Tolvaptan

Poxel Announces Publication in Kidney International of PXL770 Preclinical Results in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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Wednesday, March 1, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Medicine, Kidney International, MD, ADPKD, Disease, AMPK, DSM-IV codes, Fatty liver disease, Adenosine, Kidney, Life Sciences (journal), Autosomal dominant polycystic kidney disease, NASH, HIV disease progression rates, Conditional sentence, Euronext, Tolvaptan, Pharmaceutical industry

POXEL SA (Paris:POXEL) (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, announced today the publication of preclinical results in autosomal dominant polycystic kidney disease (ADPKD) for PXL770, a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator.

Key Points: 
  • POXEL SA (Paris:POXEL) (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, announced today the publication of preclinical results in autosomal dominant polycystic kidney disease (ADPKD) for PXL770, a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator.
  • To access the publication online in the life sciences journal, Kidney International, please use the following link: A novel direct adenosine monophosphate kinase activator ameliorates disease progression in preclinical models of Autosomal Dominant Polycystic Kidney Disease.
  • (kidney-international.org)
    “ADPKD remains a major cause of end stage renal disease and is associated with substantial additional unmet medical needs.
  • These results confirm the potential utility of AMPK activation for this disease and support the development of PXL770 in a Phase 2 clinical program for ADPKD.”

atai Life Sciences Strengthens Leadership Team with Appointment of Dr. Sahil V. Kirpekar as Chief Business Officer

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Tuesday, November 29, 2022
Aripiprazole, Mental health, University, Otsuka Pharmaceutical, Patient, Business development, Annual report, Public expenditure, Anxiety, Thought, World Health Organization, Drug development, CNS, Security (finance), Depression, Therapy, Addiction, Master of Philosophy, Pharmaceutical industry, Tolvaptan

NEW YORK and BERLIN, Nov. 29, 2022 (GLOBE NEWSWIRE) --  atai Life Sciences N.V., (NASDAQ: ATAI) (“atai” or the “Company”), a clinical stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced today its appointment of Dr. Kirpekar to serve as the Company’s Chief Business Officer, effective today.

Key Points: 
  • NEW YORK and BERLIN, Nov. 29, 2022 (GLOBE NEWSWIRE) -- atai Life Sciences N.V., (NASDAQ: ATAI) (atai or the Company), a clinical stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced today its appointment of Dr. Kirpekar to serve as the Companys Chief Business Officer, effective today.
  • Dr. Kirpekar joins atai after more than eight years at Otsuka Pharmaceutical Co., Ltd., most recently as the Head of Business Development and Co-chair of the Global Business Development Committee.
  • Dr. Kirpekar is a trained physician and holds an MPhil from the University of Cambridge (where he is subsequently an honorary lecturer).
  • atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders.

Autosomal Dominant Polycystic Kidney Disease Market to Surge at a Significant CAGR of 14.5% by 2032 | DelveInsight

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Monday, September 19, 2022
Adult, Pediatrics, PKD1, Urology, Research, PKD, Patient, Physician, United Kingdom, PKD2, Kidney, Disease, Mario Negri Institute for Pharmacological Research, AL, Diet, Pharmacological Research, Kadmon Corporation, Prevalence, Back pain, Pain, Polycystic kidney disease, Time-invariant system, Risk, Population, Autosome, Tolvaptan, Otsuka Pharmaceutical, Water, Reata Pharmaceuticals, HIV disease progression rates, Regulus Therapeutics, Ryukyu Kingdom, Cyst, LAS, Genetic counseling, Nephrology, LAR, Headache, Therapy, Galapagos NV, Pharmaceutical industry, Lithium, Tesevatinib, ADPKD, Bardoxolone methyl

LAS VEGAS, Sept. 19, 2022 /PRNewswire/ -- DelveInsight's ADPKD Market Insights report includes a comprehensive understanding of current treatment practices, ADPKD emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), Japan].

