Last update 01 Nov 2024

Nedosiran

Overview

Basic Info

Drug Type
siRNA
Synonyms
DCR-PHSS, DCR-PHXC, Nedosiran sodium
+ [2]
Target
Mechanism
LDHA inhibitors(L-lactate dehydrogenase A chain inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Primary Hyperoxaluria Type 1
US
29 Sep 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Primary Hyperoxaluria Type 1Phase 3
ES
09 Jul 2019
Primary Hyperoxaluria Type 1Phase 3
NL
09 Jul 2019
Primary Hyperoxaluria Type 1Phase 3
JP
09 Jul 2019
Primary Hyperoxaluria Type 1Phase 3
TR
09 Jul 2019
Primary Hyperoxaluria Type 1Phase 3
NO
09 Jul 2019
Primary Hyperoxaluria Type 1Phase 3
IT
09 Jul 2019
Primary Hyperoxaluria Type 1Phase 3
CA
09 Jul 2019
Primary Hyperoxaluria Type 1Phase 3
DE
09 Jul 2019
Primary Hyperoxaluria Type 1Phase 3
AU
09 Jul 2019
Primary Hyperoxaluria Type 1Phase 3
LB
09 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
35
lbizdsrwhp(ijoivlnqnw) = chxizqkwik txldrlmvtq (jdcbafrzyz, qisgzratii - jbmkeswjtj)
-
22 May 2024
Phase 3
-
(elrhkolbjf) = There were no drug-related SAEs or study discontinuations, or deaths prxibaytub (zarsfsrcdv )
Positive
03 Nov 2022
Placebo
Phase 1
6
(qszizorbdp) = all AEs were mild and unrelated,cAE was back pain,no SAE licnlujrfx (lckxfqznyu )
Positive
19 Oct 2021
Placebo
Phase 1
43
(Group A;healthy participants)
(yywkxbhauo) = omrzihratr atgdqypjeg (nyjgwyymuf )
Positive
02 Sep 2021
(Group B;patients with PH1 or PH2)
(yywkxbhauo) = qupkobtbdt atgdqypjeg (nyjgwyymuf )
Not Applicable
-
(leoapeavjz) = deszvdatcl cglqsbndfx (lyffkqijab )
-
01 Sep 2021
Phase 3
16
(unkxrjxace) = xddiiqewma gzgzygdfuv (uralrgxxjc )
Positive
22 Oct 2020
Phase 3
Primary Hyperoxaluria Type 2
genetically confirmed
16
(oipmfksbth) = Treatment-emergent adverse events (AEs) were observed in 11 participants. Seven participants experienced 33 AEs considered related to study drug: administration-site events (18), blood chemistry findings (6), pain (2), dysuria (1), nasal congestion (1), edema (1), and erectile dysfunction (1). Three AEs were uncoded at this time. None of the participants experienced injection-site reactions (defined as occurring 4 hr or more after injection). All drug-related AEs were mild. There were no drug-related serious AEs. bsrdppwihp (fvevrvxopr )
Positive
19 Oct 2020
Phase 1
-
auiiboljvh(tfojmahhfs) = rknfqqbjyo dlmpythnls (klzjwybcrd )
Positive
05 Nov 2019
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