Non-muscle Invasive Bladder Cancer

Oncology
8
Pipeline Programs
6
Companies
10
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

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

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Asieris Pharmaceuticals
3 programs
1
2
APL-1202Phase 31 trial
APL-1202 in combination with EpirubicinPhase 31 trial
APL-1202 treatmentPhase 21 trial
Active Trials
NCT04498702CompletedEst. Jan 2017
NCT04736394UnknownEst. Dec 2025
NCT04490993UnknownEst. May 2022
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
1 program
1
VB4-845 InjectionPhase 31 trial
Active Trials
NCT04859751UnknownEst. Dec 2023
Protara Therapeutics
3 programs
2
1
TARA-002Phase 21 trial
TARA-002Phase 11 trial
TARA-002Phase 11 trial
Active Trials
NCT05085990Completed10Est. Sep 2024
NCT05085977Completed12Est. Oct 2024
NCT05951179Recruiting131Est. Aug 2030
ImmunityBio
ImmunityBioSAN DIEGO, CA
1 program
1
BCG+N-803Phase 1/21 trial
Active Trials
NCT02138734Recruiting596Est. Dec 2038
CG Oncology
CG OncologyIRVINE, CA
1 program
Cretostimogene GrenadenorepvecN/A1 trial
Active Trials
NCT06443944Available
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
En Bloc resectionN/A1 trial
Active Trials
NCT05223491Completed220Est. Dec 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Asieris PharmaceuticalsAPL-1202
Qilu PharmaceuticalVB4-845 Injection
Asieris PharmaceuticalsAPL-1202 in combination with Epirubicin
Protara TherapeuticsTARA-002
Asieris PharmaceuticalsAPL-1202 treatment
ImmunityBioBCG+N-803
Protara TherapeuticsTARA-002
Protara TherapeuticsTARA-002
Novo NordiskEn Bloc resection

Clinical Trials (10)

Total enrollment: 969 patients across 10 trials

NCT04736394Asieris PharmaceuticalsAPL-1202

A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients

Start: Sep 2021Est. completion: Dec 2025
Phase 3Unknown
NCT04859751Qilu PharmaceuticalVB4-845 Injection

Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer

Start: Mar 2021Est. completion: Dec 2023
Phase 3Unknown
NCT04490993Asieris PharmaceuticalsAPL-1202 in combination with Epirubicin

Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients

Start: Mar 2017Est. completion: May 2022
Phase 3Unknown
NCT05951179Protara TherapeuticsTARA-002

Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Start: Sep 2023Est. completion: Aug 2030131 patients
Phase 2Recruiting
NCT04498702Asieris PharmaceuticalsAPL-1202 treatment

Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy

Start: May 2014Est. completion: Jan 2017
Phase 2Completed
NCT02138734ImmunityBioBCG+N-803

A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

Start: Jul 2014Est. completion: Dec 2038596 patients
Phase 1/2Recruiting
NCT05085990Protara TherapeuticsTARA-002

Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1b)

Start: May 2023Est. completion: Sep 202410 patients
Phase 1Completed
NCT05085977Protara TherapeuticsTARA-002

Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)

Start: Mar 2022Est. completion: Oct 202412 patients
Phase 1Completed
NCT06443944CG OncologyCretostimogene Grenadenorepvec

An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

N/AAvailable
NCT05223491Novo NordiskEn Bloc resection

En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Start: Mar 2022Est. completion: Dec 2025220 patients
N/ACompleted

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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

3 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 969 patients
6 companies competing in this space

Related Indications

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