Last reviewed 2026-04-22 · How we verify

BCG Tokyo-172 Strain Solution

SWOG Cancer Research Network · Phase 3 active Biologic

BCG Tokyo-172 Strain Solution is a Live attenuated vaccine / Immunotherapeutic Biologic drug developed by SWOG Cancer Research Network. It is currently in Phase 3 development for Non-muscle-invasive bladder cancer (NMIBC), high-risk disease. Also known as: Bacillus Calmette-Guerin Tokyo-172 Strain Solution, Immunobladder.

BCG Tokyo-172 is a live attenuated Mycobacterium bovis strain that stimulates the immune system to recognize and attack cancer cells, particularly in bladder cancer.

BCG Tokyo-172 is a live attenuated Mycobacterium bovis strain that stimulates the immune system to recognize and attack cancer cells, particularly in bladder cancer. Used for Non-muscle-invasive bladder cancer (NMIBC), high-risk disease.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	BCG Tokyo-172 Strain Solution
Also known as	Bacillus Calmette-Guerin Tokyo-172 Strain Solution, Immunobladder
Sponsor	SWOG Cancer Research Network
Drug class	Live attenuated vaccine / Immunotherapeutic
Target	Toll-like receptors (TLR2, TLR4); non-specific immune activation
Modality	Biologic
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

BCG works as an immunotherapeutic agent by activating innate and adaptive immune responses through toll-like receptor signaling and antigen presentation. When instilled intravesically in bladder cancer, it promotes local immune infiltration and systemic anti-tumor immunity, helping prevent recurrence and progression of non-muscle-invasive bladder cancer.

Approved indications

Non-muscle-invasive bladder cancer (NMIBC), high-risk disease

Common side effects

Dysuria
Urinary frequency
Hematuria
Fever
Systemic BCG infection (rare)

Key clinical trials

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (PHASE3)

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 Tokyo-172 Strain Solution CI brief — competitive landscape report
BCG Tokyo-172 Strain Solution updates RSS · CI watch RSS
SWOG Cancer Research Network portfolio CI

Frequently asked questions about BCG Tokyo-172 Strain Solution

What is BCG Tokyo-172 Strain Solution?

BCG Tokyo-172 Strain Solution is a Live attenuated vaccine / Immunotherapeutic drug developed by SWOG Cancer Research Network, indicated for Non-muscle-invasive bladder cancer (NMIBC), high-risk disease.

How does BCG Tokyo-172 Strain Solution work?

BCG Tokyo-172 is a live attenuated Mycobacterium bovis strain that stimulates the immune system to recognize and attack cancer cells, particularly in bladder cancer.

What is BCG Tokyo-172 Strain Solution used for?

BCG Tokyo-172 Strain Solution is indicated for Non-muscle-invasive bladder cancer (NMIBC), high-risk disease.

Who makes BCG Tokyo-172 Strain Solution?

BCG Tokyo-172 Strain Solution is developed by SWOG Cancer Research Network (see full SWOG Cancer Research Network pipeline at /company/swog-cancer-research-network).

Is BCG Tokyo-172 Strain Solution also known as anything else?

BCG Tokyo-172 Strain Solution is also known as Bacillus Calmette-Guerin Tokyo-172 Strain Solution, Immunobladder.

What drug class is BCG Tokyo-172 Strain Solution in?

BCG Tokyo-172 Strain Solution belongs to the Live attenuated vaccine / Immunotherapeutic class. See all Live attenuated vaccine / Immunotherapeutic drugs at /class/live-attenuated-vaccine-immunotherapeutic.

What development phase is BCG Tokyo-172 Strain Solution in?

BCG Tokyo-172 Strain Solution is in Phase 3.

What are the side effects of BCG Tokyo-172 Strain Solution?

Common side effects of BCG Tokyo-172 Strain Solution include Dysuria, Urinary frequency, Hematuria, Fever, Systemic BCG infection (rare).

What does BCG Tokyo-172 Strain Solution target?

BCG Tokyo-172 Strain Solution targets Toll-like receptors (TLR2, TLR4); non-specific immune activation and is a Live attenuated vaccine / Immunotherapeutic.

Drug class: All Live attenuated vaccine / Immunotherapeutic drugs
Target: All drugs targeting Toll-like receptors (TLR2, TLR4); non-specific immune activation
Manufacturer: SWOG Cancer Research Network — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-muscle-invasive bladder cancer (NMIBC), high-risk disease
Also known as: Bacillus Calmette-Guerin Tokyo-172 Strain Solution, Immunobladder

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing