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Theravance Biopharma (TBPH)
NASDAQ:TBPH
Ampreloxetine
Symptomatic Neurogenic Orthostatic Hypotension, Msa - Multiple System Atrophy
Phase III
Active Not Recruiting
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy
Jan 13, 2023
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Tiotropium, Revefenacin
Chronic Obstructive Pulmonary Disease
Phase IV
Completed
Phase 4 COPD and Suboptimal Inspiratory Flow Rate
Dec 07, 2021
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Nezulcitinib (Td-0903) Dose A, Nezulcitinib (Td-0903) Dose B
Acute Lung Injury (Ali) Due To Coronavirus Disease-2019 (Covid-19)
Phase I
Completed
TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation
Oct 12, 2021
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Moxifloxacin, Ampreloxetine <Dose A>, Ampreloxetine <Dose B>
Symptomatic Neurogenic Orthostatic Hypertension, Noh
Phase I
Completed
Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects
Dec 23, 2020
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Td-1058
Idiopathic Pulmonary Fibrosis (Ipf)
Phase I
Terminated
TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis
Oct 08, 2020
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Td-1473 [Tablet A], Td-1473 [Tablet B]
Bowel Diseases, Inflammatory, Intestinal Disorder
Phase I
Completed
Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects
Oct 07, 2020
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Td-0903
Acute Lung Injury (Ali) Associated With Covid-19, Lung Inflammation Associated With Covid-19
Phase II
Completed
TD-0903 for ALI Associated With COVID-19
May 22, 2020
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Td-0903
Acute Lung Injury (Ali) Associated With Covid-19, Inflammatory Lung Conditions Associated With Covid-19
Phase I
Completed
First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
Apr 14, 2020
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Ampreloxetine
Symptomatic Neurogenic Orthostatic Hypertension, Noh
Phase I
Completed
Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855
Dec 13, 2019
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Td-8236
Asthma
Phase II
Completed
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Oct 15, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Theravance Biopharma (TBPH) have in its pipeline
TBPH is currently developing the following drugs: Ampreloxetine, Tiotropium, Revefenacin, Nezulcitinib (Td-0903) Dose A, Nezulcitinib (Td-0903) Dose B. These drug candidates are in various stages of clinical development as the company works toward FDA approval.