A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of TNO155 in Participants With Mild, Moderate, or Severe Renal Impairment Compared to Matched Healthy Control Participants

The purpose of this Phase 1 study is to evaluate the effect of various degrees of renal impairment on plasma pharmacokinetics (PK), safety and tolerability of TNO155. The results of this study will guide the Novartis recommendation regarding whether or not a dose adjustment may be needed when treating patients with renal impairment

Start Date19 Mar 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

[+1]

NCT05490030

/ WithdrawnPhase 1

A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of TNO155 in Participants With Mild, Moderate, or Severe Hepatic Impairment Compared to Matched Healthy Control Participants

The purpose of this study is to evaluate the effect of various degrees of hepatic impairment on plasma pharmacokinetics (PK), safety and tolerability of TNO155.
The results of this study will guide the Novartis recommendation regarding whether or not a dose adjustment may be needed when treating patients with hepatic impairment.

Start Date06 Mar 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

[+1]

NCT05408663

/ CompletedPhase 1

EXT608 in Human Healthy Adults; A First-in-Human, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation Study

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo.

Start Date21 Jul 2022

Sponsor / Collaborator

Extend Biosciences, Inc.

[+3]

100 Clinical Results associated with Pharmaceutical Research Associates, Inc.

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02 Jan 2024·Journal of Clinical Investigation

The nociceptin/orphanin FQ receptor partial agonist sunobinop promotes non-REM sleep in rodents and patients with insomnia

Article

Author: Hummel, Michele ; Cipriano, Alessandra ; Uehira, Masahiro ; Shet, Manjunath S ; Whiteside, Garth T ; He, Ellie ; Matsuo, Yoshiyuki ; Harris, Stephen C ; Kapil, Ram P ; Willsie, Sandra K ; Hiroyama, Shuichi ; Knappenberger, Terri ; Kyle, Donald J ; Takai, Nozomi ; Fukumura, Kazuya ; Zhou, Mingyan

The potent and partial agonist sunobinop activates the nociceptin/orphanin-FQ peptide receptor and promotes non-REM sleep in rodents and patients with insomnia.

01 Jan 2018·Clinical Therapeutics

Phase 1b Study of the Safety, Pharmacokinetics, and Disease-related Outcomes of the Matrix Metalloproteinase-9 Inhibitor Andecaliximab in Patients With Rheumatoid Arthritis

Article

Author: Zheng, Hao ; Ap, Sophe ; Cieslarová, Blanka ; Smith, Victoria ; Sundy, John S ; Lal, Preeti ; Xin, Yan ; Gossage, David L ; Chen, Guang

PURPOSEAndecaliximab (GS-5745) is a highly selective monoclonal antibody against matrix metalloproteinase-9 (MMP9), a proteolytic enzyme implicated in the pathogenesis of rheumatoid arthritis (RA). This study assessed the safety and pharmacokinetic (PK) parameters of andecaliximab in patients with RA and evaluated the effects of andecaliximab treatment on exploratory disease biomarkers.METHODSIn this double-blind, Phase 1b trial, patients with active RA were randomized (4:1) to receive 400-mg andecaliximab or placebo every 2 weeks for a total of 3 intravenous infusions. The primary and secondary end points were safety and the PK parameters of andecaliximab, respectively. Data were summarized by using descriptive statistics.FINDINGSA total of 18 patients were randomized; 15 received andecaliximab (participants with confirmed RA diagnosis without current administration of a biologic DMARD a biologic DMARD (disease-modifying antirheumatic drug), aged 18 to 70 years old, weighing >45 to <120 kg). No deaths, serious adverse events, or study discontinuations occurred. All reported adverse events were grade 1 or grade 2 in severity. Mean plasma andecaliximab exposure was 587 d · µg/mL and 878 d · µg/mL at days 1 and 29, respectively, suggesting moderate accumulation. The median terminal t_1/2 was 5.65 days; mean volume of distribution at steady state was 4560 mL. Mean MMP9 coverage (the percentage of total plasma MMP9 bound by therapeutic antibody) was maintained at ~80% after the first administration of andecaliximab.IMPLICATIONSAndecaliximab administered as 3 infusions over 29 days was generally safe and well tolerated in patients with RA. The majority of total plasma MMP9 was bound by andecaliximab after the first administration. Clinical studies of increased treatment duration in larger patient cohorts are warranted. ClinicalTrials.gov identifier: NCT02176876. Registered on 25 June 2014.

