Wednesday, July 8, 2026

Drug profile · INN

givosiran sodium

givosiran sodium (GIVLAARI) is a 5-aminolevulinate synthase mrna rnai inhibitor. Associated with Alnylam Netherlands B.V.. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 20
Pipeline programs 3
News articles 1
Drug details — givosiran sodium

Quick answer

givosiran sodium (GIVLAARI) is a 5-aminolevulinate synthase mrna rnai inhibitor. Associated with Alnylam Netherlands B.V.. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN givosiran sodium
Brand GIVLAARI
Mechanism 5-aminolevulinate synthase mRNA RNAi inhibitor
Target 5-aminolevulinate synthase mRNA
Route SUBCUTANEOUS
Formulation SOLUTION

Mechanism of action

5-aminolevulinate synthase mRNA RNAi inhibitor

Primary target: 5-aminolevulinate synthase mRNA

Approval history

Authority Status Date
FDA approved

Recent coverage

Pipeline programs

  1. Givosiran Phase 3 · Alnylam Netherlands · Acute Hepatic Porphyria
  2. Givosiran Phase 2 · Alnylam Netherlands · Acute Intermittent Porphyria
  3. Givosiran Phase 1 · Alnylam Netherlands · Acute Intermittent Porphyria (AIP)

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Frequently asked questions

What is givosiran sodium?

givosiran sodium (GIVLAARI) is a 5-aminolevulinate synthase mrna rnai inhibitor. Associated with Alnylam Netherlands B.V.. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for givosiran sodium?

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

What is the US approval status of givosiran sodium?

givosiran 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.