Rivfloza

(Nedosiran)

PreclinicalRNA therapy

Novo Nordisk

Rivfloza is one of 5 small molecule programs targeting Primary Hyperoxaluria Type 1. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Primary Hyperoxaluria Type 1Active, not recruiting

Primary Hyperoxaluria Type 1Preclinical

Active, not recruiting

Competition

Competitive Landscape

9 competitors in Primary Hyperoxaluria Type 1

#DrugCompanyPhaseTrials

Diacomit

BBiocodex

Phase 3

1 2

Oxlumo

Alnylam Pharmaceuticals

Phase 2

6 3

DCR-PHXC

DDicerna Pharmaceuticals, Inc., a Novo Nordisk company

Phase 2

1 4

ABO-101

AArbor Biotechnologies

Phase 2

1 5

Rivfloza

Novo Nordisk

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Pediatric Patients1 trial

Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function

Completed·DDicerna Pharmaceuticals, Inc., a Novo Nordisk company·Phase 2·NCT05001269·27 enrolled

Primary Hyperoxaluria Type 11 trial

Treatment of Primary Hyperoxaluria Type 1 With Nedosiran

No longer available·DDicerna Pharmaceuticals, Inc., a Novo Nordisk company··NCT05993416

Regulatory

FDA Approval Timeline[4]

Sep 29, 2023

RIVFLOZA

NDA NDA215842

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Nedosiran. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nedosiran compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nedosiran. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215842). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Rivfloza. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novo Nordisk company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: RNA therapy[2]
Highest Phase: Preclinical[1]
Company: Novo Nordisk

Patent Landscape[5]

Patent Cliff

Oct 9, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11359203Oct 9, 2035

10738311Oct 9, 2035

10351854Oct 9, 2035

11053502Oct 29, 2035

11661604Oct 12, 2038

1 more patents

11286488Oct 12, 2038

Rivfloza

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Pediatric Patients1 trial

Primary Hyperoxaluria Type 11 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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