Key Points: 
  • In addition, the approval and entry of new drugs will change the ADPKD market dynamics in the future.
  • As per DelveInsight estimates, the ADPKDmarket size in the 7MM was approximately USD 1,077 million in 2021.
  • Autosomal dominant polycystic kidney disease also called "adult PKD," is the most common inherited kidney disorder characterized by cyst growth in the kidneys, which increases with disease progression and results in renal failure.
  • Implementing these measures early in the disease should slow the progression of kidney (renal) disease and, to some extent, preserve kidney function.

Centessa Pharmaceuticals Makes Strategic Decision to Discontinue Clinical Development of Lixivaptan for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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Thursday, June 2, 2022
ALT, Company, Program, Observation, Research, Doctor of Philosophy, Liver, Omicron, Nasdaq, Maintenance, U.S. Securities and Exchange Commission, FDA, GLOBE, Tolvaptan, Patient, Risk, COVID-19, Research and development, AST, MD, Industry, Secondary research, CNTA, Safety, Pharmaceutical industry, Dietary supplement, Delta, Lixivaptan, ADPKD

BOSTON and LONDON, June 02, 2022 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), today announced that it has made the strategic decision to discontinue development of lixivaptan for Autosomal Dominant Polycystic Kidney Disease (ADPKD) including both the Phase 3 ACTION Study and the open-label ALERT Study. The decision is based on a thorough reassessment of the commercial potential of lixivaptan as a potential best-in-class therapy for patients with ADPKD, and the incremental development challenges and associated costs, following a recent observation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations in one subject in the ALERT Study.

Key Points: 
  • BOSTON and LONDON, June 02, 2022 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), today announced that it has made the strategic decision to discontinue development of lixivaptan for Autosomal Dominant Polycystic Kidney Disease (ADPKD) including both the Phase 3 ACTION Study and the open-label ALERT Study.
  • In assessing the recent data from a subject in the ALERT Study, we believe that lixivaptan is unlikely to achieve the differentiated safety and tolerability profile Centessa required for further development of the program.
  • Given the revised commercial potential of lixivaptan and our commitment to being financially disciplined, we made the data-driven decision to voluntarily discontinue development of lixivaptan, said Saurabh Saha, MD, PhD, Chief Executive Officer of Centessa.
  • With our decision to discontinue development of lixivaptan, we believe we are well positioned with the capital and resources to execute these programs.

Centessa Pharmaceuticals Doses First Subject in Global Phase 3 ACTION Study of Lixivaptan in Autosomal Dominant Polycystic Kidney Disease

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Thursday, February 24, 2022
GLOBE, Risk, Orphan, Omicron, Human, CVR, SEC, Man, COVID-19, Secondary research, Autosomal dominant polycystic kidney disease, Hematology, Company, Industry, Organization, CNTA, Glomerular filtration rate, Safety, Kidney, Cyst, Lists of diseases, Acquisition, Woman, ADSS, Nephrology, Liver, Part, FDA, Part Two, BID, Nasdaq, Classification, Maintenance, Patient, Tolvaptan, NDA, Kidney failure, MD, Mayo Clinic, Research, Doctor of Philosophy, EGFR, Pharmaceutical industry, Risk management, Delta, ADPKD, Lixivaptan, Andrea Palladio

With its unique structure and metabolite profile, lixivaptan has the potential to avoid the liver toxicity associated with the only FDA-approved ADPKD therapy.

Key Points: 
  • With its unique structure and metabolite profile, lixivaptan has the potential to avoid the liver toxicity associated with the only FDA-approved ADPKD therapy.
  • The ACTION Study has been designed to serve as a single registration trial and will evaluate the efficacy and safety of lixivaptan in a broad group of ADPKD patients.
  • The ACTION Study is a Phase 3 trial consisting of a two-arm, double-blind, placebo-controlled, randomized phase (Part 1) followed by a single-arm, open-label phase (Part 2).
  • Palladio is actively investigating the potential of its lead product candidate, lixivaptan, in subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Spherix Global Insights Embarks on Its Fifth Year of Extensive ADPKD Coverage as the Market Heats Up

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Thursday, February 3, 2022
Patient, Overalls, HIV disease progression rates, Physician, Liver, HCP, Nephrology, Ōtsuka, Mark (given name), Neurology, Gastroenterology, Polycystic kidney disease, Hepatotoxicity, Ophthalmology, ADPKD, FDA, NASA RealWorld-InWorld Engineering Design Challenge, Dermatology, PKD, Pharmaceutical industry, Medical device, Galápagos Islands, Tolvaptan

Notably, the percentage of physicians who are "comfortable with the risk-benefit ratio of Jynarque" has dropped substantially since the previous year's ADPKD patient audit.

