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Last update 11 May 2025

Pioglitazone Hydrochloride

Last update 11 May 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

Action

agonists

Mechanism

PPARγ agonists(Peroxisome proliferator-activated receptor γ agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication

Abdominal PainAlzheimer DiseaseAsthma+ [24]

Originator Organization

Takeda Pharmaceutical Co., Ltd.

Active Organization

Accord Healthcare SLU

Takeda Pharmaceutical Co., Ltd.Takeda Pharmaceuticals U.S.A., Inc.

+ [6]

Inactive Organization

KRKA ddTeva Pharmaceuticals Europe BVVaia S.A.

+ [4]

License Organization

Celltrion, Inc.

Celltrion Healthcare Co., Ltd.

Eli Lilly & Co.

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (15 Jul 1999),

Diabetes Mellitus, Type 2

RegulationOrphan Drug (United States), Orphan Drug (European Union)

Structure/Sequence

Molecular FormulaC19H21ClN2O3S

InChIKeyGHUUBYQTCDQWRA-UHFFFAOYSA-N

CAS Registry112529-15-4

511

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 May 2025

Sponsor / Collaborator

Mayo Clinic

[+1]

NCT06922656

/ Not yet recruitingPhase 4IIT

Can the Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?

Previous data from our clinical trial has demonstrated that the combination of dapagliflozin plus pioglitazone cause robust decrease in the plasma glucose concentration without significant increase in plasma ketone concentration in subjects with T1DM receiving multiple insulin injections or insulin pump. Although patients receiving insulin therapy with pump have participated in the study, none has insulin delivered in automated pump (780 pump) which automatically adjusts the rate of insulin infusion based upon the measured plasma glucose concentration. Although automated insulin pumps have been introduced to practice only last year, they are gaining popularity in the care of T1DM patients worldwide. The aim of this amendment is to demonstrate the efficacy (decrease in HbA1c) and safety (no significant increase in plasma ketone concentration) of combination of dapagliflozin plus pioglitazone in T1DM patients receiving insulin therapy with automated insulin pump.

Start Date15 Apr 2025

Sponsor / Collaborator

Dasman Diabetes Institute

ChiCTR2500100193

/ SuspendedPhase 4IIT

Clinical observation of pioglitazone or sitaglipta sodium combined with metformin in the treatment of newly diagnosed type 2 diabetes with fatty liver

Start Date15 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Pioglitazone Hydrochloride

100 Translational Medicine associated with Pioglitazone Hydrochloride

100 Patents (Medical) associated with Pioglitazone Hydrochloride

6,940

Literatures (Medical) associated with Pioglitazone Hydrochloride

31 Dec 2025·ANNALS OF MEDICINE

PPAR-mediated reduction of lipid accumulation in hepatocytes involves the autophagy-lysosome-mitochondrion axis

Article

Author: Cetti, Federica ; Ossoli, Alice ; Gomaraschi, Monica ; Da Dalt, Lorenzo ; Garavaglia, Carola ; Norata, Giuseppe Danilo

BACKGROUND AND AIM:

Lipid accumulation in hepatocytes is reduced by the activation of the peroxisome proliferator-activated receptor (PPAR) α, which is associated with increased lysosomal acid lipase (LAL) activity, transcription factor EB (TFEB) expression, and mitochondrial β-oxidation.Aim of the study was to assess whether the three isoforms of PPAR, i.e. α, δ and γ, share the same ability to reduce lipid accumulation in hepatocytes and to clarify the involvement of autophagy activation, lysosomal hydrolysis, and mitochondrial β-oxidation in lipid clearance induced by PPARs.

METHODS:

HepG2 cells were treated with oleate/palmitate (O/P) to induce lipid accumulation and exposed to the PPARα agonist fenofibric acid, the γ agonist pioglitazone, the δ agonist seladelpar, or the dual α/γ agonist saroglitazar.

RESULTS:

The treatment of HepG2 cells with fenofibric acid, pioglitazone, seladelpar, or saroglitazar halved lipid accumulation induced by O/P. PPAR agonists increased TFEB, p62, and LC3 expression and rescued LAL impairment induced by O/P. Moreover, PPAR agonists significantly increased mitochondrial mass and the expression of genes involved in mitochondrial dynamics and fatty acid catabolism. Interestingly, PPAR agonists lost their ability to reduce lipid accumulation when autophagic flux, LAL activity, or fatty acid transport in the mitochondria were blocked by specific inhibitors.

