olezarsen 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antisense oligonucleotides 5846 None

Description:

MoleculeDescription

Molfile

Synonyms:

  • olezarsen
  • tryngolza
  • ISIS 678354
  • akcea-apociii-lrx
  • ION-678354
  • olezarsen sodium
Olezarsen is an antisense oligonucleotide (ASO) directed against apolipoprotein C-III (APOC3) mRNA. Olezarsen binds to APOC3 mRNA and reduces production of APOC3 protein through degradation of the target mRNA.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Dec. 19, 2024 FDA Ionis Pharmaceuticals
Sept. 17, 2025 EMA Swedish Orphan Biovitrum AB

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA CS M0025055 Oligonucleotides, Antisense
MeSH PA D057847 Lipid Regulating Agents
FDA EPC N0000191626 Antisense Oligonucleotide
FDA EPC N0000194144 APOC-III-directed RNA Interaction
FDA PE N0000194154 Increased RNA Degradation
CHEBI has role CHEBI:35554 cardiovascular drug

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Familial chylomicronemia syndrome indication 402786009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) TRYNGOLZA (AUTOINJECTOR) IONIS PHARMS INC N218614 Dec. 19, 2024 RX SOLUTION SUBCUTANEOUS 9157082 April 27, 2032 USE IN REDUCING TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS)
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) TRYNGOLZA (AUTOINJECTOR) IONIS PHARMS INC N218614 Dec. 19, 2024 RX SOLUTION SUBCUTANEOUS 9593333 Feb. 14, 2034 USE IN REDUCING TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS)
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) TRYNGOLZA (AUTOINJECTOR) IONIS PHARMS INC N218614 Dec. 19, 2024 RX SOLUTION SUBCUTANEOUS 12509684 May 1, 2034 USE IN REDUCING TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) TRYNGOLZA (AUTOINJECTOR) IONIS PHARMS INC N218614 Dec. 19, 2024 RX SOLUTION SUBCUTANEOUS Dec. 19, 2031 ADJUNCT TO DIET TO REDUCE TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
apolipoprotein C-III (apoC-III) mRNA RNA ANTISENSE INHIBITOR IC50 6.74 DRUG LABEL DRUG LABEL

External reference:

IDSource
2097587-83-0 SECONDARY_CAS_RN
CHEMBL4650438 ChEMBL_ID
C000731151 MESH_SUPPLEMENTAL_RECORD_UI
4044091 VANDF
C5556529 UMLSCUI
CHEBI:758324 CHEBI
CHEMBL4650263 ChEMBL_ID
11801 INN_ID
2298451-31-5 SECONDARY_CAS_RN
13658 IUPHAR_LIGAND_ID
S3RS2SA30L UNII
2701417 RXNORM
D13023 KEGG_DRUG
43610 MMSL
d10239 MMSL
019949 NDDF
019950 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TRYNGOLZA HUMAN PRESCRIPTION DRUG LABEL 1 71860-101 INJECTION, SOLUTION 80 mg SUBCUTANEOUS NDA 31 sections
TRYNGOLZA HUMAN PRESCRIPTION DRUG LABEL 1 71860-102 INJECTION, SOLUTION 50 mg SUBCUTANEOUS NDA 31 sections