Neurogenic Detrusor Overactivity

8
Pipeline Programs
3
Companies
5
Clinical Trials
3
Approved Products

Pipeline by Development Stage

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

On Market (3)

Approved therapies currently available

U
MIRABEGRONApproved
mirabegron
Unknown Company
beta3-Adrenergic Agonist [EPC]oral2022
U
MYRBETRIQApproved
mirabegron
Unknown Company
beta3-Adrenergic Agonist [EPC]oral2012
U
MYRBETRIQ GRANULESApproved
mirabegron
Unknown Company
beta3-Adrenergic Agonist [EPC]oral2021

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Astellas
AstellasChina - Shenyang
3 programs
1
2
MirabegronPhase 31 trial
mirabegronPhase 31 trial
MirabegronPhase 11 trial
Active Trials
NCT02211846Completed34Est. Sep 2015
NCT02751931Completed91Est. May 2019
NCT05621616Active Not Recruiting7Est. Sep 2026
Recordati
RecordatiFrance - Saint-Victor
1 program
1
Rec 0/0438 1 mg or Rec 0/0438 2 mgPhase 1/21 trial
Active Trials
NCT03482037Completed42Est. Mar 2019
Pfizer
PfizerNEW YORK, NY
1 program
1
4 mg Fesoterodine ER tablet from ZwickauPhase 11 trial
Active Trials
NCT04478357Completed18Est. Nov 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Astellasmirabegron
AstellasMirabegron
RecordatiRec 0/0438 1 mg or Rec 0/0438 2 mg
Pfizer4 mg Fesoterodine ER tablet from Zwickau
AstellasMirabegron

Clinical Trials (5)

Total enrollment: 192 patients across 5 trials

NCT05621616Astellasmirabegron

A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity

Start: Feb 2024Est. completion: Sep 20267 patients
Phase 3Active Not Recruiting
NCT02751931AstellasMirabegron

Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity

Start: Jun 2016Est. completion: May 201991 patients
Phase 3Completed
NCT03482037RecordatiRec 0/0438 1 mg or Rec 0/0438 2 mg

Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury

Start: Jun 2018Est. completion: Mar 201942 patients
Phase 1/2Completed
NCT04478357Pfizer4 mg Fesoterodine ER tablet from Zwickau

BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS (TOVIAZ™), MANUFACTURED AT ZWICKAU VERSUS FREIBURG

Start: Nov 2019Est. completion: Nov 202018 patients
Phase 1Completed
NCT02211846AstellasMirabegron

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder

Start: Sep 2014Est. completion: Sep 201534 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

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