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BCG for Therapeutic Use
BCG for Therapeutic Use is a Live attenuated vaccine / Immunostimulant Small molecule drug developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. It is currently in Phase 3 development for Non-muscle invasive bladder cancer (intravesical immunotherapy), Therapeutic vaccine for infectious diseases (investigational). Also known as: BCG.
BCG (Bacillus Calmette-Guérin) activates the innate and adaptive immune system to enhance anti-tumor and anti-pathogen immune responses.
BCG (Bacillus Calmette-Guérin) activates the innate and adaptive immune system to enhance anti-tumor and anti-pathogen immune responses. Used for Non-muscle invasive bladder cancer (intravesical immunotherapy), Therapeutic vaccine for infectious diseases (investigational).
At a glance
| Generic name | BCG for Therapeutic Use |
|---|---|
| Also known as | BCG |
| Sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
| Drug class | Live attenuated vaccine / Immunostimulant |
| Target | Pattern recognition receptors (TLRs); non-specific immune activation |
| Modality | Small molecule |
| Therapeutic area | Oncology / Immunology |
| Phase | Phase 3 |
Mechanism of action
BCG is a live attenuated mycobacterium that stimulates both innate immunity through pattern recognition receptors and adaptive immunity through T-cell and B-cell activation. In therapeutic use, it acts as an immunostimulant to enhance the body's natural defense mechanisms against disease, particularly in cancer and infectious disease contexts. The mechanism involves toll-like receptor signaling and activation of dendritic cells, macrophages, and lymphocytes.
Approved indications
- Non-muscle invasive bladder cancer (intravesical immunotherapy)
- Therapeutic vaccine for infectious diseases (investigational)
Common side effects
- Local irritation at administration site
- Fever
- Fatigue
- BCG-itis (systemic BCG infection)
Key clinical trials
- Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) (PHASE1)
- BCG for Therapeutic Use Phase Ⅲ Clinical Trial (PHASE3)
- Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) (PHASE3)
- A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer (PHASE2)
- Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer (PHASE2)
- Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix (EARLY_PHASE1)
- Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG (PHASE2)
- Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer (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 Therapeutic Use CI brief — competitive landscape report
- BCG for Therapeutic Use updates RSS · CI watch RSS
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. portfolio CI
Frequently asked questions about BCG for Therapeutic Use
What is BCG for Therapeutic Use?
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What drug class is BCG for Therapeutic Use in?
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Related
- Drug class: All Live attenuated vaccine / Immunostimulant drugs
- Target: All drugs targeting Pattern recognition receptors (TLRs); non-specific immune activation
- Manufacturer: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology / Immunology
- Indication: Drugs for Non-muscle invasive bladder cancer (intravesical immunotherapy)
- Indication: Drugs for Therapeutic vaccine for infectious diseases (investigational)
- Also known as: BCG
- Compare: BCG for Therapeutic Use vs similar drugs
- Pricing: BCG for Therapeutic Use cost, discount & access