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Theravance Biopharma Inc

TBPH
Healthcare|Biotechnology|USA
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Clinical Trials (74)

TrialConditionsPhaseStatusEnrollmentDesignDrug
NCT07133880
Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
COPD (Chronic Obstructive Pulmonary Disease)
P4
Recruiting72RCT, Double-blindumeclidinium 62.5 µg and vilanterol 25 µg, Revefenacin 175 µg, Formoterol 20 µg, Placebo ( Revefenacin and Formoterol ), Placebo DPI
NCT05696717
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy
Symptomatic Neurogenic Orthostatic Hypotension, MSA - Multiple System Atrophy
P3
Active102RCT, Double-blindAmpreloxetine, Placebo
NCT05165485
Phase 4 COPD and Suboptimal Inspiratory Flow Rate
Chronic Obstructive Pulmonary Disease
P4
Completed404RCT, Double-blindRevefenacin, Tiotropium, Revefenacin Placebo, Tiotropium Placebo
NCT02392208
Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
End-Stage Renal Disease, Stage 5 Chronic Kidney Disease
P4
Completed8Open-labelTelavancin
NCT03095456
Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)
P3
Completed207RCT, Double-blindRevefenacin, Placebo for Revefenacin, Placebo for Spiriva Handihaler®
NCT02518139
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD)
P3
Completed1,060RCT, Double-blindTD-4208, Tiotropium
NCT02459080
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD)
P3
Completed619RCT, Double-blindTD-4208, Placebo
NCT02512510
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD)
P3
Completed611RCT, Double-blindTD-4208, Placebo
NCT03573817
A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
Chronic Obstructive Pulmonary Disease (COPD)
P3
Completed122RCT, Double-blindRevefenacin, Placebo, Formoterol
NCT03758443
Efficacy & Safety of TD-1473 in Ulcerative Colitis
Ulcerative Colitis (UC)
P2P3
Terminated239RCT, Double-blindTD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C, Placebo
NCT04095793
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Symptomatic Neurogenic Orthostatic Hypotension
P3
Terminated110Open-labelampreloxetine
NCT03750552
Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Symptomatic Neurogenic Orthostatic Hypotension
P3
Completed195RCT, Double-blindampreloxetine, Placebo
NCT03920254
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
Ulcerative Colitis (UC)
P2P3
Terminated46Double-blindTD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C
NCT03829657
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Symptomatic Neurogenic Orthostatic Hypotension, MSA
P3
Terminated203RCT, Double-blindampreloxetine, Placebo
NCT04315558
Revefenacin in Acute Respiratory Insufficiency in COPD
COPD, Acute Respiratory Failure
P2
Completed21RCT, Double-blindRevefenacin Inhalation Solution [Yupelri], Ipratropium Bromide
NCT01704404
7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
COPD
P2
Completed62RCT, Double-blindTD-4208, Placebo
NCT02040792
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
COPD
P2
Completed355RCT, Double-blindTD-4208, Placebo
NCT02109172
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease, COPD
P2
Completed64RCT, Double-blindTD-4208, Placebo
NCT03064113
Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease, COPD
P2
Completed32RCT, Double-blindPlacebo, TD-4208 700 μg, TD-4208 350 μg, Ipratropium 500 μg
NCT01401985
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
Opioid Induced Constipation
P2
Completed95Single-blindTD-1211, Placebo
NCT04402866
TD-0903 for ALI Associated With COVID-19
Acute Lung Injury (ALI) Associated With COVID-19, Lung Inflammation Associated With COVID-19
P2
Completed235RCT, Double-blindTD-0903, Placebo
NCT01718938
Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis
Gastroparesis
P2
Completed34RCT, Double-blindvelusetrag dose 1, velusetrag dose 2, velusetrag dose 3, placebo
NCT01321879
Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients
Infection, Bacteremia
P2
Completed40Open-labelTelavancin
NCT00674817
An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs.
Pulmonary Disease, Chronic Obstructive
P2
Completed45RCT, Double-blind400 microgrammes GSK961081, 1200 microgrammes GSK961081
NCT01458340
A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention-Deficit/Hyperactivity Disorder, ADHD
P2
Completed295RCT, Double-blindTD-9855, TD-9855, Placebo
NCT03635112
Efficacy and Safety of TD-1473 in Crohn's Disease
Crohn's Disease
P2
Terminated167RCT, Double-blindPlacebo, TD-1473
NCT02267525
The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
Gastroparesis
P2
Completed233RCT, Double-blindVelusetrag, Placebo
NCT04150341
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Asthma
P2
Completed24RCT, Double-blindTD-8236, Placebo
NCT00442832
TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection
Staphylococcal Skin Infection
P2
Completed203RCT, Double-blindTD-1792, Vancomycin
NCT01333540
A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation
Opioid-induced Constipation (OIC)
P2
Completed69RCT, Double-blindTD-1211, Placebo
NCT01953081
A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance
Enteral Feeding Intolerance
P1P2
Completed13RCT, Double-blindTD-8954, Metoclopramide
NCT02705755
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
Neurogenic Orthostatic Hypotension, Multiple System Atrophy (MSA) With Orthostatic Hypotension
P2
Completed34RCT, Single-blindTD-9855, Placebo
NCT01459926
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
Opioid Induced Constipation
P2
Completed217RCT, Double-blindTD-1211, TD-1211, TD-1211, Placebo
NCT01693692
Phase 2 Study of TD-9855 to Treat Fibromyalgia
Fibromyalgia
P2
Completed392RCT, Double-blindTD-9855 Group 1, TD-9855 Group 2, Placebo
NCT00391820
Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)
Chronic Constipation
P2
Completed360RCT, Double-blindTD-5108
NCT01040637
A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
Healthy, Opioid-induced Constipation
P1P2
Completed102RCT, Double-blindTD-1211, TD-1211, TD-1211, TD-1211, TD-1211, TD-1211, TD-1211, TD-1211, TD-1211, Placebo
NCT02581592
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
Hepatic Impairment
P1
Completed16Open-labelTD-4208
NCT02772159
TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
Chronic Obstructive Pulmonary Disease (COPD)
P1
Completed9Open-labelTD-4208
NCT02820311
Thorough QT (TQT) Study of TD-4208 in Healthy Subjects
Cardiac Repolarization in Healthy Subjects
P1
Completed48RCT, Double-blindTD-4208 175 mcg, TD-4208 700 mcg, Placebo for TD-4208, Moxifloxacin 400 mg
NCT02578082
Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment
Renal Impairment
P1
Completed16Open-labelTD-4208
NCT02657122
SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects
Healthy
P1
Completed72RCT, Double-blindTD-1473 for SAD, Placebo for SAD, TD-1473 for MAD, Placebo for MAD
NCT00887406
Study of GSK961081 in Healthy Volunteer Subjects
Pulmonary Disease, Chronic Obstructive
P1
Completed46RCT, Double-blindGSK961081 15mcg SD, GSK961081 3mcg SD, GSK961081 50mcg SD, Placebo SD, GSK961081 100mcg SD, GSK961081 200mcg SD, GSK961081 300mcg SD, GSK961081 100mcg RD, GSK961081 300mcg RD, Placebo RD
NCT02116543
TD-6450 MAD Study in HCV Infected Subjects
Hepatitis C, HCV
P1
Completed47RCT, Double-blindTD-6450, Placebo
NCT01655771
TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
Constipation
P1
Completed47Open-labelTD-1211 Dose 1, TD-1211 Dose 2
NCT01949103
TD-1607 MAD Study in Healthy Subjects
Infections, Bacterial Infections
P1
Completed48RCT, Double-blindTD-1607, Placebo
NCT03652038
Single and Multiple Ascending Dose Study of TD-8236 by Inhalation
Asthma
P1
Completed94RCT, Double-blindTD-8236, Placebo
NCT01791049
TD-1607 SAD Study in Healthy Subjects
Serious Infections Due to Known or Suspected Gram-positive Pathogens
P1
Completed64RCT, Double-blindTD-1607, Placebo
NCT02903095
Single Ascending Dose Study of TD-1439 in Healthy Subjects
Healthy Subjects
P1
Completed66RCT, Double-blindTD-1439, Placebo
NCT00687700
A Study to Investigate the Pharmacology of a Dual Pharmacophore in Healthy Volunteers
Pulmonary Disease, Chronic Obstructive
P1
Completed23RCTGSK961081, GSK961081 matching placebo, Propranolol, Propranolol matching placebo
NCT01568411
A Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Inhibitor of Cytochrome P450 Isoenzyme 3A4 and Permeability Glycoprotein 1 on the Pharmacokinetics of TD-1211
Healthy
P1
Completed20Open-labelTD-1211, TD-1211+ itraconazole
NCT02753855
Pharmacokinetics of Telavancin in Normal and Obese Subjects
Healthy
P1
Completed32Open-labelTelavancin
NCT01644240
A Phase 1, Multiple Intravenous Dose Study to Examine Safety, Tolerability, and PK of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
Gastrointestinal Motility Disorder
P1
Terminated16RCT, Double-blindTD-8954, Placebo - saline
NCT03555617
Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study
Inflammatory Bowel Disease
P1
Completed36RCT, Open-labelTD-1473, Itraconazole
NCT01467726
Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
Alzheimer's Disease
P1
Completed40RCT, Double-blindVelusetrag, Velusetrag, Placebo
NCT05091723
TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation
Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19)
P1
Completed14Open-labelNezulcitinib (TD-0903) Dose A, Nezulcitinib (TD-0903) Dose B
NCT04587713
Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects
Intestinal Disorder, Bowel Diseases, Inflammatory
P1
Completed58RCT, Open-labelTD-1473 [Tablet A], TD-1473 [Tablet B]
NCT02709928
Multiple Ascending Dose Study of TD-0714 in Healthy and Elderly Subjects
Healthy Adults, Elderly Subjects
P1
Completed50RCT, Double-blindTD-0714, Placebo
NCT02954263
Multiple Ascending Dose Study of TD-1439 in Healthy Adult and Elderly Subjects
Healthy Adults, Elderly Subjects
P1
Completed40RCT, Double-blindTD-1439, Placebo
NCT04688632
Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects
Symptomatic Neurogenic Orthostatic Hypertension, nOH
P1
Completed72RCT, Double-blindAmpreloxetine <Dose A>, Ampreloxetine <Dose B>, Ampreloxetine Placebo, Moxifloxacin, Moxifloxacin Placebo
NCT04200573
Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855
Symptomatic Neurogenic Orthostatic Hypertension, nOH
P1
Completed31Open-labelAmpreloxetine
NCT04589260
TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
P1
Terminated72RCT, Double-blindTD-1058, Placebo
NCT01924143
TD-9855 Mass Balance Study
ADHD, Fibromyalgia
P1
Completed6Open-labelTD-9855
NCT02663089
A Phase 1 (Ph1), Single Dose (SD), GSK961081 Absorption, Distribution, Metabolism, and Excretion (ADME) Study in Healthy Subjects
Pulmonary Disease, Chronic Obstructive
P1
Completed6Open-label[14C]-GSK961081 solution for IV infusion, [14C]-GSK961081 oral solution, GSK961081 dry powder for inhalation
NCT04350736
First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
Acute Lung Injury (ALI) Associated With COVID-19, Inflammatory Lung Conditions Associated With COVID-19
P1
Completed54RCT, Double-blindTD-0903, Placebo
NCT02639078
Single Ascending Dose Study of TD-0714 in Healthy Subjects
Healthy
P1
Completed56RCT, Double-blindTD-0714, Placebo Comparator
NCT03103412
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
P1
Completed32RCT, Double-blindTD-3504, 15N2-tofacitinib, Placebo
NCT02818686
TD-1473 for Active Ulcerative Colitis (UC)
Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe
P1
Completed40RCT, Double-blindTD-1473, Placebo
NCT02022306
TD-6450 SAD and MAD in Healthy Subjects
Hepatitis C
P1
Completed111RCT, Double-blindTD-6450, Placebo
NCT03432793
Drug-Drug Interaction (DDI) Study for TD-9855
Drug Drug Interaction (DDI)
P1
Completed41Open-labelTD-9855, Fluvoxamine, Itraconazole, Caffeine
NCT00550225
Succinate Salt Version of GSK961081 for Healthy Volunteers
Pulmonary Disease, Chronic Obstructive
P1
Completed18RCTGSK961081, GSK961081 matching placebo
NCT03408470
TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
Intestinal Disorders, Bowel Diseases, Inflammatory
P1
Completed20RCT, Open-labelTD-1473 oral capsule, [14C]-TD-1473 IV bolus, [14C]-TD-1473 Oral Capsule
NCT03750565
Multiple Dose Ethnobridging PK Study in Healthy Subjects
Inflammatory Bowel Diseases, IBD
P1
Completed60RCT, Double-blindTD-1473 - Dose A, TD-1473 - Dose B, TD-1473 - Dose C, Placebo
NCT04044339
Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects
Healthy
P1
Completed56RCT, Double-blindTD-5202, Placebo
NCT04681079
Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19
COVID-19
Completed14albuterol sulfate (MDI), albuterol sulfate (nebulizer)