[Translation] A randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy, safety, and tolerability of oral tropifexor (LJN452) and licogliflozin (LIK066) combination therapy versus monotherapy versus placebo in adult subjects with nonalcoholic steatohepatitis (NASH) and fibrosis (ELIVATE)

本研究的目的为根据NASH临床研究网络（CRN）组织学评分，在伴肝纤维化（2期或3期）的NASH受试者中比较tropifexor和licogliflozin联合治疗、各单药治疗与安慰剂组治疗的疗效、安全性和耐受性。

[Translation]

The aim of this study was to compare the efficacy, safety, and tolerability of tropifexor plus licogliflozin, each agent alone, and placebo in subjects with NASH and fibrosis (stage 2 or 3) according to the NASH Clinical Research Network (CRN) histology score.

Start Date21 Jul 2021

Sponsor / Collaborator

Aptuit (Verona) Srl

[+3]

NCT04065841 / TerminatedPhase 2

A Randomized, Double-blind, Parallel-group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Oral Tropifexor (LJN452) & Licogliflozin (LIK066) Combination Therapy and Each Monotherapy, Compared With Placebo for Treatment of Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis.(ELIVATE)

Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

Start Date30 Dec 2019

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT03320941 / CompletedPhase 2

A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 12 Weeks Treatment With 4 Doses of LIK066 Compared to Placebo in Japanese Patients With Obesity Disease

The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.

Start Date07 Dec 2017

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with Licogliflozin

100 Translational Medicine associated with Licogliflozin

100 Patents (Medical) associated with Licogliflozin

Literatures (Medical) associated with Licogliflozin

21 Sep 2024·EXPERT OPINION ON PHARMACOTHERAPY

A systematic review on effect of sodium-glucose cotransporter-2 inhibitors on the metabolic and endocrinological profile of patients with polycystic ovarian syndrome

Review

Author: Parveen, Rizwana ; Roy, Madhura ; Majid, Haya ; Khan, Parvej ; Saxena, Rajesh ; Nidhi ; Pathak, Mani

BACKGROUND:

Polycystic ovarian syndrome (PCOS) has been a common metabolic and endocrinal disorder, prevalent amongst women belonging to the reproductive age group. The aim of this systematic review was to assess the safety and efficacy profile of sodium-glucose cotransporter 2 (SGLT2) inhibitors (Canagliflozin, Dapagliflozin, Empagliflozin, and Licogliflozin) for the treatment of women suffering from PCOS.

METHODS:

A literature search in PubMed, Science Direct, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov was conducted for randomized clinical trials of SGLT-2 inhibitors in PCOS patients by applying predetermined inclusion and exclusion criteria. The articles in English language were included.

RESULTS:

Four randomized controlled trials including 146 subjects were included in the review. The clinical studies indicated a significant decrease in the levels of total testosterone, free androgen index, total body fat, homeostasis model assessment-estimated insulin resistance (HOMA-IR), body mass index (BMI), dehydroepiandrosterone sulfate (DHEAS) and fasting plasma glucose (FPG). However, no significant difference was reported in levels of sex hormone-binding globulin (SHBG). Overall, there was improvement in metabolic and endocrine profiles, suggesting a potentially beneficial impact of SGLT2 inhibitors in the management of PCOS.

CONCLUSION:

There is a requirement for large extensive clinical trials to demonstrate the efficacy of SGLT-2 inhibitors in PCOS patients.

12 Dec 2022·Angewandte Chemie (International ed. in English)

Cu Single Atom Nanozyme Based High‐Efficiency Mild Photothermal Therapy through Cellular Metabolic Regulation

Article

Author: Wen, Ding ; Chang, Mengyu ; Wang, Man ; Zhao, Yanli ; Liu, Yuhui ; Hou, Zhiyao ; Lin, Jun ; Li, Chunxia

Abstract:

Upregulation of heat shock proteins (HSPs) drastically compromises the treatment effect of mild photothermal therapy (PTT). Herein, we designed a polyporous Cu single atom nanozyme (Cu SAzyme) loaded with licogliflozin (LIK066) for HSP‐silencing induced mild PTT. On one hand, LIK066 inhibits glucose uptake by shutting sodium‐dependent glucose transporter (SGLT) “valve”, effectively blocking the energy source for adenosine triphosphate (ATP) generation. Without sufficient energy, cancer cells cannot synthesize HSPs. On the other hand, Cu SAzyme presents extraordinary multienzyme activities to induce reactive oxygen species (ROS) storm formation, which can damage the existing HSPs in cancer cells. Through a two‐pronged strategy of SGLT inhibitor and ROS storm, LIK066‐loaded Cu SAzyme shows high efficiency for comprehensive removal of HSPs to realize mild PTT.

