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Bacille Calmette-Guerin
Bacille Calmette-Guerin (BCG) is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and destroy cancer cells in the bladder.
Bacille Calmette-Guerin (BCG) is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and destroy cancer cells in the bladder. Used for Non-muscle invasive bladder cancer (NMIBC), high-grade or recurrent, Carcinoma in situ (CIS) of the bladder.
At a glance
| Generic name | Bacille Calmette-Guerin |
|---|---|
| Also known as | BCG |
| Sponsor | Urological Oncology Council of Northern Tokyo |
| Drug class | Live attenuated vaccine / Immunotherapeutic agent |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
BCG works as an immunotherapeutic agent by activating innate and adaptive immune responses against bladder cancer cells. When instilled directly into the bladder, it triggers local inflammation and recruits immune cells (macrophages, T cells, natural killer cells) that target and eliminate malignant urothelial cells. The mechanism involves pattern recognition receptor activation and non-specific immune stimulation rather than targeting a specific molecular pathway.
Approved indications
- Non-muscle invasive bladder cancer (NMIBC), high-grade or recurrent
- Carcinoma in situ (CIS) of the bladder
Common side effects
- Dysuria (painful urination)
- Urinary frequency
- Hematuria (blood in urine)
- Fever
- Malaise/fatigue
- BCG infection/sepsis (rare)
Key clinical trials
- Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans (PHASE1)
- Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection (PHASE2)
- Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections (PHASE2)
- A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC (PHASE1, PHASE2)
- Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS) (PHASE2)
- BCG Vaccination to Protect Healthcare Workers Against COVID-19 (PHASE3)
- Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer (PHASE1, PHASE2)
- A Controlled Human Infection Model (CHIM) With Intradermal BCG in Malawi (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bacille Calmette-Guerin CI brief — competitive landscape report
- Bacille Calmette-Guerin updates RSS · CI watch RSS
- Urological Oncology Council of Northern Tokyo portfolio CI