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Clinical Pipeline

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Trials for Market Approval Download PPT

Pre-Clinical (GLP)

OTB-658
Institute of Materia Medica, CAMS & PUMC
Sanfetrinem
GlaxoSmithKline, Bill & Melinda Gates Foundation
Spectinamide 1810
Microbiotix, Inc.

Phase 1

TBAJ-587, Diarylquinoline
TB Alliance, University of Auckland, Merck & Co., Inc.
GSK-286
GlaxoSmithKline, TB Drug Accelerator, Bill & Melinda Gates Foundation
Phase 1 Safety, Tolerability and Pharmacokinetics of GSK2556286
TBI-223
TB Alliance, Institute of Materia Medica
SPR720
Spero Therapeutics, LLC, Bill & Melinda Gates Medical Research Institute
Phase 1 Safety, Tolerability, and Pharmacokinetics of SPR720
BVL-GSK098
BioVersys AG, GlaxoSmithKline
Phase 1 Safety, Tolerability and Pharmacokinetics of BVL-GSK098
Macozinone (MCZ, PBTZ-169)
iM4TB - Innovative Medicines for Tuberculosis, Bill & Melinda Gates Foundation
TBAJ-876 Diarylquinoline
TB Alliance, University of Auckland
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
TBI-166
Institute of Materia Medica, CAMS & PUMC
TBA-7371
TB Alliance, Bill & Melinda Gates Medical Research Institute, Foundation for Neglected Disease Research
Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371

Phase 2

TB-PRACTECAL
Médecins Sans Frontières
BTZ-043
University of Munich, Hans-Knöll Institute, Jena, German Center for Infection Research (DZIF), European and Developing Countries Clinical Trials Partnership (EDCTP), Radboud University
BTZ-043 Multiple Ascending Dose / EBA
Telacebec (Q203)
Qurient Co., Ltd, Qurient Co. Ltd. / LLC "Infectex", a portfolio firm of Maxwell Biotech Venture Fund
Q203 Phase 1b Q203-TB-PI-US002
Phase 2 Telacebec (Q203) EBA
Rifampicin
PanACEA, EDCTP, NIAID, NIH, DHHS, USAID
ReDEFINe High-Dose RIF for Meningitis
High-Dose Rifampin
Macozinone (MCZ, PBTZ-169)
Nearmedic Plus LLC
Phase 2a Study of PBTZ169
Sutezolid
Sequella, Inc, TB Alliance
Linezolid
TB Alliance
TBTC Study 30: A Phase I/II Pilot Study for Evaluation of Low Dose, Once Daily, Linezolid Plus Optimized Background Therapy (OBT) Versus Placebo Plus OBT for the Treatment of Multi-drug Resistant Tube
TBTC Study 30PK Linezolid Pharmacokinetics and Pharmacodynamics in the Treatment of Multi-Drug Resistant and Extensively-Drug Resistant Tuberculosis
Nix-TB (B-Pa-L)
OPC-167832
Otsuka Pharmaceutical Development & Commercialization, Inc.
OPC-167832 Phase 1 / 2 EBA
GSK 3036656
GlaxoSmithKline, European Union Horizon 2020, NIAID, NIH, DHHS
EBA, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
Bedaquiline, Pretomanid, Moxifloxacin, Pyrazidamide (BPaMZ)
TB Alliance
SimpliciTB
SQ109
Sequella, Inc
Delpazolid (LCB01-0371)
LegoChem Biosciences, Inc.
NCT02836483 A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
PredictTB
NIAID, NIH, DHHS, Bill & Melinda Gates Foundation, EDCTP
Levofloxacin
CDC TBTC, NIAID, NIH, DHHS, Boston University
TBTC Study 32, Opti-Q
INH, RIF, PZA, MOX
NexGen EBA
Bedaquiline - Delamanid with MBT for MDR
ACTG 5343 Bedaquiline - Delamanid with MBT for MDR

Phase 3

Bedaquiline
Janssen Research & Development, LLC
STREAM Trial Stage 2
Nix-TB (B-Pa-L)
SimpliciTB
Delamanid
Otsuka Pharmaceutical Development & Commercialization, Inc.
Delamanid with OBR for MDR TB
Pediatric PK and Safety Trial Delamanid in MDR TB
OPC-167832 Phase 1 / 2 EBA
TRUNCATE-TB
University College, London, SPRINT TB (National University of Singapore)
Rifapentine
CDC TBTC, Sanofi
TBTC Study 31 ACTG 5349 4-month treatment regimens
BEAT-TB
Bedaquiline - Pretomanid - Linezolid
TB Alliance
Nix-TB (B-Pa-L)
ZeNix (B-Pa-L) NC-007
endTB
Médecins Sans Frontières
Clofazimine
Novartis
Rifampicin
St. George's Hospital University of London
RIFASHORT
Bedaquiline - Linezolid - Levofloxacin with OBR
Bedaquiline - Linezolid with OBR MDR (NExT Trial)