Plozasiran: First Approval

Funding The preparation of this review was not supported by any external funding. DeclarationsAuthorship and Conflict of interest Yahiya Y. Syed is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable Additional information about this Adis Drug Review can be found here AbstractPlozasiran (Redemplo®) is a first-in-class GalNAc-conjugated small interfering RNA (siRNA) designed to reduce hepatic apolipoprotein C-III (ApoC3) production. It is being developed by Arrowhead Pharmaceuticals for the treatment of familial chylomicronemia syndrome (FCS), severe hypertriglyceridaemia and mixed hyperlipidaemia. Plozasiran degrades ApoC3 mRNA via RNA interference, reducing hepatic and serum ApoC3 levels and thereby enhancing catabolism and clearance of serum triglycerides. It received its first approval in the USA on 18 November 2025 as an adjunct to diet to reduce triglycerides in adults with FCS. This article summarizes the key milestones in the clinical development of plozasiran leading to its first approval for FCS. © Springer Nature Switzerland AG 2026