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Drug ReportsLumasiran
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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 Application2023-10-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
primary hyperoxaluria—D006960E72.53
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
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 hyperoxaluriaD006960—E72.53123—38
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rnai therapeuticsD000067492———1———1
RecurrenceD012008———1———1
NephrolithiasisD053040—N20.0—1———1
Kidney calculiD007669EFO_0004253N20—1———1
Chronic renal insufficiencyD051436—N18—1———1
Kidney diseasesD007674EFO_0003086N08—1———1
Cardiovascular diseasesD002318HP_0001626——1———1
Heart disease risk factorsD000082742———1———1
Renal dialysisD006435EFO_0010690Z99.2—1———1
HyperoxaluriaD006959—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 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)Loading
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Oxlumo – Alnylam Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 520 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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