Drug Type siRNA |
Synonyms DCR-PHSS, DCR-PHXC, Nedosiran sodium + [3] |
Target |
Mechanism LDHA inhibitors(L-lactate dehydrogenase A chain inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (29 Sep 2023), |
RegulationOrphan Drug (US) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Primary Hyperoxaluria Type 1 | US | 29 Sep 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Primary hyperoxaluria type III | Phase 3 | DE | 09 Jul 2019 | |
Primary hyperoxaluria type III | Phase 3 | IT | 09 Jul 2019 | |
Primary hyperoxaluria type III | Phase 3 | NO | 09 Jul 2019 | |
Primary hyperoxaluria type III | Phase 3 | LB | 09 Jul 2019 | |
Primary hyperoxaluria type III | Phase 3 | JP | 09 Jul 2019 | |
Primary hyperoxaluria type III | Phase 3 | TR | 09 Jul 2019 | |
Primary hyperoxaluria type III | Phase 3 | AU | 09 Jul 2019 | |
Primary hyperoxaluria type III | Phase 3 | US | 09 Jul 2019 | |
Primary hyperoxaluria type III | Phase 3 | GB | 09 Jul 2019 | |
Primary hyperoxaluria type III | Phase 3 | FR | 09 Jul 2019 |
Phase 2 | 35 | hepctpinoe(exsxlrpjsc) = oqadspxref iznabvmjip (aetvrbehgc, llwhwxmkih - vwteqbxjhs) View more | - | 22 May 2024 | |||
Phase 3 | Primary Hyperoxaluria Type 1 LDHA gene | - | (arkufgmcrn) = There were no drug-related SAEs or study discontinuations, or deaths xystagdqlh (aafbnulzfb ) View more | Positive | 03 Nov 2022 | ||
Placebo | |||||||
Phase 1 | 6 | (ctxvsahsum) = all AEs were mild and unrelated,cAE was back pain,no SAE mhdllhigzi (acapnzlova ) View more | Positive | 19 Oct 2021 | |||
Placebo | |||||||
Phase 1 | 43 | (Group A;healthy participants) | (uisfakkzmj) = jzbvzhtloa wrowcsohch (wfakrfredd ) | Positive | 02 Sep 2021 | ||
(Group B;patients with PH1 or PH2) | (uisfakkzmj) = solpbffdap wrowcsohch (wfakrfredd ) View more | ||||||
Not Applicable | - | (jeqabcczkd) = fawnnbwrim ostdrjhtsr (uiqceeeesd ) | - | 01 Sep 2021 | |||
Phase 3 | 16 | (zjhndvoeik) = uvodljsvzt kljvocpekh (iodbywxhbi ) View more | Positive | 22 Oct 2020 | |||
Phase 3 | Primary Hyperoxaluria Type 2 genetically confirmed | 16 | (dhajnhslon) = 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. lxpasseixo (owcjwwwykz ) View more | Positive | 19 Oct 2020 | ||
Phase 1 | - | pozflckgbp(hhtrtsokih) = qmbpiaverr lnzsgzjduz (jqgtaqnnlb ) | Positive | 05 Nov 2019 |