• Clinical trials. (who.int)
  • A legal protection that data collected (e.g. the results of clinical trials) for the purpose of obtaining marketing approval may not be used for a specified period by the regulatory authorities to grant approval to a generic equivalent. (who.int)
  • An obligation imposed on third parties to protect test data (e.g. the results of clinical trials) - usually collected in order to comply with government regulations on the safety, efficacy, and quality of a broad range of products (e.g. drugs, pesticide, medical devices). (who.int)
  • These compounds are FDA-approved agents that have undergone testing in either COVID-19 clinical trials or observational studies. (medicalnewstoday.com)
  • BIP parallels central aspects of the structure of favipiravir, an oral antiviral medication that clinical trials are testing as a treatment for mild COVID-19 disease and comparing with remdesivir for treating moderate disease. (medicalnewstoday.com)
  • Eliminating poor candidates early will help to reduce attrition rates during clinical trials. (genengnews.com)
  • It quickly became clear that AMS could have broad applications in biomedical research and, specifically, in human clinical trials. (genengnews.com)
  • This table shows clinical trials for potential 505(b)(2) applications. (drugpatentwatch.com)
  • Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to pass clinical trials so as to move on to the next phase. (anavex.com)
  • however, the clinical significance of this activity against P. acnes was not examined in clinical trials with this product. (nih.gov)
  • TauRx also plans to test its compound in two Phase 3 AD trials: a 12-month study of 833 people with mild to moderate AD, and an 18-month study of 500 people with mild AD. (alzforum.org)
  • The genus Gymnopilus has approximately 250 species described in the literature and biosynthesizes bioactive compounds, including polysaccharides. (mdpi.com)
  • In vitro toxicity tests demonstrated that all the bioactive compounds showed far less toxicity against human erythrocytes. (scielo.org.za)
  • The three active metabolites possessed similarities with three synthetic compounds that scientists have observed to have antiviral properties. (medicalnewstoday.com)
  • Any investigation in human subjects intended to discover or verify the clinical, pharmacological or other pharmacodynamic effects of an investigational product or to identify any adverse reactions to an investigational product or to study absorption, distribution, metabolism and excretion of an investigational product with the object of ascertaining its safety or efficacy. (who.int)
  • Antifungal efficacy of GRAS compounds and conventional preservatives was investigated against fungal pathogens. (usda.gov)
  • As a proof of concept, antifungal efficacy of twenty-one GRAS compounds plus six conventional preservatives was investigated against Aspergillus brasiliensis, one of the challenge microbes for preservative evaluation. (usda.gov)
  • In addition, it has also been reported to have antiviral efficacy against SARS-CoV-2. (biorxiv.org)
  • Our extensive pre-clinical program for ANAVEX 2-73 and the data generated so far offers the possibility of excellent safety and tolerability and encouraging signs of potential efficacy," added Dr. Durrant. (anavex.com)
  • HAMBURG, Germany ― The investigational incretin receptor agonist pemvidutide produced significant weight loss and other cardiometabolic benefits in a phase 2 randomized trial, adding a different type of "twincretin" to a growing mix of incretin-based weight-loss drugs in development that also offer additional benefits. (medscape.com)
  • Through screening of a custom clinical compound library, we identified eltrombopag (DDL-701), a thrombopoietin receptor agonist, as having PL pro inhibitory activity that is sustained in the presence of the M pro inhibitor nirmatrelvir. (biorxiv.org)
  • This review will focus on the description of selective and non-selective allosteric modulators of Sig1R, including molecular structure properties and pharmacological activity both in vitro and in vivo , with the aim of providing the latest overview from compound discovery approaches to eventual clinical applications. (frontiersin.org)
  • With respect to the skin, dose- response relationships and no-effect levels were found for both intradermal and topical induc- tion, as well as for intradermal and topical elicitation of allergenic responses in epidemiological, clinical, and animal studies. (cdc.gov)
  • The present investigation established 1,5-bis(2-hydroxyphenyl)pent-1,4-diene-3-one (lc)asalead compound with potential against a panel of pathogenic bacterial strains, Staphylococcus (coagulase negative), Escherichia coli, Pseudomonas aeruginosa, Acenetobacter sp. (scielo.org.za)
  • Remarkably, these natural bacterial metabolites resemble drugs that the Food and Drug Administration (FDA) has approved and that clinical research is exploring as treatments for COVID-19, obsessive-compulsive disorder (OCD) , or both. (medicalnewstoday.com)
  • They did this by isolating bacterial compounds and testing their antiviral proprieties in laboratory cultures of cells. (medicalnewstoday.com)
  • In case 2, focal [ 18 F]-Florbetapir retention at the site of injury in an otherwise negative scan suggests focal amyloid aggregation. (nature.com)
  • Results of a new 24-week interim analysis of data from the phase 2 pemvidutide trial, called MOMENTUM, were presented October 3 at the European Association for the Study of Diabetes (EASD) 2023 Annual Meeting by Aronne. (medscape.com)
  • The 48-week phase 2 MOMENTUM trial randomly assigned 320 participants with overweight or obesity and at least one obesity-related comorbidity but not diabetes to receive weekly doses of 1.2 mg, 1.8 mg, or 2.4 mg of pemvidutide or placebo. (medscape.com)
  • This regulatory filing marks an important milestone in the clinical development path for ANAVEX 2-73 and our strategy to aggressively complete a Phase I and IIa study in healthy human volunteers and patients, respectively," said Dr. Cameron Durrant, Executive Chairman of Anavex Life Sciences Corp. (anavex.com)
  • Phase I dosing of healthy human volunteers with ANAVEX 2-73 is scheduled to begin shortly. (anavex.com)
  • The Phase I study will be comprised of a total of 24 healthy human volunteers to allow us to test the maximally tolerated dose, pharmacokinetics, pharmacodynamics, safety and bioavailability of ANAVEX 2-73," said Dr. Angelos Stergiou, Clinical Research Physician leading the program on behalf of Anavex and President of Genesis BioPharma Group. (anavex.com)
  • Forward-looking statements in this press release include that we will complete a Phase I and IIa study in healthy human volunteers and patients, that Phase I will commence shortly and Phase IIa is currently scheduled to commence in mid 2011, and that our drug compounds show potential promise to combat certain diseases. (anavex.com)
  • Remember Rember®-the blue dye that made headlines in 2008 when Phase 2 clinical trial data suggested it slowed decline in people with Alzheimer's disease (see ARF related news story )? (alzforum.org)
  • A revamped version of this compound, which presumably inhibits tau aggregation, is now heading toward Phase 3 testing, though in a different tauopathy. (alzforum.org)
  • In the previous Phase 2 AD trial, 12-month data appeared to suggest that 60 mg Rember taken orally three times a day slowed cognitive decline as measured by the ADAS-Cog . (alzforum.org)
  • In recent studies that were conducted through a CCSRI Innovation grant, the investigators discovered that oral treatment of mice with the commonly used histamine receptor 2 (H2) antagonists ranitidine or famotidine inhibits both primary breast tumor development and metastasis, in three distinct mouse tumor models and reduces the numbers of monocytic MDSC. (drugpatentwatch.com)
  • The Anavex proprietary SIGMACEPTOR™ Discovery Platform involves the rational design of drug compounds targeted to specific receptors involved in the modulation of multiple cellular biochemical signaling pathways. (anavex.com)
  • Volatile organic compounds (VOCs) are a large group of chemicals that have been used as solvents, degreasers, and cleaning agents in industry and consumer products. (cdc.gov)
  • Generally regarded as safe (GRAS) chemicals, such as natural compounds or their structural analogs could be potential sources of sustainable antifungal agents. (usda.gov)
  • Accessibility of compound libraries. (who.int)
  • This initiative is one of the integrated components of the NIH Molecular Libraries Roadmap initiative that offers biomedical researchers access to large-scale automated high throughput screening (HTS) centers in the MLPCN, diverse compound libraries in the Small Molecule Repository (MLSMR) and information on biological activities of small molecules in the PubChem BioAssay public database. (nih.gov)
  • Fewer than 5% of screened compounds enter preclinical development, and only 2% of these enter clinical testing. (genengnews.com)
  • Xceleron is capable of managing the entire clinical development project, including registration, preclinical toxicology, clinical studies, and bioanalysis. (genengnews.com)
  • The objective was to define the mechanism of the growth inhibition of active hexose correlated compound (AHCC) alone and evaluate its activity in combination with pegylated liposomal doxorubicin (PLD). (researchgate.net)
  • In this study, we employed the weighted gene co-expression network (WGCNA) method and the connectivity map (CMap) database to identify the candidate target genes and potential compounds. (frontiersin.org)
  • In conclusion, this study identified the significant modules, signaling pathways, and hub genes relevant to OA and highlighted the potential clinical value of anisomycin and MG-262 as novel therapies in OA management. (frontiersin.org)
  • Many natural products are "generally regarded as safe (GRAS)" compounds, and are potential sources of antifungal agents, either in their intact structure or as lead compounds for more potent structural analogs. (usda.gov)
  • The FTD field is excited to finally have an agent worthy of a clinical trial as a potential disease-modifying agent. (alzforum.org)
  • The clinical trial and clinical study are synonymous. (who.int)
  • A clinical study to evaluate of the combination of AHCC plus PLD in the treatment of ovarian cancer is being pursued. (researchgate.net)
  • Using a traditional approach this study provides pre-clinical data to support the benefits previously observed and reported in the clinical setting and supports future endeavors to integrate AHCC into standard of care to be given with chemotherapy. (researchgate.net)
  • So, when the pandemic hit New York City, they pivoted their diverse laboratories to study the SARS-CoV-2 virus's interactions with the human microbiome. (medicalnewstoday.com)
  • The present study indicated that daily supplementation with 100 mg of pine bark extract in patients with type 2 diabetes mellitus and microalbuminuria had favorable effects on glycemic control, serum VCAM-1, and urinary albumin to creatine ratio level, as well as total cholesterol concentrations and abdominal obesity which could be helpful in the control of diabetes complications," they concluded. (lifeextension.com)
  • For more on the practice of adding study compounds to placebo, see author Q&A below . (alzforum.org)
  • The prevalence of disinfection by-products in drinking water supplies has raised concerns about possible adverse health effects from chronic exposure to these potentially carcinogenic compounds. (cdc.gov)
  • The mode of antibacterial action of 1c was also studied by scanning electron microscopy, which showed membrane disruption and cell lysis of the organisms during the exposure of the tested compound. (scielo.org.za)
  • Anavex Life Sciences Corp. ("Anavex", AVXL:OB) announced today that it has filed the regulatory submission for ANAVEX 2-73 with the German Health Authority, BfArM, and the local Ethics Committee of Saxony to begin clinical studies for ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease. (anavex.com)
  • The NHANES quality assurance and quality control (QA/QC) protocols meet the 1988 Clinical Laboratory Improvement Act mandates. (cdc.gov)
  • In case 1, amyloid imaging provided improved diagnostic accuracy where standard clinical and laboratory criteria were inadequate. (nature.com)
  • Out of twenty-one GRAS compounds examined (Clinical Laboratory Standards Institute protocol), five compounds showed the highest antifungal activity, viz. (usda.gov)
  • Pemvidutide (Altimmune, Inc) is a long-acting "balanced" dual agonist of both glucagon-like peptide 1 (GLP-1) and glucagon that is in development for the treatment of obesity and nonalcoholic steatohepatitis (NASH) but not type 2 diabetes, as its effect on glucose is neutral. (medscape.com)
  • Underlying this deficit is an expensive and lengthy clinical development process. (genengnews.com)
  • 2. Markowitz C. Development of interferon-beta as a therapy for multiple sclerosis. (clinimmsoc.org)
  • The volatile organic compound section of the Mobile Examination Center (MEC) Interview and Phlebotomy Component (PH) provide personal interview data. (cdc.gov)
  • The degree of accumulation calculated from the plasma and urinary excretion data was ~2-fold. (nih.gov)
  • I want to get the latest chemistry news from C&EN in my inbox every week. (acs.org)
  • Binding of interferon beta-1a to its receptor leads to induction of many interferon inducible genes, including beta 2-microglobulin and neopterin, both of which can serve as biomarkers for interferon beta-1a administration. (clinimmsoc.org)