CONCLUSION:

All PPAR agonists were able to promote the clearance of lipids in cells loaded with long-chain fatty acids. The key role of acid hydrolysis to generate fatty acids, which can be then catabolized in the mitochondria, and the ability of the PPAR system to sustain each phase of this clearing process were elucidated.

01 Dec 2025·INFLAMMATION RESEARCH

Peroxisome proliferator-activated receptor gamma prevents activation of RBL-2H3 cells by inhibiting FcεRI-mediated signal transduction

Article

Author: Xie, Yuhang ; Ruan, Suyu ; Wang, Weihua ; Zhang, Yu ; Rui, Xiaoqing ; Zhou, Jianjun

BACKGROUND:

Mast cells are essential contributors to the pathophysiology of allergic diseases. Peroxisome proliferator-activated receptor gamma (PPAR-γ) has recently been identified as being involved in the anti-inflammatory response by inhibiting mast cell activation.

METHOD:

In this study, the PPAR-γ agonist pioglitazone (PIO) was employed to evaluate the effects of PPAR-γ on the degranulation and production of pro-inflammatory mediators in RBL-2H3 cells. Meanwhile, differentially expressed genes (DEGs) were characterised in mast cells exposed to PIO, and pathway enrichment analysis were conducted. Furthermore, we conducted validation to confirm the involvement of PPAR-γ signaling pathways in the FcεRI-mediated signal transduction in mast cells.

RESULTS:

Administration of PIO significantly reduced the release of β-hexosaminidase and the mRNA expression levels of pro-inflammatory cytokines induced by the cross-linking of FcεRIs expressed on the surface of RBL-2H3 cells. A total of 24 DEGs were identified between RBL-2H3 cells treated with and without PIO, and there were 15 up-regulated and 9 down-regulated. GO and KEGG analyses revealed that the immune system, signal transduction, infectious disease, and signaling molecules and interactions were the most enriched annotations. According to PPI network analysis, most DEGs interacted with PPAR-γ. PPAR-γ agonist could activate PPAR-γ and NRF2 signaling pathways in resting RBL-2H3 cells. The protein expression levels of PPAR-γ, Cpt1a, and Acsl4 were greatly upregulated in activated RBL-2H3 cells mediated by FcεRI aggregation. Moreover, the suppressive effects of PPAR-γ agonist on degranulation and phosphorylation levels of FcεRI-mediated signaling molecules in RBL-2H3 cells were PPAR-γ-dependent.

CONCLUSION:

These data demonstrate that PPAR-γ inhibits FcεRI-mediated mast cell activation by modulating intracellular-specific signal transduction in a PPAR-γ-dependent manner.

01 Dec 2025·JOURNAL OF COMPUTER-AIDED MOLECULAR DESIGN

Computational investigation to identify multi-targeted anti-hyperglycemic potential of substituted 2-Mercaptobenzimidazole derivatives and synthesis of new α-glucosidase inhibitors

Article

Author: Ahmed, Madiha ; Zargaham, Muhammad Kazim ; Waseem, Tanya ; Rajput, Tausif Ahmed ; Nadeem, Humaira ; Amin, Adnan

