Oxlumo(lumasiran)
Oxlumo (lumasiran) is an oligonucleotide pharmaceutical. Lumasiran was first approved as Oxlumo on 2020-11-19. It has been approved in Europe to treat primary hyperoxaluria.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Oxlumo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lumasiran sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OXLUMO | Alnylam Pharmaceuticals | N-214103 RX | 2020-11-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| oxlumo | New Drug Application | 2023-10-06 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LUMASIRAN SODIUM, OXLUMO, ALNYLAM PHARMS INC | |||
| 2029-10-06 | ODE-415 | ||
| 2027-11-23 | ODE-339 | ||
| 2025-11-23 | NCE | ||
| 2025-10-06 | I-901 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Lumasiran Sodium, Oxlumo, Alnylam Pharms Inc | |||
| 11261447 | 2038-11-20 | DS, DP | U-2995 |
| 10478500 | 2035-10-09 | DS, DP | U-2995 |
| 11446380 | 2035-10-09 | DS, DP | |
| 10612024 | 2035-08-14 | DS, DP | U-2995 |
| 10612027 | 2035-08-14 | DS, DP | U-2995 |
| 11401517 | 2035-08-14 | DS, DP | U-2995 |
| 9828606 | 2034-12-26 | DS, DP | |
| 10435692 | 2034-12-26 | U-2995 | |
| 10465195 | 2034-12-26 | DS, DP | U-2995 |
| 10487330 | 2034-12-26 | DS, DP | U-2995 |
| 11060093 | 2034-12-26 | DS, DP | U-2995 |
| 8106022 | 2029-12-12 | DS, DP | U-2995 |
| 8828956 | 2028-12-04 | DS, DP | U-2995 |
| 10131907 | 2028-08-24 | DS, DP | U-2995 |
HCPCS
Code | Description |
|---|---|
| J0224 | Injection, lumasiran, 0.5 mg |
Clinical
Clinical Trials
10 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 |
|---|---|---|---|---|---|---|---|---|---|
| Primary hyperoxaluria | D006960 | — | E72.53 | 1 | 2 | 3 | — | 3 | 8 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rnai therapeutics | D000067492 | — | — | — | 1 | — | — | — | 1 |
| Recurrence | D012008 | — | — | — | 1 | — | — | — | 1 |
| Nephrolithiasis | D053040 | — | N20.0 | — | 1 | — | — | — | 1 |
| Kidney calculi | D007669 | EFO_0004253 | N20 | — | 1 | — | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 1 | — | — | — | 1 |
| Heart disease risk factors | D000082742 | — | — | — | 1 | — | — | — | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | 1 | — | — | — | 1 |
| Hyperoxaluria | D006959 | — | E72.53 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lumasiran |
| INN | lumasiran |
| Description | Lumasiran, sold under the brand name Oxlumo, is a medication for the treatment of primary hyperoxaluria type 1 (PH1).
|
| Classification | Oligonucleotide |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1834610-13-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297779 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15935 |
| UNII ID | RZT8C352O1 (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Oxlumo – Alnylam Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 537 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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132 adverse events reported
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