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Drug

Olezarsen sodium

Approved · FDA / EMA

Also known as Tryngolza, olezarsen (as sodium).

3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Olezarsen sodium
Aliases & brands
Tryngolzaolezarsen (as sodium)
RxNorm CUI
2701417
Regulatory jurisdictions
emafda

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2024-12-192026-06-24)
Earliest approval
2024-12-19
Latest approval
2026-06-24
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-06-24Indication expansionMulti-authority
Indication expansion: OLEZARSEN SODIUM (NDA218614)
Evidence ↗
2024-12-19ApprovalMulti-authority
Approval: OLEZARSEN SODIUM (NDA218614)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2025-09-17ApprovalMulti-authority
Approval: Tryngolza (EMA)

Indication: Tryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). 

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Regulatory event sources are credited in the Regulatory Timeline above.