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Bedaquiline

Phase 2

Tuberculosis, Multidrug-Resistant | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: May 1, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment138
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05007821Linezolid Dosing Strategies in Drug-Resistant TBPHASE2 COMPLETED 138Sep 27, 2022Jan 13, 2026May 1, 202613 Botswana, Brazil +5
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Study Endpoints
Primary Endpoints
Time to 26 Weeks Stable Culture Conversion in Liquid Media
Up to 26 weeks

Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If the 1st MTB-neg liquid culture was at week 26, then conversion was met. If a participant did not convert by week 26, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions at week 26 and the Cox proportional hazards regression model hazard ratio were calculated; between-arm differences were tested with the log rank test.

Proportion of Participants With Permanent Discontinuation of At Least One Anti-TB Drug Due To Adverse Events, Intolerance, Or Death
Up to 26 weeks

Time of permanent discontinuation of at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request by week 26, they were censored at the date of permanent treatment discontinuation of all study drugs or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with permanent discontinuation were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.

Secondary Endpoints
Proportion of Participants Achieving Stable Liquid Culture Conversion
At week 8
Proportion of Participants With Permanent Discontinuation of LZD Due To Adverse Events, Intolerance, or Death
Up to 26 weeks
Proportion of Participants With Temporary Discontinuation of LZD For Any Reason
Up to 26 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTALEveryone in the study took bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ) once a day for the entire treatment period. Arm A participants took linezolid (LZD) once a day for the entire treatment period. * Weeks 1-26: LZD 600 mg once daily (QD) * Weeks 1-2: BDQ 200 mg QD + DLM 300 mg QD + CFZ 300 mg QD * Weeks 3-8: BDQ 200 mg QD + DLM 300 mg QD + CFZ 100 mg QD * Weeks 9-26: BDQ 100 mg QD + DLM 300 mg QD + CFZ 100 mg QD
Arm BEXPERIMENTALEveryone in the study took bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ) once a day for the entire treatment period. Arm B participants took a higher dose of linezolid (LZD) once a day for 4 weeks and then took that higher dose of LZD just three times a week for the rest of the treatment period. * Weeks 1-4: LZD 1200 mg once daily (QD) * Weeks 5-26: LZD 1200 mg three times per week (TIW) * Weeks 1-2: BDQ 200 mg QD + DLM 300 mg QD + CFZ 300 mg QD * Weeks 3-8: BDQ 200 mg QD + DLM 300 mg QD + CFZ 100 mg QD * Weeks 9-26: BDQ 100 mg QD + DLM 300 mg QD + CFZ 100 mg QD
Interventions
NameTypeDescription
Linezolid 600 mgDRUGOne 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26
Linezolid 1200 mg (QD)DRUGTwo 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4
Linezolid 1200 mg (TIW)DRUGTwo 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26
Bedaquiline 200 mgDRUGTwo 100mg tablets taken orally once daily in the morning during weeks 1-8
Bedaquiline 100 mgDRUGOne 100mg tablet taken orally once daily in the morning during weeks 9-26
Delamanid 300 mgDRUGSix 50mg tablets taken orally once daily in the morning during weeks 1-26
Clofazimine 300 mgDRUGThree 100mg capsules taken orally once daily in the morning during weeks 1-2
Clofazimine 100 mgDRUGOne 100mg capsule taken orally once daily in the morning during weeks 3-26
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Newly diagnosed pulmonary drug-resistant tuberculosis (DR-TB), with resistance to at least rifampicin or rifampin (which is a drug used in the therapy of tuberculosis) confirmed from a sputum specimen collected within 60 days prior to entry. 2. HIV-1 infection status document...

Countries:BotswanaBrazilHaitiPeruPhilippinesSouth AfricaThailand
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