Drug Type siRNA |
Synonyms DCR-PHSS, DCR-PHXC, Nedosiran sodium + [2] |
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 1 | Phase 3 | ES | 09 Jul 2019 | |
Primary Hyperoxaluria Type 1 | Phase 3 | NL | 09 Jul 2019 | |
Primary Hyperoxaluria Type 1 | Phase 3 | JP | 09 Jul 2019 | |
Primary Hyperoxaluria Type 1 | Phase 3 | TR | 09 Jul 2019 | |
Primary Hyperoxaluria Type 1 | Phase 3 | NO | 09 Jul 2019 | |
Primary Hyperoxaluria Type 1 | Phase 3 | IT | 09 Jul 2019 | |
Primary Hyperoxaluria Type 1 | Phase 3 | CA | 09 Jul 2019 | |
Primary Hyperoxaluria Type 1 | Phase 3 | DE | 09 Jul 2019 | |
Primary Hyperoxaluria Type 1 | Phase 3 | AU | 09 Jul 2019 | |
Primary Hyperoxaluria Type 1 | Phase 3 | LB | 09 Jul 2019 |
Phase 2 | 35 | lbizdsrwhp(ijoivlnqnw) = chxizqkwik txldrlmvtq (jdcbafrzyz, qisgzratii - jbmkeswjtj) View more | - | 22 May 2024 | |||
Phase 3 | Primary Hyperoxaluria Type 1 LDHA gene | - | (elrhkolbjf) = There were no drug-related SAEs or study discontinuations, or deaths prxibaytub (zarsfsrcdv ) View more | Positive | 03 Nov 2022 | ||
Placebo | |||||||
Phase 1 | 6 | (qszizorbdp) = all AEs were mild and unrelated,cAE was back pain,no SAE licnlujrfx (lckxfqznyu ) View more | 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 ) View more | ||||||
Not Applicable | - | (leoapeavjz) = deszvdatcl cglqsbndfx (lyffkqijab ) | - | 01 Sep 2021 | |||
Phase 3 | 16 | (unkxrjxace) = xddiiqewma gzgzygdfuv (uralrgxxjc ) View more | 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 ) View more | Positive | 19 Oct 2020 | ||
Phase 1 | - | auiiboljvh(tfojmahhfs) = rknfqqbjyo dlmpythnls (klzjwybcrd ) | Positive | 05 Nov 2019 |