What is Bedaquiline long-acting being developed for?

Bedaquiline long-acting is being investigated as an injectable intramuscular formulation for tuberculosis preventive treatment among people at high risk of developing active TB disease.

Is Bedaquiline long-acting approved?

No. Bedaquiline long-acting injection is currently investigational and has not yet been approved by any health authority.

How is Bedaquiline long-acting administered?

It is being investigated as an intramuscular injection, including single-dose 5 mL dosing and other phase 1 dose schedules.

Who developed Bedaquiline long-acting?

Bedaquiline long-acting is developed by Janssen/Johnson & Johnson.

What clinical trial is listed for Bedaquiline long-acting?

The listed clinical trial is EUCT 2023-508810-41-00, a phase 1 study in Austria assessing pharmacokinetics, safety and tolerability of a single intramuscular dose of bedaquiline long-acting injection in healthy participants.

Bedaquiline Long-Acting | TB Prevention & LAI Research

Drug information

Drug's link(s)

https://go.drugbank.com/drugs/DB08903

Generic name

long-acting bedaquiline

Brand names

Sirturo (long-acting version)

Compound type

Small molecule

Drug class/category

Not provided

Summary

Long-Acting Bedaquiline is investigated as a single-dose 5mL (TBC) injectable intramuscular formulation for TB Preventive Treatment (TPT). The ongoing phase 1 (final results end of 2026) will allow for the selection of the LAI target dose with predicted pharmacodynamics ar least equivalent to 3HP ( 3 months of weekly isoniazid and rifapentine), the current standard of care. The interim analysis shows no safety concerns. Bedaquiline's properties may allow for this novel regimen among individuals at high risk of developing active TB disease. It is active against both drug-resistant (DR) and drug-sensitive (DS) forms of M. tuberculosis. It has activity in paucibacillary mouse model compared to established oral TPT.

Approval status

BDQ LAI is currently being investigated in phase 1 study. It will them move to phase 3 TB prevention study, with 3HP as comparator, in a multiyear, multisite, innovative design pivotal study.

Regulatory authorities

BDQ LAI is currently being investigated and is not yet approved by any health authority.

Therapeutic area(s)

Use case(s)

Post-Exposure Prophylaxis (PEP)
Prevention

Administration route

Intramuscular

Associated long-acting platforms

unknown, unknown

Use of drug

Ease of administration

Administered by a community health worker
Administered by a nurse
Administered by a specialty health worker

Frequency of administration

Once

User acceptance

VAS scores used in phase 1 indicated overall moderate pain (median 1.0 (range 0-7) in group receiving 1x5mL IM injection, in the absence of application of ice at injection site.

Dosage

Available dose and strength

single dose 5mL IM (investigational)

Maximum dose

Not provided

Recommended dosing regimen

BDQ LAI is being investigated in phase 1 at various doses (2x 2.5 mL; 1x 5mL; 2x 5mL)

Additional comments

Not provided

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Not provided

Associated technologies

Not provided

Additional information

BDQ LAI is included in the priority list of medicines by the Medicines Patent Pool (2025).

Developer(s)

Originator

United States

Johnson & Johnson

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Excipients & delivery device(s)

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Delivery device(s)

Not provided

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided