Bacillus Calmette-Guerin

Phase 3Small molecule

Bacillus Calmette-Guerin is one of 16 small molecule programs targeting Non Muscle Invasive Bladder Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Non Muscle Invasive Bladder CancerActive, not recruiting

Side Effect of DrugActive, not recruiting

Non Muscle Invasive Bladder CancerPhase 3

Active, not recruiting

Side Effect of DrugPhase 3

Active, not recruiting

Competition

Competitive Landscape

17 competitors in Non Muscle Invasive Bladder Cancer

#DrugCompanyPhaseTrials

Imfinzi

AstraZeneca

Phase 3

3 2

Taxotere

AAvyxa

Phase 3

3 3

Disitamab Vedotin

Pfizer

Phase 2

2 4

Cretostimogene Grenadenorepvec

CCG Oncology, Inc.

Phase 3

3 5

Bacillus Calmette-Guerin

AstraZeneca

Phase 3

3 6

Nadofaragene Firadenovec

Ferring

Phase 3

2 7

Trodelvy

Gilead

Preclinical

1 8

Gemcitabin

GGerman Cancer Research Center

Phase 2

1 9

Theracys® BCG

FFudan University

Phase 2

1 10

TARA-002

PProtara Therapeutics

Phase 2

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Non Muscle Invasive Bladder Cancer

NCT04165317

Q4 2028

Phase 3Active, not recruiting

Non Muscle Invasive Bladder Cancer

NCT03528694

Q4 2030

Phase 3Active, not recruiting

Non Muscle Invasive Bladder Cancer

NCT05538663

Post-ApprovalActive, not recruiting

Study completion

NCT04701151

Clinical

Trials by Indication[1]

Bladder Cancer6 trials

Sequential Bacillus Calmette-Guérin (BCG) and Electromotive Mitomycin-C Versus Bacillus Calmette-Guérin (BCG) Alone for High Risk Superficial Bladder Cancer

Completed·UUniversity of Rome Tor Vergata·Phase 3·NCT01442519·212 enrolled

Immunological Response of Bladder Cancer Patients Under BCG

Completed·UUniversity of Campinas, Brazil·Phase 3·NCT04806178·30 enrolled

Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT00974818·50 enrolled

Show 3 more trials

PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT02326168·25 enrolled

Comparison of BCG RIVM and Russian Strains for Treating Non-Muscle-Invasive Bladder Cancer (NMIBC)

Completed·—·Phase 4·NCT06767982·160 enrolled

Machine Learning-Based Prediction of BCG Response in High-Risk Non-Muscle Invasive Bladder Cancer Patients

Unknown·MMansoura University··NCT05332353·100 enrolled

Non Muscle Invasive Bladder Cancer3 trials

A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT04165317·1,068 enrolled

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT05538663·870 enrolled

A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT03528694·1,018 enrolled

Immunization1 trial

A Pilot Study of the Effects of BCG Immunization on CSF and Blood-based Biomarkers in Older Adults.

Completed·MMassachusetts General Hospital·Phase 2·NCT04507126·20 enrolled

Tuberculosis1 trial

Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65(III-healthy)

Completed· Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. logo

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.·Phase 3·NCT02795260·1,802 enrolled

NMIBC1 trial

First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC

Withdrawn·BBioniche Life Sciences Inc.·Phase 3·NCT01284205

2 more indications

Urothelial Carcinoma Bladder1 trial

Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume in Patients With Non-muscle Invasive Bladder Cancer Patients

Completed·AAssiut University·Approved·NCT05701332·86 enrolled

Unspecified1 trial

NORTH-REG Dwell-Time Study

Active, not recruiting·JJørgen Bjerggaard Jensen·Phase 4·NCT04701151·314 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Bacillus Calmette-Guerin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Bacillus Calmette-Guerin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Bacillus Calmette-Guerin. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

Bacillus Calmette-Guerin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2028

Q4 2030

Trials by Indication[1]

Bladder Cancer6 trials

Non Muscle Invasive Bladder Cancer3 trials

Immunization1 trial

Tuberculosis1 trial

NMIBC1 trial

Urothelial Carcinoma Bladder1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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