Our Pipeline
Clinical Programs
We apply insights and innovation at each stage of our business and utilize our internal capabilities and those of our partners around the world. The table below summarizes the status of our key programs for internal development or co-development.
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YULPERI® |
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YULPERI® |
Phase 1 | Phase 2 | Phase 3 | Filed | Marketed | |||||
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YUPELRI®– US VIATRIS COPD Patients |
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YUPELRI®– CHINA VIATRIS COPD Patients |
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Pipeline Asset |
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Pipeline Asset |
Phase 1 | Phase 2 | Phase 3 | Filed | Marketed | |||||
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AMPRELOXETINE FULLY OWNED
MSA |
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Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor (NRI) in development for the treatment of patients with symptomatic neurogenic orthostatic hypotension (nOH). It has high affinity for binding to norepinephrine transporters. By blocking the action of these transporters, ampreloxetine causes an increase in extracellular concentrations of norepinephrine. In a Phase 3, 16-week open label/6-week randomized withdrawal study (REDWOOD, Study 0170) ampreloxetine treatment prevented symptom worsening, and blood pressure decrease in MSA patients with nOH. Symptoms were measured by the Orthostatic Hypotension Symptom Assessment Composite Score (OSHA Composite) which measures dizziness, vision, weakness, fatigue, trouble concentrating and head/neck discomfort. After reaching alignment with FDA on study design, the company initiated a new Ph3 study (CYPRESS) in MSA patients with symptomatic nOH with OHSA Composite as the primary endpoint. |
Economic Interest
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TRELEGY COPD and Asthma |
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Glossary
COPD
Chronic Obstructive Pulmonary Disease
FF
Fluticasone Furoate
LAMA
Long-Acting Muscarinic Agent
MSA
Multiple System Atrophy
nOH
Neurogenic Orthostatic Hypotension
NRI
Norepinephrine Reuptake Inhibitor
UMEC
Umeclidinium
VI
Vilanterol
PHASE 1
Initial clinical safety testing into patients or healthy human volunteers, or studies directed toward understanding the mechanisms of action of the drug
PHASE 2
Further clinical safety testing and preliminary efficacy testing in a limited patient population
PHASE 3
Evaluation of clinical efficacy and safety within an expanded patient population
FILED
A marketing application has been submitted to a regulatory authority