Olezarsen sodium
Highest phase reached
Approved
Drug type
Oligonucleotide
First approval year
2024
- First approval year
- 2024
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Oligonucleotide
- Drug name
- Olezarsen sodium
- tryngolza
- Tryngolza
- 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
- CAS registry numbers
- 2298451-31-5
- ChEMBL ID
- CHEMBL4650263
- RxNorm IDs (RxCUI)
- 2701417
- FDA ingredient codes (UNII)
- NSY2BY6PSB
- Applicant
- IONIS PHARMS INC
- Approval date
- 19 Dec 2024
- Application number
- NDA218614
- 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
- Drug name stem
- -rsen
Administration routes
- Parenteral
- 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
- 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
- Dose
- 80 mg
- Route
- Subcutaneous
- How often
- Once monthly
- Do not use if particulate matter, cloudiness, or discoloration is observed
- Train patients and/or caregivers on proper preparation and administration
- 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+
- 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
- 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 Phase 1
- Hypertriglyceridemia Phase 1