01 Nov 2022·Diabetes & metabolic syndrome

Dose-dependent efficacy and safety of licogliflozin on obese adults: A systematic review and meta-analysis of randomized controlled trials

Review

Author: Abo-Elnour, Dina Essam ; Salama, Moaz Khaled ; Abdalla, Yomna Emad ; Elboraay, Toka ; Abdelhaleem, Ibrahim Abdelmonaem ; Hassan, Rehab Yosri ; Zaki, Alaa Mohamed

BACKGROUND AND AIM:

Licogliflozin is a dual SGLT1/2 inhibitor acting on the intestine and kidney by reducing glycemic and calorie content. We aimed to determine the efficacy and safety of licogliflozin on Anthropometric measurements and cardiometabolic parameters in obese participants.

METHODS:

We systematically searched the PubMed, Cochrane Library, Scopus, and Web of Science databases for randomized controlled trials (RCTs) relevant to our eligibility criteria. We performed a subgroup analysis based on licogliflozin doses and the diabetic state of participants. This meta-analysis was registered on PROSPERO (CRD42021286936).

RESULTS:

We identified five RCTs with a total of 905 obese and overweight participants. All participants had a weight reduction of 2.43 kg (95% CI: -3.17 to -1.69, p < 0.00001) compared with placebo. The mean difference in HbA1c of obese diabetic patients was (MD: -0.30%; 95% CI: -0.45, -0.16); I2 = 46% in favor of licogliflozin. The incidence of serious adverse events, all-cause mortality, headache, nausea, and vomiting were similar between licogliflozin and placebo (p = 0.72, 0.97, 0.09, 0.53, and 0.89, respectively). However, there was a higher incidence of diarrhea in the licogliflozin group.

CONCLUSION:

We found that licogliflozin was safe and tolerable. It reduces body weight significantly. Moreover, it improves glycemic control and other cardiometabolic parameters.