  • A randomized trial reported on February 18, 2021 in Complementary Therapies in Medicine resulted in improvement of several factors related to type 2 diabetes among men and women who were given supplements containing French maritime pine bark extract. (lifeextension.com)
  • The outcome of pre-clinical studies in mice warrant further investigation into transferability to humans. (drugpatentwatch.com)
  • DDL-701 thus represents a drug that can immediately be repurposed and undergo clinical evaluation as a PL pro inhibitor that may be most effectively used in a protease inhibitor cocktail with an M pro inhibitor such as nirmatrelvir (Paxlovid) for the treatment of COVID-19. (biorxiv.org)
  • The scientists posed this question: Can the human microbiome produce metabolites, or small molecules, that inhibit the growth of the SARS-CoV-2 virus? (medicalnewstoday.com)
  • In contrast, the dual GLP-1-glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide (Mounjaro, Lilly) has been approved for the treatment of type 2 diabetes. (medscape.com)
  • It is logical to test a compound targeting tau aggregation in multiple tauopathies, and a bvFTD trial seems justified by the current lack of treatment options for this disorder, suggested Dirk Beher of Merck Serono S.A., Geneva, Switzerland, in an e-mail to Alzforum. (alzforum.org)
  • Skin damage or irritation may result in a significant reduction of the no-effect level for a specific compound. (cdc.gov)
  • The researchers tested all three microbiome-derived anti-SARS-CoV-2 active metabolites for activity against a panel of RNA viruses, in addition to SARS-CoV-2. (medicalnewstoday.com)
  • Application of proper types of surfactants was crucial for achieving optimum antifungal activity of compounds, thus emphasizing the importance of compound-compound or surfactant specificity during antifungal application. (usda.gov)
  • Allosteric modulators of sigma-1 receptor (Sig1R) are described as compounds that can increase the activity of some Sig1R ligands that compete with (+)-pentazocine, one of the classic prototypical ligands that binds to the orthosteric Sig1R binding site. (frontiersin.org)
  • Thus, allosteric modulators of Sig1R are described as compounds that can increase the activity of Sig1R ligands that compete with [ 3 H](+)-pentazocine for binding to Sig1R. (frontiersin.org)
  • Scientists have found some metabolites in the human microbiome that could possibly slow down SARS-CoV-2 infection. (medicalnewstoday.com)
  • The bvFTD trial will take place at 25 to 30 sites worldwide, enrolling 180 adults with clinical and brain scan evidence of probable bvFTD. (alzforum.org)
  • In addition, contract laboratories randomly perform repeat testing on 2% of all specimens. (cdc.gov)
  • One such emerging technology, accelerator mass spectrometry (AMS), is poised to revolutionize early clinical studies. (genengnews.com)
  • In two adequate and well controlled clinical studies of 758 patients, 214 used Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5%, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. (nih.gov)
  • Less than 2% of the dose enters systemic circulation as benzoic acid. (nih.gov)
  • The new compound is a stabilized, reduced form of methylthionine, and is more readily absorbed and tolerated at a 10-fold higher dose than Rember®, Wischik said. (alzforum.org)
  • Background: In China, traditional Chinese medicine (TCM) has been used to treat type 2 diabetes mellitus (T2DM) for centuries. (benthamscience.com)
  • While about 20% to 25% of people with obesity also have type 2 diabetes, not everybody does. (medscape.com)
  • It's not going to be one compound for everybody," said Louis J. Aronne, MD, director of the Center for Weight Management and Metabolic Clinical Research, Weill-Cornell Medical College, New York. (medscape.com)
  • Xceleron became the first company to commercialize AMS technology for clinical research. (genengnews.com)
  • SARS-CoV-2 requires two cysteine proteases for viral polypeptide processing to allow maturation and replication: the 3C-like protease also known as the Main protease (M pro ) and the papain-like protease (PL pro ). (biorxiv.org)
  • We describe two clinical cases, one with a history of multiple concussions during a career in the National Football League (NFL) and the second with frontotemporal dementia and a single, severe TBI. (nature.com)
  • SARS-CoV-2 has left thousands with a distorted or lost sense of smell. (acs.org)
  • People need to take [the compound] with food, or else they get nauseous," Wischik said. (alzforum.org)