Overview
Nedosiran is an RNA interference targeting hepatic lactate dehydrogenase, the enzyme responsible for the conversion of glyoxylate to oxalate. Oxalate, particularly calcium oxalate, precipitation is the main cause of kidney stones formation; therefore, blocking the production of oxalate can help alleviate renal symptoms. Nedosiran was approved by the FDA on October 2, 2023, under the brand name RIVFLOZA to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function. This approval is based on the favorable results from the pivotal phase 2 PHYOX2 and interim data from the ongoing phase 3 PHYOX3 clinical trials.
Indication
RIVFLOZA is indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥ 30 mL/min/1.73 m.
Associated Conditions
- Primary Hyperoxaluria Type 1 (PH1)
- Urine oxalate increased
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/08/15 | N/A | AVAILABLE | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | ||
2021/08/11 | Phase 2 | Completed | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | ||
2020/10/08 | Phase 2 | Recruiting | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | ||
2020/09/18 | Phase 1 | Completed | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | ||
2019/08/02 | Phase 3 | Active, not recruiting | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | ||
2019/02/20 | Phase 2 | Completed | |||
2018/01/08 | Phase 1 | Completed | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novo Nordisk | 0169-5306 | SUBCUTANEOUS | 160 mg in 1 mL | 9/29/2023 | |
| Novo Nordisk | 0169-5307 | SUBCUTANEOUS | 128 mg in 0.8 mL | 9/29/2023 | |
| Novo Nordisk | 0169-5308 | SUBCUTANEOUS | 80 mg in 0.5 mL | 9/29/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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