A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Study to Explore the Safety and Efficacy of ALS-L1023 in Patients With Non-alcoholic Steatohepatitis (NASH)

The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis

Start Date04 Dec 2019

Sponsor / Collaborator

AngioLab, Inc.

NCT03725501

/ CompletedPhase 2

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Three-arm Parallel-Group, 12-Month Study to Evaluate the Safety and Efficacy of ALS-L1023 Administered in Combination With Ranibizumab in Patients With Wet-AMD

The objective of this phase 2 study is to determine the optimal dose of ALS-L1023 by evaluating the safety and efficacy of ALS-L1023 comparing with placebo when used in combination with Ranibizumab for the treatment of wet age-related macular degeneration(AMD).
The study is designed as multicenter, randomized, placebo-controlled, double-blind, three-arm parallel-group phase 2 study in patients with neovascular age-related macular degeneration.
This study consists of two separate phases: a loading phase and a PRN(pro re nata) phase.
Once the subject provides a written informed consent, subject information including demographics, medical history, and concomitant medications will be collected, and only those who meet the inclusion/exclusion criteria will participate in the study.
All subjects who are enrolled in the study will be randomized into three groups Group A (Ranibizumab 0.5mg & ALS-L1023 600mg) or Group B (Ranibizumab 0.5mg & ALS-L1023 1200mg) or Group C (Ranibizumab & placebo) in a 1:1:1 ratio. Randomization will be stratified by whether or not the subject has PCV(polypoidal choroidal vasculopathy) confirmed at Screening test.
During the 3-month loading phase, all subjects will receive a Ranibizumab 0.5mg injection into the vitreous every month and take either the placebo or ALS-L1023 orally twice a day. During the following 3-12 month PRN phase, subjects will continue to take the placebo or ALS-L1023 in the same frequency as above but receive Ranibizumab injection only when it meets retreatment criteria. Subjects must instill antibacterial eye drops three times a day for three days after Ranibizumab injection.
Subjects will visit the study site monthly during the 12 month study period in order to receive scheduled assessments and evaluate safety and efficacy of treatment. Image interpretation will be performed by a central reading center. The central reading center will confirm eligibility for enrollment and the discrimination of Polypoidal Choroidal Vasculopathy(PCV) at screening and play a role in interpreting whole images of all subjects after the end of the study.

Start Date07 Dec 2018

Sponsor / Collaborator

AngioLab, Inc.

KCT0003361

/ Not yet recruitingPhase 2

Start Date19 Nov 2018

Sponsor / Collaborator

AngioLab, Inc.

100 Clinical Results associated with Ethyl acetate extract

100 Translational Medicine associated with Ethyl acetate extract

100 Patents (Medical) associated with Ethyl acetate extract

Literatures (Medical) associated with Ethyl acetate extract

20 Apr 2023·Pharmaceuticals (Basel, Switzerland)

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ALS-L1023 in Non-Alcoholic Fatty Liver Disease.

Article

Author: Yoon, Eileen L ; Jung, Seungwon ; Jeong, Soung Won ; Hwang, Jungwook ; Kang, Bo-Kyeong ; Jun, Dae Won ; Kim, Gi-Ae ; Cho, Hyun Chin ; Kim, Mimi

Preclinical data have shown that the herbal extract, ALS-L1023, from Melissa officinalis reduces visceral fat and hepatic steatosis. We aimed to assess the safety and efficacy of ALS-L1023 as the treatment of non-alcoholic fatty liver disease (NAFLD). We conducted a 24-week randomized, double-blind, placebo-controlled 2a study in patients with NAFLD (MRI-proton density fat fraction [MRI-PDFF] ≥ 8% and liver fibrosis ≥ 2.5 kPa on MR elastography [MRE]) in Korea. Patients were randomly assigned to 1800 mg ALS-L1023 (n = 19), 1200 mg ALS-L1023 (n = 21), or placebo (n = 17) groups. Efficacy endpoints included changes in liver fat on MRI-PDFF, liver stiffness on MRE, and liver enzymes. For the full analysis set, a relative hepatic fat reduction from baseline was significant in the 1800 mg ALS-L1023 group (-15.0%, p = 0.03). There was a significant reduction in liver stiffness from baseline in the 1200 mg ALS-L1023 group (-10.7%, p = 0.03). Serum alanine aminotransferase decreased by -12.4% in the 1800 mg ALS-L1023 group, -29.8% in the 1200 mg ALS-L1023 group, and -4.9% in the placebo group. ALS-L1023 was well tolerated and there were no differences in the incidence of adverse events among the study groups. ALS-L1023 could reduce hepatic fat content in patients with NAFLD.