One of the most widespread diseases recognized all over the world is diabetes, accounting for 1.5 million deaths each year. Recent studies have demonstrated benzimidazole derivatives as potential antidiabetic agents. Hence, the present study is focused on designing new derivatives of 2-mercaptobenzimidazole by C-S cross-coupling reaction and are subjected to computational screening to identify the most promising candidate. Molecular docking and MM-GBSA calculations were performed to ascertain the binding potential with different antidiabetic targets, including α-glucosidase, PPaR-γ, DPP-4, and AMPK. We observed somewhat moderate binding interactions of the synthesized compound against the α-glucosidase. Since binding affinities can be improved using synthetic chemistry approaches, synthesis of analogues (A-18a-c) by designing hybrids at sites such as the acidic functionality of A-18 was done. The analogue A-18a, with p-fluorobenzyl substitution, exhibited enhanced binding affinity (-4.339 Kcal/mol) with the α-glucosidase compared to the parent compound (-3.827 Kcal/mol). The synthesized analogues were also subjected to an in-vitro α-glucosidase inhibitory assay. Among them, A-18a exhibited the most significant inhibitory potential, with an IC₅₀ value of 0.521 ± 0.01 µM as compared to the standard drug Acarbose (IC₅₀ 21.0 ± 0.5 µM). This aligns with the computational study findings, where A-18a exhibited stronger binding interactions within the active site of the enzyme. Hence, a promising analogue of the designed compound was synthesized through a computationally guided approach as an anti-hyperglycaemic agent. Additionally, most of the designed compounds showed significantly greater binding affinity with PPaR-γ as compared to the standard pioglitazone. A-18 was successfully synthesized by S-arylation reaction using CuI in 89% yield and was subjected to MD-simulation against PPaR-γ, which revealed stable binding throughout the 200 ns run. Future studies will focus on exploring the activity of the designed drugs against PPaR-γ through in-vitro and in-vivo assays.

News (Medical) associated with Pioglitazone Hydrochloride

01 May 2025

·investors.alnylam.com

Alnylam Pharmaceuticals Reports First Quarter 2025 Financial Results and Highlights Recent Period Progress

