Palmitoylethanolamide and polydatin effect on pain and dysmenorrhea in women scheduled for laparoscopic treatment of possible endometriosis: a double blind randomised controlled trial.

Start Date12 Jul 2021

Sponsor / Collaborator

University of Melbourne

CTR20160804 / RecruitingPhase 2

初步评价虎杖苷注射液治疗临床创伤性休克有效性及安全性的随机、双盲、安慰剂平行对照、多中心Ⅱ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to preliminarily evaluate the efficacy and safety of polydatin injection in the treatment of clinical traumatic shock

在Ⅱ期前期试验的基础上，进一步探索并评价虎杖苷注射液对创伤性休克的有效性及安全性，为Ⅲ期确证性临床试验设计提供依据。

[Translation]

On the basis of the preliminary Phase II trial, we further explored and evaluated the effectiveness and safety of polydatin injection on traumatic shock, and provided a basis for the design of Phase III confirmatory clinical trials.

Start Date08 May 2015

Sponsor / Collaborator

Shenzhen Neptunus Pharmaceutical Co. Ltd.

CTR20132636 / CompletedPhase 2

虎杖苷注射液治疗烧伤合并全身炎症反应综合征有效性及安全性的随机双盲、多中心II期临床试验

[Translation] A randomized, double-blind, multicenter phase II clinical trial on the efficacy and safety of polydatin injection in the treatment of burns complicated with systemic inflammatory response syndrome

以安慰剂对照，评价虎杖苷注射液对烧伤合并SIRS的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of polydatin injection in the treatment of burns complicated with SIRS by placebo control.

Start Date07 Jun 2013

Sponsor / Collaborator

Shenzhen Neptunus Pharmaceutical Co. Ltd.

100 Clinical Results associated with Polydatin

100 Translational Medicine associated with Polydatin

100 Patents (Medical) associated with Polydatin

1,510

Literatures (Medical) associated with Polydatin

01 Mar 2025·Combinatorial Chemistry & High Throughput Screening

Exploring the Constituents and Mechanisms of Polygonum multiflorum Thunb. in Mitigating Ischemic Stroke: A Network Pharmacology and Molecular Docking Study

Article

Author: Zheng, Mengyun ; Wang, Junsong ; Fan, Zhiwei ; Yang, Jingtian ; Ruan, Lingyu ; Xia, Xinru ; Wang, Liqun ; Qing, Qing ; Lin, Hongyan ; Wang, Yating ; Pang, Chaofan ; Tao, Yuheng

Backgound::Polygonum multiflorum Thunb. (PMT) has shown promise in exerting cerebrovascular protective effects, and its potential for treating ischemic stroke (IS) has garnered attention. However, the lack of clarity regarding its chemical constituents and mechanisms has significantly hindered its clinical application.Methods::In this study, we employed network pharmacology and molecular docking techniques for the first time to elucidate the potential compounds and targets of PMT in treating IS. The databases CTD, DrugBank, DisGeNET, GeneCards, OMIM, TTD, PGKB, NCBI, TCMIP, CNKI, PubMed, ZINC, STITCH, BATMAN, ETCM and Swiss provided information on targets related to IS and components of PMT, along with their associated targets. We constructed “compoundtarget” and protein-protein interaction (PPI) networks sourced from the STRING database using the Cytoscape software. Gene Ontology (GO) enrichment analysis and KEGG pathway analysis were conducted using the DAVID database. Molecular docking between core targets and active compounds was conducted using Autodock4 software. Experiments were performed in an oxygen- glucose deprivation and reperfusion (OGD/R) model to validate the anti-IS activity of compounds isolated from PMT preliminarily. Network pharmacological analysis revealed 16 core compounds, including resveratrol, polydatin, TSG, ω-hydroxyemodin, emodin anthrone, tricin, moupinamide, and others, along with 11 high-degree targets, such as PTGS1, PTGS2, ADORA1, ADORA2, CA1, EGFR, ESR1, ESR2, SRC, MMP3 and MMP9.Results::GO and KEGG enrichment analyses revealed the involvement of HIF-1, Akt signaling pathway and energy metabolism-related signaling pathways. Molecular docking results emphasized eight key compounds and confirmed their interactions with corresponding targets. In vitro OGD/R model experiments identified TSG and tricin as the primary active substances within PMT for its anti-stroke activity.Conclusion::This study contributes new insights into the potential development of PMT for stroke prevention and treatment.

01 Dec 2024·Phytomedicine

Cardioprotective effects of polydatin against myocardial injury in HFD/stz and high glucose-induced diabetes via a Caveolin 1-dependent mechanism

Article

Author: Zhang, Yuanyuan ; Bai, Lin ; Sun, Xiaohong ; Liu, Yingying ; Lv, Dongxin ; Wang, Yu ; Luo, Hui ; Gong, Wenyan ; Jiao, Qibin ; Chen, Zhen ; Zhao, Gangfeng ; Lei, Qingqing ; Zhang, Ningzhi

BACKGROUNDDiabetic cardiomyopathy (DCM) is defined as cardiac dysfunction involving changes in structure, function, and metabolism in the absence of coronary artery disease, which eventually developed into heart failure. There is still a lack of effective drugs for the treatment of DCM, while the ameliorative effects of traditional herbs on DCM have been commonly reported. Polydatin (PD) is a glucoside derivative of traditional herbs of resveratrol, which has been shown to ameliorate the pathological development of DCM. However, the cardioprotective effect and mechanism of PD in the improvement of myocardial injury are still unclear.AIM OF STUDYThis study aimed to investigate the cardio-protective role of PD on DCM and reveal the critical effect of Cav1 in PD' regulation of DCM.MATERIALS AND METHODSThe Cav1^-/- and Cav1^+/+mice and H9C2 cells were used to induce DCM models and then given PD treatment (150 mg/kg) or not. The cardiac functions of all mice were checked via echocardiography, and myocardial histological changes were measured by H&E, periodic acid-schiff (PAS) and Masson staining. The markers expression of heart fibrosis and inflammation, and hypertrophic factors were detected using western blotting. The NF-κB signaling activation was performed by confocal, immunohistochemical, Electrophoretic mobility shift assay (EMSA) and western blotting.RESULTSHere, we found that PD significantly improved the cardiac function and injury of diabetic Cav1^+/+ mice, and enhanced the expression of Cav1 in the cardiac tissues of diabetic Cav1^+/+ mice and HG-induced H9C2 cells. Further investigation showed that when Cav1 was knocked down, PD no longer plays the cardioprotective effect and inhibits the NF-κB signaling pathway activation in HFD/stz-treated diabetic mice and HG-induced H9C2 cells.CONCLUSIONThese results demonstrated that PD inhibited the hyperglycemia-induced myocardial injury and inflammatory fibrosis of DCM models in vivo and in vitro, and targeting Cav1 may provide a novel understanding the mechanism of the treatment of PD in DCM.

01 Dec 2024·Food Chemistry

Engineering regioselectivity of glycosyltransferase for efficient polydatin synthesis

Article

Author: Liu, Dandan ; Yan, Zixu ; Zhu, Fucheng ; Zang, Yongjun ; Xu, Qilin ; Ma, Menghua ; Dai, Jingli ; Chen, Naidong

Resveratrol is a promising functional ingredient applied in food products. However, low bioavailability and poor water solubility, which can be improved by glycosylation, hinder its application. A uridine diphosphate-dependent glycosyltransferase (UGT) from Bacillus subtilis 168 (named UGT_BS) presents potential application for resveratrol glycosylation; nonetheless, imprecise regioselectivity renders the synthesis of resveratrol-3-O-β-D-glucoside (polydatin) difficult. Therefore, molecular evolution was applied to UGT_BS. A triple mutant Y14I/I62G/M315W was developed for 3-OH glycosylation of resveratrol and polydatin accounted for 91% of the total product. Kinetic determination and molecular docking indicated that the enhancement of hydrogen bond interaction and altered conformation of the binding pocket increases the enzyme's affinity for the 3-OH group, stabilizing the enzyme-substrate intermediate and promoting polydatin formation. Furthermore, a fed-batch cascade reaction by periodic addition of resveratrol was conducted and nearly 20 mM polydatin was obtained. The mutant Y14I/I62G/M315W can be used for polydatin manufacture.

News (Medical) associated with Polydatin

13 May 2024

·www.prnewswire.com

Sumitomo Pharma Announces FDA Acceptance of Supplemental New Drug Application for Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia

–Supplemental New Drug Application (sNDA) submission based on Phase 3 study of vibegron 75mg (GEMTESA) demonstrating statistically significant reductions in daily micturition and urgency episodes– –If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH– MARLBOROUGH, Mass., May 13, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), announced today the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH. The FDA has set a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA). The sNDA is supported by the results from URO-901-3005 a Phase 3 multicenter, randomized, double-blind, parallel-group, fixed-dose study, which evaluated the efficacy, safety, and tolerability of vibegron versus placebo over 24 weeks in approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH. The study met all co-primary endpoints at Week 12, demonstrating statistically significant reductions from baseline in the average number of micturition (urination) episodes per day and in the average number of daily urgency episodes (the sudden urge to urinate that is difficult to control) compared to placebo as well as all secondary endpoints, including reduction of nocturia episodes (awakening to use the bathroom per night) and instances of urge urinary incontinence episodes (unintentional loss of urine immediately after an urgent need to urinate) per day. Vibegron was well-tolerated throughout the study and there were no new safety signals compared to prior vibegron studies. "This milestone is important in our efforts to bring novel treatments to those living with urological conditions including OAB and BPH," said Tsutomu Nakagawa, Ph.D, President and Chief Executive Officer of SMPA. "We are pleased the FDA has recognized the strength of the Phase 3 data for vibegron in the URO-901-3005 study within our application. We look forward to working with the FDA during the review period in the hopes of potentially providing a new, safe, and effective treatment option for men struggling with OAB symptoms receiving pharmacological therapy for BPH." BPH is increasingly prevalent in men as they get older and associated symptoms of OAB can often be mistaken as a natural part of aging. Nearly half of all men between ages 51 and 60 have BPH while up to 90% of men over age 80 have BPH.1 Approximately 46% of patients with bladder outlet obstruction secondary to BPH also have OAB.2 Vibegron is currently approved for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. About GEMTESA (vibegron) Vibegron, a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia in the United States (U.S.). In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. GEMTESA works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. In China and Europe, vibegron is currently under investigation in a Phase 3 clinical study for the treatment of OAB. About Overactive Bladder Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).3 About 33 million U.S. adults experience the bothersome symptoms of OAB.4 About Benign Prostatic Hyperplasia Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).5,6 LUTS can be divided into storage, voiding, and postmicturition symptoms.7 Over half of men with BPH report storage symptoms and about a quarter report voiding symptoms.6 This suggests that many men with a diagnosis of BPH may have overactive bladder.6 Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.5,6 About half of all men between ages 51 and 60 have BPH and up to 90% of men over age 80 are living with the condition.1 INDICATIONS AND USAGE GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product. WARNINGS AND PRECAUTIONS Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention. ADVERSE REACTIONS Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Please see full Prescribing Information . About Sumitomo Pharma Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA is a trademark of Urovant Sciences GmbH, and registered in the U.S., and in other countries. © 2024 Sumitomo Pharma America, Inc. All rights reserved. References Prostate Enlargement (Benign Prostatic Hyperplasia). National Institute of Diabetes and Digestive and Kidney Diseases. September 2014. Herschorn S, McVary K, Santos J, Foley S, Kristy R, Choudhury N, Hairston J, Kaplan S. Mirabegron Vs Placebo Add-on Therapy in Men With Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Safety Analysis From the Randomized, Phase 4 PLUS Study. Urology, volume 147, p235-242, January 2021. Published online 2020 October 09. doi: Overactive bladder – symptoms and causes. Mayo Clinic. 2022. Accessed August 25, 2023. Gomelsky A. Update on the management of overactive bladder: patient considerations and adherence. Journal of Urology. Open Access J Urol. 2011; 3: 7–17. Published online 2010 Dec 30. doi: 10.2147/OAJU.S7233 Burnett AL, Walker DR, Feng Q, Johnston KM, Lozano-Ortega G, Nimke D, Hairston JC. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: A retrospective observational study. Neurourol Urodyn. 2020 Jun;39(5):1378-1386. doi: 10.1002/nau.24348. Epub 2020 May 8. PMID: 32383533; PMCID: PMC7384148. Anger, JT, Goldman, HB, Luo, X, et al. Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States. Neurourology and Urodynamics. 2018; 37: 213–222. Lepor H. Pathophysiology of lower urinary tract symptoms in the aging male population. Rev Urol. 2005;7 Suppl 7(Suppl 7):S3-S11. PMID: 16986059; PMCID: PMC1477625. SOURCE Sumitomo Pharma America

Phase 3Clinical ResultDrug ApprovalNDA

10 Oct 2023

·www.biospace.com

Health Canada Grants BioHarvest Sciences License for VINIA Sales in Canada

Significant milestone marking the beginning of VINIA® geographical expansion beyond Israel and the US Further validation from global health authorities of BioHarvest's Botanical Synthesis Technology Platform Canadian Sales and Marketing to begin in early 2024 Vancouver, British Columbia and Rehovot, Israel--(News - October 10, 2023) - BioHarvest Sciences Inc, (CSE: BHSC) (OTCQB: CNVCF) (FSE: 8MV) ("BioHarvest" or "the Company") announces that VINIA®, its flagship nutraceutical product derived from red grape cells, has received its Canadian product license from Health Canada's Natural and Non-Prescription Health Products Directorate. This Product License authorizes BioHarvest Sciences to sell VINIA® in Canada. The expansion of the reach of VINIA® into additional geographies (beyond Israel and the US) is one of the important factors in the sales growth strategy of BioHarvest for the years to come. "We are pleased that VINIA® has been granted its Canadian product license on schedule, and that Health Canada's review resulted in favourable approvals on VINIA's functional claims," stated CEO Ilan Sobel, adding, "Canada is an integral step in our global expansion strategy, and our Canadian product license will accelerate our growth in this health-conscious market by enabling us to directly target Canadian consumers locally with a strong on-line and local retail presence." The Health Canada License includes the approval of compelling health claims that supports VINIA's clinically proven health benefits: Helps to maintain and/or support cardiovascular health Helps support endothelial function Helps maintain endothelium-dependent vasodilation, which contributes to normal blood flow Source of an antioxidant/Provides an antioxidant that helps fight/protect (cells) against/reduce (the oxidate effect of/the oxidative damage by/cell damage caused by) free radicals VINIA® was launched into the US in 2021, and its rapidly growing customer base is being built via a "direct-to-consumer" and "direct-to-doctor" model, with the product purchased online, at and on , as well as being available at many of the top integrative medicine centers in the US. BioHarvest Sciences expects Canadian sales to include similarly optimized e-commerce sales and direct-to-doctor sales, with the potential for a retail vertical, to capitalize on Canada's well established Health Product distribution networks. Future Global Expansion Following the Canadian launch, BioHarvest is targeting further expansion into other major global markets including the USD $40 Billion Dollar Chinese Health Supplement market, where it expects to initially build a strong presence via cross border e-commerce marketplace platforms. About VINIA® VINIA® is the first commercially released product developed using BioHarvest's proprietary Botanical Synthesis platform, which can consistently produce patentable botanical compositions without growing the plant itself. The platform can elicit (increase) specific active phytochemicals to achieve concentrations many times what is found in nature, making this technology efficient and economic. VINIA® contains multiple polyphenols, including Piceid Resveratrol, with an amount in each daily 400mg capsule that is equivalent to 1,000 grapes, resulting in a powerful nutraceutical that has been clinically proven to significantly increase arterial dilation. In late 2023 and early 2024, BioHarvest is expecting to launch several new product verticals that include VINIA®, which will include functional coffee, protein bars, and sports hydration products. About BioHarvest Sciences BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at an industrial scale, without the need to grow the plant itself. BioHarvest is currently focused on leveraging its botanical synthesis technology to develop the next generation of science-based and clinically proven therapeutic solutions, within two major business verticals - nutraceutical health and wellness products such as dietary supplements, and development of plant cell-based Active Pharmaceutical Ingredients (API's) that focus on specific medical indications. BioHarvest Sciences Inc. Ilan Sobel, Chief Executive Officer For further information, please contact: Dave Ryan, VP Investor Relations & Director Phone: 1 (604) 622 -1186 Email: info@bioharvest.com Forward-Looking Statements Information set forth in this news release might include forward-looking statements that are based on management's current estimates, beliefs, intentions, and expectations, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Launching new products is subject to risks and uncertainties including the risk that the market will not accept the product or that government approvals required for sale or import of the products will not be obtained. There is no assurance the company will enter the Chinese market or that Chinese market entry will be successful, as consumer preferences and acceptance may be different than in the Company's existing markets. Global expansion may require expenditure of significant financial resources which cannot be assured and may require business and product licensing and approvals that are difficult to obtain. There is no assurance of success of proposed new product verticals because consumer preferences are difficult to forecast and may be subject to rapid unexpected changes and evolutions which could impact product acceptance. All forward-looking statements are inherently uncertain and actual results may be affected by a number of material factors beyond our control. Readers should not place undue reliance on forward-looking statements. BHSC does not intend to update forward-looking statement disclosures other than through our regular management discussion and analysis disclosures. Neither the Canadian Securities Exchange nor its Regulation Services Provider accept responsibility for the adequacy or accuracy of this release. To view the source version of this press release, please visit

100 Deals associated with Polydatin

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KEGG	Wiki	ATC	Drug Bank
-	Polydatin	-	DB11263

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ischemic cerebrovascular disease	Phase 2	CN	Shenzhen Neptunus Bioengineering Co., Ltd.	30 Jan 2022
Ischemic cerebrovascular disease	Phase 2	US	Shenzhen Neptunus Bioengineering Co., Ltd.	30 Jan 2022
Microvascular Disease	Phase 2	US	Shenzhen Neptunus Bioengineering Co., Ltd.	30 Jan 2022
Microvascular Disease	Phase 2	CN	Shenzhen Neptunus Bioengineering Co., Ltd.	30 Jan 2022
Shock	Phase 2	US	Shenzhen Neptunus Bioengineering Co., Ltd.	30 Jan 2022
Shock	Phase 2	CN	Shenzhen Neptunus Bioengineering Co., Ltd.	30 Jan 2022
Shock, Traumatic	Phase 2	CN	Shenzhen Neptunus Pharmaceutical Co. Ltd.	08 May 2015
Burns	Phase 1	CN	Shenzhen Neptunus Pharmaceutical Co. Ltd.	07 Jun 2013

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