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 Canada, Inc.

NCT03205150

/ CompletedPhase 2

A 12-week Randomized, Patient and Investigator Blinded, Placebo-controlled, Parallel Group Study to Investigate the Efficacy of LIK066 in Obese Patients With Non-alcoholic Steatohepatitis (NASH)

The purpose of this study was to assess the effects of LIK066 on a variety of metabolic and inflammation biomarkers in patients with non-alcoholic steatohepatitis (NASH)

Start Date04 Oct 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

03 Jul 2025·Expert Opinion On Drug Safety

Risk of limb amputation and bone fractures with sodium glucose cotransporter-2 inhibitors: a network meta-analysis and meta-regression

Review

Author: Sridharan, Kannan ; Sivaramakrishnan, Gowri

BACKGROUND:

Sodium glucose cotransporter-2 inhibitors (SGLT2is) have gained immense attention for a variety of indications. Limb amputations (LA) and fractures were reported in clinical trials. This network meta-analysis and meta-regression were carried out to quantify the risks of these events.

RESEARCH DESIGN AND METHODS:

Randomized clinical trials evaluating SGLT2is and reporting patients developing LA/fracture were included. Odds ratios (OR) with 95% confidence intervals (95% CI) were the effect estimates. Sub-group analyses and meta-regression analysis were carried out.

RESULTS:

Ninety articles were included (LA: 36 studies; 96522 participants and fracture: 66 studies; 102,862 participants). An increased risk of LA (OR: 1.2; 95% CI: 1.1, 1.3) was observed. Amongst SGLT2is, canagliflozin was associated with increased risk of LA (OR: 1.6, 95% CI: 1.1, 2.4) while dapagliflozin with fracture (OR: 1.1, 95% CI: 1, 1.2). Sub-group analysis revealed increased risk of LA with an OR of 1.3 among those in the age group of > 40 to < 65, body-mass index of > 30 kg/m², HbA1c category of > 7%, duration of diabetes of > 10 years, type 2 diabetes, and an OR of 1.2 for SGLT2is administration of > 6 months.

CONCLUSIONS:

SGLT2is were observed with an increased risk of LA. High- risk categories were identified for which precautions should be recommended in the standard treatment guidelines.

PROTOCOL REGISTRATION:

Open Science Framework (https://osf.io/5fwyk).

09 Apr 2025·Journal of the American Chemical Society

Kinetic Steering of Amyloid Formation and Polymorphism by Canagliflozin, a Type-2 Diabetes Drug

Article

Author: Alexander I. P. Taylor ; Martin Wilkinson ; Alice Brinkworth ; Richard Foster ; Yong Xu ; Sheena E. Radford ; Neil A. Ranson ; Anastasia Zhuravleva ; Pijush Chakraborty ; Leon F. Willis

Amyloid formation is involved in widespread health conditions such as Alzheimer's disease, Parkinson's disease, and type-2 diabetes. Amyloid fibrils have a similar cross-β architecture, but fibrils formed by a single protein sequence can have diverse structures, varying with time, self-assembly conditions, and sequence modifications. Fibril structure has been proposed to be diagnostic of disease, but why different structures result under different conditions, especially in vitro, remains elusive. We previously identified a small molecule, YX-I-1, which inhibits in vitro amyloid formation by islet amyloid polypeptide (IAPP), a peptide hormone whose amyloid formation is involved in type-2 diabetes. Here, using YX-I-1 as a lead, we identified regulator-approved drugs with similar structures by chemical similarity analysis and substructure searches and monitored the effect of 24 of these potential ligands on IAPP amyloid assembly in vitro. We show that one such compound, canagliflozin (Invokana), a type-2 diabetes drug already in clinical use, can strongly delay the kinetics of IAPP amyloid formation, an activity independent of its intended mode of action [sodium-glucose linked transporter 2 (SGLT2) inhibitor] that may have important therapeutic implications. Combining analysis of amyloid self-assembly kinetics, biophysical characterization of monomer and fibril binding, and cryo-EM of the assembly products, we show that YX-I-1 and canagliflozin target IAPP early in aggregation, remodeling the energy landscape of primary nucleation and profoundly altering the resulting fibril structures. Early binding events thus imprint long-lasting effects on the amyloid structures that form.

01 Feb 2025·CLINICAL THERAPEUTICS

Recent Advances in Individualized Clinical Strategies for Polycystic Ovary Syndrome: Evidence From Clinical Trials and Emerging Pharmacotherapies

Review

Author: Moka, Murali Krishna ; George, Melvin ; Sriram, Damal Kandadai

PURPOSE:

Clinical trials are advancing the treatment of polycystic ovary syndrome (PCOS), an endocrine disorder affecting 8-13% of women. Lifestyle interventions, including nutritional plans, physical activity, and stress management, can improve reproductive hormones and metabolic health. Novel pharmacotherapies targeting hormonal, metabolic, and reproductive abnormalities are being explored for individualized treatment. Combination therapies and lifestyle interventions like acupuncture, high-intensity interval training, and vitamin D3 supplementation are also being explored.

