A Prospective, Open, Self-controlled Study of the Effects of Chiglitazar Sodium on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes Mellitus (T2DM)

The goal of this clinical trial is to learn about inour study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration.
The main question[s] it aims to answer are:
Quantitative lipidomics information enables in-depth analysis of lipids and can reveal Chiglitazar Sodium-specific lipid metabolic patterns, thereby strengthening lipidomics as a promising tool for exploring the molecular mechanisms of T2DM.
It can also be applied to other T2DM lipidomics studies to better understand lipid metabolism patterns and integration with other omics measures.

Start Date31 Jan 2024

Sponsor / Collaborator

Shanghai First People's Hospital

NCT06125587 / Enrolling by invitationPhase 2/3IIT

Chiglitazar Versus Metformin for Insulin Resistance in Non-obese Patients With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (NIH criteria) to 18% (Rotterdamcriteria). It is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. Moreover it is often accompanied by insulin resistance and obesity. Now, metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. Chiglitazar is a novel peroxisome proliferation activated receptor (PPAR) agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. However, there is limited evidence for its treatment of insulin resistance in women with PCOS. Therefore, we applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.

Start Date01 Nov 2023

Sponsor / Collaborator

ShengJing Hospital

100 Clinical Results associated with Chiglitazar Sodium

100 Translational Medicine associated with Chiglitazar Sodium

100 Patents (Medical) associated with Chiglitazar Sodium

Literatures (Medical) associated with Chiglitazar Sodium

02 Aug 2024·MOLECULAR AND CELLULAR ENDOCRINOLOGY

Chiglitazar attenuates high-fat diet-induced nonalcoholic fatty liver disease by modulating multiple pathways in mice.

Article

Author: Sun, Weiming ; Zhen, Donghu ; Liu, Jinjin ; Liu, Lijuan ; Guan, Conghui ; Tang, Xulei ; Fu, Songbo

Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide; however, effective intervention strategies for NAFLD are still unavailable. The present study sought to investigate the efficacy of chiglitazar, a pan-PPAR agonist, in protecting against NAFLD in mice and its underlying molecular mechanism. Male C57BL/6 J mice were fed a high-fat diet (HFD) for 8 weeks to generate NAFLD and the HFD was continued for an additional 10 weeks in the absence or presence of 5 mg/kg/d or 10 mg/kg/d chiglitazar by gavage. Chiglitazar significantly improved dyslipidemia and insulin resistance, ameliorated hepatic steatosis and reduced liver inflammation and oxidative stress in NAFLD mice. RNA-seq revealed that chiglitazar alleviated HFD-induced NAFLD in mice through multiple pathways, including fatty acid metabolism regulation, insulin signaling pathway, and AMPK signaling pathway. This study demonstrated the potential therapeutic effect of chiglitazar on NAFLD. Chiglitazar ameliorated NAFLD by modulating multiple pathways.

01 Feb 2024·Journal of diabetes

Impact of chiglitazar on glycemic control in type 2 diabetic patients with metabolic syndrome and insulin resistance: A pooled data analysis from two phase III trials

Article

Author: Pan, Desi ; Yao, He ; Ning, Zhiqiang ; Cao, Haixiang ; Lu, Xianping ; Ai, Guoqiang ; Chen, Bo

Abstract:

Background:

To evaluate the glycemic control effects of vhiglitazar (carfloglitazar), a novel peroxisome proliferator‐activated receptor pan‐agonist, in patients with type 2 diabetes mellitus (T2DM) with metabolic syndrome (MetS) or insulin resistance (IR) using pooled data analysis of two phase III clinical trials.

Methods:

Data were collected from two randomized phase III clinical trials in China, comparing chiglitazar to placebo or sitagliptin in T2DM patients. The MetS was defined by the Adult Treatment Panel III MetS criteria, and IR was defined by homeostatic model assessment for insulin resistance (HOMA‐IR) ≥4.31 (male) or 4.51 (female). The main end point of this analysis was glycemic control in the different arms within each subgroup.

Results:

In the MetS subgroup, changes in glycated hemoglobin (HbA1c) from baseline at week 24 in the chiglitazar 32 mg, chiglitazar 48 mg, and sitagliptin 100 mg arms were −1.44%, −1.68%, and −1.37%, respectively; p < .05 was obtained when chiglitazar 48 mg was compared with sitagliptin. In the IR subgroup, the changes in HbA1c were −1.58%, −1.56%, and −1.26% in chiglitazar 32 mg, chiglitazar 48 mg, and sitagliptin 100 mg arms, respectively; p < .05 was obtained when chiglitazar 32 mg was compared with sitaligptin. The two doses of chiglitazar demonstrated a greater reduction in fasting plasma glucose and 2 h postprandial plasma glucose than sitagliptin in the pooled population and in the MetS and IR subgroups.