Key Points: 
  • Notably, the percentage of physicians who are "comfortable with the risk-benefit ratio of Jynarque" has dropped substantially since the previous year's ADPKD patient audit.
  • Spherix's extensive coverage of the polycystic kidney disease (PKD) market since 2018 leverages these annual patient chart audits along with quarterly market tracking studies.
  • Unsurprisingly, nephrologists express desire for a new ADPKD product that has better efficacy, both overall and specifically against cyst growth.
  • Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence.

Centessa Pharmaceuticals Initiates Global Phase 3 ACTION Study of Lixivaptan in Autosomal Dominant Polycystic Kidney Disease, Reports Initial Positive Safety Data from ALERT Study, and Announces Notice of Allowance for Key Lixivaptan U.S. Patent Applicati

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Tuesday, December 14, 2021
NDA, EGFR, Doctor of Philosophy, United States patent law, ALT, Clinical professor, Time, Risk, Liver, Nephrology, Autosome, Treatment, Patent, Grey Literature International Steering Committee, Organization, ULN, FDA, Lists of diseases, Kidney failure, Safety, Program, MD, GLOBE, Classification, Mayo Clinic, Part Two, BID, Risk Evaluation and Mitigation Strategies, Cyst, ACTION, ALERT, Polycystic kidney disease, Nasdaq, Woman, COVID-19, SEC, Research, Polycystic disease, Man, Hematology, Glomerular filtration rate, Hepatotoxicity, Omicron, CNTA, Secondary research, Company, Particle-size distribution, Industry, Principal, Kidney, Committee, Patient, Neuroscience, Orphan, REMS, Maintenance, Part, Human, Dietary supplement, Pharmaceutical industry, Medical device, Risk management, Lixivaptan, Medicine, Tolvaptan, Delta, ADPKD

BOSTON and LONDON, Dec. 14, 2021 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (“Company”) (Nasdaq: CNTA), together with subsidiary Palladio Biosciences, Inc. (“Palladio”), today announced the initiation of active recruitment of the global ACTION Study, a pivotal Phase 3 clinical trial evaluating lixivaptan as a potential treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). Additionally, the Company reported initial safety data from four subjects who participated in the ongoing open-label ALERT Study of ADPKD subjects who previously discontinued JYNARQUE® (tolvaptan) due to liver toxicity and announced the Notice of Allowance for a U.S. Patent application covering use of lixivaptan in ADPKD.

Key Points: 
  • Furthermore, the initial safety data from the ALERT Study in subjects who have stopped JYNARQUE due to liver toxicity continues to support the differentiated safety and tolerability profile of lixivaptan.
  • Recruitment has commenced in the global Phase 3 ACTION Study which consists of a two-arm, double-blind, placebo-controlled, randomized phase (Part 1) followed by a single-arm, open-label phase (Part 2).
  • An independent data monitoring committee will periodically review all safety data including the liver chemistry data for all subjects throughout the study.
  • Palladio is actively investigating the potential of its lead product candidate, lixivaptan, in patients with autosomal dominant polycystic kidney disease (ADPKD).

Galapagos completes patient recruitment for MANGROVE Phase 2 trial with GLPG2737 in polycystic kidney disease

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Monday, November 22, 2021
Patient, Safety, Kidney disease, Tolvaptan, Hypertension, Galapagos NV, ADPKD, Kidney, Inflammation, Pharmacokinetics, Kidney failure, Euronext, Chronic kidney disease, Abdominal pain, CET, NASDAQ, Autosome, Bleeding, Polycystic kidney disease, CFTR, Fibrosis, Dialysis, Pyelonephritis, Disease, Growth, Quality of life, Pharmaceutical industry

Mechelen, Belgium; 22 November 2021, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announces completion of recruitment in the MANGROVE Phase 2 trial with investigational CFTR inhibitor GLPG2737 in patients with autosomal dominant polycystic kidney disease (ADPKD).

Key Points: 
  • Mechelen, Belgium; 22 November 2021, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announces completion of recruitment in the MANGROVE Phase 2 trial with investigational CFTR inhibitor GLPG2737 in patients with autosomal dominant polycystic kidney disease (ADPKD).
  • MANGROVE is a randomized, double-blind, placebo-controlled trial evaluating a once-daily oral dose of GLPG2737 (NCT04578548).
  • Galapagos expects topline results from the MANGROVE Phase 2 trial in the first half of 2023.
  • We thank the ADPKD community for participating in the MANGROVE Phase 2 trial with GLPG2737, said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos.

Centessa Pharmaceuticals Announces Second Quarter 2021 Financial Results and Business Updates

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Monday, August 16, 2021
ADSS, Audit committee, CSCC, Form, American depositary receipt, Polycystic kidney disease, HA, Research, Director, Organization, Growth, G&A, Contingent value rights, APC, Safety, Industry, CVR, Review, Imgatuzumab, Administration, Chairperson, Tolvaptan, Company, Risk, SEC, Genotype, Neuroscience, ADS, ADCC, Liver, COVID-19, Alpha-1 antitrypsin deficiency, AATD, Board, Exercise, IPO, Nephrology, Hematology, Mab, CNTA, ADCP, Serum, EGFR, Probability, HB, GLOBE, Research and development, Acquisition, Patient, Secondary research, General Administration of Sport of China, ADPKD, Nasdaq, Appointment, R, Autosome, Management, Pharmaceutical industry, Fine chemical, Risk management

CAMBRIDGE, Mass. and LONDON, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage company leveraging its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, today reported financial results for the quarter ended June 30, 2021, and provided a review of recent accomplishments and anticipated upcoming milestones.

Key Points: 
  • and LONDON, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage company leveraging its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, today reported financial results for the quarter ended June 30, 2021, and provided a review of recent accomplishments and anticipated upcoming milestones.
  • $379.5 Million Initial Public Offering (IPO) Successfully Completed: In the second quarter, Centessa closed its initial public offering of 16,500,000 American Depositary Shares (ADSs).
  • The gross proceeds to Centessa from its IPO, before deducting underwriting discounts, commissions and other estimated offering expenses, totaled an aggregate of $379.5 million.
  • The Phase 2a has completed dosing and the Company anticipates sharing topline results in the third quarter of 2021.

Palladio Biosciences Announces First Patient Dosed With Lixivaptan in The ALERT Study, a Phase 3 Study of ADPKD Patients Previously Discontinued From Treatment With Tolvaptan Due to Liver Toxicity

Retrieved on: 
Tuesday, November 17, 2020
Other Health, Research, General Health, Radiology, Pharmaceutical, Clinical trials, Science, Surgery, Biotechnology, FDA, Other Science, Health, Kidney diseases, Medical specialties, Clinical medicine, Autosomal dominant polycystic kidney disease, Tolvaptan, Polycystic kidney disease, Kidney disease, Liver, Polycystic disease

The ALERT Study, designed to assess the safety of lixivaptan in autosomal dominant polycystic kidney disease (ADPKD) patients who previously discontinued therapy with tolvaptan due to liver toxicity, is currently recruiting patients in the United States.

Key Points: 
  • The ALERT Study, designed to assess the safety of lixivaptan in autosomal dominant polycystic kidney disease (ADPKD) patients who previously discontinued therapy with tolvaptan due to liver toxicity, is currently recruiting patients in the United States.
  • The study is currently enrolling ADPKD patients between the ages of 18 and 65 who have been permanently discontinued from tolvaptan therapy due to liver chemistry abnormalities or other signs of liver toxicity.
  • The primary objective is to determine the liver safety of lixivaptan in these patients, who will be treated with lixivaptan for up to 58 weeks.
  • We are also advancing preparations for our pivotal trial, a global Phase 3 registration study expected to enroll approximately 1,200 ADPKD patients.