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| Stem definition | Drug id | CAS RN |
|---|---|---|
| antisense oligonucleotides | 5755 | 1637600-16-8 |
| Molecule | Description |
|---|---|
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Synonyms:
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Eplontersen is an antisense oligonucleotide-GalNAc conjugate that causes degradation of mutant and wild-type TTR mRNA through binding to the TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 21, 2023 | FDA | IONIS PHARMS INC |
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| Source | Code | Description |
|---|---|---|
| ATC | N07XX21 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
| FDA CS | M0025055 | Oligonucleotides, Antisense |
| FDA PE | N0000008852 | Decreased RNA Integrity |
| FDA PE | N0000009531 | Increased Protein Breakdown |
| FDA EPC | N0000191626 | Antisense Oligonucleotide |
| FDA EPC | N0000193849 | Transthyretin-directed RNA Interaction |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Polyneuropathy of hereditary transthyretin-mediated amyloidosis | indication | 442012008 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | WAINUA | ASTRAZENECA AB | N217388 | April 15, 2026 | RX | SOLUTION | SUBCUTANEOUS | 10683499 | Aug. 25, 2034 | TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS |
| EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | WAINUA (AUTOINJECTOR) | ASTRAZENECA AB | N217388 | Dec. 21, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10683499 | Aug. 25, 2034 | TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | WAINUA (AUTOINJECTOR) | ASTRAZENECA AB | N217388 | Dec. 21, 2023 | RX | SOLUTION | SUBCUTANEOUS | Dec. 21, 2028 | NEW CHEMICAL ENTITY |
| EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | WAINUA (AUTOINJECTOR) | ASTRAZENECA AB | N217388 | Dec. 21, 2023 | RX | SOLUTION | SUBCUTANEOUS | Dec. 21, 2030 | TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| transthyretin (TTR) mRNA | RNA | ANTISENSE INHIBITOR | IC50 | 7.23 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEMBL4594334 | ChEMBL_ID |
| C000730926 | MESH_SUPPLEMENTAL_RECORD_UI |
| 13606 | IUPHAR_LIGAND_ID |
| DB16199 | DRUGBANK_ID |
| 4042878 | VANDF |
| C5421141 | UMLSCUI |
| CHEBI:757832 | CHEBI |
| CHEMBL4594335 | ChEMBL_ID |
| 11482 | INN_ID |
| 2131025-75-5 | SECONDARY_CAS_RN |
| 42442 | MMSL |
| d10154 | MMSL |
| 019642 | NDDF |
| 019643 | NDDF |
| 0GRZ0F5XJ6 | UNII |
| 2671939 | RXNORM |
| 44076011000001103 | SNOMEDCT_US |
| 44076111000001102 | SNOMEDCT_US |
| D12754 | KEGG_DRUG |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| WAINUA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-9400 | INJECTION, SOLUTION | 45 mg | SUBCUTANEOUS | NDA | 25 sections |
| WAINUA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-9420 | INJECTION, SOLUTION | 45 mg | SUBCUTANEOUS | NDA | 25 sections |