Prescription medicine
Plozasiran Brand names: Redemplo
Plozasiran (Redemplo) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the plozasiran FDA label on DailyMed (effective August 25, 2026, Arrowhead Pharmaceuticals, Inc.); the NDA 219947 record on Drugs@FDA; every plozasiran label on DailyMed.
Highlights of the record
FDA label of August 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageREDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
Forms and strengths
- 25 mg/.5ml
Injection (solution).
On the market
- Earliest approval on file
- November 18, 2025 Redemplo, Arrowhead; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 10, 2038 Redemplo injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 56 through July 30, 2026
What is plozasiran used for?
From the label: indications and usageREDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). REDEMPLO is an apolipoprotein C-III ( apoC-III )-directed small interfering ribonucleic acid (siRNA) indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
FDA pharmacologic class: APOC-III-directed RNA Interaction and Small Interfering RNA.
Source: FDA drug label (REDEMPLO), Arrowhead Pharmaceuticals, Inc., effective August 25, 2026 (SPL set 7fd37993-f85a-4af1-8bbe-133299f226ed), via openFDA; the full label on DailyMed
Is there a generic for plozasiran (Redemplo)?
No generic plozasiran is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Redemplo injection: the compound patent runs to September 10, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for plozasiran?
The FDA Adverse Event Reporting System holds 56 reports that list plozasiran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 8 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other apoc-iii-directed rna interactions
- the pharmacologic class, with prices and generics
- Plozasiran side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other