02 Nov 2022·Journal of agricultural and food chemistry

Evaluation of the Perceptual Interaction among Ester Odorants and Nonvolatile Organic Acids in Baijiu by GC-MS, GC-O, Odor Threshold, and Sensory Analysis

Article

Author: Zheng, Fuping ; Li, Hehe ; Sun, Baoguo ; Li, Zexia ; Wang, Guangnan ; Wang, Xinlei ; Jing, Si

By applying the aroma extract dilution analysis, 13 esters were found to have high FD factors in the Laobaigan flavor type of Baijiu. These were then quantified using GC-MS. In addition, 35 nonvolatile organic acids were quantified by a derivatization method combined with GC-MS. The perceptual interactions of lactic acid and ethyl lactate and that of lactic acid and ethyl acetate were studied through the olfactory threshold. The S curve was used to evaluate the changes in the olfactory thresholds. After adding lactic acid (1142, 20 000, and 53 703 mg/L), the olfactory thresholds of ethyl lactate (1000, 724, and 295 mg/L) and ethyl acetate (398, 324, and 257 mg/L) decreased obviously, which revealed that lactic acid gave additive or synergistic odor effects for the two esters. Furthermore, it was discovered that as the concentrations of lactic acid increased, the extent of the interaction among these compounds was also greater in the mixture.

01 Feb 2022·Reproductive sciences (Thousand Oaks, Calif.)Q3 · MEDICINE

Effects of Solvents, Emulsions, Cosolvents, and Complexions on Ex Vivo Mouse Myometrial Contractility

Q3 · MEDICINE

Article

Author: Boatwright, Naoko ; Hansen, Christopher J ; Siricilla, Shajila ; Herington, Jennifer ; Rogers, Jackson H ; Kumi, Melissa E

Abstract:

A great need exists to develop tocolytic and uterotonic drugs that combat poor, labor-related maternal and fetal outcomes. A widely utilized method to assess novel compounds for their tocolytic and uterotonic efficacy is the isometric organ bath contractility assay. Unfortunately, water-insoluble compounds can be difficult to test using the physiological, buffer-based, organ bath assay. Common methods for overcoming solubility issues include solvent variation, cosolvency, surfactant or complexion use, and emulsification. However, these options for drug delivery or formulation can impact tissue function. Therefore, the goal of this study was to evaluate the ability of common solvents, surfactants, cosolvents, and emulsions to adequately solubilize compounds in the organ bath assay without affecting mouse myometrial contractility. We found that acetone, acetonitrile, and ethanol had the least effect, while dimethylacetamide, ethyl acetate, and isopropanol displayed the greatest inhibition of myometrial contractility based on area under the contractile curve analyses. The minimum concentration of surfactants, cosolvents, and human serum albumin required to solubilize nifedipine, a current tocolytic drug, resulted in extensive bubbling in the organ bath assay, precluding their use. Finally, we report that an oil-in-water base emulsion containing no drug has no statistical effect beyond the control (water), while the drug emulsion yielded the same potency and efficacy as the freely solubilized drug.

News (Medical) associated with Ethyl acetate extract

11 Dec 2023

·www.prnewswire.com

Viridis Chemical Wins at S&P Global Commodity Insights' 25th Annual Platts Global Energy Awards for Sustainable Chemicals Best Product

