bacillus Calmette-Guérin

Phase 3Biologic

Bristol-Myers Squibb

bacillus Calmette-Guérin is one of 129 biologic programs targeting Diabetes Mellitus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

128

Competitors

Pipeline

Status by Indication[3][1]

Indication

Diabetes MellitusActive, not recruiting

Bladder CancerActive, not recruiting

Type 1 DiabetesActive, not recruiting

Diabetes Mellitus, Type 1Active, not recruiting

Urothelial CarcinomaActive, not recruiting

Diabetes MellitusPhase 2

Active, not recruiting

Bladder CancerPhase 3

Active, not recruiting

Type 1 DiabetesPhase 2

Active, not recruiting

Diabetes Mellitus, Type 1Phase 2

Active, not recruiting

Urothelial CarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

384 competitors in Type 1 Diabetes

#DrugCompanyPhaseTrials

bacillus Calmette-Guérin

Bristol-Myers Squibb

Phase 3

1 2

Symlin

AstraZeneca

Preclinical

4 3

Aldomet

Neurocrine Biosciences

Preclinical

2 4

Pitocin

RRetrophin

Preclinical

1 5

Glargine

Eli Lilly

Preclinical

4 6

Cytoxan

BBaxter Healthcare Corporation

Preclinical

1 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Foradil

Viatris

Preclinical

1 9

SGLT2 Inhibitor

Eli Lilly

Preclinical

1 10

Teplizumab

Sanofi

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Bladder Cancer

NCT04179162

Phase 1/2Recruiting

Urothelial Carcinoma

NCT03317158

Q1 2031

Phase 2Active, not recruiting

Diabetes Mellitus, Type 1

NCT05180591

Q2 2031

Phase 2Active, not recruiting

Diabetes Mellitus

NCT05866536

Q3 2031

Phase 2Active, not recruiting

Type 1 Diabetes

NCT02081326

Clinical

Trials by Indication[1]

Bladder Cancer4 trials

Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT04179162·54 enrolled

Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02281383·80 enrolled

A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04149574·13 enrolled

Show 1 more trial

Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer

Terminated·MMedical Enterprises Europe B.V.·Phase 3·NCT00384891·190 enrolled

Immunogenicity2 trials

Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents

Completed·AAeras·Phase 2·NCT02075203·989 enrolled

Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

Completed·—·N/A·NCT03246230·911 enrolled

Urothelial Carcinoma2 trials

Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03504163·45 enrolled

Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder

Recruiting·NNoah Hahn, M.D.·Phase 1/2·NCT03317158·55 enrolled

Type 1 Diabetes1 trial

Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT02081326·150 enrolled

Vaccination1 trial

Biological Samples Obtained by Leukapheresis Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US

Completed·AAeras·Phase 1·NCT03175380·15 enrolled

3 more indications

Chemotherapy1 trial

SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I

Withdrawn·MMedical Enterprises Europe B.V.·Phase 3·NCT02254915

Diabetes Mellitus1 trial

Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT05866536·100 enrolled

Diabetes Mellitus, Type 11 trial

Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT05180591·150 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for bacillus Calmette-Guérin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — bacillus Calmette-Guérin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for bacillus Calmette-Guérin. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: Bristol-Myers Squibb

bacillus Calmette-Guérin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2031

Q2 2031

Q3 2031

Trials by Indication[1]

Bladder Cancer4 trials

Immunogenicity2 trials

Urothelial Carcinoma2 trials

Type 1 Diabetes1 trial

Vaccination1 trial

Chemotherapy1 trial

Diabetes Mellitus1 trial

Diabetes Mellitus, Type 11 trial

References

Drug Info

Quick Facts

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