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Delamanid + Bedaquiline + OPC-167832 10 mg

Phase 2
OTSUKA (OTSKF)

Phase 2

Development Phase

0

Upcoming Catalysts

0

Historical Events

2

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Pulmonary TB

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Drug Information

Target Indication

Pulmonary TB

Clinical Trial

NCT05221502

Last updated: 12/17/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA4/27/2014

Deltyba

Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

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EMA3/5/2014

Sirturo

Sirturo is indicated for use as part of an appropriate combination regimen in adult and paediatric patients (2 years to less than 18 years of age and weighing at least 7 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

View on EMA
Drug Science
Mechanism of action & safety profile
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