Aprocitentan: First Approval

NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398(10304):957–80.

Article  Google Scholar 

GBD. Risk Factors Collaborators (2020) Global burden of 87 risk factors in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2019;396(10258):1223–49.

Google Scholar 

Noubiap JJ, Nansseu JR, Nyaga UF, et al. Global prevalence of resistant hypertension: a meta-analysis of data from 3.2 million patients. Heart. 2019;105(2):98–105.

Article  PubMed  Google Scholar 

Carey RM, Calhoun DA, Bakris GL, et al. Resistant hypertension: detection, evaluation, and management: a scientific statement from the American Heart Association. Hypertension. 2018;72(5):e53–90.

Article  CAS  PubMed  Google Scholar 

Clozel M. Aprocitentan and the endothelin system in resistant hypertension. Can J Physiol Pharmacol. 2022;100(7):573–83.

Article  CAS  PubMed  Google Scholar 

Burnier M. Update on endothelin receptor antagonists in hypertension. Curr Hypertens Rep. 2018;20(6):51.

Article  PubMed  Google Scholar 

US FDA. Corrected New Drug Application approval: aprocitentan. 2024. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217686Orig1s000Correctedltr.pdf. Accessed 10 Apr 2024.

Idorsia Pharmaceuticals US Inc. TRYVIOTM (aprocitentan): US prescribing information. 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217686s000lbl.pdf. Accessed 22 Mar 2024.

Actelion Pharmaceuticals. Actelion provides an update on the progress towards launching Idorsia - key results for pipeline assets to be developed by Idorsia [media release]. 22 May 2017. https://www.globenewswire.com/en/news-release/2017/05/22/994421/0/en/Actelion-provides-an-update-on-the-progress-towards-launching-Idorsia-Key-results-for-pipeline-assets-to-be-developed-by-Idorsia.html.

Idorsia Pharmaceuticals. Idorsia announces collaboration with Janssen Biotech on aprocitentan [media release]. 4 Dec 2017. https://www.idorsia.com/investors/news-and-events/media-releases/media-release-details?id=1381336.

Idorsia Pharmaceuticals. Idorsia reacquires the world-wide rights to aprocitentan [media release]. 6 Sep 2023. https://www.idorsia.com/investors/news-and-events/media-releases/media-release-details?id=3073952.

Iglarz M, Binkert C, Morrison K, et al. Pharmacology of macitentan, an orally active tissue-targeting dual endothelin receptor antagonist. J Pharmacol Exp Ther. 2008;327(3):736–45.

Article  CAS  PubMed  Google Scholar 

Trensz F, Bortolamiol C, Kramberg M, et al. Pharmacological characterization of aprocitentan, a dual endothelin receptor antagonist, alone and in combination with blockers of the renin angiotensin system, in two models of experimental hypertension. J Pharmacol Exp Ther. 2019;368(3):462–73.

Article  CAS  PubMed  Google Scholar 

Sidharta PN, Brussee JM, Schultz A, et al. The clinical evaluation of QTc interval prolongation for the dual endothelin receptor antagonist aprocitentan in a thorough QT/QTc study [abstract no. 024]. Clin Pharmacol Drug Dev. 2022;11(Suppl 1):66–7.

Google Scholar 

Sidharta PN, Melchior M, Kankam MK, et al. Single- and multiple-dose tolerability, safety, pharmacokinetics, and pharmacodynamics of the dual endothelin receptor antagonist aprocitentan in healthy adult and elderly subjects. Drug Des Devel Ther. 2019;13:949–64.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Sidharta PN, Fischer H, Dingemanse J. Absorption, distribution, metabolism, and excretion of aprocitentan, a dual endothelin receptor antagonist, in humans. Curr Drug Metab. 2021;22(5):399–410.

Article  CAS  PubMed  Google Scholar 

Fontes MSC, Dingemanse J, Sidharta PN. Multiple-dose pharmacokinetics, safety, and tolerability of aprocitentan, a dual endothelin receptor antagonist, in healthy Japanese and Caucasian subjects. Clin Pharmacol Drug Dev. 2021;10(7):718–25.

Article  CAS  PubMed  Google Scholar 

Fontes MSC, Dingemanse J, Halabi A, et al. Single-dose pharmacokinetics, safety, and tolerability of the dual endothelin receptor antagonist aprocitentan in subjects with moderate hepatic impairment. Sci Rep. 2022;12(1):19067.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Angeli F, Verdecchia P, Reboldi G. Aprocitentan, a dual endothelin receptor antagonist under development for the treatment of resistant hypertension. Cardiol Ther. 2021;10(2):397–406.

Article  PubMed  PubMed Central  Google Scholar 

Sidharta PN, Dingemanse J. Effect of multiple-dose aprocitentan administration on the pharmacokinetics of midazolam in healthy male subjects. Eur J Drug Metab Pharmacokinet. 2020;45(2):227–34.

Article  CAS  PubMed  Google Scholar 

Sidharta PN, Dingemanse J. Effects of multiple-dose administration of aprocitentan on the pharmacokinetics of rosuvastatin. Clin Pharmacol Drug Dev. 2020;9(8):995–1002.

Article  CAS  PubMed  Google Scholar 

Schlaich MP, Bellet M, Weber MA, et al. Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial. Lancet. 2022;400(10367):1927–37.

Article  CAS  PubMed  Google Scholar 

Danaietash P, Verweij P, Wang JG, et al. Identifying and treating resistant hypertension in PRECISION: a randomized long-term clinical trial with aprocitentan. J Clin Hypertens (Greenwich). 2022;24(7):804–13.

Article  CAS  PubMed  Google Scholar 

Schlaich M, Weber M, Bakris G, et al. Effects of the dual endothelin antagonist aprocitentan on ambulatory blood pressure indices in patients with resistant hypertension. Results from the PRECISION study [abstract]. J Hypertens. 2023;41(Suppl 3):e71.

Article  Google Scholar 

Weber MA, Wang J, Flack JM, et al. Percentage of patients achieving blood pressure goals with aprocitentan, a dual endothelin receptor antagonist: results from a randomized, controlled phase 3 study (PRECISION) [abstract no. 13836]. Circulation. 2023;148(Suppl 1):A13836.

Google Scholar 

Bakris GL, Flack JM, Narkiewicz K, et al. Effects of aprocitentan for blood pressure lowering and proteinuria in patients with CKD and resistant hypertension [abstract no. FR-OR96]. J Am Soc Nephrol. 2023;34:56.

Article  Google Scholar 

Flack JM, Schlaich M, Weber M, et al. Effects of aprocitentan, a dual endothelin receptor antagonist, on blood pressure in Black/African American patients with resistant hypertension: results from a randomized, controlled study (PRECISION) including a withdrawal phase [abstract no. 118]. Hypertension. 2023;80(Suppl 1):A118.

Google Scholar 

Verweij P, Danaietash P, Flamion B, et al. Randomized dose-response study of the new dual endothelin receptor antagonist aprocitentan in hypertension. Hypertension. 2020;75(4):956–65.

Article  CAS  PubMed  Google Scholar 

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