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NMIBC

5
Pipeline Programs
6
Companies
5
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
0
2
3
0
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

ADC
2100%
+ 6 programs with unclassified modality

Competitive Landscape

6 companies ranked by most advanced pipeline stage

RemeGen
RemeGenChina - Yantai
2 programs
2
Distitamab Vedotin in combination with TislelizumabPhase 2ADC
RC48-ADC in Combination with gemcitabinePhase 21 trial
Active Trials
NCT05943379Recruiting85Est. Dec 2026
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1
Distitamab Vedotin in combination with TislelizumabPhase 2ADC
Sunshine Biopharma
Sunshine BiopharmaQC - Varennes
1 program
1
SPGL008Phase 1/2
Biocorp
BiocorpFrance - Issoire
1 program
1
SPGL008Phase 1/21 trial
Active Trials
NCT07445308Not Yet Recruiting120Est. Dec 2029
ImmunityBio
ImmunityBioSAN DIEGO, CA
2 programs
rMBCGN/A1 trial
Intravesical Recombinant MycobacteriumPHASE_1_21 trial
Active Trials
NCT06810141Available
NCT06800963Recruiting40Est. Feb 2028
Prokarium
ProkariumUK - London
1 program
ZH9PHASE_11 trial
Active Trials
NCT06181266Active Not Recruiting22Est. Jul 2027

Trial Timeline

Clinical trial activity over time

2023
2024
2025
2026
2027
2028
2029
RemeGenRC48-ADC in Combination with gemcitabine
BiocorpSPGL008
ImmunityBioIntravesical Recombinant Mycobacterium
ProkariumZH9

Clinical Trials (5)

Total enrollment: 267 patients across 5 trials

NCT05943379RemeGenRC48-ADC in Combination with gemcitabine

RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects

Start: Jun 2023Est. completion: Dec 202685 patients
Phase 2Recruiting

The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

Start: Mar 2026Est. completion: Dec 2029120 patients
Phase 1/2Not Yet Recruiting
NCT06800963ImmunityBioIntravesical Recombinant Mycobacterium

ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG

Start: Oct 2025Est. completion: Feb 202840 patients
Phase 1/2Recruiting

A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

Start: Jan 2024Est. completion: Jul 202722 patients
Phase 1Active Not Recruiting

ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer

N/AAvailable

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 actively recruiting trials targeting 267 patients
6 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.