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Plozasiran FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 20, 2025.

FDA Approved: No
Generic name: plozasiran
Company: Arrowhead Pharmaceuticals, Inc.
Treatment for: Familial Chylomicronemia Syndrome

Plozasiran is a first-in-class investigational RNA interference (RNAi) therapeutic in development for the treatment of familial chylomicronemia syndrome.

Development timeline for plozasiran

DateArticle
Jan 17, 2025Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Nov 18, 2024Arrowhead Pharmaceuticals Presents New Data at AHA24 from PALISADE Phase 3 Study and Open-Label Extension from MUIR and SHASTA-2 Studies of Plozasiran
Nov 18, 2024Arrowhead Pharmaceuticals Submits New Drug Application to U.S. FDA for Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Sep 10, 2024Arrowhead Pharmaceuticals Receives FDA Breakthrough Therapy Designation for Plozasiran
Sep  2, 2024Arrowhead Pharmaceuticals Presents New Pivotal Phase 3 Data at ESC 2024 from PALISADE Study of Plozasiran in Patients with Familial Chylomicronemia Syndrome
Jun 25, 2024Arrowhead Pharmaceuticals to Advance RNAi-based Plozasiran into Phase 3 CAPITAN Cardiovascular Outcomes Trial
Jun  3, 2024Arrowhead Pharmaceuticals Reports Successful Topline Results for Plozasiran from the Pivotal Phase 3 PALISADE Study in Patients with Familial Chylomicronemia Syndrome
May 28, 2024Arrowhead Pharmaceuticals Presents New Phase 2 Data of Plozasiran in Patients with Mixed Hyperlipidemia
Apr  7, 2024Arrowhead Pharmaceuticals Announces New Phase 2 Data of Plozasiran Published in JAMA Cardiology and Presented at American College of Cardiology 73rd Annual Scientific Session & Expo
Mar 25, 2024Arrowhead Pharmaceuticals Initiates Expanded Access Program for Plozasiran and Announces Upcoming Presentation of Clinical Data

Further information

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