65 completed, 7 terminated, 2 recruiting, 1 active not recruiting. 39 Phase 1, 24 Phase 2, 11 Phase 3, 4 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 39 | Completed 37, Terminated 2 |
| Phase 2 | 24 | Completed 21, Terminated 3 |
| Phase 3 | 11 | Completed 6, Terminated 4, Active not recruiting 1 |
| Phase 4 | 4 | Completed 2, Recruiting 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD Nebulized therapy of similar medication solutions, Continue handheld therapy - COPD (Chronic Obstructive Pulmonary Disease), Chronic Obstructive Pulmonary Disease (COPD) | Phase 4 | Recruiting | COPD Foundation | 120 | 2026-07-14 | 2026-09-14 |
| Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators umeclidinium 62.5 µg and vilanterol 25 µg, Revefenacin 175 µg, Formoterol 20 µg, Placebo ( Revefenacin and Formoterol ) - COPD (Chronic Obstructive Pulmonary Disease) | Phase 4 | Recruiting | University of Tennessee Graduate School of Medicine | 72 | 2023-12-05 | 2026-10-19 |
| Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy Ampreloxetine, Placebo - Symptomatic Neurogenic Orthostatic Hypotension, MSA - Multiple System Atrophy | Phase 3 | Active not recruiting | Theravance Biopharma | 102 | 2023-06-27 | 2025-09-05 |
| Phase 4 COPD and Suboptimal Inspiratory Flow Rate Revefenacin, Tiotropium, Revefenacin Placebo - Chronic Obstructive Pulmonary Disease | Phase 4 | Completed | Theravance Biopharma | 404 | 2022-01-07 | 2024-12-20 |
| TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation Nezulcitinib (TD-0903) Dose A, Nezulcitinib (TD-0903) Dose B - Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19) | Phase 1 | Completed | Theravance Biopharma | 14 | 2021-10-13 | 2021-12-10 |
| Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19 albuterol sulfate (MDI), albuterol sulfate (nebulizer) - COVID-19 | Completed | Theravance Biopharma | 14 | 2021-05-04 | 2022-01-28 | |
| Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects Ampreloxetine <Dose A>, Ampreloxetine <Dose B>, Ampreloxetine Placebo - Symptomatic Neurogenic Orthostatic Hypertension, nOH | Phase 1 | Completed | Theravance Biopharma | 72 | 2021-01-18 | 2021-04-20 |
| Revefenacin in Acute Respiratory Insufficiency in COPD Revefenacin Inhalation Solution [Yupelri], Ipratropium Bromide - COPD, Acute Respiratory Failure | Phase 2 | Completed | University of California, Los Angeles | 21 | 2020-11-01 | 2026-10-14 |
| Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects TD-1473 [Tablet A], TD-1473 [Tablet B] - Intestinal Disorder, Bowel Diseases, Inflammatory | Phase 1 | Completed | Theravance Biopharma | 58 | 2020-10-16 | 2021-04-09 |
| TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis TD-1058, Placebo - Idiopathic Pulmonary Fibrosis (IPF) | Phase 1 | Terminated | Theravance Biopharma | 72 | 2020-10-15 | 2022-02-23 |
| TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study TD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C - Ulcerative Colitis (UC) | Phase 2 / Phase 3 | Terminated | Theravance Biopharma | 46 | 2020-07-23 | 2022-11-02 |
| TD-0903 for ALI Associated With COVID-19 TD-0903, Placebo - Acute Lung Injury (ALI) Associated With COVID-19, Lung Inflammation Associated With COVID-19 | Phase 2 | Completed | Theravance Biopharma | 235 | 2020-06-24 | 2022-03-17 |
| First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19 TD-0903, Placebo - Acute Lung Injury (ALI) Associated With COVID-19, Inflammatory Lung Conditions Associated With COVID-19 | Phase 1 | Completed | Theravance Biopharma | 54 | 2020-04-23 | 2021-07-01 |
| Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855 Ampreloxetine - Symptomatic Neurogenic Orthostatic Hypertension, nOH | Phase 1 | Completed | Theravance Biopharma | 31 | 2020-01-13 | 2021-09-08 |
| Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response TD-8236, Placebo - Asthma | Phase 2 | Completed | Theravance Biopharma | 24 | 2019-11-06 | 2022-03-18 |
| Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure ampreloxetine - Symptomatic Neurogenic Orthostatic Hypotension | Phase 3 | Terminated | Theravance Biopharma | 110 | 2019-09-19 | 2022-11-30 |
| Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects TD-5202, Placebo - Healthy | Phase 1 | Completed | Theravance Biopharma | 56 | 2019-08-08 | 2021-01-14 |
| Efficacy & Safety of TD-1473 in Ulcerative Colitis TD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C - Ulcerative Colitis (UC) | Phase 2 / Phase 3 | Terminated | Theravance Biopharma | 239 | 2019-03-11 | 2022-11-15 |
| Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure ampreloxetine, Placebo - Symptomatic Neurogenic Orthostatic Hypotension, MSA | Phase 3 | Terminated | Theravance Biopharma | 203 | 2019-02-22 | 2023-01-20 |
| Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure ampreloxetine, Placebo - Symptomatic Neurogenic Orthostatic Hypotension | Phase 3 | Completed | Theravance Biopharma | 195 | 2019-01-24 | 2022-09-14 |
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Pulmonary Disease, Chronic Obstructive (19) · Inflammatory Bowel Diseases (7) · Constipation (5) · Opioid-Induced Constipation (5) · COVID-19 (4) · Parkinson Disease (4) · Pure Autonomic Failure (4) · Acute Lung Injury (3) · Asthma (3) · Colitis, Ulcerative (3) · Dizziness (3) · Hypotension (3) · Hypotension, Orthostatic (3) · Infections (3) · Syncope (3)
revefenacin (16) · ampreloxetine (9) · izencitinib (6) · 3-(8-(2-(cyclohexylmethyl(2,3-dihydroxypropionyl)amino)ethyl)-8-azabicyclo(3.2.1)oct-3-yl)benzamide (5) · TD-5108 (4) · Tiotropium Bromide (3) · batefenterol (3) · nezulcitinib (3) · telavancin (3) · 4-((4-((2-isopropyl-1H-benzoimidazole-4-carbonyl)amino)methyl)piperidin-1-ylmethyl)piperidine-1-carboxylic acid methyl ester (2) · Formoterol Fumarate (2) · Ipratropium (2) · Itraconazole (2) · Moxifloxacin (2) · Albuterol (1)
United States (62) · United Kingdom (15) · Australia (8) · New Zealand (8) · France (7) · Germany (7) · Israel (7) · Poland (7) · Portugal (7) · Spain (7) · Ukraine (7) · Bulgaria (6) · Canada (6) · Hungary (6) · Italy (6)
Brett Haumann, SVP, Clinical Development (1) · Bruce A. Mueller, PharmD (1) · Daniel Canafax, PharmD, FCCP (1) · Deanna Nguyen, MD (1) · Donald Tashkin, MD (1) · Igor Z Barjaktarevic, MD, PhD (1) · Issam Raad, MD (1) · Keith A. Rodvold, Pharm.D. (1)
PMID 33124005, PMID 31632000, PMID 32161949, PMID 32343967, PMID 32393215, PMID 32856281, PMID 36681255, PMID 38560416, PMID 42475649, PMID 21039672, PMID 26482312, PMID 28987804, PMID 29096627, PMID 29311094, PMID 30230263, PMID 31150963, PMID 31647854, PMID 31666076, PMID 31990087, PMID 33782836, PMID 33811761, PMID 34613416, PMID 34657222, PMID 36624727, PMID 37029122, PMID 37460276, PMID 38654484, PMID 39429809
2018 (6), 2019 (2), 2016 (1)