We believe that our lead product candidates have demonstrated, in clinical trials and/or in relevant preclinical models, potential advantages such as substantial increases in potency, duration of action and/or selectivity relative to existing medicines or potential medicines in late-stage clinical studies.
Late-stage development programs in:
Theravance Programs
THERAPEUTIC AREA U.S. DEVELOPMENT STATUS
Program Phase 1 Phase 2 Phase 3 Filed
RESPIRATORY  
RELOVAIR™: COPD
RELOVAIR™: Asthma
MABA: COPD
BACTERIAL INFECTIONS  
Telavancin: NP*
TD-1792: Gram-positive
GASTROINTESTINAL  
TD-5108: GI Motility
TD-1211: Opioid - Induced Constipation
COGNITIVE DISORDERS - ALZHEIMER'S DISEASE  
TD-5108
TD-8954
CHRONIC PAIN  
TD-9855
*We believe that the U.S. Food and Drug Administration's (FDA) position is that it will require data from an additional clinical study or studies before it will consider the Nosocomial Pneumonia (NP) New Drug Application (NDA) for approval and we do not currently intend to conduct such studies. The telavancin Market Authorization Application (MAA) under review by the European Medicines Agency (EMEA) seeks approval for both NP and complicated skin and soft tissue infections (cSSTI).
Legend:
 
  Proof of Concept
 
  Pre-Proof of Concept

In the table above:
  • Development Status indicates the most advanced stage of development that has been completed or is in process.
  • Phase 1 indicates initial clinical safety testing in healthy volunteers, or studies directed toward understanding the mechanisms of action of the drug.
  • Phase 2 indicates further clinical safety testing and preliminary efficacy testing in a limited patient population.
  • Phase 3 indicates evaluation of clinical efficacy and safety within an expanded patient population.
  • Filed indicates that a NDA or MAA has been submitted to and accepted for filing by the FDA or EMEA, respectively.
  • We consider programs in which at least one compound has successfully completed a Phase 2a study showing efficacy and tolerability as having achieved Proof of Concept.
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