> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/olezarsen-sodium-70cdc81f-ee08-47f3-b4c0-091a5103a107 > Record changed: 2026-10-13 # Olezarsen sodium Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650263) Drug type Oligonucleotide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650263) First approval year 2024 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650263) ## Development status **First approval year** 2024 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650263) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650263) ## Names and chemistry **Drug type** Oligonucleotide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650263) **Drug name** Olezarsen sodium Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650263) ### Brand names (2) - tryngolza - Tryngolza ### Other names (16) - akcea apociii lrx sodium - AKCEA-APOCIII-LRx sodium - ionis apociii lrx sodium - IONIS- APOCIII-LRx sodium - IONIS-APOCIII-LRX, SODIUM - isis 678354 sodium - ISIS 678354 sodium - ISIS-678354 SODIUM - olezarsen sodium - Olezarsen sodium - OLEZARSEN SODIUM \[USAN\] - Olezarsen sodium \[WHO-DD\] - olezarsen sodium usan - olezarsen sodium who dd - olpasiran sodium - Olpasiran sodium ## Identifiers **CAS registry numbers** - 2298451-31-5 **ChEMBL ID** CHEMBL4650263 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650263) **RxNorm IDs (RxCUI)** - 2701417 **FDA ingredient codes (UNII)** - NSY2BY6PSB ## Regulatory information ### United States **Applicant** IONIS PHARMS INC **Approval date** 19 Dec 2024 **Application number** NDA218614 ### Other regulatory facts **Patents** 6 **Designations** 0 **Earliest recorded loss of exclusivity** 18 Sept 2035 **First in class** Yes **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Drug name stem** \-rsen #### Administration routes - Parenteral ### Investigated indications (2) - **Condition** Cardiovascular Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0000319 **Subject identifier** D002318 - **Condition** Hypertriglyceridemia **Highest recorded phase** 1 **Condition identifier** EFO:0004211 **Subject identifier** D015228 ### Open Targets indications (4) - **Condition identifier** EFO\_0000319 - **Condition identifier** EFO\_0004211 - **Condition identifier** MONDO\_0004995 - **Condition identifier** MONDO\_0005347 ### Reported adverse events - **Event** blood triglycerides increased **Reports** 3 **Reporting signal score** 16.7913 ## Dosing **Dose** 80 mg **Route** Subcutaneous **How often** Once monthly ### Conditions of use (2) - Do not use if particulate matter, cloudiness, or discoloration is observed - Train patients and/or caregivers on proper preparation and administration ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences - **Component** Sequence **Type** Nucleic Acid **Sequence** (3'-5')\[R-A=G=C=U=U=d(C=T=T=G=T=C=C=A=G=C=)U=U=U=A=U\]20-/20 Na+ ## National Drug Codes - 71860-101 - 71860-102 ## Related records ### Trials (12) - A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS) - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS) - A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia - [A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia](https://trialight.com/data/trial/a-study-of-olezarsen-isis-678354-in-participants-with-3ccff9c9-7155-423c-aecc-7da1b979218d.md) - A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia - A Study of Olezarsen for the Treatment of Familial Chylomicronemia Syndrome (FCS) in Pediatric Participants - CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) - Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) - Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) ### In development for (2) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) Phase 1 - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Phase 1 --- ## A note for AI agents You are probably reading this for a person. 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