Conclusions:

Chiglitazar shows promising efficacy for glycemic control in patients with T2DM associated with MetS or IR. Further prospective trials are required to validate these findings.

01 Nov 2023·iScience

Personalized glucose-lowering effect of chiglitazar in type 2 diabetes

Article

Author: Huang, Qi ; Chen, Yingli ; Zhou, Jian ; Jia, Weiping ; Cai, Xiaoling ; Zhou, Lingli ; Ji, Linong ; Gao, Leili ; Gao, Fei ; Zou, Xiantong

Chiglitazar (carfloglitazar) is a peroxisome proliferator-activated receptor pan-agonist presenting non-inferior glucose-lowering efficacy with sitagliptin in patients with type 2 diabetes. To delineate the subgroup of patients with greater benefit from chiglitazar, we conducted a machine learning-based post-hoc analysis in two randomized controlled trials. We established a character phenomap based on 13 variables and estimated HbA_1c decline to the effects of chiglitazar in reference to sitagliptin. Out of 1,069 patients, 63.3% were found to have greater reduction in HbA_1c levels with chiglitazar, while 36.7% showed greater reduction with sitagliptin. This distinction in treatment response was statistically significant between groups (p_interaction<0.001). To identify patients who would gain the most glycemic control benefit from chiglitazar, we developed a machine learning model, ML-PANPPAR, which demonstrated robust performance using sex, BMI, HbA_1c, HDL, and fasting insulin. The phenomapping-derived tool successfully identified chiglitazar responders and enabled personalized drug allocation in patients with drug-naïve diabetes.

News (Medical) associated with Chiglitazar Sodium

19 Jul 2024

·www.prnewswire.com

Treatment of Type 2 diabetes with Chiglitazar combined with Metformin Approved for listing by the National Medical Products Administration

