Onpattro(patisiran)
Onpattro (patisiran) is an oligonucleotide pharmaceutical. Patisiran was first approved as Onpattro on 2018-08-10. It has been approved in Europe to treat familial amyloidosis.
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Commercial
Trade Name
FDA
EMA
Onpattro
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Patisiran sodium
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ONPATTRO | Alnylam Pharmaceuticals | N-210922 RX | 2018-08-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
onpattro | New Drug Application | 2020-10-28 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
PATISIRAN SODIUM, ONPATTRO, ALNYLAM PHARMS INC | |||
2025-08-10 | ODE-197 | ||
2023-08-10 | NCE |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Patisiran Sodium, Onpattro, Alnylam Pharms Inc | |||
11079379 | 2035-08-27 | DS, DP | U-2378 |
8158601 | 2030-11-10 | DP | U-2378 |
8802644 | 2030-10-21 | DP | U-2378 |
8168775 | 2029-10-20 | DS, DP | U-2378 |
8741866 | 2029-10-20 | U-2378 | |
9234196 | 2029-10-20 | DP | U-2378 |
10240152 | 2029-10-20 | DS, DP | U-2378 |
8058069 | 2029-04-15 | DP | |
8492359 | 2029-04-15 | DP | |
8822668 | 2029-04-15 | DP | U-2378 |
9364435 | 2029-04-15 | DP | U-2378 |
11141378 | 2029-04-15 | DP | |
8642076 | 2027-10-03 | DP | |
8334373 | 2025-05-27 | DS, DP | |
9943538 | 2023-11-04 | DP | |
9943539 | 2023-11-04 | DP |
HCPCS
Code | Description |
---|---|
J0222 | Injection, patisiran, 0.1 mg |
Clinical
Clinical Trials
13 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | — | 2 | — | 1 | 4 |
Familial amyloidosis | D028226 | — | — | 3 | — | 1 | 4 | ||
Familial amyloid neuropathies | D028227 | E85.1 | — | — | 1 | — | 1 | 2 | |
Amyloid neuropathies | D017772 | — | — | 1 | — | 1 | 2 | ||
Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | — | 1 | — | 1 | 2 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Polyneuropathies | D011115 | EFO_0009562 | A69.22 | 1 | — | — | — | 1 | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | PATISIRAN |
INN | patisiran |
Description | Patisiran, sold under the brand name Onpattro, is a medication used for the treatment of polyneuropathy in people with hereditary transthyretin-mediated amyloidosis, a fatal rare disease that is estimated to affect 50,000 people worldwide.
|
Classification | Oligonucleotide |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | 1420706-45-1 |
RxCUI | 2053490 |
ChEMBL ID | CHEMBL3989987 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB14582 |
UNII ID | 50FKX8CB2Y (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Onpattro - Alnylam Pharmaceuticals
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€
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,144 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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12,256 adverse events reported
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