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Bacillus Calmette-Guérin
Bacillus Calmette-Guérin is a Live attenuated vaccine / Immunotherapy Biologic drug developed by Massachusetts General Hospital. It is currently in Phase 3 development for Non-muscle-invasive bladder cancer (NMIBC), including carcinoma in situ, High-grade urothelial carcinoma of the bladder. Also known as: BCG.
Bacillus Calmette-Guérin (BCG) is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and destroy cancer cells, particularly in the bladder.
Bacillus Calmette-Guérin (BCG) is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and destroy cancer cells, particularly in the bladder. Used for Non-muscle-invasive bladder cancer (NMIBC), including carcinoma in situ, High-grade urothelial carcinoma of the bladder.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Bacillus Calmette-Guérin |
|---|---|
| Also known as | BCG |
| Sponsor | Massachusetts General Hospital |
| Drug class | Live attenuated vaccine / Immunotherapy |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BCG works by activating innate and adaptive immune responses through pattern recognition receptors on immune cells. When instilled directly into the bladder, it triggers local inflammation and recruitment of immune cells that target bladder cancer cells. This immunotherapy approach has been the gold standard for non-muscle-invasive bladder cancer for decades, though the exact mechanisms of anti-tumor activity remain incompletely understood.
Approved indications
- Non-muscle-invasive bladder cancer (NMIBC), including carcinoma in situ
- High-grade urothelial carcinoma of the bladder
Common side effects
- Dysuria (painful urination)
- Urinary frequency
- Hematuria (blood in urine)
- Fever
- Malaise/fatigue
- BCG sepsis (rare)
Key clinical trials
- ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer
- Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) (PHASE3)
- A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) (PHASE3)
- A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) (PHASE3)
- A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (PHASE2)
- A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (PHASE3)
- Intravesical Gem/Doce in Patients With NMIBC (PHASE2)
- A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) (PHASE2)
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:
- Bacillus Calmette-Guérin CI brief — competitive landscape report
- Bacillus Calmette-Guérin updates RSS · CI watch RSS
- Massachusetts General Hospital portfolio CI
Frequently asked questions about Bacillus Calmette-Guérin
What is Bacillus Calmette-Guérin?
How does Bacillus Calmette-Guérin work?
What is Bacillus Calmette-Guérin used for?
Who makes Bacillus Calmette-Guérin?
Is Bacillus Calmette-Guérin also known as anything else?
What drug class is Bacillus Calmette-Guérin in?
What development phase is Bacillus Calmette-Guérin in?
What are the side effects of Bacillus Calmette-Guérin?
Related
- Drug class: All Live attenuated vaccine / Immunotherapy drugs
- Manufacturer: Massachusetts General Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-muscle-invasive bladder cancer (NMIBC), including carcinoma in situ
- Indication: Drugs for High-grade urothelial carcinoma of the bladder
- Also known as: BCG
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing