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Last update 28 Feb 2025

Pioglitazone Hydrochloride

Last update 28 Feb 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(±)-5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-2,4-thiazolidinedione, 5-{4-[2-(5-ethylpyridin-2-yl)ethoxy]benzyl}-1,3-thiazolidine-2,4-dione, pioglitazone

+ [38]

Target

PPARγ

Mechanism

PPARγ agonists(Peroxisome proliferator-activated receptor γ agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication

Alzheimer DiseaseAsthmaCardiovascular Diseases+ [22]

Originator Organization

Takeda Pharmaceutical Co., Ltd.

Active Organization

Takeda Pharmaceuticals U.S.A., Inc.

Takeda Pharmaceutical Co., Ltd.Accord Healthcare SLU

+ [6]

Inactive Organization

Vaia S.A.Takeda Pharma A/S

KRKA dd

+ [4]

Drug Highest PhaseApproved

First Approval Date

US (15 Jul 1999),

Diabetes Mellitus, Type 2

RegulationOrphan Drug (US), Orphan Drug (EU)

Structure/Sequence

Molecular FormulaC19H21ClN2O3S

InChIKeyGHUUBYQTCDQWRA-UHFFFAOYSA-N

CAS Registry112529-15-4

486

Clinical Trials associated with Pioglitazone Hydrochloride

NCT06729996

/ RecruitingPhase 2IIT

Randomized, Parallel Group, Dose Escalation Trial of Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/recurrent Acute Pancreatitis Associated Diabetes Mellitus: the PEP-DM Trial

The purpose of this study is to evaluate efficacy of pioglitazone (PIO) versus empagliflozin (EMPA) to improve glycemic control in people with Chronic Pancreatitis (CP) or Recurrent Acute Pancreatitis (RAP) associated with Diabetes Mellitus (DM). To evaluate mixed meal response in PIO versus EMPA group to better understand physiology of both therapies in CP-DM.

Start Date01 Mar 2025

Sponsor / Collaborator

Mayo Clinic

[+1]

IRCT20200623047902N15

/ SuspendedNot Applicable

Bioequivalence Study of Pioglitazone 30 mg tablet manufactured by Sanamed company versus the originator brand in healthy volunteers

Start Date20 Dec 2024

Sponsor / Collaborator-

NCT06336798

/ RecruitingPhase 2IIT

Effect of Pioglitazone on Mitochondrial Metabolism in Pulmonary Hypertension Due to Chronic Lung Disease

The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is:
• Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD.
Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo).

Start Date17 Dec 2024

Sponsor / Collaborator

Emory University

[+1]

100 Clinical Results associated with Pioglitazone Hydrochloride

100 Translational Medicine associated with Pioglitazone Hydrochloride

100 Patents (Medical) associated with Pioglitazone Hydrochloride

6,652

Literatures (Medical) associated with Pioglitazone Hydrochloride

04 Mar 2025·JOURNAL OF ASTHMA

Pioglitazone and asthma: a review of current evidence

Review

Author: Gourgoulianis, Konstantinos I. ; Daniil, Zoe ; Papanas, Nikolaos ; Barkas, Georgios I. ; Kotsiou, Ourania S. ; Karakousis, Nikolaos D.

OBJECTIVE:

This review aims to present existing evidence on the impact of pioglitazone, a thiazolidinedione class anti-diabetic drug, on asthma control and lung function, providing a comprehensive understanding of its potential as a treatment for asthma.

DATA SOURCES:

The review draws upon data from preclinical animal studies and clinical trials investigating the effects of pioglitazone on asthma, focusing on its role in reducing airway inflammation, hyperreactivity, and remodeling, and its impact on pulmonary function.

STUDY SELECTIONS:

Relevant studies were selected based on their examination of pioglitazone's therapeutic effects in asthma, including both animal models and clinical trials involving human asthma patients.

