Last reviewed 2026-04-22 · How we verify

BCG-Bulgaria

Bandim Health Project · FDA-approved active Biologic

BCG-Bulgaria is a Live attenuated vaccine Biologic drug developed by Bandim Health Project. It is currently FDA-approved for Tuberculosis prevention, Bladder cancer (intravesical BCG therapy). Also known as: BCG-Sofia.

BCG-Bulgaria is a live attenuated Mycobacterium bovis bacillus Calmette-Guérin vaccine that stimulates innate and adaptive immune responses to provide immunological protection.

BCG-Bulgaria is a live attenuated Mycobacterium bovis bacillus Calmette-Guérin vaccine that stimulates innate and adaptive immune responses to provide immunological protection. Used for Tuberculosis prevention, Bladder cancer (intravesical BCG therapy).

At a glance

Generic name	BCG-Bulgaria
Also known as	BCG-Sofia
Sponsor	Bandim Health Project
Drug class	Live attenuated vaccine
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	FDA-approved

Mechanism of action

BCG is a live vaccine derived from an attenuated strain of Mycobacterium bovis. It works by activating both innate immunity (through pattern recognition receptors) and adaptive immunity (Th1 and Th17 cell responses), priming the immune system against tuberculosis and potentially providing non-specific immunological benefits. The Bulgarian strain is a specific regional variant of the BCG vaccine.

Approved indications

Tuberculosis prevention
Bladder cancer (intravesical BCG therapy)

Common side effects

Local reaction at injection site (erythema, induration)
Regional lymphadenitis
Fever
BCG-itis (disseminated infection, rare)

Key clinical trials

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-Bulgaria CI brief — competitive landscape report
BCG-Bulgaria updates RSS · CI watch RSS
Bandim Health Project portfolio CI

Frequently asked questions about BCG-Bulgaria

What is BCG-Bulgaria?

BCG-Bulgaria is a Live attenuated vaccine drug developed by Bandim Health Project, indicated for Tuberculosis prevention, Bladder cancer (intravesical BCG therapy).

How does BCG-Bulgaria work?

BCG-Bulgaria is a live attenuated Mycobacterium bovis bacillus Calmette-Guérin vaccine that stimulates innate and adaptive immune responses to provide immunological protection.

What is BCG-Bulgaria used for?

BCG-Bulgaria is indicated for Tuberculosis prevention, Bladder cancer (intravesical BCG therapy).

Who makes BCG-Bulgaria?

BCG-Bulgaria is developed and marketed by Bandim Health Project (see full Bandim Health Project pipeline at /company/bandim-health-project).

Is BCG-Bulgaria also known as anything else?

BCG-Bulgaria is also known as BCG-Sofia.

What drug class is BCG-Bulgaria in?

BCG-Bulgaria belongs to the Live attenuated vaccine class. See all Live attenuated vaccine drugs at /class/live-attenuated-vaccine.

What development phase is BCG-Bulgaria in?

BCG-Bulgaria is FDA-approved (marketed).

What are the side effects of BCG-Bulgaria?

Common side effects of BCG-Bulgaria include Local reaction at injection site (erythema, induration), Regional lymphadenitis, Fever, BCG-itis (disseminated infection, rare).

Drug class: All Live attenuated vaccine drugs
Manufacturer: Bandim Health Project — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Tuberculosis prevention
Indication: Drugs for Bladder cancer (intravesical BCG therapy)
Also known as: BCG-Sofia

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