SHENZHEN, China, July 19, 2024 /PRNewswire/ -- On July 19, Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") announced that it has received the Drug Registration Certificate approved and issued by the National Medical Products Administration (NMPA) for Chiglitazar, a noval PPAR (Peroxidase Proliferator Activated Receptor) full agonist developed by the company's independently, combined with Metformin for the treatment of type 2 diabetes. This is a further expansion of the clinical application of Chiglitazar after it was approved as a single agent for the treatment of type 2 diabetes in October 2021, and will provide a noval therapeutic option of combination for type 2 diabetes patients. As of 2021, the number of diabetes patients in China has reached 141 million, ranking first globally. Type 2 diabetes accounts for more than 90% of the total. As a progressive disease, it seriously affects the quality of life of patients and causes a heavy burden on society. As the disease progresses, the probability of monotherapy failure in type 2 diabetic patients gradually increases. Researches have shown that 50% of newly diagnosed T2DM patients require combination therapy after three years of treatment for patients with initial diabetes; After 9 years of treatment, 75% of patients require combination therapy; In addition, for newly treated patients with high blood glucose levels, such as HbA1c>9%, combination therapy is often necessary to achieve good glycemic control. Therefore, combination therapy is essential for diabetes patients. Insulin resistance, as one of the important pathological mechanisms of the occurrence and development of type 2 diabetes, has always been a focus and challenge of drug development and clinical treatment. It will not only cause hyperglycemia but also lead to hyperlipidemia, overweight/obesity, fatty liver, atherosclerotic cardiovascular disease, etc. Now, Chiglitazar has been approved for adjunction to metformin to improve glycemic control in patients with type 2 diabetes with poor blood glucose control after metformin monotherapy. The randomized, double-blind, placebo-controlled pivotal Phase III clinical trial showed that compared with placebo combined with metformin, Chiglitazar combined with metformin can achieve more clinical benefits such as continuous glucose reduction, blood lipid regulation and cardiovascular risk reduction, which shows the promising application of Chiglitazar in combination with diabetes drugs of different mechanisms. Dr. Xianping Lu, chairman of Chipscreen, said: "Although there are multiple drugs available for the treatment of T2DM, the rapid growth of the number of patients with diabetes indicates that there are still significant unmet clinical needs in this field, whether it is monotherapy or combination therapy. As the first PPAR full agonist approved to treat type 2 diabetes in the world, Chiglitazar with a new mechanism of action has broken the long-term dilemma of etiological treatment of insulin resistance, effectively targeted the metabolic syndrome caused by metabolic disorder, opening up a new path for the treatment of type 2 diabetes and providing clinicians and patients with a more flexible and effective combination drug regimen. About Chiglitazar Chiglitazar (Shuangluoping ®/ Bilessglu ®) is a new mechanism hypoglycemic drug independently developed by Shenzhen Chipscreen Biosciences Co., Ltd. As a new chemical molecule，it belongs to a national Class 1 new drug, national "Major New drug creation" special achievement . It is the first PPAR full agonist which approved for the treatment of type 2 diabetes in the world. Chiglitazar can control blood glucose level and ameliorate the lipid and energy metabolic disorders that accompany T2DM, helping to prevent and control cardiovascular complications. This makes Chiglitazar a potentially more comprehensive treatment option for T2DM. Many basic studies have confirmed that insulin resistance is one of the core pathological mechanisms for the occurrence and development of type 2 diabetes, and it is also the common soil for various metabolic abnormalities such as blood sugar and blood lipid. Insulin resistance will not only cause hyperglycemia, but also lead to hyperlipidemia, overweight/obesity, fatty liver, atherosclerotic cardiovascular disease (ASCVD), etc. However, there are relatively few drug options directly targeting the improvement of insulin resistance in clinical practice. Chiglitazar, a PPAR total agonist, can moderately activate three PPAR receptor subtypes with different functions in regulating glucose, lipid and energy metabolism in vivo, and selectively changes a series of gene expressions related to insulin sensitivity, targeting insulin resistance, the core pathological mechanism of the occurrence and development of type 2 diabetes. Through improving the sensitivity of diabetes patients to insulin, regulating blood sugar, improving their complicated lipid metabolism disorder, potentially reducing the occurrence and harm of cardiovascular complications, bringing better efficacy and safety, and achieving comprehensive treatment of diabetes and its complications. In addition to the indications for type 2 diabetes, Chiglitazar has also carried out clinical exploration of compound preparations of diabetes drugs (metformin-chiglitazar compound, Empagliflozin-chiglitazar compound) and phase II clinical research of single drug treatment of nonalcoholic fatty liver steatohepatitis in China. In October 2021, Chiglitazar was approved by the National Drug Administration (NMPA) to be marketed for the treatment of type 2 diabetes. In January 2023, Chiglitazar was included in the national medical insurance directory. In March 2024, the Phase II clinical trial (CGZ203 study) of Chiglitazar monotherapy for non-alcoholic steatohepatitis achieved the primary efficacy endpoint. In July 2024, the treatment of type 2 diabetes patients with poor blood glucose control after single drug treatment of metformin with Chiglitazar and metformin was approved for marketing by the National Drug Administration (NMPA) of China. About Chipscreen Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Chipscreen Biosciences has formed a complete industrial chain covers from early exploratory discovery to commercialization, providing original Chinese new drugs for global patients. Based on the global development strategy of China's early stage research, Chipscreen Biosciences has been able to open the whole process from basic research to clinical transformation with Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center bringing together top scientists and teams with senior experience in related fields, and applying the integrated technology platform based on AI-driven design and chemical genomics. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, we have marketed two drugs for four indications in Mainland China, two indications in Japan, and one indication in Taiwan, China. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals. Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 660 invention patents in China and worldwide, with over 180 granted. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

Drug ApprovalPhase 2Phase 3

18 Mar 2024

·www.fiercebiotech.com

Chinese biotech's MASH candidate reduces liver fat in phase 2 trial

Chiglitazar has already been approved in China as a treatment for type 2 diabetes in addition to diet and exercise, with Chipscreen looking to expand its use in combination with anti-diabetic drug metformin. Chipscreen Biosciences' metabolic dysfunction-associated steatohepatitis (MASH) candidate reduced patients' liver fat levels, adding further momentum to drugs aimed at the condition. The Shenzhen, China-based biotech says chiglitazar produced “significant and dose-dependent reductions” in liver fat content from baseline compared to placebo during a phase 2 study, according to a Monday press release. The company did not provide data to support the primary endpoint win and said more will be revealed at an upcoming conference or in a medical journal. Chipscreen also reported that patients given chiglitazar “showed significant or dose-dependent trend of improvements” on a number of secondary endpoints. As for safety, Chipscreen kept it short and sweet: “The overall safety is good.” Chiglitazar has already been approved in China as a treatment for type 2 diabetes in addition to diet and exercise, with Chipscreen looking to expand its use in combination with anti-diabetic drug metformin. The sampling of phase 2 data teased Monday comes days after Madrigal Pharmaceuticals scored the first-ever FDA approval to treat MASH, which has previously been known as non-alcoholic steatohepatitis (NASH). The much-hyped class of GLP-1 medications have also shown promise as potential MASH treatments. Chipscreen’s metabolic ambitions have grown in parallel with the biotech’s oncology work, centered on its epigenetic modulator, chidamide. The drug is approved in China as a treatment for peripheral T-cell lymphoma and breast cancer, with ongoing trials testing it in patients with diffuse large B cell lymphoma and non-small cell lung cancer.

Drug ApprovalClinical ResultPhase 2

18 Mar 2024

·www.prnewswire.com

Positive results from Phase II clinical trial (CGZ203 study) of Chiglitazar monotherapy for non-alcoholic steatohepatitis

SHENZHEN, China, March 18, 2024 /PRNewswire/ -- On March 18 2024, Shenzhen chipscreen biosciences Co., Ltd. (hereinafter referred to as "chipscreen biosciences", stock code: 688321. SH) announced that the Phase II clinical trial (CGZ203 study) of chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH) was successfully completed with data cleaning and database locking on February 22, 2024. The primary efficacy endpoint of the trial has been achieved, and further data analysis is currently underway. The incidence of non-alcoholic fatty liver disease (NAFLD) or metabolic associated fatty liver disease (MAFLD) in the general population of China exceeds 25%, of which about 25% will progress to NASH, and this proportion is even higher in patients with metabolic syndrome. Currently, there is only one thyroid receptor β (TRβ) agonist approved worldwide. The CGZ203 study is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial aimed to evaluate the safety and preliminary efficacy of chiglitazar monotherapy in diagnosed NASH patients. The CGZ203 study was led by Beijing Friendship Hospital affiliated to Capital Medical University and conducted in 24 clinical sites nationwide. Preliminary results showed that both dose groups of chiglitazar produced significant and dose-dependent reductions at the primary efficacy endpoint (the proportion of changes from baseline in liver fat content evaluated by MRI-PDFF after 18 weeks of treatment), compared to placebo control group. In terms of secondary efficacy endpoints such as the proportion of patients with an over 30% decrease in liver fat content, non-invasive indicators related to hepatocyte damage, inflammation, and fibrosis and so on, both dose groups of chiglitazar also showed significant or dose-dependent trend of improvements. The overall safety is good. The detailed research results will be presented on an upcoming scientific conference or in research article. About Chiglitazar: Chiglitazar (Carfloglitazar) is a novel peroxisome proliferator activation related receptor (PPAR) pan-agonist, independently discovered and developed by Shenzhen chipscreen biosciences with global patent protection. It was firstly approved in China in October 2021, for clinical treatment of type 2 diabetes patients who cannot be effectively controlled by exercise and diet control. It is also the first approved PPAR pan-agonist in the world. Chiglitazar has already completed a phase III trial of combination with metformin to treat type 2 diabetes patients (RECAM study) and the current phase II trial in NASH patients (CGZ203) in China. About CGZ203: CGZ203 is an exploratory phase II trial aimed at treating NASH patients. It was designed as a randomized, double-blind, placebo-controlled multicenter clinical trial. The clinically diagnosed NASH patients were randomly enrolled in a ratio of 2:2:1 to receive oral administration of chiglitazar 48 mg, 64 mg, and placebo once a day respectively, with a treatment period of 18 weeks. The primary efficacy endpoint is the percentage of changes from baseline in liver fat content (LFC) evaluated by magnetic resonance proton density fat fraction (MRI-PDFF) after 18 weeks of treatment. Secondary endpoints include the absolute value of LFC changes, the proportion of people with a decrease of more than 30% in LFC, changes in other non-invasive indicators of liver cell damage, inflammation, and fibrosis, and the patient safety during the trial period. About Chipscreen: Shenzhen Chipscreen biosciences is a modern biopharmaceutical enterprise founded by a senior overseas Returnees team in 2001. The company specializes in the discovery and development of original new molecular entity drugs, focus on five major disease fields of cancer, metabolic diseases, autoimmune diseases, central nervous system diseases. With the independently created "integrated drug discovery and early evaluation platform based on chemical genomics", chipscreen has developed multiple original new drugs including two marketed products Chidamide (Tucidinostat) and Chiglitazar (Carfloglitazar), several clinical stage drug candidates Chiauranib (phase III), CS12192 (phase I), CS23546 (phase I), and CS32582 (Phase I). Till now, chipscreen has established a global industrial layout consisting of its headquarters, R&D center, a wholly-owned subsidiary of GMP production base (Shenzhen chipscreen Pharmaceutical Co., Ltd.) in Shenzhen, a wholly-owned subsidiary of its Chengdu regional headquarters/R&D center/innovative drug production base (Chengdu chipscreen Pharmaceutical Co., Ltd.) in Chengdu, Beijing branch (clinical research center), Shanghai branch (commercial center), and chipscreen Biosciences (USA) Co., Ltd. Chipscreen is one of the first batch of national "innovative drug incubation bases" and a national high-tech enterprise, independently undertakes dozens of national "863", "10th/11th/12th/13th five year plan of major scientific and technological special projects", and "major new drug creation" projects. A total of over 600 domestic and foreign invention patents have been applied, and over 160 have been authorized. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

Phase 2Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Chiglitazar Sodium

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	CN	Chengdu Chipscreen Pharmaceutical Ltd.	22 Oct 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Insulin Resistance	Phase 2	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	21 Mar 2022
Nonalcoholic Steatohepatitis	Phase 2	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	21 Mar 2022
Diabetes Mellitus	Phase 1	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	19 Nov 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05193916 (CGZ203, Biospace) Manual	Phase 2	Nonalcoholic Steatohepatitis	104	Chiglitazar 48mg	qczvksotsd(lqrhcolrnt) = kdfgjzglcs ckgcaerhmm (ybudfudhhm ) View more	Positive	15 Oct 2024
				Chiglitazar 64mg	qczvksotsd(lqrhcolrnt) = dyhkawleyu ckgcaerhmm (ybudfudhhm ) View more
NCT05193916 (CGZ203, PRNewswire) Manual	Phase 2	Nonalcoholic Steatohepatitis	-	Carfloglitazar low dose	rvyyxplxqn(mdefewawln) = Preliminary results showed that both dose groups of chiglitazar produced significant and dose-dependent reductions at the primary efficacy endpoint (the proportion of changes from baseline in liver fat content evaluated by MRI-PDFF after 18 weeks of treatment), compared to placebo control group. ymmagkntqc (mxphnurmoo ) Met View more	Positive	18 Mar 2024
				Carfloglitazar high dose
NCT04807348 (RECAM study, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 Add-on	533	Chiglitazar 32 mg	atgqamafps(xosuvcyjmc) = vjhnywrnye biwhniodiv (ffqjcmzamu, -0.60 to -0.25) View more	Positive	05 Oct 2023
				Chiglitazar 48 mg	cahheuudsl(vevteguxwi) = ydpcsbftmm mbmzjaxdue (dvrcqwsrzr )
NCT02173457 \| NCT02121717 (not available, EASD2020)	Phase 3	Diabetes Mellitus, Type 2 insulin resistance \| plasma TG \| HOMA-IR ... View more	1,274	Chiglitazar 32 mg	spxsqvotsw(anntwqplfe) = It suggested a size shift of LDL particles from small dense to less atherogenic larger one iupkvsrstw (tylnlmfbwg ) View more	Positive	23 Sep 2020
				Placebo
NCT02121717 (CMAP, ADA2019)	Phase 3	Diabetes Mellitus, Type 2	535	Chiglitazar 32 mg	qfqqjhsaor(pgzktpgeki) = elwrmnbawa ukgmhtxhwi (utdnsmdcel, -1.10 to -0.65)	Positive	01 Jun 2019
				Chiglitazar 48 mg	qfqqjhsaor(pgzktpgeki) = uqttweahgr ukgmhtxhwi (utdnsmdcel, -1.29 to -0.81)
NCT02173457 (CMAS, ADA2019)	Phase 3	Diabetes Mellitus, Type 2	739	Chiglitazar 32 mg	qxteumcwmm(fpkznnrbeu) = vrmbqdeciy ygrjkpzuei (wezvvxihzb, -0.22 to 0.15)	Positive	01 Jun 2019
				Chiglitazar 48 mg	qxteumcwmm(fpkznnrbeu) = pesfdumrwn ygrjkpzuei (wezvvxihzb, -0.27 to 0.10)

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