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A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers

The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU. The study is being conducted in 350 subjects being recruited in about 30 centers in India.

开始日期2018-12-26

申办/合作机构

NovaLead Pharma Pvt Ltd.

CTRI/2018/11/016295 / Recruiting临床3期

A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (GALNOBAXÂ®) in Treating Diabetic Foot Ulcers.

开始日期2018-11-10

申办/合作机构

NovaLead Pharma Pvt Ltd.

NCT01113515 / Completed临床1/2期

An Interventional, Placebo-Controlled, Randomized, Double-blinded Dose Comparison, Phase I/II Study to Determine the Safety and Efficacy of a New Gel Formulation of Esmolol Hydrochloride (Galnobax®) for the Treatment of Diabetic Foot Ulcer (DFU)

The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.

开始日期2014-02-20

申办/合作机构

NovaLead Pharma Pvt Ltd.

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项与 NovaLead Pharma Pvt Ltd. 相关的文献（医药）

2019-06-30·European Journal of Organic Chemistry

Synthesis of 4‐C‐β‐D‐Glucosylated Isoliquiritigenin and Analogues for Aldose Reductase Inhibition Studies

作者: Mukhopadhyay, Sami ; Reddy, Utkarsh A. ; Reddy, Geereddy Bhanuprakash ; Ingle, Kundane ; Reddy, Mannem Rajeswara ; Aidhen, Indrapal Singh

Inspired from natural product isoliquiritine, an O‐glucoside and the corresponding aglycon chalcone, isoliquiritigenin (ISL), several C‐glucosylated chalcones and dihydrochalcones have been synthesized and evaluated for aldose reductase (AR) inhibition activity, for the first time. The initial inputs from molecular docking studies were also encouraging. Claisen‐Schmidt condensation reaction between 4‐C‐glucosylated benzaldehyde, a key building block developed during the synthetic efforts and acetophenones enabled convenient access to the targeted compounds in good yields. Excellent AR inhibition has been observed with C‐glucosylated ISL with IC50 value of 21 µM. This is similar to the chalcone ISL, displaying IC50 of 19 µM. In the light of limited aqueous solubility of ISL, the observed AR inhibition with C‐glucosylated ISL, gains importance. Additionally, the studies have revealed significance of the oxygenation pattern on the aromatic residue and paved way for the identification of few more new compounds with equally promising AR inhibition.

2016-02-01·Chemosphere2区 · 环境科学与生态学

3D QSAR studies of hydroxylated polychlorinated biphenyls as potential xenoestrogens

2区 · 环境科学与生态学

Article

作者: Ingale, Kundan ; Ruiz, Patricia ; Mumtaz, Moiz ; Wheeler, John S

Mono-hydroxylated polychlorinated biphenyls (OH-PCBs) are found in human biological samples and lack of data on their potential estrogenic activity has been a source of concern. We have extended our previous in silico 2D QSAR study through the application of advance techniques such as docking and 3D QSAR to gain insights into their estrogen receptor (ERα) binding. The results support our earlier findings that the hydroxyl group is the most important feature on the compounds; its position, orientation and surroundings in the structure are influential for the binding of OH-PCBs to ERα. This study has also revealed the following additional interactions that influence estrogenicity of these chemicals (a) the aromatic interactions of the biphenyl moieties with the receptor, (b) hydrogen bonding interactions of the p-hydroxyl group with key amino acids ARG394 and GLU353, (c) low or no electronegative substitution at para-positions of the p-hydroxyl group, (d) enhanced electrostatic interactions at the meta position on the B ring, and (e) co-planarity of the hydroxyl group on the A ring. In combination the 2D and 3D QSAR approaches have led us to the support conclusion that the hydroxyl group is the most important feature on the OH-PCB influencing the binding to estrogen receptors, and have enhanced our understanding of the mechanistic details of estrogenicity of this class of chemicals. Such in silico computational methods could serve as useful tools in risk assessment of chemicals.

2014-01-03·FEBS Letters3区 · 生物学

Identification of a novel ATPase activity in 14‐3‐3 proteins – Evidence from enzyme kinetics, structure guided modeling and mutagenesis studies

3区 · 生物学

Article

作者: Mukhopadhyay, Sami ; Nanaware, Padma P ; Somavarapu, Arun Kumar ; Venkatraman, Prasanna ; Ramteke, Manoj P ; Ramamoorthy, Vidhya ; Gautam, Amit Kumar Singh ; Karanam, Sudheer ; Shelke, Pradnya

14‐3‐3 Proteins bind phosphorylated sequences in proteins and regulate multiple cellular functions. For the first time, we show that pure recombinant human 14‐3‐3 ζ, γ, ε and τ isofoms hydrolyze ATP with similar Km and kcat values. In sharp contrast the sigma isoform has no detectable activity. Docking studies identify two putative binding pockets in 14‐3‐3 zeta. Mutation of D124A in the amphipathic pocket enhances binding affinity and catalysis. Mutation of a critical Arg (R55A) at the dimer interface in zeta reduces binding and decreases catalysis. These experimental results coincide with a binding pose at the dimer interface. This newly identified function could be a moon lighting function in some of these isoforms.

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