Achieved global net product revenues for AMVUTTRA and ONPATTRO for the first quarter of $310 million and $49 million , respectively, representing 36% growth compared to Q1 2024. Achieved global net product revenues for GIVLAARI and OXLUMO for the first quarter of $67 million and $42 million , respectively, representing 8% growth compared to Q1 2024. Strong progress making AMVUTTRA available for ATTR-CM in various global markets. Received U.S. FDA approval of the supplemental New Drug Application (sNDA) for AMVUTTRA for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. Received approval from ANVISA ( Brazilian Health Regulatory Agency ) for ATTR-CM. Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of vutrisiran for the treatment of ATTR-CM. Marketing authorization applications based on data from the landmark HELIOS-B Phase 3 clinical trial are currently under review by several global health agencies including the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Presented new data from HELIOS-B at the American College of Cardiology Scientific Session 2025, further supporting vutrisiran’s compelling therapeutic profile, including: Echocardiographic data demonstrating that treatment with vutrisiran led to significant improvements in diastolic function and attenuation of declines in left ventricular (LV) and right ventricular (RV) systolic function at Month 18, compared to placebo. HELIOS-B included the largest systematic echocardiographic study conducted to date in an ATTR pivotal trial. An exploratory subgroup analysis demonstrating that vutrisiran reduced all-cause mortality and recurrent cardiovascular events compared to placebo across a range of baseline heart failure severities in patients with ATTR-CM. These data were also published in the Journal of the American College of Cardiology . A separate analysis confirming that vutrisiran significantly maintained or improved functional capacity, and patient-reported health status and quality of life, compared to placebo over 30 months. These data were also published in the Journal of the American College of Cardiology . Presented updates from the Company’s robust pipeline and organic platform at R&D Day. Disclosed two new clinical programs: ALN-6400, targeting liver-derived plasminogen, which could represent a universal hemostatic agent for the treatment of bleeding disorders without the risk of thrombosis. ALN-4324, targeting GRB14, a potential insulin sensitizer for the treatment of type 2 diabetes. Alnylam announces today that a Phase 1 clinical trial for ALN-4324 has been initiated. Shared encouraging data from our expanding neuroscience franchise, including an update on the new ALN-HTT02 program, which has a highly differentiated exon-1-targeting approach to lower huntingtin (HTT) for Huntington’s disease. Presented new preclinical data on delivery solutions with best-in-class potential for adipose, muscle, heart, and kidney tissue and for crossing the blood-brain barrier, supporting Alnylam’s aspiration to unlock every major tissue for RNAi therapeutics by 2030. Received U.S. FDA approval of the supplemental New Drug Application (sNDA) for AMVUTTRA for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. Received approval from ANVISA ( Brazilian Health Regulatory Agency ) for ATTR-CM. Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of vutrisiran for the treatment of ATTR-CM. Marketing authorization applications based on data from the landmark HELIOS-B Phase 3 clinical trial are currently under review by several global health agencies including the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Echocardiographic data demonstrating that treatment with vutrisiran led to significant improvements in diastolic function and attenuation of declines in left ventricular (LV) and right ventricular (RV) systolic function at Month 18, compared to placebo. HELIOS-B included the largest systematic echocardiographic study conducted to date in an ATTR pivotal trial. An exploratory subgroup analysis demonstrating that vutrisiran reduced all-cause mortality and recurrent cardiovascular events compared to placebo across a range of baseline heart failure severities in patients with ATTR-CM. These data were also published in the Journal of the American College of Cardiology . A separate analysis confirming that vutrisiran significantly maintained or improved functional capacity, and patient-reported health status and quality of life, compared to placebo over 30 months. These data were also published in the Journal of the American College of Cardiology . Disclosed two new clinical programs: ALN-6400, targeting liver-derived plasminogen, which could represent a universal hemostatic agent for the treatment of bleeding disorders without the risk of thrombosis. ALN-4324, targeting GRB14, a potential insulin sensitizer for the treatment of type 2 diabetes. Alnylam announces today that a Phase 1 clinical trial for ALN-4324 has been initiated. Shared encouraging data from our expanding neuroscience franchise, including an update on the new ALN-HTT02 program, which has a highly differentiated