RESULTS:

Animal studies have suggested that pioglitazone could alleviate inflammation, airway hyperreactivity, and airway remodeling, thereby improving pulmonary function in asthma. However, clinical trials have not demonstrated significant therapeutic benefits, with minimal improvements observed in asthma control and lung function, and the presence of notable side effects.

CONCLUSION:

Despite promising preclinical data, the efficacy of pioglitazone in treating human asthma remains unproven, with safety concerns and limited clinical benefits observed in trials. Further research is needed to assess the safety and effectiveness of pioglitazone in asthma treatment and to explore its impact on other inflammatory mechanisms.

01 Mar 2025·Clinics and Research in Hepatology and Gastroenterology

Efficacy and safety of dapagliflozin compared to pioglitazone in diabetic and non-diabetic patients with non-alcoholic steatohepatitis: A randomized clinical trial

Article

Author: Raziky, Maissa El ; Adel, Abdulmoneim ; Hassany, Mohamed ; Abdel Monem, Mona S ; Abbassi, Maggie M ; Sabry, Nirmeen A ; Abdelaziz, Doaa H

BACKGROUND:

Non-alcoholic steatohepatitis (NASH) is a serious end-stage spectrum of non-alcoholic fatty liver disease (NAFLD) with associated high risk of hepatic and extrahepatic complications. Several studies showed the significant beneficial effect of dapagliflozin on body composition, hepatic and metabolic parameters on NAFLD/NASH patients. The study aimed to investigate the efficacy and safety of dapagliflozin in both diabetic and non-diabetic biopsy-proven NASH patients; compared to pioglitazone.

METHODS:

This was a four-group, prospective, randomized, parallel, open label study in which 100 biopsy-proven NASH patients were selected, stratified to diabetics and non-diabetics and randomized with 1:1 allocation to either 30 mg pioglitazone or 10 mg dapagliflozin, once daily for 24 weeks. Histological evaluation, anthropometric measures, hepatic, metabolic biochemical markers, fibrosis non-invasive markers, quality of life (QOL) and medications adverse events were examined.

RESULTS:

Dapagliflozin showed a comparable histological effect to pioglitazone in both diabetic and non-diabetic patients (P>0.05). As assessed by transient elastography, it also showed a comparable effect on liver fibrosis grade improvement from baseline in diabetics (P=0.287) versus a significant superiority in non-diabetics (P=0.018). Dapagliflozin showed a significant superiority in all anthropometric measures (P<0.001) and QOL (P<0.05) among both diabetics and non-diabetics. There was a significant interaction between interventions and diabetes status on change from baseline of hepatic and metabolic panel collectively (P=0.023) in favor to dapagliflozin among diabetics.

CONCLUSION:

Compared to pioglitazone, dapagliflozin had a comparable effect histologically, superior effect biochemically among diabetics and superior effect on liver fibrosis, steatosis and insulin resistance among non-diabetics.

TRIAL REGISTRATION:

The study was registered on clinicaltrials.gov, identifier number NCT05254626.

01 Mar 2025·TALANTA

Utilizing two-dose difference combined with stable isotope tracing for effective and comprehensive metabolite identification of pioglitazone via ultra-high-performance liquid chromatography–mass spectrometry

Article

Author: Shih, Chia-Lung ; Yu, Hui-I ; Yen, Meng-Chi ; Chiou, Yi-Shiou ; Wu, Zih-Han ; Wang, Jie-Huei

Drug metabolite identification is an essential characterization process spanning multiple phases of drug discovery and development. Various data processing techniques have been employed in metabolite identification using high-resolution mass spectrometry. However, metabolite identification is not consistent among approaches. Thus, a more comprehensive approach to drug metabolite identification is required. This paper proposes two-dose difference in conjunction with stable isotope tracing (SIT) to identify pioglitazone (PIO) metabolites. The results of this study revealed thatincubating both native and isotope-labeled PIOs in the same tube led to more stable metabolite identification compared with separated incubation. Our approach offers a high accuracy rate in metabolite identification, with approximately 70 % of metabolites validated as potential PIO metabolites. We compared our developed approach with other 3 approaches, namely the dose-response technique coupled with SIT, mass defect filter coupled with SIT, and orthogonal partial least squares-discriminant analysis. The results revealed that our developed approach was able to identify not only all the potential PIO metabolites identified by the other 3 approaches but also additional metabolites. These results suggest that two-dose difference coupled with SIT is an effective and comprehensive approach for drug metabolite identification.