Viridis biobased ethyl acetate (ETAC) was named a winner as a renewable, low-carbon, and scalable solution that increases sustainability and benefits the environment Winners Hailed from Belgium, Germany, India, Saudi Arabia, Singapore, Thailand, UK, Ukraine, United Arab Emirates and US HOUSTON, Dec. 11, 2023 /PRNewswire/ -- Viridis Chemical, a manufacturer of renewable, biobased, low-carbon chemicals, announced that its commercial-scale ethyl acetate has been named a winner at the 25th Annual Platts Global Energy Awards in the Sustainable Chemicals Best Product category. S&P Global Commodity Insights, the leading global independent provider of data, insights, analysis and benchmark prices for the commodities, energy and energy transition markets, honored industry excellence in 21 performance categories and winners from nearly a dozen countries at the Platts Global Energy Awards gala. The Awards program, now in its 25th year and often described as the "Oscars of the energy industry", recognizes corporate and individual innovation, leadership, and performance in the energy and petrochemicals sectors, and bestowed honors on companies from Belgium, Germany, India, Singapore, Thailand, UK, Ukraine, United Arab Emirates and US. "We are honored to be named a winner of the esteemed Platts Global Energy Award," said Carl V Rush, Jr., CEO and co-founder of Viridis Chemical. "It is exciting to see the chemical industry's stewardship, advances, and focus on circular economy, climate protection, carbon mitigation and management, and environmental protection. With our proprietary catalytic process, Viridis is delivering high-quality, industrial-scale ETAC to many industries and pushing boundaries with a 40–80% lower carbon footprint than the next best fossil fuel-based manufacturing technology." Since its launch in February 2021, Viridis Chemical has gone from a start-up chemical company to a world-class manufacturer of renewable, 100% biobased, low-carbon ethyl acetate with growing sales throughout North America and Europe. Saugata Saha, President of S&P Global Commodity Insights, said: "At this celebratory quarter-of-a-century milestone for the Platts Global Energy Awards, we are particularly honored by the industry's continued recognition of the program as the energy industry's longstanding premier awards event and welcome the opportunity to congratulate not only the finalists and winners of 2023 but those across the history of the event. Each has contributed not only to a better energy future, but in recent years, has demonstrated an enhanced commitment to greater community service, energy security and a more sustainable energy transition." An independent panel of judges chose the winners of the 2023 Platts Global Energy Awards from finalists selected from nominations that represented 33 different countries. Viridis' 100% biobased ETAC is marketed worldwide by HELM AG, one of the world's largest chemical distribution companies. This partnership with HELM AG gives Viridis access to an international sales force, introducing Viridis' high-quality, low-carbon, sustainability ethyl acetate story to customers and prospects across the globe in various industries, including paints and coatings, adhesives, packaging, personal care, food and beverage, and pharmaceuticals. "We are delighted to see our long-term partner Viridis recognized with this prestigious award. Our customers have been providing positive feedback on the quality of Viridis's ethyl acetate product and the reliability of our service to markets. With the severely reduced carbon footprint, we are excited to continue to help customers deliver a game-changing impact in their markets," said Björn Steckel, President of Chemicals Americas of HELM. Viridis Chemical's ethyl acetate is a United States Department of Agriculture (USDA)-certified, biobased product meeting all requirements under the USDA BioPreferred® Program. Traditionally, ethyl acetate has been manufactured from fossil fuel-based resources. Earlier this year, Viridis received International Sustainability & Carbon Certification PLUS (ISCC PLUS) for its manufacturing facility in Columbus, Nebraska. Products certified to the ISCC PLUS standard assure companies, brand owners, and consumers that high sustainability requirements have been met. Additionally, in June 2023, Viridis received the Independent Commodity Intelligence Services (ICIS) 2023 Product Innovation Award in the Small and Medium-sized Business category. To learn more visit . For more details about other Award winners of this year's Platts Global Energy Awards, access the December issue of the S&P Global Commodity Insights Magazine or visit the Platts Global Energy Awards website. About Viridis Chemical Headquartered in Houston, Texas, Viridis Chemical, LLC, is a world-class manufacturer of renewable, biobased, low-carbon chemicals and the only industrial-scale manufacturer of 100 percent biobased ethyl acetate in North America. Viridis is committed to the safe, environmentally sound, and economically viable conversion of bio-ethanol into circular, sustainable products previously derived from fossil fuel-based resources. Viridis is a member of the American Chemistry Council (ACC), holds International Sustainability & Carbon PLUS Certification (ISCC PLUS) for its manufacturing facility in Columbus, Nebraska, and has a USDA-certified, biobased product meeting all requirements under the USDA BioPreferred® program. For more information, please visit . About HELM AG HELM is a Hamburg, Germany-based family-owned company established in 1900. HELM is one of the world's largest chemicals marketing companies and is committed to providing solutions to its partners that support a successful transformation to a sustainable economy and society. The company secures access to the world's key markets through its specific regional knowledge and its multinational presence in more than 30 countries. As a multifunctional marketing organization, HELM is active in the chemicals industry, in the agricultural industry, in energy materials, and in pharmaceuticals, generating global revenues of EUR 8 billion per year. Learn more at . About S&P Global Commodity Insights At S&P Global Commodity Insights, our complete view of global energy and commodity markets enables our customers to make decisions with conviction and create long-term, sustainable value.  We're a trusted connector that brings together thought leaders, market participants, governments, and regulators and we create solutions that lead to progress. Vital to navigating commodity markets, our coverage includes oil and gas, power, chemicals, metals, agriculture, shipping and energy transition. Platts® products and services, including leading benchmark price assessments in the physical commodity markets, are offered through S&P Global Commodity Insights. S&P Global Commodity Insights maintains clear structural and operational separation between its price assessment activities and the other activities carried out by S&P Global Commodity Insights and the other business divisions of S&P Global. S&P Global Commodity Insights is a division of S&P Global (NYSE: SPGI). S&P Global is the world's foremost provider of credit ratings, benchmarks, analytics and workﬂow solutions in the global capital, commodity and automotive markets. With every one of our offerings, we help many of the world's leading organizations navigate the economic landscape so they can plan for tomorrow, today. For more information visit . MEDIA CONTACTS Viridis Chemical: Kathleen Van Gorden | [email protected] | 401-480-1840 SOURCE Viridis Chemical

