Drug

BCG Vaccine

In clinical development

Emerging researchLate-stage developmentSteady momentum

Also known as BACILLUS CALMETTE-GUERIN LIVE ANTIGEN, UNSPECIFIED SUBSTRAIN, BACILLUS CALMETTE-GUERIN VACCINE, BCG, Bacillus Calmette Guerin+1 more

BACILLUS CALMETTE-GUERIN LIVE ANTIGEN, UNSPECIFIED SUBSTRAIN, BACILLUS CALMETTE-GUERIN VACCINE, BCG, Bacillus Calmette Guerin, Bacillus Calmette-Guérin.

RxNorm1344 ChEMBLCHEMBL2108905 ATCL03AX03UNII8VJE55B0VG

Research papers

Active clinical trials

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes

Clinical trial2026-06-26Results expected Q1 2031 · ClinicalTrials.gov

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

Clinical trial2026-06-26Results expected Q2 2031 · ClinicalTrials.gov

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Clinical trial2026-06-18Results expected Q4 2029 · ClinicalTrials.gov

Phase I/II Trial of Bacillus Calmette-Guérin (BCG) and Intravesical Gemcitabine for Patients With BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer

Clinical trial2026-06-16Results expected Q4 2027 · ClinicalTrials.gov

PhAse 1/2 StuDy of Modern ImmunotherApy in BCG-Unresponsive, BCG-RelaPsing, and High-Risk BCG-Naive Non-muscle Invasive UroThelial Carcinoma of the BLADDER

Clinical trial2026-04-15Results expected Q4 2026 · ClinicalTrials.gov

Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

Clinical trial2026-04-13Results expected Q3 2029 · ClinicalTrials.gov

Phase II Study of 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 Cell Carcinoma (NMI-UTUCC)

Clinical trial2026-04-01Primary completion · ClinicalTrials.gov

Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC

Clinical trial2026-03-03Results expected Q4 2026 · ClinicalTrials.gov

Single-cell immune aging clocks reveal inter-individual heterogeneity during infection and vaccination.

Research2025-03-05Nature aging

Advances in diagnosis and treatment of bladder cancer.

Research2024-02-12BMJ (Clinical research ed.)

Trained immunity-inducing vaccines: Harnessing innate memory for vaccine design and delivery.

Research2024-02-09Clinical immunology (Orlando, Fla.)

Multi-omics analysis of innate and adaptive responses to BCG vaccination reveals epigenetic cell states that predict trained immunity.

Research2024-01-01Immunity

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

BCG Vaccine

Aliases & brands

BACILLUS CALMETTE-GUERIN LIVE ANTIGEN, UNSPECIFIED SUBSTRAINBACILLUS CALMETTE-GUERIN VACCINEBCGBacillus Calmette GuerinBacillus Calmette-Guérin

RxNorm CUI

1344

ChEMBL ID

CHEMBL2108905

ATC codes

L03AX03

UNII

8VJE55B0VG

Clinical trials

68 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 68

Early Phase 13Phase 14Phase 1 / 25Phase 215Phase 2 / 32Phase 324Phase 412Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC

Active, not recruitingPH IVJørgen Bjerggaard Jensenn=3142030

BCG2-DTP3: Providing BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine to Improve Female Survival in Africa

Enrolling by invitationPH IVKey trialBandim Health Projectn=6,0002030

Diabetes Diagnosis, Management, Prevention and Education in Guinea-Bissau

Active, not recruitingPH IVBandim Health Projectn=2002029

A Human Experimental Medicine Study to Assess Whether the Gut Microbiota Regulates Specific and Non-specific Immune Responses to Vaccination

RecruitingPH IVSouth Australian Health and Medical Research Instituten=3482028

Specific and Non-specific Effects of Measles and BCG Vaccines for Mother and Child

RecruitingPH IVKey trialBandim Health Projectn=2,4002027

Recent completions

Trials that read out recently, adding to the completed evidence base.

Using Live Vaccines to Induce Beneficial Innate Immune Training and Reduce Systemic Inflammation in COPD Patients.

CompletedPH IVJosefin Eklöfn=602025

Systemic Immunological Response of Bladder Cancer Patients Under Bacillus Calmette Guérin Treatment

CompletedPH IIIUniversity of Campinas, Braziln=302024

Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses

CompletedPH IVTexas A&M Universityn=6592023

A Randomized Prospective Trial Comparing Bacillus Calmette-Guerin (BCG) RIVM and Russian Strains in Non-Muscle Invasive Bladder Cancer: Efficacy and Side Effects

CompletedPH IVAnkara Universityn=1602022

Effects of Bacillus Calmette-Guérin (BCG) Immunization on Cerebrospinal Fluid (CSF) and Blood-Based Biomarkers in Older Adults: A Pilot

CompletedPH IIMassachusetts General Hospitaln=202022

Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

CompletedN/ABoston Children's Hospitaln=9112022

Research activity

10 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20122025

Most influential

Bacille Calmette-Guerin induces NOD2-dependent nonspecific protection from reinfection via epigenetic reprogramming of monocytes.

Proceedings of the National Academy of Sciences of the United States of America · 2012 · 1,288 cites

Bladder Cancer: A Review.

JAMA · 2020 · 1,249 cites

Advances in diagnosis and treatment of bladder cancer.

BMJ (Clinical research ed.) · 2024 · 306 cites

BCG-Induced Cross-Protection and Development of Trained Immunity: Implication for Vaccine Design.

Frontiers in immunology · 2019 · 243 cites

Epidemic and pandemic viral infections: impact on tuberculosis and the lung: A consensus by the World Association for Infectious Diseases and Immunological Disorders (WAidid), Global Tuberculosis Network (GTN), and members of the European Society of Clinical Microbiology and Infectious Diseases Study Group for Mycobacterial Infections (ESGMYC).

The European respiratory journal · 2020 · 104 cites

Multi-omics analysis of innate and adaptive responses to BCG vaccination reveals epigenetic cell states that predict trained immunity.

Immunity · 2024 · 80 cites

Related diseases

4 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Urinary Bladder Neoplasms3 COVID-192 Neoplasm Invasiveness2 Tuberculosis2

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

COVID-19 Vaccines

Studied across 7 of the same disease areas as BCG Vaccine in the shared literature.

7 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials