TheraRadar
Data updated: May 26, 2026

REDEMPLO (plozasiran sodium)

First-in-Class Orphan Drug Breakthrough Therapy Fast Track
Metabolic Approved 2025-11-18

Redemplo helps adults with familial chylomicronemia syndrome (FCS) manage high triglyceride levels alongside dietary changes. It is used to lower triglycerides in patients with this specific condition. This medication provides a targeted approach to reducing fats in the blood by focusing on the underlying protein production.

Source: FDA Label • ARROWHEAD • APOC-III-directed RNA Interaction

How REDEMPLO Works

Redemplo works by using RNA interference to break down the messenger RNA responsible for producing the apoC-III protein. By reducing the amount of this protein in the liver and blood, the drug allows the body to more effectively clear triglycerides from the bloodstream.

1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-11-18
Patent Cliff
2038

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Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: PLOZASIRAN SODIUM

REDEMPLO Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Nov 2025 ORIGINAL
New Drug · Type 1 - New Molecular Entity

What REDEMPLO Treats

1 indications

REDEMPLO is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Familial Chylomicronemia Syndrome
Source: FDA Label

REDEMPLO Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

1

Same target(s) AND same indication — head-to-head.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to REDEMPLO

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

TRYNGOLZA (AUTOINJECTOR)
OLEZARSEN SODIUM
1 shared
IONIS PHARMS INC
Shared indications:
Familial Chylomicronemia Syndrome
🔬

Active Pipeline

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Key Completed Trials

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Trial Timeline

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

REDEMPLO FDA Label Details

Indications & Usage

FDA Label (PDF)

REDEMPLO is indicated for the treatment of Familial Chylomicronemia Syndrome.

View full patent landscape →
5 OB patents · 2 families · 95 international docs across 25 countries

REDEMPLO Patents & Exclusivity

Latest Patent: Sep 2038

Patents (5 active)

US12365899 Expires Sep 10, 2038
US11214801 Expires Sep 10, 2038
US10597657 Expires Sep 10, 2038
US10294474 Expires Mar 7, 2037
US11174481 Expires Mar 7, 2037
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2038
  • 5 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 1 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.