Wednesday, July 8, 2026

Drug profile · INN

inclisiran sodium

inclisiran sodium (LEQVIO) is a pcsk9 mrna rnai inhibitor. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 9
Pipeline programs 4
News articles 0
Drug details — inclisiran sodium
US status
approved
Class
Route
SUBCUTANEOUS
Patents
9
Programs
4
Data quality
0.84

Quick answer

inclisiran sodium (LEQVIO) is a pcsk9 mrna rnai inhibitor. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN inclisiran sodium
Brand LEQVIO
Mechanism PCSK9 mRNA rnai inhibitor
Target PCSK9 mRNA
Route SUBCUTANEOUS
Formulation SOLUTION

Mechanism of action

PCSK9 mRNA rnai inhibitor

Primary target: PCSK9 mRNA

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. CKJX839B12302 Phase 3 · Novartis India · Atherosclerotic cardiovascular disease (ASCVD)
  2. CKJX839D12303 Phase 3 · Novartis India · Non-obstructive Coronary Artery Disease
  3. CKJX839A12402 Approved · Novartis India · Hypercholesterolemia
  4. CKJX839A1DE02 Approved · Novartis India · Hypercholesterolemia

Related & competitor drugs

  1. inclisiran Cardiovascular system (C10)

Related patents

  1. US 10851377

    Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder

    Expires Mon Nov 26 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10806791

    Carbohydrate conjugates as delivery agents for oligonucleotides

    Expires Mon Oct 15 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10131907

    Glycoconjugates of RNA interference agents

    Expires Mon Nov 15 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10125369

    PCSK9 iRNA compositions and methods of use thereof

    Expires Mon Nov 08 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 9370582

    Carbohydrate conjugates as delivery agents for oligonucleotides

    Expires Mon Jun 16 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 8828956

    Carbohydrate conjugates as delivery agents for oligonucleotides

    Expires Mon Sep 04 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 8809292

    Compositions and methods for inhibiting expression of the PCSK9 gene

    Expires Mon Aug 14 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 8222222

    Compositions and methods for inhibiting expression of the PCSK9 gene

    Expires Mon Jul 12 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 8106022

    Carbohydrate conjugates as delivery agents for oligonucleotides

    Expires Mon Jan 26 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is inclisiran sodium?

inclisiran sodium (LEQVIO) is a pcsk9 mrna rnai inhibitor. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for inclisiran sodium?

LEQVIO is a marketed brand name for inclisiran sodium. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of inclisiran sodium?

inclisiran sodium has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.