News (Medical) associated with Licogliflozin

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

16 Aug 2022

·www.biospace.com

Craig T. Basson, MD, PhD Joins Olatec Therapeutics’ Board of Directors

Aug. 16, 2022 12:30 UTC NEW YORK--(BUSINESS WIRE)-- Olatec Therapeutics LLC, a leader in the developing class of selective NLRP3 inhibitors, today announced that Craig T. Basson, MD, PhD has been elected to their Board of Directors. This press release features multimedia. View the full release here: Craig T. Basson, MD, PhD Joins the Board of Directors of Olatec Therapeutics, a leader in the developing class of selective NLRP3 inhibitors (Photo: Business Wire) Excited to join Olatec’s Board of Directors, Dr. Basson explained: “I am thrilled to contribute to Olatec’s development of lead compound, dapansutrile – starting in gouty arthritis and to realize [dapansutrile’s] potential to translate the science of the NLRP3 inflammasome in multiple disease areas. I am confident in Olatec’s ultimate ability to deliver this important medicine globally to the many patients suffering from inflammatory diseases.” A veteran of both large pharmaceutical and biotechnology companies, Dr. Basson served as Chief Medical Officer, Global Head of Research and Development and/or interim Chief Executive Officer of Boston Pharmaceuticals, Inc., between February 2020 and August 2022 when he became an advisor to the Board of Directors. At Boston Pharmaceuticals, Dr. Basson led the acquisition and development of a broad pipeline of innovative drug candidates into the clinic. In the preceding decade, Dr. Basson served as the Global Head of Translational Medicine for the Cardiovascular and Metabolic Therapeutic Areas at the Novartis Institutes for Biomedical Research (NIBR) in Cambridge, MA. Leading a team of physicians with expertise in translational medicine, Dr. Basson oversaw more than 10 successful clinical studies and supported the development of Entresto™, licogliflozin, iscalimab and abelacimab, among other novel medicines, for patients suffering from cardiovascular disease, diabetes and metabolic disorders. Dr. Basson’s experience in drug development synergizes with Olatec’s focus in inflammation, since his work at Novartis advanced clinical programs for the anti-IL-1β biologic, canakinumab (Ilaris™), into multiple disease areas and supported translational studies in the landmark CANTOS trial. Prior to joining Novartis, Dr. Basson was the Gladys and Roland Harriman Professor of Cardiology and Internal Medicine at Weill Cornell Medical College, whose faculty he joined in 1997. He completed his BA and MA at Washington University in St. Louis, MO and received an MSc in Physiological Sciences from the University of Oxford as a Marshall Scholar. Dr. Basson holds an MD and PhD from Yale University. He completed his residency in Internal Medicine at Johns Hopkins Hospital and his clinical Cardiology fellowship and postdoctoral Cardiovascular Genetics fellowship at Harvard University and the Brigham and Women’s Hospital. Dr. Basson is an elected member of the American Society for Clinical Investigation and a Fellow of the American Heart Association and of the American College of Cardiology. Currently, Dr. Basson is a Senior Lecturer at Harvard Medical School and an attending physician at Brigham and Women’s Hospital, while also serving on scientific advisory boards. Reflecting on Dr. Basson’s election, Olatec’s CEO & Chairman, Damaris B. Skouras, said: “We are very pleased to have Craig join our Board. Craig brings to Olatec deep, proven expertise in translational medicine and an impressive track record in drug development directly relevant to our field of inflammation therapeutics. Craig will undoubtedly make valuable contributions to the development journey of dapansutrile and our OLT Analogues.” About Dapansutrile Dapansutrile (lab code: OLT1177®) is an investigational small molecule, new chemical entity that specifically binds to and blocks NLRP3 (nucleotide-binding and oligomerization domain [NOD, leucine rich repeat-, pyrin domain-containing 3), the sensor molecule integral in the formation of the NLRP3 inflammasome. Inflammasomes are multiprotein complexes involved in intracellular surveillance of danger signals that trigger an intense inflammatory response, via generation of bioactive IL-1β and IL-18 through caspase-1 activation. Dapansutrile has been shown to prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL‑1β and IL‑18. NLRP3 is one of the most well characterized inflammasome sensors due to its involvement in a wide range of disorders, including sterile inflammation, infections and rare genetic autoimmune syndromes. Dapansutrile is in Phase 2 clinical development and has been well tolerated and shown to improve clinical outcomes in patients with acute gout flare (see The Lancet Rheumatology) and heart failure (see Journal of Cardiovascular Pharmacology). Dapansutrile has also been observed to have anti-inflammatory properties and other promising activity in a broad spectrum of over 20 preclinical animal models including arthritis, asthma, acute myocardial infarction, diabetes, contact dermatitis, melanoma, pancreatic and breast cancers, spinal cord injury and Alzheimer’s disease. About Olatec Therapeutics LLC Olatec is a privately held, clinical-stage biopharmaceutical company developing a platform of oral NLRP3 inhibitors to treat and prevent a broad spectrum of acute and chronic inflammatory diseases known to be mediated by IL-1. In addition to the lead compound, dapansutrile, Olatec’s platform of proprietary compounds includes approximately 60 analogues (OLT Analogues) being screened as viable drug candidates. An IP portfolio protecting Olatec’s compounds consists of over 130 patents granted, covering dapansutrile and OLT Analogues. Olatec’s drug development team is comprised of experienced management and international experts in translational medicine with unparalleled expertise in inflammation and immunology and has been involved in the discovery and development of first-line inflammation treatments in the market today. For more information, please visit . Disclaimer & Forward-looking Statement The information contained herein is being provided for information purposes only. The Company makes no express or implied representation or warranty as to the completeness of this information. Any forward-looking statements contained in this release are based on assumptions made by Olatec at the time this Press Release was prepared. Any forward-looking statement contained in this Press Release is subject to known and unknown risks, uncertainties and other factors that may be materially different from those contemplated in such forward-looking statements. All information with respect to industry data has been obtained from sources believed to be reliable and current, but the accuracy thereof cannot be guaranteed by the Company. Olatec does not undertake any obligation to update or revise the forward-looking statements contained in this Press Release to reflect events or circumstances occurring after the date this Press Release was prepared, or to reflect the occurrence of unanticipated events.

