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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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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
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
OXLUMOAlnylam PharmaceuticalsN-214103 RX2020-11-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
oxlumoNew Drug Application2020-11-24
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
LUMASIRAN SODIUM, OXLUMO, ALNYLAM PHARMS INC
2029-10-06ODE-415
2027-11-23ODE-339
2025-11-23NCE
2025-10-06I-901
Patent Expiration
Patent
Expires
Flag
FDA Information
Lumasiran Sodium, Oxlumo, Alnylam Pharms Inc
112614472038-11-20DS, DPU-2995
104785002035-10-09DS, DPU-2995
114463802035-10-09DS, DP
106120242035-08-14DS, DPU-2995
106120272035-08-14DS, DPU-2995
114015172035-08-14DS, DPU-2995
98286062034-12-26DS, DP
104356922034-12-26U-2995
104651952034-12-26DS, DPU-2995
104873302034-12-26DS, DPU-2995
110600932034-12-26DS, DPU-2995
81060222029-12-12DS, DPU-2995
88289562028-12-04DS, DPU-2995
101319072028-08-24DS, DPU-2995
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AX: Various alimentary tract and metabolism products
— A16AX18: Lumasiran
HCPCS
Code
Description
J0224
Injection, lumasiran, 0.5 mg
Clinical
Clinical Trials
7 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 hyperoxaluriaD006960E72.53—12—14
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rnai therapeuticsD000067492—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 nameLUMASIRAN
INNlumasiran
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-ID1834610-13-7
RxCUI—
ChEMBL IDCHEMBL4297779
ChEBI ID—
PubChem CID—
DrugBankDB15935
UNII IDRZT8C352O1 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Oxlumo - Alnylam Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 348 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6 adverse events reported
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