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
Therapeutic Areas
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 | 2023-01-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| familial amyloidosis | — | D028226 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PATISIRAN SODIUM, ONPATTRO, ALNYLAM PHARMS INC | |||
| 2025-08-10 | ODE-197 | ||
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 | |
HCPCS
Code | Description |
|---|---|
| J0222 | Injection, patisiran, 0.1 mg |
Clinical
Clinical Trials
16 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 | 3 | 2 | 5 | — | 6 | 16 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | 1 | — | 1 | — | 4 | 6 |
| Familial amyloid neuropathies | D028227 | — | E85.1 | — | — | 3 | — | 2 | 5 |
| Familial amyloidosis | D028226 | — | — | — | — | 3 | — | 2 | 5 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | 1 | — | 2 | 3 |
| Amyloid neuropathies | D017772 | — | — | — | — | 1 | — | 2 | 3 |
| Disease progression | D018450 | — | — | — | — | 1 | — | 1 | 2 |
| Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | — | 1 | — | 1 | 2 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | — | — | — | 1 | 1 |
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
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Variants
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Financial
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Onpattro – Alnylam Pharmaceuticals
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,894 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,414 adverse events reported
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