Bacillus Calmette-Guerin

Phase 3Small molecule

AstraZeneca

Bacillus Calmette-Guerin is one of 66 small molecule programs targeting Bladder Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Bladder CancerActive, not recruiting

TuberculosisActive, not recruiting

Non Muscle Invasive Bladder CancerActive, not recruiting

Bladder CancerPhase 3

Active, not recruiting

TuberculosisPhase 3

Active, not recruiting

Non Muscle Invasive Bladder CancerPhase 3

Active, not recruiting

Competition

Competitive Landscape

378 competitors in Bladder Cancer

#DrugCompanyPhaseTrials

Taxol

Teva

Phase 3

15 2

Trexall

Alnylam Pharmaceuticals

Phase 3

13 3

Adriamycin

Pfizer

Phase 3

6 4

Javlor

Bristol-Myers Squibb

Phase 3

5 5

Taxotere

AAvyxa

Phase 3

11 6

Bacillus Calmette-Guérin

Bristol-Myers Squibb

Phase 3

4 7

Cetrelimab

Johnson & Johnson

Phase 3

2 8

Bacillus Calmette-Guerin

AstraZeneca

Phase 3

7 9

Ropivacaine Hydrochloride

Shanghai Hengrui Pharmaceutical Co., Ltd.

Phase 3

1 10

Hexvix

Ipsen

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Bladder Cancer

NCT04165317

Q4 2028

Phase 3Active, not recruiting

Non Muscle Invasive Bladder Cancer

NCT03528694

Q4 2030

Phase 3Active, not recruiting

NMIBC

NCT05538663

Post-ApprovalActive, not recruiting

Study completion

NCT04701151

Clinical

Trials by Indication[1]

Bladder Cancer7 trials

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

Completed·—·Phase 4·NCT06767982·160 enrolled

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

Show 4 more trials

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

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

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT04165317·1,068 enrolled

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

Unknown·MMansoura University··NCT05332353·100 enrolled

NMIBC2 trials

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

Withdrawn·BBioniche Life Sciences Inc.·Phase 3·NCT01284205

Intravesical BCG vs GEMDOCE in NMIBC

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

Gemcitabine1 trial

Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume

Unknown status·—·Phase 4·NCT05701332·25 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

2 more indications

Non Muscle Invasive Bladder Cancer1 trial

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

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 Cancer7 trials

NMIBC2 trials

Tuberculosis1 trial

Gemcitabine1 trial

Immunization1 trial

Non Muscle Invasive Bladder Cancer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

Related News