exon-1-targeting approach to lower huntingtin (HTT) for Huntington’s disease. Presented new preclinical data on delivery solutions with best-in-class potential for adipose, muscle, heart, and kidney tissue and for crossing the blood-brain barrier, supporting Alnylam’s aspiration to unlock every major tissue for RNAi therapeutics by 2030. ALN-6400, targeting liver-derived plasminogen, which could represent a universal hemostatic agent for the treatment of bleeding disorders without the risk of thrombosis. ALN-4324, targeting GRB14, a potential insulin sensitizer for the treatment of type 2 diabetes. Alnylam announces today that a Phase 1 clinical trial for ALN-4324 has been initiated. Net product revenues increased 28% and 30% at actual currency and CER, respectively, during the three months ended March 31, 2025 , as compared to the same period in 2024, due to growth from AMVUTTRA driven by increased patient demand, partially offset by a decrease in ONPATTRO due to patient switches to AMVUTTRA, as well as an increased number patients on GIVLAARI. Net revenues from collaborations decreased during the three months ended March 31, 2025 , as compared to the same period in 2024, primarily due to recognition of $65.0 million of revenue associated with a milestone under our Roche Collaboration from dosing the first patient in the zilebesiran KARDIA-3 clinical trial during the three months ended March 31, 2024 , which did not reoccur during the three months ended March 31, 2025 . This was partially offset by increased revenue recognized in connection with our Regeneron Collaboration during the three months ended March 31, 2025 as a result of an increase in activities under our licensed programs and recognition of a $30.0 million payment in connection with the amendment to our agreement with Vir Biotechnology, Inc. in March 2025 . Cost of goods sold as a percentage of net product revenues was consistent during the three months ended March 31, 2025 , as compared to the same period in 2024. GAAP R&D expenses increased during the three months ended March 31, 2025 , as compared to the same period in 2024, primarily due to: increased stock-based compensation expense; and increased clinical trial expenses primarily associated with zilebesiran in the KARDIA-3 clinical trial and mivelsiran in the cAPPRicorn-1 clinical trial due to increased Phase 2 activities, as well as startup activities and other clinical trial expenses associated with zilebesiran in the KARDIA-6 cardiovascular outcomes trial and nucresiran in the TRITON-CM Phase 3 clinical trial in patients with ATTR amyloidosis with cardiomyopathy. increased stock-based compensation expense; and increased clinical trial expenses primarily associated with zilebesiran in the KARDIA-3 clinical trial and mivelsiran in the cAPPRicorn-1 clinical trial due to increased Phase 2 activities, as well as startup activities and other clinical trial expenses associated with zilebesiran in the KARDIA-6 cardiovascular outcomes trial and nucresiran in the TRITON-CM Phase 3 clinical trial in patients with ATTR amyloidosis with cardiomyopathy. decreased expenses within other clinical programs, specifically the HELIOS-B Phase 3 clinical trial of vutrisiran due to the wind-down of clinical activities. GAAP and non-GAAP SG&A expenses increased during the three months ended March 31, 2025 , as compared to the same period in 2024, primarily due to increased marketing investment associated with the promotion of our TTR therapies and increased employee compensation expenses. Interest expense for the three months ended March 31, 2025 of $38.6 million included interest of $35.0 million attributed to the liability related to the sale of future Leqvio royalties. Other expense, net for the three months ended March 31, 2025 of $59.7 million included a charge associated with the change in fair value of the development derivative liability of $58.9 million , attributed to valuation updates primarily driven by the regulatory approval of AMVUTTRA for the treatment ATTR-CM. During the three months ended March 31, 2025 , we recorded a provision for income taxes of $15.9 million , primarily due to income generated in Switzerland . We will utilize deferred tax assets in Switzerland to offset current cash tax liabilities and will continue to maintain a full valuation allowance against our net deferred tax assets in the U.S. and certain deferred tax assets in Switzerland . Cash, cash equivalents and marketable securities were $2.63 billion as of March 31, 2025 , as compared to $2.69 billion as of December 31, 2024 , with the decrease primarily driven by operating activities. Net cash used in operating activities for the three months ended March 31, 2025 of $118.3 million , included $61.7 million of payments associated with the liability related to the sale of future Leqvio royalties allocated to interest. Net cash provided by financing activities for the three months ended March 31, 2025 of $44.1 million , included $5.3 million of payments associated with an achieved development milestone for the development derivative liability.

