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United Therapeutics (UTHR)
NASDAQ:UTHR
10 Ge Xenokidney
Kidney Transplantation, Esrd (End-Stage Renal Disease), Xenotransplantation
Phase I/II
Recruiting
Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
Mar 03, 2025
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Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
Interstitial Lung Disease, Progressive Pulmonary Fibrosis
Phase III
Recruiting
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Jul 05, 2023
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Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Phase III
Completed
Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Feb 15, 2022
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Oral Treprostinil, Parenteral Treprostinil
Pulmonary Arterial Hypertension
Phase IV
Active Not Recruiting
A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension
Jan 10, 2022
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Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Progressive Pulmonary Fibrosis
Phase III
Enrolling By Invitation
Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
May 20, 2021
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Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Phase III
Active Not Recruiting
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Jan 12, 2021
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Ralinepag
Cardiovascular Diseases, Hypertension, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Connective Tissue Diseases, Vascular Diseases, Lung Diseases, Pah, Hypertension, Pulmonary, Familial Primary Pulmonary Hypertension, Respiratory Tract Disease
Phase III
Enrolling By Invitation
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Sep 19, 2018
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Ralinepag
Cardiovascular Diseases, Hypertension, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Connective Tissue Diseases, Vascular Diseases, Lung Diseases, Pah, Hypertension, Pulmonary, Familial Primary Pulmonary Hypertension, Respiratory Tract Disease
Phase III
Active Not Recruiting
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
Jul 27, 2018
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Oral Treprostinil
Pah
Phase II
Completed
Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years
Oct 21, 2014
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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 United Therapeutics (UTHR) have in its pipeline
UTHR is currently developing the following drugs: 10 Ge Xenokidney, Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer, Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer. These drug candidates are in various stages of clinical development as the company works toward FDA approval.