- |||||||||| Uptravi (selexipag) / J&J, Nippon Shinyaku, Opsumit (macitentan) / Nippon Shinyaku, J&J
Journal: Pharmacological counseling in hepatotoxicity induced by macitentan and selexipag: a case report. (Pubmed Central) - Oct 26, 2022 We grouped the individual drugs based on treatment pathways: ambrisentan, bosentan, macitentan, and sitaxsentan were considered A multidisciplinary approach based on clinical evaluation, as well as pharmacological counseling and evaluation of the patient's genetic profile, might be useful for identification of patients with a high chance of drug-induced liver injury, avoiding unnecessary risks in therapy selection and prescription.
- |||||||||| Thelin (oral sitaxsentan) / Pfizer, Tracleer (bosentan) / J&J, Roche
Biomarker, Enrollment change, Trial withdrawal: Pharmacogenomics in Pulmonary Arterial Hypertension (clinicaltrials.gov) - Dec 9, 2021 P=N/A, N=0, Withdrawn, A multidisciplinary approach based on clinical evaluation, as well as pharmacological counseling and evaluation of the patient's genetic profile, might be useful for identification of patients with a high chance of drug-induced liver injury, avoiding unnecessary risks in therapy selection and prescription. N=1300 --> 0 | Recruiting --> Withdrawn
- |||||||||| Thelin (sitaxsentan) / Pfizer, Tracleer (bosentan) / J&J, Roche
Clinical, Journal: Liver safety evaluation of endothelin receptor antagonists using HepatoPac : A single model impact assessment on hepatocellular health, function and bile acid disposition. (Pubmed Central) - Oct 16, 2020 Differences across hepatocellular health (cellular adenosine triphosphate/glutathione content), function (urea production/albumin secretion) and taurocholic acid transport (biliary clearance/excretion index) were compared using amiodarone and ciclosporin A as positive controls...Although traditional animal testing provides adequate safety coverage for advancement of novel pharmaceuticals into clinical trials, supplemental assays employing human MPCCs may strengthen weight-of-evidence predictions for sensitive human populations. Proving the predictive value of this single impact assessment model in advance of clinical trial information for human liver injury risk is needed across more pharmaceuticals.
- |||||||||| Thelin (sitaxsentan) / Pfizer
Preclinical, Journal: Application of a Novel Mass Spectral Data Acquisition Approach to Lipidomic Analysis of Liver Extracts from Sitaxentan-treated Liver-Humanized PXB Mice. (Pubmed Central) - Aug 27, 2020 This method of data generation provides both precursor and fragment ion information, at high specificity, allowing for greater accuracy of compound identification, without the need for spectral libraries. The value of the approach in simplifying and "de-cluttering" the spectra of co-eluting lipids is shown with examples from lipidomic profiles obtained in investigations of the composition of organic extracts of livers obtain from SCID and chimeric liver-humanized mice administered under various experimental conditions.
- |||||||||| Thelin (oral sitaxsentan) / Pfizer
Enrollment change: Drug Interaction Between Ritonavir And Sitaxsentan (clinicaltrials.gov) - Mar 7, 2015 P1, N=0, Withdrawn, Active, not recruiting --> Completed | Trial primary completion date: Sep 2010 --> Sep 2009 N=18 --> 0
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