News (Medical) associated with Pioglitazone Hydrochloride

30 Jan 2025

·www.prnewswire.com

Metabolic Dysfunction-Associated Steatohepatitis Market to Register Stunning Growth at a CAGR of 17.9% in the US by 2034 | DelveInsight

The MASH treatment landscape is evolving rapidly, driven by a diverse array of therapeutic classes, each with unique mechanisms and potential impacts. The forecast period reveals significant shifts and emerging trends that will shape future market dynamics. LAS VEGAS, Jan. 30, 2025 /PRNewswire/ -- DelveInsight's Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report According to DelveInsight's analysis, the market size for MASH was found to be USD 2.1 billion in the 7MM in 2023. In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM. Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years. The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others. In March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis. Discover which therapies are expected to grab the major MASH market share @ Metabolic Dysfunction-Associated Steatohepatitis Market Report Metabolic Dysfunction-Associated Steatohepatitis Overview Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer. The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition. MASH is often asymptomatic in its early stages. When symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise. Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity. Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The MASH market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of MASH Diagnosed Prevalent Cases of MASH Gender-specific Diagnosed Prevalent Cases of MASH Severity-specific Diagnosed Prevalent Cases of MASH Metabolic Dysfunction-Associated Steatohepatitis Treatment Market The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients' quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease. The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient. Antifibrotic agents can help prevent the progression of liver fibrosis and MASLD into fibrotic MASH. The role of pioglitazone, an anti-diabetic medication, in improving MASH histology in T2DM patients is well-documented, but concerns remain regarding potential side effects like weight gain, fluid retention, cancer risk, and bone fractures. Additional therapeutic targets for MASLD and MASH include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRα), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery, or weight loss surgery, is the most effective intervention for treating obesity and diabetes, as it reduces food absorption while influencing gut hormone secretion and metabolic function. To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies Lanifibranor (IVA337): Inventiva Pharma Semaglutide: Novo Nordisk A/S Azemiglitazone (MSDC-0602K): Cirius Therapeutics Efruxifermin (EFX): Akero Therapeutics BIO89-100 (Pegozafermin): 89bio Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma GR-MD-02 (Belapectin): Galectin Therapeutics LPCN1144: Lipocine VK2809: Viking Therapeutics Tirzepatide: Eli Lilly and Company BOS-580: Boston Pharmaceuticals Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer HTD1801: HighTide Biopharma Leronlimab (PRO 140): CytoDyn Efinopegdutide: Merck & Co./Hanmi Pharmaceutical HPG1860: Hepagene (Shanghai) Rencofilstat (CRV431): Hepion Pharmaceuticals EYP001 (Vonafexor): Enyo Pharmaceuticals Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences PXL065: Poxel SA Saroglitazar Magnesium: Zydus Therapeutics Denifanstat (TVB-2640): Sagimet Biosciences ION224: Ionis Pharmaceuticals Miricorilant (CORT118335): Corcept Therapeutics Discover more about MASH drugs in development @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation. Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM. However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA's draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption. Moreover, MASH treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth. Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends Table of Contents Related Reports Non-Alcoholic Steatohepatitis Epidemiology Forecast Non-Alcoholic Steatohepatitis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted NASH epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., 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, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc. , among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key NAFLD companies, including BeiGene, Inventiva Pharma, Cirius Therapeutics, Madrigal Pharma, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Dr. Falk Pharma GmbH, Sagimet Biosciences, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Afimmune, Poxel SA, AngioLab, Pfizer, Oramed Pharmaceuticals, Can Fite Biopharma, MediciNova, Metacrine, Inc., 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, Enanta Pharmaceuticals, Cascade Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

