What Was Approved?
On November 18, 2025, the U.S. Food and Drug Administration approved Redemplo (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome, or FCS.
FCS is a rare inherited disorder that can cause extremely high triglyceride levels.
How Does Redemplo Work?
Redemplo is an APOC-III-directed small interfering RNA, or siRNA, therapy.
It is designed to reduce production of apolipoprotein C-III, a protein involved in triglyceride metabolism.
How Is Redemplo Given?
The recommended dose is:
25 mg by subcutaneous injection once every 3 months.
It may be injected into the thigh or abdomen. The upper arm may also be used when the injection is given by a healthcare professional or caregiver.
What Did the Clinical Trial Show?
FDA approval was supported by a randomized, double-blind, placebo-controlled trial in 75 adults with FCS.
Participants continued a very low-fat diet and received Redemplo or placebo every three months for one year.
The main outcome was the percentage change in fasting triglyceride levels at Month 10.
Does Redemplo Replace a Low-Fat Diet?
No.
Redemplo is approved as an adjunct to diet.
Dietary fat restriction remains an important part of FCS management, and patients should follow the nutrition plan recommended by their healthcare team.
What Are the Main Safety Considerations?
Patients should use Redemplo according to the FDA-approved prescribing information and report concerning reactions to their healthcare professional.
Because FCS is a rare metabolic disorder with a risk of serious complications, including pancreatitis, treatment should be managed by clinicians familiar with severe hypertriglyceridemia.
Bottom Line
Redemplo (plozasiran) is an FDA-approved injectable treatment for adults with familial chylomicronemia syndrome.
It is given once every three months and is used together with dietary management to reduce triglyceride levels.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2025.
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Redemplo.
- U.S. Food and Drug Administration (FDA) — Redemplo (plozasiran) Prescribing Information, November 2025.