Our Pipeline

CLINICAL PROGRAMS
ECONOMIC INTERESTS

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.

YULPERI®

YULPERI®

 Phase 1 Phase 2 Phase 3 Filed Marketed

YUPELRI®– US
(REVEFENACIN)
LAMA

VIATRIS

COPD Patients
Marketed

COPD Patients

Phase 1
Phase 2
Phase 3
Filed
Marketed
Marketed

YUPELRI®– CHINA
(REVEFENACIN)
LAMA

VIATRIS

COPD Patients
(Phase 3
Completed)
Phase 3

COPD Patients
(Phase 3
Completed)

Phase 1
Phase 2
Phase 3
Filed
Marketed
Phase 3

Pipeline Asset

Pipeline Asset

 Phase 1 Phase 2 Phase 3 Filed Marketed

AMPRELOXETINE
NRI

FULLY OWNED

MSA
Patients
with
Symptomatic
nOH
Phase 3

MSA
Patients
with
Symptomatic
nOH

Phase 1
Phase 2
Phase 3
Filed
Marketed
Phase 3

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

TRELEGY
FF/UMEC/VI

COPD and Asthma
Marketed

COPD and Asthma

Phase 1
Phase 2
Phase 3
Filed
Marketed
Marketed

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