08 Jan 2025

·www.prnewswire.com

Cirius to Present at WuXi Global Forum during J.P. Morgan Healthcare Week

GRAND RAPIDS, Mich., Jan. 8, 2025 /PRNewswire/ -- Cirius Therapeutics, Inc. today announced Robert Beardsley, Ph.D., President & CEO, and Jerry Colca, Ph.D., CSO, will present and host a roundtable discussion, "Unlocking the Next Frontier of Metabolic Medications in Combination with the GLP-1s," at the Wuxi Global Forum. The WuXi Forum is being held at the Hilton Union Square in San Francisco. coinciding with the 43rd Annual J.P. Morgan Healthcare Conference. Cirius' roundtable is Tuesday, January 14 at 5:00 – 6:00 PM PT. Drs. Beardsley and Colca will discuss Cirius' novel oral insulin sensitizer, azemiglitazone (MSDC-0602K), and particularly its potential benefits in combination with GLP-1s in patients with type 2 diabetes (T2D) or obesity/overweight. In Phase 2 clinical trials, 0602K has improved glycemic control in patients already on background GLP-1 therapy but not able to achieve their HbA1c goal, a problem that confronts substantial numbers of patients with T2D and their doctors. In pre-clinical experiments, 0602K has also been shown to improve body composition, and quality of weight loss in combination with GLP-1s. About Cirius Cirius is a clinical-stage pharmaceutical company developing innovative therapies for patients suffering with diseases caused by insulin resistance, including type 2 diabetes (T2D) and obesity/overweight. Its lead product candidate, azemiglitazone (MSDC-0602K), is a potential best-in-class small molecule being developed as a once-daily oral therapy designed to selectively inhibit the mitochondrial target MPC. Proper function of MPC is crucial for maintaining metabolic balance and energy homeostasis. Inhibition re-balances mitochondrial metabolism and restores insulin response in cells and organs throughout the body. This improves glycemic control in T2D, body composition in obesity, liver function and fibrosis in metabolic dysfunction-associated steatohepatitis (MASH), and outcomes in cardiometabolic disorders. About Azemiglitazone (MSDC-0602K) Azemiglitazone has completed 7 US clinical trials, including a 52-week placebo-controlled Phase 2b study in subjects with MASH with and without T2D, and a 28-day placebo-controlled Phase 2a study in subjects with T2D. It has completed preclinical studies demonstrating increased lean muscle mass and function, and marked shifts to metabolically beneficial adipose tissue, ("good fat"), including brown adipose tissue ("brown fat"). Selectively targeting MPC – while avoiding PPARg activation – 0602K harnesses the real-world proven efficacy of 1st generation insulin sensitizers but without their side effect concerns. Coupling this potent pharmacology with that of the GLP-1s could particularly benefit both patients with T2D and those with obesity/overweight. Phase 3 clinical development will confirm the potential of 0602K to fulfill the promise of direct insulin sensitizers in reversing insulin resistance, the underlying pathophysiology of chronic metabolic disease. SOURCE Cirius Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2

