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BCG for Injection
BCG (Bacillus Calmette-Guérin) is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and attack cancer cells, particularly in the bladder.
BCG (Bacillus Calmette-Guérin) is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and attack cancer cells, particularly 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 | BCG for Injection |
|---|---|
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Drug class | Live attenuated vaccine / Immunotherapy |
| Target | Toll-like receptors (TLR2, TLR4); non-specific immune activation |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BCG works by activating innate and adaptive immune responses through toll-like receptor signaling and promoting Th1-type immunity. When instilled directly into the bladder, it triggers local immune activation that leads to infiltration of immune cells (macrophages, T cells, NK cells) that target and destroy urothelial cancer cells. This mechanism has been the gold standard for non-muscle-invasive bladder cancer treatment for decades.
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
- Nausea
- BCG sepsis (rare but serious)
Key clinical trials
- A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (PHASE2)
- A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer. (PHASE1)
- Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (PHASE1, PHASE2)
- A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer (PHASE1)
- A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC (PHASE3)
- Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (PHASE1)
- Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans (PHASE1)
- Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines (PHASE1)
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:
- BCG for Injection CI brief — competitive landscape report
- BCG for Injection updates RSS · CI watch RSS
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. portfolio CI