CollaborateInnovative DrugSmall molecular drugAHAAcquisition

100 Deals associated with Licogliflozin

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis, Liver	Phase 2	US	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	JP	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	AR	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	BE	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	BR	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	BG	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	CA	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	CL	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	CO	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	DK	Novartis Pharmaceuticals Corp.	30 Dec 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03205150 (Pubmed \| Nat Med)	Phase 2	Nonalcoholic Steatohepatitis	107	Licogliflozin 30mg	(kepeaxsmnr) = Diarrhea occurred in 77% (33 of 43), 49% (21 of 43) and 43% (9 of 21) of patients treated with licogliflozin 150 mg, 30 mg and placebo, respectively, which was mostly mild in severity. vguifsvoap (wdghtruosj )	Positive	20 Jun 2022
				Licogliflozin 150mg
NCT03152591 (Pubmed) Manual	Phase 2	Polycystic Ovary Syndrome	-	licogliflozin	rwkumulsod(vrdhxjetsu) = Concentration of FT did not change rfjascnkyu (nveymvxkxq )	Positive	01 Nov 2021
				Placebo
NCT03131479 (Pubmed) Manual	Phase 2	Chronic Kidney Diseases	53	Licogliflozin	sxquvmmcnm(qgtgbxkkci) = increased in all pts but not in severe (6.2 [-0.71, 13.18] g) CKD gfwrexvrnx (klpuuouejg ) View more	Positive	01 May 2021
				Placebo
NCT03100058 (Pubmed \| Obesity (Silver Spring)) Manual	Phase 2	Overweight \| Obesity	-	Licogliflozin	ojyvobvsjp(ixmasfizzr) = wiaedbvisz xqwbaviwms (exsvcpyimp )	Positive	01 May 2020
				Placebo	-
NCT03320941 (CTgov)	Phase 2	Obesity	126	Placebo	davpzobtuf(uzwifdebfm) = prrwypggxq rkynrhoeux (gxykuixgad, jbgzrscuvj - zxbjzlroyr) View more	-	02 Oct 2019
NCT03152552 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Heart Failure	125	LIK066 (LIK066 2.5mg)	npbxemirbd(tljwmpcwqe) = snfuzxunlk yqiexurklf (dtnqlxqyoa, jjwehvoply - mtdpglrbvx) View more	-	28 Aug 2019
				LIK066 (LIK066 10mg)	npbxemirbd(tljwmpcwqe) = lurzquhcjq yqiexurklf (dtnqlxqyoa, spamylonrr - qkothyucfo) View more
NCT03152591 (PCOS, CTgov)	Phase 2	Polycystic Ovary Syndrome \| Obesity	29	LIK066 (LIK066)	grhhwmguwu(rugqzjkiqm) = icaqwzfwgg ipermlosjv (kprsjzvzua, bzwnxxevpc - ekeopdavnz) View more	-	09 May 2019
				Placebo (Placebo)	grhhwmguwu(rugqzjkiqm) = xcwnpeewvp ipermlosjv (kprsjzvzua, sqxrgbmeud - uszynpdfhx) View more
NCT03131479 (CTgov)	Phase 2	Renal Insufficiency	53	LIK066 (Normal)	unxrqtyfzc(uumbitghht) = ydirmemcci ckpggplebm (uettdpldpn, tujmrjcnds - rsbqwjmcqa) View more	-	06 Feb 2019
				LIK066 (Mild)	unxrqtyfzc(uumbitghht) = npicquzrqw ckpggplebm (uettdpldpn, davllaelbp - kbfwqflivo) View more
NCT02470403 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Prediabetic State \| Weight Gain	181	LIK066 (Part 1: LIK066 150 mg Once Daily (qd))	hyskgeseqf(bfvplffvxd) = ypadpfidwj dxmbdqpxzp (ywabbsmucd, nezbuqakzk - zkfvoaaqsh) View more	-	12 May 2017
				LIK066 (Part 1: Placebo Once Daily)	hyskgeseqf(bfvplffvxd) = bsnymkcrvd dxmbdqpxzp (ywabbsmucd, npviftzwzt - rebtwwnerj) View more

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