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Antibiotics NCE pipeline

There are at least 53 systemic antibiotic NCEs in clinical development, of which 13 have reached Phase III testing. Programs sorted by clinical stage. (A) In 2011, Advanced Life Sciences Holdings Inc. (Pink:ADLS) suspended operations and terminated its staff due to lack of liquidity. (B) In October, GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) returned GSK2251052 to Anacor Pharmaceuticals Inc. (NASDAQ:ANAC) following a microbiological finding of resistance in a small number of patients. Sources: BCIQ: BioCentury Online Intelligence; company documents; www.clinicaltrials.gov

See also: Cover Story: Antibiotics reset

BCIQ
 
Company Product Class/Structure MOA Lead indication Lead status
Basilea Pharmaceutica AG (SIX:BSLN) Ceftobiprole Beta-lactam Inhibit cell wall synthesis Hospital-acquired bacterial pneumonia (HABP) Under review (EU)
Johnson & Johnson (NYSE:JNJ)/Global Alliance for TB Drug Development Bedaquiline (TMC207) Diarylquinoline Inhibit mycobacterial ATP synthase Multi-drug resistant tuberculosis (TB) Under review (U.S./EU)
Otsuka Pharmaceutical Co. Ltd. Delamanid (OPC-67683) Nitroimidazole Inhibit mycolic-acid biosynthesis  Multi-drug resistant TB Under review (EU); Ph III (U.S./Japan)
Advanced Life Sciences Holdings Inc. (Pink:ADLS) (A) Restanza cethromycin Ketolide Inhibit protein synthesis Community-acquired bacterial pneumonia (CABP) Ph III (obtained SPA in 2010)
AstraZeneca plc (LSE:AZN)/Forest Laboratories Inc. (NYSE:FRX) Avibactam / ceftazidime (CAZ104) Beta-lactamase inhibitor (avibactam); beta-lactam (ceftazidime) Inhibit beta lactamase; inhibit cell wall synthesis Complicated urinary tract infection (cUTI) Ph III
Cubist Pharmaceuticals Inc. (NASDAQ:CBST) Tazobactam /ceftolozane (CXA-201) Beta-lactamase inhibitor (tazobactam); beta-lactam (ceftolozane) Inhibit beta lactamase; inhibit cell wall synthesis cUTI; complicated intra-abdominal infection (cIAI) Ph III
Cubist Pharmaceuticals Inc. (NASDAQ:CBST) CB-315 Lipopeptide Membrane depolarization Clostridium difficile-associated diarrhea (CDAD)  Ph III
Dong Wha Pharmaceutical Industrial Co. Ltd. (KSE:000020)/Iaso Pharma Inc. Zabofloxacin (PB-101) Fluoroquinolone  Inhibit DNA replication Acute bacterial exacerbation of chronic obstructive pulmonary disease (COPD) Ph III
Dong-A Pharmaceutical Co. Ltd. (KSE:000640)/Trius Therapeutics Inc. (NASDAQ:TSRX)/Bayer AG (Xetra:BAYN) Tedizolid (TR-701) Oxazolidinone Inhibit protein synthesis Acute bacterial skin and skin structure infection (ABSSSI) Ph III
Durata Therapeutics Inc. (NASDAQ:DRTX) Dalbavancin Glycopeptide Inhibit cell wall synthesis ABSSSI Ph III
TaiGen Biotechnology Co. Ltd./Warner Chilcott plc (NASDAQ:WCRX) Nemonoxacin (TG-873870) Quinolone Inhibit DNA replication CABP Ph III
The Medicines Co. (NASDAQ:MDCO) Oritavancin Glycopeptide Inhibit cell wall synthesis ABSSSI Ph III (FDA complete response letter in 2008)
Toyama Chemical Co. Ltd./Astellas Pharma Inc. (Tokyo:4503) Garenoxacin (T-3811) Fluoroquinolone Inhibit DNA replication Bacterial infection Ph III; approved in Japan
Cempra Inc. (NASDAQ:CEMP)/Optimer Pharmaceuticals Inc. (NASDAQ:OPTR) Solithromycin (CEM-101) Ketolide Inhibit protein synthesis CABP Start Ph III 4Q12
Paratek Pharmaceuticals Inc. Omadacycline (PTK796) Tetracycline Inhibit protein synthesis ABSSSI Start Ph III 1Q13
Actelion Ltd. (SIX:ATLN) Cadazolid (179811) Oxazolidinone-quinolone hybrid Inhibit DNA replication and protein synthesis C. difficile infection Ph II
ActivBiotics Pharma LLC Rifalazil Rifamycin Inhibit RNA synthesis Chlamydia infection Ph II
Affinium Pharmaceuticals Ltd. AFN-1252 FabI enoyl-(acyl carrier protein) reductase inhibitor Inhibit fabI ABSSSI Ph II
CrystalGenomics Inc. (KOSDAQ:83790) CG400549 FabI enoyl-(acyl carrier protein) reductase inhibitor Inhibit fabI Complicated ABSSSI Ph II
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) GSK1322322 Peptide deformylase (PDF) inhibitor Inhibit PDF  Bacterial infection Ph II
Global Alliance for TB Drug Development/Novartis AG (NYSE:NVS; SIX:NOVN) PA-824 Nitroimidazole Inhibit cell wall and protein synthesis Multi-drug resistant TB Ph II
MerLion Pharmaceuticals Pte. Ltd./Novartis AG (NYSE:NVS; SIX:NOVN) Finafloxacin Fluoroquinolone Inhibit DNA replication Helicobacter pylori infection; Uncomplicated UTI (uUTI) Ph II
Achaogen Inc./Isis Pharmaceuticals Inc. (NASDAQ:ISIS)  Plazomicin (ACHN-490) Aminoglycoside Inhibit protein synthesis cUTI Ph II
Furiex Pharmaceuticals Inc. (NASDAQ:FURX)/Johnson & Johnson (NYSE:JNJ) JNJ-32729463 ( JNJ-Q2) Fluoroquinolone  Inhibit DNA replication ABSSSI; CABP Ph II
Nabriva Therapeutics AG/Forest Laboratories Inc. (NYSE:FRX) BC-3781 Pleuromutilin  Inhibit protein synthesis ABSSSI Ph II
Novartis AG (NYSE:NVS) LFF571 Thiopeptide Inhibit protein synthesis C. difficile infection Ph II
Pfizer Inc. (NYSE:PFE) PNU-100480 Oxazolidinone Inhibit protein synthesis TB Ph II
PolyMedix Inc. (OTCBB:PYMX) Brilacidin (PMX-30063) Defensin-mimetics Membrane lysis ABSSSI Ph II
Rib-X Pharmaceuticals Inc. Delafloxacin (RX-3341) Fluoroquinolone  Inhibit DNA replication ABSSSI Ph II
Rib-X Pharmaceuticals Inc. Radezolid (RX-1741) Oxazolidinone Inhibit protein synthesis CABP; uncomplicated skin and skin structure infection (uSSSI) Ph II
Sequella Inc. SQ109 Ethylene diamine Inhibit cell wall synthesis H. pylori infection; TB Ph II
Tetraphase Pharmaceuticals Inc. Eravacycline (TP-434) Tetracycline Inhibit protein synthesis cIAI Ph II
Theravance Inc. (NASDAQ:THRX) TD-1792 Beta-lactam-glycopeptide hybrid Inhibit cell wall synthesis Gram-positive complicated skin and skin structure infections (cSSSI) Ph II
Wockhardt Ltd. (BSE:532300) WCK 771 Fluoroquinolone  Inhibit DNA replication MRSA Ph II
Wockhardt Ltd. (BSE:532300) WCK 2349 Fluoroquinolone  Inhibit DNA replication Gram-positive cSSSI Ph II
Nanotherapeutics Inc. Ramoplanin Lipoglycodepsipeptide Inhibit cell wall production CDAD Ph II
Anacor Pharmaceuticals Inc. (NASDAQ:ANAC) GSK2251052 (AN3365) Boron-containing leucyl-tRNA synthetase (LARS; LeuRS) inhibitor Inhibit LeuRS cUTI; cIAI Ph II suspended (B)
Cempra Inc. (NASDAQ:CEMP) Taksta sodium fusidate (CEM-102) Fusidane Inhibit protein synthesis Prosthetic joint infection Start Ph II (U.S.) in 4Q12
2M BioTech L.P. CBR-2092 Rifamycin-quinolone hybrid Inhibit DNA replication and RNA synthesis S. aureus infections Ph I
Achaogen Inc. ACHN-975 N-acetylglucosamine deacetylase (LpxC) inhibitor Inhibit LpxC Gram-negative infection Ph I
aRigen Pharmaceuticals Inc. ARH-1029 NA NA H. pylori infection Ph I (Japan/Korea)
aRigen Pharmaceuticals Inc./Green Cross Corp. WAP-8294A2 Depsipeptide Disrupt membrane MRSA Ph I (U.S.)
AstraZeneca plc (LSE:AZN) AZD5847  Oxazolidinone Inhibit protein synthesis TB Ph I
Basilea Pharmaceutica AG (SIX:BSLN) BAL30072 Beta-lactam (monocyclic) Inhibit cell wall synthesis Gram-negative infection Ph I
FAB Pharma S.A.S. FAB001 (MUT056399) FabI enoyl-(acyl carrier protein) reductase inhibitor Inhibit fabI S. aureus infection Ph I
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) GSK2140944 NA Inhibit topoisomerase II (TOP2) Bacterial infection Ph I
Kalidex Pharmaceuticals Inc. KPI-10  Fluoroquinolone  Inhibit DNA replication Gram-negative and Gram-positive infections Ph I
Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569) KRP-AM1977X Quinolone  Inhibit DNA replication Gram-positive infection Ph I (Japan)
MicuRx Pharmaceuticals Inc. MRX-I  Oxazolidinone Inhibit protein synthesis Gram-positive infection Ph I
Novacta Biosystems Ltd. NVB302 Lantibiotic Inhibit cell wall synthesis C. difficile infection Ph I
Rempex Pharmaceuticals Inc. Carbavance (RPX7009 / biapenem) Beta-lactamase inhibitor with boron core (RPX7009); beta lactam (biapenem) Inhibit cell wall synthesis Gram-negative infection Ph I
Shionogi & Co. Ltd. (Tokyo:4507)/GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) S-649266 Beta-lactam Inhibit cell wall synthesis Bacterial infection Ph I (Japan)
Tetraphase Pharmaceuticals Inc. TP-2758  Tetracycline Inhibit protein synthesis cUTI Ph I