12 Apr 2017·Current Pharmaceutical DesignQ4 · MEDICINE

Blood Serum Atherogenicity: Cellular Test for the Development of Anti- Atherosclerotic Therapy

Q4 · MEDICINE

Review

Author: Orekhov, Alexander N ; Myasoedova, Veronika A ; Sobenin, Igor A ; Ivashinnikova, Galina A ; Ivanova, Ekaterina A

Atherosclerosis is one of the main problems in modern medical practice. This multifactorial disease can remain asymptomatic for a long time before manifesting itself in cardiovascular disorders, causing ischemic heart disease, myocardial infarction and even sudden death. Many synthetic drugs have been developed to reduce the symptoms of atherosclerosis, however, their efficacy in terms of reduction of atherosclerotic lesions progression is a matter of debate. Adverse effects of the exiting therapy should also be taken into account. The development of cellular models and improved understanding of the mechanisms of atherogenesis at the vascular wall level helped establishing the "direct anti-atherosclerosis therapy" approach. In this approach, the decrease of intracellular lipid deposition and atherogenicity of human blood serum are considered primary (direct) antiatherosclerotic effects. Screening of synthetic and natural substances for anti-atherosclerotic activity revealed a number of botanicals that could be used for direct anti-atherosclerotic therapy to treat early-stage atherosclerosis. As a result, 3 novel non-pharmaceutical products were developed (Allicor, Inflaminat and Karinat). Studies on in vitro and ex vivo models of atherogenesis confirmed their anti-atherosclerotic and anti-atherogenic activities and safety in patients. Clinical studies of Allicor, Inflminat and Karinat were carried out in subjects with diagnosed early stage atherosclerosis, demonstrating a clinically significant anti-atherosclerotic effect of the drugs. In this overview, we will present the complete process of the development of novel non-pharmaceutical products and report the results obtained in the conducted pre-clinical and clinical studies of these medications.

News (Medical) associated with Pharmaceutical Research Associates, Inc.

03 Jan 2023

·www.businesswire.com

Worldwide Analytical Laboratory Services Industry to 2029 - Featuring Syneos Health, Cardinal Health, Wuxi Apptec, SGS and Eurofins Scientific Among Others - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Analytical Laboratory Services Market Analysis by Service Type, by Test Type, by End-Users, and by Region - Global Forecast to 2029" report has been added to ResearchAndMarkets.com's offering. An increase in market players' investment in analytical testing, rising number of drug approvals and clinical trials, initiatives of the government to improve analytical testing capacities, the rising cost of drugs and medical products, and rising need for advanced analytical testing services are some of the primary market drivers. However, expensive advanced analytical labs, regular laboratory costs for drug development, and limitations in the analysis of new complex products are expected to restrain the market growth. Regional Markets In 2021, North America had the greatest share of the market due to the growing number of clinical trials, the significant investment in quality testing, the strong regulatory situation, and the region's well-established government testing facilities. However, during the projection period, Asia-Pacific is predicted to develop at the fastest CAGR. This can be contributed to the region's rapidly growing pharmaceutical industry, an increase in the number of highly competitive and highly fragmented pharmaceutical companies, increased government spending to establish new laboratories, and increased government spending on healthcare in Asian countries. Companies Mentioned Syneos Health (US) Cardinal Health Inc. (US) Covance (a subsidiary of laboratory corporation of america holdings) (US) Wuxi Apptec (China) SGS S.A (Switzerland) Eurofins Scientific (France) Charles River Laboratories (US) Federal Institute for Drugs & Medical Devices (bfarm) (Germany) European Medicines Agency (European Union) Central Drugs Standard Control Organization (India) Evotec se (Germany) Agenzia italiana del farmaco - aifa (italy) Bioagilytix Labs (US) Pharmaceutical Research Associates Inc. (US) ALS Limited (Australia) Market Segmentation: Service Type (Revenue, USD Million) Stand-alone Laboratories Hospital-based Laboratories Clinics based Laboratories Test Type (Revenue, USD Million) Stability Testing Bioanalytical Testing Method Validation Raw Material Testing Batch Release Testing Physical Characterization Environmental Monitoring Microbial Testing End-Users (Revenue, USD Million) Biotechnology Companies Pharmaceutical Companies Others By Region (Revenue, USD Million) North America U.S Canada Europe Germany France UK Spain Italy Rest of Europe Asia Pacific China Japan India Australia South Korea Rest of APAC Latin America Brazil Mexico Argentina Rest of LATAM Middle East & Africa South Africa GCC Rest of MEA For more information about this report visit https://www.researchandmarkets.com/r/etdobc

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Drug(Targets)	Indications	Global Highest Phase

Warfarin Sodium ( VKOR )	-	Withdrawn
Warfarin Potassium ( VKOR )	-	Withdrawn
Quinidine Polygalacturonate ( CYPs x P-gp x SCNA x α-adrenergic receptor )	Ventricular Arrhythmia More	Withdrawn
Sulfaphenazole ( DHPS )	Bacterial Infections More	Withdrawn
Trolamine Polypeptide Oleate Condensate	Ear Diseases More	Withdrawn

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