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Primary Hyperoxaluria

6
Pipeline Programs
3
Companies
8
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
2
2
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

3 companies ranked by most advanced pipeline stage

OxThera
OxTheraSweden - Stockholm
5 programs
1
1
2
1
Oxabact OC5 - Oxalobacter formigenes HC-1Phase 31 trial
Oxalobacter formigenesPhase 2/31 trial
Oxalobacter formigenesPhase 2/31 trial
Oxalobacter formigenesPhase 21 trial
Oxabact OC5 capsulesPhase 1/21 trial
Active Trials
NCT02012985Completed28Est. Jan 2015
NCT02000219Completed12Est. Jan 2020
NCT00638703Completed43Est. Oct 2008
+2 more trials
Biocodex
BiocodexFrance - Gentilly
1 program
1
stiripentolPhase 21 trial
Active Trials
NCT03819647Completed15Est. Mar 2021
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
2 programs
DCR-PHXCPHASE_11 trial
nedosiranPHASE_21 trial
Active Trials
NCT03392896Completed43Est. Nov 2019
NCT05001269Completed27Est. Feb 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
OxTheraOxabact OC5 - Oxalobacter formigenes HC-1
OxTheraOxalobacter formigenes
OxTheraOxalobacter formigenes
Novo Nordisknedosiran
Biocodexstiripentol
OxTheraOxalobacter formigenes
OxTheraOxabact OC5 capsules
Novo NordiskDCR-PHXC

Clinical Trials (8)

Total enrollment: 229 patients across 8 trials

NCT03116685OxTheraOxabact OC5 - Oxalobacter formigenes HC-1

A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

Start: Jan 2018Est. completion: Apr 202125 patients
Phase 3Completed
NCT01037231OxTheraOxalobacter formigenes

Phase 2/3 Oxabact Study

Start: Dec 2009Est. completion: Jan 201136 patients
Phase 2/3Completed
NCT00638703OxTheraOxalobacter formigenes

Study to Evaluate the Efficacy and Safety of OxabactTM on Reduction of Urinary Oxalate in Primary Hyperoxaluria Patients

Start: Oct 2007Est. completion: Oct 200843 patients
Phase 2/3Completed
NCT05001269Novo Nordisknedosiran

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

Start: Feb 2022Est. completion: Feb 202527 patients
Phase 2Completed
NCT03819647Biocodexstiripentol

Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria

Start: May 2019Est. completion: Mar 202115 patients
Phase 2Completed
NCT02000219OxTheraOxalobacter formigenes

Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis

Start: May 2014Est. completion: Jan 202012 patients
Phase 2Completed
NCT02012985OxTheraOxabact OC5 capsules

Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria

Start: Dec 2013Est. completion: Jan 201528 patients
Phase 1/2Completed
NCT03392896Novo NordiskDCR-PHXC

Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria

Start: Dec 2017Est. completion: Nov 201943 patients
Phase 1Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
3 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.