Last reviewed · How we verify
Rivfloza (NEDOSIRAN)
Nedosiran, a GalNAc-conjugated siRNA, binds to ASGPR on hepatocytes, degrades LDHA mRNA, reducing hepatic LDH and oxalate production.
At a glance
| Generic name | NEDOSIRAN |
|---|---|
| Sponsor | Novo |
| Target | LDHA mRNA |
| Modality | Oligonucleotide |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Nedosiran is a siRNA that targets the liver. It binds to specific receptors on liver cells, which allows it to enter and degrade the mRNA for LDHA, a protein involved in producing oxalate. By reducing LDHA, it lowers oxalate levels.
Approved indications
- primary hyperoxaluria type 1
- primary hyperoxaluria type 1
Common side effects
- Injection site reactions
- Erythema
- Pain
- Bruising
- Rash
- Atrophy
Key clinical trials
- Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD (PHASE2)
- Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function (PHASE2)
- Treatment of Primary Hyperoxaluria Type 1 With Nedosiran
- Long Term Extension Study in Patients With Primary Hyperoxaluria (PHASE3)
- Study to Evaluate Safety, Tolerability, PK and PD of DCR-PHXC in PH Type 3 Patients (PHASE1)
- A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2 (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rivfloza CI brief — competitive landscape report
- Rivfloza updates RSS · CI watch RSS
- Novo portfolio CI