07 Nov 2023

·www.prnewswire.com

REGENATIVE LABS AND DR. ROBERT PARKER ANNOUNCE NEW CARE ADVANCEMENTS USING WHARTON'S JELLY ALLOGRAFTS IN ACHILLES TENDON DEFECTS

Improvement of patient-reported pain and functionality warrants future research. The homologous-use application validated by Dr. Parker sets a precedent for non-surgical allograft application. PENSACOLA, Fla., Nov. 7, 2023 /PRNewswire/ -- Regenative Labs (Regenative), a leading HCT/P manufacturer, announces a retrospective case report demonstrating new care advancements using its Wharton's Jelly allografts in the supplementation of Achilles tendon defects. Board-certified in foot and ankle surgery and lower extremity nerve specialist, Dr. Robert Parker of Parker Foot and Ankle in Texas, has presented for publication a novel case study of Wharton's Jelly, an umbilical cord connective tissue, applied to the structural tissue defect of the Achilles tendon in tandem with shock wave and laser therapy. The homologous use application validated by Dr. Parker sets a precedent for non-surgical allograft application. "As practitioners, we all share the knowledge that long-acting steroids, the acetates, are not only detrimental to tendons, they are in my opinion, contraindicated. This is especially true around larger tendons such as the Achilles. We also know the effect of short-acting steroids, the phosphates, though not as destructive, may give some pain relief but do absolutely nothing to help tissues heal themselves. I am very encouraged and optimistic about utilizing umbilical cord connective tissue as a structural allograft which helps my patient's own tissues heal themself even at multiple sites besides the Achille's tendon," shared Dr. Parker. The patient represented in this case report suffered with chronic Achilles tendinosis from chronic enthesopathy at the Achilles tendon insertion with a retrocalcaneal exostosis for three years and has failed standard-of-care practices for over two years. After application of Wharton's Jelly allografts, such as those provided by Regenative, in addition to extracorporeal pulsed-activated therapy (EPAT) and class IV laser therapy treatments, the patient's pain had improved from a 10/10 VAS to a 0/10 VAS in 13 weeks. While Achilles tendonitis and related tendon damage, also known as enthesopathies, is rampant among athletes, it does not exclusively affect athletes. Approximately 65 percent of Achilles injuries diagnosed in general practice are not sport related. Standard care practices for Achilles tendinosis vary from over-the-counter anti-inflammatories or corticosteroid injections with functional rehabilitation therapy to surgical intervention in severe cases. These costs can range upwards of $15k for a surgical repair and do not guarantee complete pain relief. The rising annual number of surgeries is enough to implement conservative protocols alternative to invasive surgical repair of the Achilles tendon. To advance the necessary research and fill the need for non-surgical alternatives, Regenative has been tracking data in its comprehensive retrospective data repository in which physicians across specialties submit patient data as they track patient outcomes up to 120 days after the patient receives an application of Regenative's products, like its Wharton's Jelly allografts. Regenative has collected data from clinics nationwide on Wharton's Jelly applications for Achilles tendon defects and is excited to highlight Dr. Parker's unique procedures in the first of many publications on regenerative podiatric medicine. "Given the high incidence rate and few effective treatment options for defects in the Achilles tendon, this study aims to provide a new, promising alternative intervention for patients who have failed