29 Sep 2024

·www.biospace.com

Lilly, Takeda Face Class-Action Racketeering Lawsuit Over Diabetes Drug

Pictured: Judicial gavel and scales of justice/Courtesy iStock A California Federal Judge has certified a class-action case against Eli Lilly and Takeda, accusing the pharmaceutical companies of racketeering after they allegedly marketed their diabetes drug Actos (pioglitazone) without disclosing its risk of bladder cancer, according to a report by Bloomberg. In his May 24 opinion, which was unsealed Monday, District Judge John Holcomb granted the certification of a National Third-Party Payer (TPP) Class consisting of thousands of TPPs that reimbursed patients for Actos between July 1, 1999 and September 17, 2010. Holcomb appointed Painters and Allied Trades District Council 82 Health Care Fund to represent this class. However, the district judge refused to certify a California Consumer Class, citing lack of convincing evidence. This class was supposed to represent all consumers in the state who paid or otherwise incurred costs related to Actos. Holcomb also directed both parties—the TPP plaintiffs as well as Lilly and Takeda—to settle on a case schedule by June 16. BioSpace reached out to Takeda and Lilly for comment on the class-action lawsuit, but the companies were not immediately available. Actos was approved by the FDA in July 1999 to improve glycemic control in adults with Type 2 diabetes. The drug’s label bears a boxed warning for congestive heart failure. Actos also comes with a risk of edema, hepatic side effects, hypoglycemia and bladder cancer. The FDA announced in September 2010 that it was conducting a review of an epidemiological study to assess whether Actos was associated with a heightened likelihood of bladder cancer. When this review ended in June 2011, the regulator found that prolonged use of Actos, lasting for more than a year, could aggravate the risk of this malignancy. “The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone,” the FDA wrote at the time. Actos’ label was amended accordingly following these findings. In their lawsuit, the plaintiffs allege that Lilly and Takeda knew of this risk and instead misled the FDA “by generating false studies, manipulating study results, and controlling the messaging about Actos to conceal aspects about the drug’s mechanism that could have raised concerns,” Holcomb wrote in his opinion. Several patients and payers filed lawsuits against the companies, which culminated in a $9 billion jury ruling in 2014 against Lilly and Takeda, though this payout was eventually drastically reduced. Takeda settled the lawsuits in April 2015 for around $2.4 billion. Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Drug ApprovalPatent Infringement

100 Deals associated with Pioglitazone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00945	Pioglitazone Hydrochloride	A10BG03	DB01132

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	Takeda Pharmaceuticals U.S.A., Inc.	15 Jul 1999