Drug ApprovalPhase 1Phase 3Clinical ResultFinancial Statement

19 Mar 2025

·www.drugs.com

American Academy of Dermatology, March 7 to 11

The annual meeting of the American Academy of Dermatology was held from March 7 to 11 in Orlando, Florida, and attracted clinicians, academicians, allied health professionals, and others interested in dermatology. The conference highlighted recent advances in the diagnosis and management of dermatological conditions. During one presentation, Joshua Cook, M.D., of the Columbia University Irving Medical Center in New York City, noted that targeting insulin resistance and hyperinsulinemia is important not only for the treatment of obesity and diabetes, but potentially also independently for improving metabolism-related inflammatory skin diseases like psoriasis and hidradenitis suppurativa. Cook discussed the tight epidemiologic connection between obesity, type 2 diabetes, and inflammatory skin diseases, especially psoriasis. The mechanistic basis of this connection is likely due to insulin resistance and/or hyperinsulinemia. Cook noted that hyperinsulinemia likely drives excessive proliferation and inflammation of skin lesions in psoriasis and other inflammatory skin diseases, even in the setting of systemic insulin resistance. "We are currently performing clinical studies to better understand the role of insulin action in psoriasis," Cook said. "Health care providers should strongly consider screening patients with overweight/obesity and inflammatory skin diseases with hemoglobin A1c, fasting glucose, and lipid profiles. Treatment of obesity and type 2 diabetes with glucagon-like peptide-1 receptor agonists may improve inflammatory skin disease activity (an area of active research). There may also be roles for metformin and pioglitazone in inflammatory skin disease treatment in select patients." Abstract During another presentation, Daniel Charles Butler, M.D., of the University of Arizona College of Medicine in Tucson, discussed the connection between itch and aging. Butler discussed how itch is very common in the older adult population. He noted there are many etiologic contributors to itch, including the immune system, the skin barrier, and the cutaneous nerves, all of which are uniquely impacted by aging. "As practicing clinicians, we need to substantiate itch as a real, impactful but targetable symptom and disease," Butler said. "The connection between age and itching allows us to target contributing etiologies with available treatments. For example, itch in older adults is often multifactorial with immunologic changes and neuropathic changes. This allows us to use treatment to target multiple contributors." Butler disclosed financial ties to the pharmaceutical industry. Abstract Adam J. Friedman, M.D., of the George Washington School of Medicine and Health Sciences in Washington, D.C., discussed how food allergy is an extremely rare cause of chronic urticaria with no identifiable cause (CSU), and some food intolerances may contribute, but responses are highly individualized and elimination diets should only be done in a structured way. Friedman provided insight into how urticaria, both acute and chronic, is a common condition, affecting as many as 80 percent of people at some point in their lives. For approximately 1 percent of individuals who develop chronic urticaria, this condition can last for years, significantly impacting quality of life. While patients often search for a clear trigger, more than two-thirds of cases occur without an identifiable cause. Although food allergies can trigger acute urticaria, particularly in children, when it comes to CSU, food allergy is rarely a culprit. Friedman noted that, instead, he often sees food intolerances or pseudoallergic reactions, which may contribute to symptoms in some individuals. This distinction is important because a true food allergy involves an immune response, and food intolerances tend to be more variable, harder to predict, and less understood. A number of studies have explored dietary interventions in CSU, but the results so far have been mixed at best. "At the end of the day, lifestyle modifications are cost-effective, noninvasive, and worth exploring, but they require proper education and guidance -- both for patients and physicians. This remains an underfunded and underresearched area, but as interest grows, we may gain clearer insights into how diet influences CSU," Friedman said. "While it's tempting to believe that cutting out a few foods might be a silver bullet, CSU is a complex, multifactorial condition. And as with most things in dermatology, there's rarely a one-size-fits-all approach." Friedman disclosed financial ties to the pharmaceutical industry. Abstract Peggy A. Wu, M.D., of the University of California Davis in Sacramento, discussed how systemic contact dermatitis (SCD) is a diagnosis to consider in the setting of a chronic, recalcitrant rash in the right clinical setting, although the diagnosis is not common. Wu discussed how SCD represents a small subset of allergic contact dermatitis (ACD) diagnoses. Like ACD, SCD is thought to be a delayed hypersensitivity reaction, and as such, reactions follow exposures in hours to days. SCD can present in a myriad of ways, including, most commonly, vesicular bilateral hand dermatitis, generalized dermatitis, and periorificial dermatitis. Frequent causes of SCD include exposure to nickel, balsam of Peru, and fragrance. The diagnosis is usually made in the setting of a chronic rash with positive patch test results to an allergen with plausible, relevant dietary sources and following topical avoidance of identified allergens. "Physicians should consider the diagnosis of SCD in the setting of a recalcitrant chronic rash with certain phenotypes (vesicular bilateral hand dermatitis, generalized dermatitis, periorificial) and positive patch test reactions to allergen(s) with a possible relevant dietary source," Wu said. "A recommended approach to SCD is to start with a one-month trial of dietary modification. Longer courses of dietary modification may benefit from working with a dietitian to maintain nutritional need." Abstract AAD: Baricitinib Efficacious for Hair Regrowth in Teens With Severe Alopecia Areata TUESDAY, March 18, 2025 -- For adolescents with severe alopecia areata, baricitinib is efficacious for hair regrowth, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Read Full Text AAD: Maintenance of Low Eczema Activity Seen After About 80 Days Off Tapinarof FRIDAY, March 14, 2025 -- Patients with atopic dermatitis who achieve completely clear skin with tapinarof ( Vtama ) cream maintain low disease activity after about 80 days off treatment, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Read Full Text AAD: Ivarmacitinib 4 mg, 8 mg Efficacious for Adults With Severe Alopecia Areata THURSDAY, March 13, 2025 -- For adults with severe alopecia areata, ivarmacitinib, a selective Janus kinase 1 inhibitor, at doses of 4 and 8 mg is efficacious and tolerable, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

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

100 Deals associated with Pioglitazone Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D00945	Pioglitazone Hydrochloride	A10BG03	DB01132