all other standard-of-care treatments. This is just one of many homologous-use applications in regenerative medicine to improve patient outcomes," shared Regenative Labs CEO Tyler Barrett. Barrett is committed to providing patients with alternative options and, through what may be revealed in these studies, offers proven protocols to better address the root cause of their pain. Barrett and his team hope to enlist physicians to take part in studies regarding uncovered uses. Physicians will have their outcomes highlighted, furthering the understanding of regenerative medicine and uncovering new applications for this groundbreaking field of medicine. "We're doing the research at Regenative, and the results are very promising. We are calling on all physicians across the country to engage with us and advance the field of regenerative medicine," Barrett concluded. Contact Regenative to get your practice involved today. About Regenative Labs: Regenative Labs produces regenerative medicine products to address the root cause of a patient's conditions using Wharton's Jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with the daily challenges of innovations in healthcare, the company provides non-addictive, non-invasive options for patients. Regenative Labs' expert product research and development team complies with FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at Regenative's website: About Dr. Robert Parker: Dr. Robert G. Parker is a native Houstonian practicing in Houston, Texas. He graduated from the Ohio College of Podiatric Medicine (currently Kent State University) and was the first board-certified podiatric surgeon recognized by the American Board of Foot and Ankle Surgery in Houston. Dr. Parker is a faculty instructor of the advanced and fundamental Didactic and Cadaver courses for the Association of Extremity Nerve Surgeons. Additionally, he is a Founding Member and fellow of the Association of Extremity of Nerve Surgeons and served as the organization's president in 2013. Dr. Parker served on the American Board of Podiatric Medicine as an examiner for over a decade and was one of two cofounders of The Harris County Podiatric Residency program. He was also the President of the SW division of the American College of Foot Surgeons and has received numerous awards spanning his decades-long career. Learn more at Parker Foot and Ankle's website: SOURCE Regenative Labs

Clinical 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 Ethyl acetate extract

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Abdominal Obesity Metabolic Syndrome	Phase 3	South Korea	Hanmi Pharmaceutical Co., Ltd.	01 May 2013
Obesity, Abdominal	Phase 3	South Korea	Hanmi Pharmaceutical Co., Ltd.	01 May 2013
Nonalcoholic Steatohepatitis	Phase 2	South Korea	AngioLab, Inc.	04 Dec 2019
Wet Macular Degeneration	Phase 2	South Korea	AngioLab, Inc.	07 Dec 2018
Metabolic dysfunction-associated steatotic liver disease	Phase 2	South Korea	AngioLab, Inc.	-
Otitis Media With Effusion	Phase 2	South Korea	AngioLab, Inc.	-
Wet age-related macular degeneration	Phase 2	South Korea	AngioLab, Inc.	-
Rosacea	Phase 1	South Korea	AngioLab, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AASLD2023	Phase 2	Metabolic dysfunction-associated steatotic liver disease	-	1800 mg ALS-L1023	kkczolcmtx(zznxinhyba) = nqptbcllha onrpxqzjfr (gxsxvneasy ) View more	-	10 Nov 2023
				1200 mg ALS-L1023	kkczolcmtx(zznxinhyba) = jenqfbjrfu onrpxqzjfr (gxsxvneasy ) View more
ARVO2014	Not Applicable	Choroidal Neovascularization	32	ALS-L1023 50 mg/kg	uuplzwqgph(rszzuxnlzo) = sanzrretgs lxxuhmcuku (pfxwnyvybw )	-	01 Apr 2014
				ALS-L1023 100 mg/kg	uuplzwqgph(rszzuxnlzo) = zzspiakfjz lxxuhmcuku (pfxwnyvybw )

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