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.

0 Patents (Medical) associated with Pharmaceutical Research Associates, Inc.

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

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 ; Kapil, Ram P ; Matsuo, Yoshiyuki ; Harris, Stephen C ; 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 ; Xin, Yan ; Lal, Preeti ; Sundy, John S ; 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.

24 Aug 2022

·www.prnewswire.com

Calyptus Pharmaceuticals Announces Approval of Arformoterol Tartrate Inhalation Solution, EQ 0.015 mg Base/2 ml

PRINCETON, N.J., Aug. 24, 2022 /PRNewswire/ -- Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for a generic version of Brovana ® (Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml) to Calyptus' partner - VistaPharm, Inc., ("VistaPharm" - a Pharmaceutical Associates, Inc company). Calyptus co-developed the product in collaboration with VistaPharm. Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Arformoterol Tartrate inhalation solution is for use by nebulization only. Calyptus Co-founders - Sujeet Singh, Dr. Puiho Yuen and Shubhayu Sinharoy said, "We are thrilled with this approval in partnership with VistaPharm. We believe that combining Calyptus' know-how and expertise with partners is key to bringing affordable medicines to patients and creating shared success. The successful development, and approval of a generic formulation of Arformoterol Tartrate inhalation solution is a testimony to these efforts". According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml for the 12 months ended June 2022 were approximately $104 million. About Calyptus Calyptus is a pharmaceutical company based in Princeton, N.J., whose mission is to improve lives of patients by increasing access and affordability of quality medicines. Founded in 2017, Calyptus is developing a portfolio of sterile products (generic ANDAs and specialty 505(b)2s) that resolve technological complexity, create accelerated regulatory pathways, bridge unmet medical needs and overcome market access barriers. Additional information is available on Calyptus' website at CONTACT Name: Shubhayu Sinharoy, COO Calyptus Pharmaceuticals, Inc. Email: [email protected] Phone: 269-873-0430 Website: SOURCE Calyptus Pharmaceuticals, Inc.

Collaborate

100 Deals associated with Pharmaceutical Research Associates, Inc.

100 Translational Medicine associated with Pharmaceutical Research Associates, Inc.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

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

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Pharmaceutical Research Associates, Inc.

Overview

Related

Corporation Tree

Pipeline

Pipeline Snapshot as of 26 Nov 2024

Current Projects

Deal

Translational Medicine

Profit

Grant & Funding(NIH)

Investment

Financing