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hearing Loss, Sudden	Phase 3	Czechia	Strekin AG	24 Feb 2018
Hearing Loss, Sudden	Phase 3	Germany	Strekin AG	24 Feb 2018
Hearing Loss, Sudden	Phase 3	Switzerland	Strekin AG	24 Feb 2018
Alzheimer Disease	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Alzheimer Disease	Phase 3	Australia	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Alzheimer Disease	Phase 3	Germany	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Alzheimer Disease	Phase 3	Switzerland	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Alzheimer Disease	Phase 3	United Kingdom	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Mild cognitive disorder	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013
Mild cognitive disorder	Phase 3	Australia	Takeda Pharmaceutical Co., Ltd.	01 Aug 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04300127 (PIOGAS, CTgov)	Early Phase 1	Gastroparesis	14	Pioglitazone 30 mg	zvtpubagry(tljxgmhpuy) = jebsykrbnm qoyvqwkdtr (nnffxyeqdu, 0.9) View more	-	30 Apr 2025
NCT00179400 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	26	Pioglitazone (2000-200 Study 10-day Pioglitazone)	tyvlaxxcbr(ckizmcxyzm) = gzrniobkby jmlstgwkyq (ojcanrpkui, 0.19) View more	-	03 Mar 2025
				placebo+pioglitazone (2000-200 Study 10-day Placebo)	tyvlaxxcbr(ckizmcxyzm) = zjtueveqoc jmlstgwkyq (ojcanrpkui, 0.20) View more
NCT04604223 (Pubmed \| Front Immunol) Manual	Phase 4	COVID-19 \| Diabetes Mellitus, Type 2	350	Pioglitazone	ayefyxmckz(fzparrhtch) = no significant difference in the CRP reduction was observed between the two groups yhlutsrhnd (idwkcfiuev ) View more	Negative	06 Sep 2024
				Placebo
NCT01107717 (EDICT, CTgov)	Phase 4	Diabetes Mellitus, Type 2	318	exenatide+pioglitazone+metformin (Triple Therapy)	rlpmgzcwcq(yfpaqibhgy) = zlduwjaodz eucsberwmv (eqljbxdbjm, 0.1) View more	-	05 Sep 2024
				glargine+metformin+glyburide (Conventional Therapy)	rlpmgzcwcq(yfpaqibhgy) = fdohctzucw eucsberwmv (eqljbxdbjm, 0.1) View more
NCT04885712 (Pubmed \| Clin Ther) Manual	Phase 3	Diabetes Mellitus, Type 2 Add-on	366	Pioglitazone 15 mg	firbticpaz(rxzcjgvflg) = shntzdcpmk merifkuifu (rguikkikpd )	Positive	01 Jul 2024
				Pioglitazone 30 mg	firbticpaz(rxzcjgvflg) = rzurhgsyth merifkuifu (rguikkikpd )
ADA2024	Not Applicable	Diabetes Mellitus, Type 1	-	Dapagliflozin 10 mg + Pioglitazone 45 mg	dkfbkgincw(abehseixhy) = jxiarbbtpm gxuadczetb (sjsyckzspb, 0.18) View more	-	14 Jun 2024
				Dapagliflozin 10 mg + Placebo	dkfbkgincw(abehseixhy) = frdpczpins gxuadczetb (sjsyckzspb, 0.11) View more
ISRCTN45546616 \| ISRCTN29234515 \| ISRCTN11062950 (ISRCTN11062950;ISRCTN29234515;ISRCTN45546616, Pubmed)	Phase 3	Polycystic Ovary Syndrome HOTAIR rs1443512 genotype	65	pioglitazone	dmwibymcnn(vukvjdizpe) = ocrduzgisf fuxifewzol (rxkybsarjs ) View more	-	01 Apr 2024
NCT05226897 (Pubmed) Manual	Phase 3	Diabetes Mellitus, Type 2	249	YYC405+Metformin+Dapagliflozin	rpdvgdldwu(imwxaofggx) = 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). sdcaqrqoee (nsazfztumk )	Positive	29 Feb 2024
				Placebo+Metformin+Dapagliflozin
NCT04604223 (EASD2023)	Phase 4	COVID-19	343	Pioglitazone	zacfnbbkbo(dhsxulukwz) = rkoukgkutc tigjorlxrz (epkxusrpos )	Negative	04 Oct 2023
				Placebo	zacfnbbkbo(dhsxulukwz) = nizkrctics tigjorlxrz (epkxusrpos )
ISRCTN29234515 \| ISRCTN11062950 (ESPE2023)	Phase 3	Polycystic Ovary Syndrome HOTAIR rs1443512 genotype -	24	Pioglitazone 7.5 mg/d	jnxczmxvul(hhtgkfmgox) = owptygubra ssfnwytegc (oxjekxtezv, 0.4) View more	Positive	21 Sep 2023

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