METHODS:

We conducted a narrative review by searching English-language studies across electronic databases such as PubMed, Science direct, and Google Scholar for articles related to the topics of PCOS and novel drug therapies such as metformin, LIK-066, elagolix, saxenda, exenatide, clomiphene, letrozole, and other diagnostic interventions. Our review excluded preclinical studies and articles not in english.

FINDINGS:

In addition to pharmacological treatments, lifestyle interventions such as Tung's acupuncture, high-intensity interval training (HIIT), and vitamin D3 supplementation have proven effective in managing symptoms of PCOS and enhancing overall health outcomes. These interventions offer a complementary approach to traditional medical therapies, emphasizing the importance of integrating lifestyle modifications into the treatment plan for women with PCOS.

IMPLICATIONS:

This comprehensive approach underscores the importance of tailored treatments in optimizing clinical outcomes and quality of life for women with PCOS. The aim of this review is to highlight recent advancements in the treatment of PCOS through clinical trials and emerging pharmacotherapies, emphasizing the need for individualized and multifaceted treatment approaches.

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	United States	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	Japan	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	Argentina	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	Belgium	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	Brazil	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	Bulgaria	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	Canada	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	Chile	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	Colombia	Novartis Pharmaceuticals Corp.	30 Dec 2019
Fibrosis, Liver	Phase 2	Denmark	Novartis Pharmaceuticals Corp.	30 Dec 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03205150 (Pubmed \| Nat Med)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	107	Licogliflozin 30mg	vrbsjrknqn(pqlwputoet) = 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. msvtpdbenc (phjkbixrfs )	Positive	20 Jun 2022
				Licogliflozin 150mg
NCT03152591 (Pubmed) Manual	Phase 2	Polycystic Ovary Syndrome	-	licogliflozin	odjwvjddbh(rxtdrzlugv) = Concentration of FT did not change iefyjwdxum (tszfncmokg )	Positive	01 Nov 2021
				Placebo
NCT03131479 (Pubmed) Manual	Phase 2	Chronic Kidney Diseases	53	Licogliflozin	gepyyckmfu(fxzooxnnlh) = increased in all pts but not in severe (6.2 [-0.71, 13.18] g) CKD ujbdjgfpkh (susfpirvtt ) View more	Positive	01 May 2021
				Placebo
NCT03320941 (Pubmed \| Diabetes Obes Metab)	Phase 2	Obesity	126	Licogliflozin 2.5 mg qd	cwrfcusezx(gvyvjcoazv) = xopxnvuyde dgmflknujq (acyryzbiug, -2.92, - 0.21)	-	01 Jul 2020
				Licogliflozin 10 mg qd	cwrfcusezx(gvyvjcoazv) = pwczfauyda dgmflknujq (acyryzbiug, -4.15, - 1.7)
NCT03100058 (Pubmed \| Obesity (Silver Spring)) Manual	Phase 2	Overweight \| Obesity	-	Licogliflozin	orfsjxlrsm(xnoqqsptbz) = shhtbtmwee praqjxhlqg (gpynejrxvi )	Positive	01 May 2020
				Placebo	-
NCT03320941 (CTgov)	Phase 2	Obesity	126	Placebo	cpevqchfsu = ejsjcfuyds bbapaoodok (swrkeonaza, buxidusnwv - vqypqdwehq) View more	-	02 Oct 2019
NCT03152552 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Heart Failure \| Chronic heart failure	125	LIK066 (LIK066 2.5mg)	panulmlkns(bwckbbzeza) = mwjhdisfwb dxiscpekqf (ewhywdivla, xitiafczwr - ttuohjxglz) View more	-	28 Aug 2019
				LIK066 (LIK066 10mg)	panulmlkns(bwckbbzeza) = smqngqspzv dxiscpekqf (ewhywdivla, umnbddqjee - ersgvuuhhx) View more
NCT03152591 (PCOS, CTgov)	Phase 2	Polycystic Ovary Syndrome \| Obesity	29	LIK066 (LIK066)	yyxyozjigk(aujowttmsi) = bvbqacawxd urdxlwxhza (ildltncudi, jaquluglzt - uxrxmyhauy) View more	-	09 May 2019
				Placebo (Placebo)	yyxyozjigk(aujowttmsi) = tdjqnvazzb urdxlwxhza (ildltncudi, niildehfeb - jvjigpmopf) View more
NCT03131479 (CTgov)	Phase 2	Renal Insufficiency	53	LIK066 (Normal)	imeowccbey(acvsydfokm) = pvbwpkbxpr qkzpqkwbnx (wizyudhadt, 21.93) View more	-	06 Feb 2019
				LIK066 (Mild)	imeowccbey(acvsydfokm) = wffcfjfzii qkzpqkwbnx (wizyudhadt, 13.79) View more
NCT03198767 (CTgov)	Phase 2	Obesity	54	LIK066 (Part A: LIK066 + 50% CHO)	avyofsloap(gdlapqzmod) = mztmxyykfl zxfzifqwqz (garfqsvswm, 1.74) View more	-	25 Sep 2018
				LIK066 (Part A: LIK066 + 25% CHO)	avyofsloap(gdlapqzmod) = ohhhycenjb zxfzifqwqz (garfqsvswm, 1.42) View more

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