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hearing Loss, Sudden	Phase 3	CZ	Strekin AGStartup	24 Feb 2018
Hearing Loss, Sudden	Phase 3	DE	Strekin AGStartup	24 Feb 2018
Hearing Loss, Sudden	Phase 3	CH	Strekin AGStartup	24 Feb 2018
Alzheimer Disease	Phase 3	US	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Alzheimer Disease	Phase 3	AU	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Alzheimer Disease	Phase 3	DE	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Alzheimer Disease	Phase 3	CH	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Alzheimer Disease	Phase 3	GB	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Mild cognitive disorder	Phase 3	US	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Mild cognitive disorder	Phase 3	AU	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04604223 (Pubmed \| Front Immunol) Manual	Phase 4	COVID-19 \| Diabetes Mellitus, Type 2	350	Pioglitazone	ojcyuhydly(mkgsdfphti) = no significant difference in the CRP reduction was observed between the two groups tpkmjizsfx (gusrvyxcpk ) View more	Negative	06 Sep 2024
				Placebo
NCT01107717 (EDICT, CTgov)	Phase 4	Diabetes Mellitus, Type 2	318	exenatide+pioglitazone+metformin (Triple Therapy)	imtykgknjo(ntsyzvqova) = wjcuvabyez ldolclbnhp (rumrpjcbdu, dcdfojuyqz - rtjtunzkyy) View more	-	05 Sep 2024
				glargine+metformin+glyburide (Conventional Therapy)	imtykgknjo(ntsyzvqova) = bognimcdcf ldolclbnhp (rumrpjcbdu, byrylyaavl - jcraslhpoo) View more
NCT04885712 (Pubmed \| Clin Ther) Manual	Phase 3	Diabetes Mellitus, Type 2 Add-on	366	Pioglitazone 15 mg	afuenafzph(mycpklrwsi) = ggapldpegg wziylcbixo (opojnvsozr )	Positive	01 Jul 2024
				Pioglitazone 30 mg	afuenafzph(mycpklrwsi) = vphamsozvl wziylcbixo (opojnvsozr )
ADA2024	Not Applicable	Diabetes Mellitus, Type 1	-	Dapagliflozin 10 mg + Pioglitazone 45 mg	ydkvpyzsvl(aipyiszemh) = vwnkcckyca jntancykhv (xavfmyviur, 0.18) View more	-	14 Jun 2024
				Dapagliflozin 10 mg + Placebo	ydkvpyzsvl(aipyiszemh) = zygrybymut jntancykhv (xavfmyviur, 0.11) View more
NCT05226897 (Pubmed) Manual	Phase 3	Diabetes Mellitus, Type 2	249	YYC405+Metformin+Dapagliflozin	utwkdtnhyd(jwhbbzcjaa) = Pioglitazone administration resulted in a significant reduction in HbA1c levels (from 7.80% ± 0.72% to 7.27% ± 0.82%) compared with placebo (from 7.79% ± 0.76% to 7.69% ± 0.86%, corrected mean difference: -0.42% ± 0.08%; p < 0.01). miafyaygcl (konxzjeggv )	Positive	29 Feb 2024
				Placebo+Metformin+Dapagliflozin
NCT04604223 (EASD2023)	Phase 4	COVID-19	343	Pioglitazone	remkxqqkch(gyiumpocgv) = yfpituunxn ecdatszbto (mbhoungiqu )	Negative	04 Oct 2023
				Placebo	remkxqqkch(gyiumpocgv) = kzoqajizmk ecdatszbto (mbhoungiqu )
NCT04123067 (CTgov)	Phase 1/2	Diabetes Mellitus \| Hyperglycemia \| Acute Ischemic Stroke	1	Pioglitazone 45 mg (Pioglitazone Treatment Group)	csrcfaldkb(tkytzosagk) = ribolbqglg regwisouwk (xkhjsolxvq, fubyyfokxe - rqvrfsehcf) View more	-	15 Sep 2022
				Placebo oral tablet (Placebo Group)	csrcfaldkb(tkytzosagk) = jbpktjcxna regwisouwk (xkhjsolxvq, redzakyxhd - vdbgzwgsge) View more
NCT03011775 (EFFORT, CTgov)	Phase 4	Metabolic Syndrome \| Coronary Artery Disease \| Atherosclerosis	43	Rosuvastatin Calcium 20 MG Oral Tablet+Bisoprolol Fumarate 2.5 MG Oral Tablet+Ramipril 5 MG+Isosorbide Dinitrate 10Mg Tablet+Pioglitazone 15 mg Tablet+Acetylsalicylic Acid 75Mg Tablet (Pioglitazone + Standard Care)	jjhcazfjas(obbtyzseei) = unqybojalx oudfcorhwp (rupnokezvk, mdgubwzisp - xsepwtpozw) View more	-	10 Mar 2022
				Rosuvastatin Calcium 20 MG Oral Tablet+Bisoprolol Fumarate 2.5 MG Oral Tablet+Ramipril 5 MG+Isosorbide Dinitrate 10Mg Tablet+Acetylsalicylic Acid 75Mg Tablet (Standard Care)	jjhcazfjas(obbtyzseei) = kcowrghntp oudfcorhwp (rupnokezvk, ildpejngwl - zofslafynh) View more
NCT02338999 (CTgov)	Phase 1/2	Systemic Lupus Erythematosus	88	Placebo+Pioglitazone (Pioglitazone, Then Placebo)	aoyxtrfiaf(slbmspxwcq) = ecwouypptg iplcfbcbyn (mkebgjjyye, syncnjunnv - cpiqxgylnq) View more	-	14 Sep 2021
				Placebo+Pioglitazone (Placebo, Then Pioglitazone)	aoyxtrfiaf(slbmspxwcq) = pvpqdcpgum iplcfbcbyn (mkebgjjyye, ssdthsqvnn - dicfrxtdzh) View more
NCT01068444 (Pubmed \| Hepatol Int)	Phase 2	Nonalcoholic Steatohepatitis	90	Pioglitazone 30 mg/day	bcjlqrqinx(jfetzvqiey) = tdksmvyytn iyibapuzxp (swxezwbbjv ) View more	Positive	12 Aug 2021

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