalcoholic steatohepatitis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Nonalcoholic Steatohepatitis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intravenous, Parenteral, Oral, Subcutaneous Therapeutics Assessment By Molecule Type: Antibody, Biologic, Cell therapy, Peptide, Protein, Small molecule Therapeutics Assessment By Mechanism of Action: Adiponutrin inhibitor, Diacylglycerol O acyltransferase inhibitor, Adiponutrin modulator, RNA interference, Glucagon like peptide 1 receptor agonist, Ornithine decarboxylase stimulant, Farnesoid X-activated receptor agonist, Thyroid hormone receptor beta agonist, Mitochondrial membrane transport protein modulator, Thyroid hormone receptor beta agonists, Peroxisome proliferator-activated receptor alpha agonist Key Nonalcoholic Steatohepatitis Companies:Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others. Key Nonalcoholic Steatohepatitis Pipeline Therapies: TERN-101, SNP-610, LJN452(tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others. Dive deep into rich insights for nonalcoholic steatohepatitis research; visit @ NASH Treatment Pipeline Table of Contents For further information on the most promising nash drugs, reach out @ NASH Medication Pipeline Related Reports Nonalcoholic Steatohepatitis Epidemiology Nonalcoholic Steatohepatitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted nonalcoholic steatohepatitis epidemiology in the 7MM. Nonalcoholic Steatohepatitis Market Nonalcoholic Steatohepatitis Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key nonalcoholic steatohepatitis companies, including Boehringer Ingelheim, Oramed Pharmaceuticals, ENYO Pharma, Terns Pharmaceuticals, Cirius Therapeutics, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key non-alcoholic fatty liver disease companies including AstraZeneca, Novartis, Pfizer, Roche, among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced non-alcoholic fatty liver disease companies, including AstraZeneca, Novartis, Pfizer, Roche, among others. Non-Alcoholic Fatty Liver Disease Epidemiology Non-Alcoholic Fatty Liver Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted non-alcoholic fatty liver disease epidemiology in the 7MM. Other Trending Reports Alcohol Use Disorder Market | Liver Cancer Market | Alcoholic Hepatitis - Market | Acute Liver Failure - Market | Liver Angiosarcoma - Market | Liver Cirrhosis - Market | Chronic Liver Disease - Market | Advanced Liver Cancer - Market | Acute On Chronic Liver Failure (ACLF) Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research LLP

Phase 2License out/inFast Track

100 Deals associated with Ervogastat

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis	Phase 2	United States	Pfizer Inc.	15 Jun 2020
Fibrosis	Phase 2	China	Pfizer Inc.	15 Jun 2020
Fibrosis	Phase 2	Japan	Pfizer Inc.	15 Jun 2020
Fibrosis	Phase 2	Bulgaria	Pfizer Inc.	15 Jun 2020
Fibrosis	Phase 2	Canada	Pfizer Inc.	15 Jun 2020
Fibrosis	Phase 2	Hong Kong	Pfizer Inc.	15 Jun 2020
Fibrosis	Phase 2	India	Pfizer Inc.	15 Jun 2020
Fibrosis	Phase 2	Poland	Pfizer Inc.	15 Jun 2020
Fibrosis	Phase 2	Puerto Rico	Pfizer Inc.	15 Jun 2020
Fibrosis	Phase 2	Slovakia	Pfizer Inc.	15 Jun 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04866225 (CTgov)	Phase 1	-	6	[14C]PF-06865571 ([14C]PF-06865571 300 mg Oral)	kabdeenfad(aqvhionfdw) = zchlswomnr furdjkqmsa (nhzlyrnsmh, 16.3) View more	-	31 Jul 2024
NCT04866225 (CTgov)	Phase 1	-	6	[14C]PF-06865571+PF-06865571 (PF-06865571 300 mg Oral & [14C]PF-06865571 100 μg IV)	kabdeenfad(aqvhionfdw) = ldfijhwsjd furdjkqmsa (nhzlyrnsmh, 15.8) View more	-	31 Jul 2024
NCT04399538 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis	75	Placebo	oxclpflebm(btvwdcyfcs) = nogprqakaf zmhtslctdo (vrolerbhuk, juhcwdwmsn - cfbjskboia) View more	-	13 Apr 2023
NCT03776175 (CTgov)	Phase 2	Metabolic dysfunction-associated steatotic liver disease	99	Placebo	mhxruthfzq(udbrlexxat) = wnbkyzrunc uofxjenhsy (fqtgzlaede, silzeqoktt - yamzpemprh) View more	-	23 Sep 2020
NCT03513588 (CTgov)	Phase 1	Nonalcoholic Steatohepatitis	48	Placebo	kzfcackfuq(fgmkwrpdan) = gwyabcoplv nhzpvsuqzu (hozkoxmsni, lgopzzjkvd - rhyxbpegck) View more	-	13 Mar 2020

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