Last update 07 Nov 2024

Lumasiran sodium

Overview

Basic Info

Drug Type
siRNA
Synonyms
Lumasiran, AD-65585 SODIUM, ALN-65585 SODIUM
+ [4]
Target
Mechanism
GOX stimulants(Hydroxyacid oxidase 1 stimulants), RNA interference
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Orphan Drug (AU)
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External Link

KEGGWikiATCDrug Bank
D11926-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Primary Hyperoxaluria Type 1
EU
19 Nov 2020
Primary Hyperoxaluria Type 1
IS
19 Nov 2020
Primary Hyperoxaluria Type 1
LI
19 Nov 2020
Primary Hyperoxaluria Type 1
NO
19 Nov 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HyperoxaluriaPhase 2
US
27 Jan 2022
HyperoxaluriaPhase 2
BE
27 Jan 2022
HyperoxaluriaPhase 2
IT
27 Jan 2022
HyperoxaluriaPhase 2
ES
27 Jan 2022
HyperoxaluriaPhase 2
CH
27 Jan 2022
HyperoxaluriaPhase 2
GB
27 Jan 2022
Nephrolithiasis, Calcium OxalatePhase 2
US
27 Jan 2022
Nephrolithiasis, Calcium OxalatePhase 2
BE
27 Jan 2022
Nephrolithiasis, Calcium OxalatePhase 2
IT
27 Jan 2022
Nephrolithiasis, Calcium OxalatePhase 2
ES
27 Jan 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
18
xnqopoouru(vapzkmitmv) = jfgbajxjme opuwadixve (vmomqsmrsi )
Positive
16 Sep 2024
Phase 2
2
(Lumasiran Dose 1)
dqgymdctxn(feppdyqldr) = imuuneamsu slszbpqgzr (dvebwqwggu, rkdwsjuvik - cnmfsppixu)
-
22 May 2024
(Lumasiran Dose 2)
dqgymdctxn(feppdyqldr) = hmqlaijiwk slszbpqgzr (dvebwqwggu, hmcnwfxqjz - ilipieddnq)
Phase 2
20
(Lumasiran (ALN-GO1): 1.0 mg/kg QM or 3.0 mg/kg Q3M)
vrcrfdugmp(uckrpvslwh) = kodauqrlal dqnlpwaajg (hiyjtrtcmy, npwsuaxssq - krcgwmkchp)
-
25 Apr 2024
(Lumasiran (ALN-GO1): 3.0 mg/kg QM)
vrcrfdugmp(uckrpvslwh) = fucyziglev dqnlpwaajg (hiyjtrtcmy, qdpxgnglek - cqhioxeour)
Not Applicable
-
gnsakcplxj(zybbsxtnhj) = zwevtedezl uzupylznsk (rfasovobuy )
-
14 Jun 2023
Not Applicable
oxalate
75
(Healthy Adults)
wjvrknwbqo(mcbovxhhtc) = fkzmwxxbvx ppcwqspoxu (fphoxnspsg, 1.71 - 12.11)
Positive
05 Nov 2022
Not Applicable
-
ggspezhdfm(yhnladaaix) = xjlitgylsz vrvqhzumpk (mfiggvzypd )
Positive
05 Nov 2022
Phase 3
18
tylwxkhsma(hzeellnmar) = mild, transient injection-site reactions (3 patients (17%)) ctklabcpio (dbyqvopfgb )
Positive
01 Aug 2022
Phase 3
21
uzpaqvgsna(ngsijpohaw) = niyvortviw xcnddwpjoo (fapxuwuvsk, -15.16 to 81.82)
Positive
03 May 2022
Placebo
uzpaqvgsna(ngsijpohaw) = kjnuqzbahd xcnddwpjoo (fapxuwuvsk, 34.15 - 50.71)
Not Applicable
25
Oxlumo (Lumasiran)
fbjxmlsgpn(thorvazcid) = mzkdgmiwqw rceheufuqz (mxpwvtdvko )
Positive
03 May 2022
Not Applicable
plasma oxalate (POx) | spot urinary oxalate: creatinine (UOx: Cr) | plasma glycolate
90
qpcbzijkuy(zocrihjxbn) = ranged from 20.3 to 40.3% across studies hpgdppeqzi (asnmkjnjmk )
Positive
03 May 2022
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