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UNITED THERAPEUTICS Corp (UTHR)

United Therapeutics Corporation, a biotechnology firm, is dedicated to discovering, developing, and bringing to market medical solutions for individuals suffering from chronic and severe, often life-threatening, illnesses. Its operations span both the United States and international markets. The company's current commercial portfolio features several key therapeutics: Remodulin, prescribed for pulmonary arterial hypertension (PAH) to lessen symptoms experienced during physical activity. Tyvaso, an inhaled form of the prostacyclin analogue treprostinil, designed to enhance exercise capacity in patients with PAH and pulmonary hypertension linked to interstitial lung disease (PH-ILD). Orenitram, a treprostinil tablet formulation, also aims to boost the exercise capabilities of PAH patients. Unituxin, a monoclonal antibody utilized in the treatment of high-risk neuroblastoma. Adcirca, an oral PDE-5 inhibitor, which helps improve exercise performance in those with PAH. United Therapeutics also maintains a robust development pipeline, including: Tyvaso DPI, a dry powder inhaler version of Tyvaso. The Remunity Pump, a compact, lightweight, and durable infusion system for treprostinil, accompanied by a separate controller. RemoPro and Ralinepag, both investigational treatments for PAH. Aurora-GT, a gene therapy product focused on regenerating blood vessels within the lungs. Clinical trials such as Tyvaso PERFECT and TETON, which are evaluating Tyvaso's efficacy in patients with World Health Organization (WHO) Group 3 pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). The company has forged strategic alliances and licensing agreements with various entities, such as DEKA Research & Development Corp. for a semi-disposable subcutaneous treprostinil delivery system; MannKind Corporation for the development and licensing of treprostinil inhalation powder and the Dreamboat device; and Arena Pharmaceuticals, Inc. for the development of Ralinepag. Established in 1996, United Therapeutics Corporation is headquartered in Silver Spring, Maryland.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

United Therapeutics Corporation logo

United Therapeutics Corporation

NASDAQ:UTHRHealthcare
+0.87%$598.72
AH$598.72+0.00%vs close
Mkt Cap$25.68B
Float41.96M
O/S42.89M
Vol
$ Vol
RVOL
Inst Own97.2%
Earnings
Dilution
United Therapeutics Corporation logoNASDAQ:UTHR$598.72+0.87%
Upcoming Catalysts
Phase Distribution
83 lead-sponsored trials·8 active·43 completed
Phase 113
Phase 1/23
Phase 214
Phase 2/35
Phase 326
Phase 413
Not applicable9
(34 more as collaborator)

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension

    treprostinil sodium

    Pulmonary Arterial Hypertension, Pulmonary Hypertension

    Enrollment
    39
    Start
    Oct 2002
    Primary Completion
    Aug 2005
    Completion
    Aug 2005
    NCT00058929
  • Phase 4
    Completed

    Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin

    treprostinil sodium

    Pulmonary Hypertension

    Enrollment
    10
    Start
    Sep 2006
    Primary Completion
    Jan 2008
    Completion
    Jan 2008
    NCT00373360
  • Phase 4
    Terminated

    Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH

    treprostinil

    Pulmonary Arterial Hypertension

    Enrollment
    8
    Start
    Feb 2007
    Primary Completion
    Sep 2009
    Completion
    Mar 2011
    NCT00439946
  • Phase 4
    Terminated

    Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction

    treprostinil sodium

    Hypertension, Pulmonary

    Enrollment
    10
    Start
    Mar 2007
    Primary Completion
    -
    Completion
    Nov 2007
    NCT00458042
  • Phase 4
    Terminated

    Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension

    Remodulin (treprostinil sodium)

    Pulmonary Arterial Hypertension

    Enrollment
    45
    Start
    Mar 2005
    Primary Completion
    Oct 2005
    Completion
    Oct 2005
    NCT00494533
  • Phase 4
    Terminated

    Rapid Switch From Flolan to Remodulin in the Outpatient Clinic

    treprostinil sodium

    Hypertension, Pulmonary

    Enrollment
    7
    Start
    Mar 2008
    Primary Completion
    Jan 2010
    Completion
    Feb 2012
    NCT00643604
  • Phase 4
    Completed

    Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects

    Inhaled treprostinil

    Pulmonary Arterial Hypertension

    Enrollment
    73
    Start
    Sep 2008
    Primary Completion
    Mar 2010
    Completion
    Dec 2010
    NCT00741819
  • Phase 4
    Completed

    Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)

    Remodulin

    Pulmonary Arterial Hypertension

    Enrollment
    39
    Start
    Apr 2012
    Primary Completion
    Mar 2014
    Completion
    Mar 2014
    NCT02847260
  • Phase 4
    Withdrawn

    An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension

    Subcutaneous Treprostinil

    Pulmonary Arterial Hypertension

    Enrollment
    0
    Start
    Jun 2017est.
    Primary Completion
    Jun 2021est.
    Completion
    Jun 2021est.
    NCT02882126
  • Phase 4
    Withdrawn

    Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial Hypertension

    Slow Dose Titration Group of Subcutaneous Treprostinil, Rapid Dose Titration Group of Subcutaneous Treprostinil

    Pulmonary Arterial Hypertension

    Enrollment
    0
    Start
    Feb 2017est.
    Primary Completion
    Apr 2018est.
    Completion
    Apr 2018est.
    NCT02893995
  • Phase 4
    Completed

    TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

    Intravenous Treprostinil

    Pulmonary Arterial Hypertension

    Enrollment
    20
    Start
    Jun 2005
    Primary Completion
    Feb 2014
    Completion
    Feb 2014
    NCT03055221
  • Phase 4
    Completed

    EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension

    Intravenous/Subcutaneous Treprostinil; Oral Treprostinil

    Pulmonary Arterial Hypertension

    Enrollment
    36
    Start
    Jan 2019
    Primary Completion
    May 2022
    Completion
    May 2022
    NCT03497689
  • Phase 4
    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

    Parenteral Treprostinil, Oral Treprostinil

    Pulmonary Arterial Hypertension

    Enrollment
    52
    Start
    Oct 2022
    Primary Completion
    Apr 2026est.
    Completion
    Apr 2028est.
    NCT05203510
  • Phase 3
    Completed

    Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary Hypertension

    UT-15

    Pulmonary Hypertension

    Enrollment
    -
    Start
    Oct 1998
    Primary Completion
    -
    Completion
    Sep 2000
    NCT00004497
  • Phase 3
    Terminated

    Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures

    Remodulin® (treprostinil sodium) Injection

    Critical Limb Ischemia, Peripheral Vascular Disease +2

    Enrollment
    30
    Start
    Feb 2003
    Primary Completion
    Sep 2004
    Completion
    Sep 2004
    NCT00060996
  • Phase 3
    Completed

    Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)

    Inhaled treprostinil, Placebo inhalation solution

    Pulmonary Hypertension

    Enrollment
    235
    Start
    Jun 2005
    Primary Completion
    Oct 2007
    Completion
    Oct 2007
    NCT00147199
  • Phase 3
    Completed

    FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

    Oral treprostinil (UT-15C) Sustained Release Tablets

    Pulmonary Hypertension

    Enrollment
    349
    Start
    Oct 2006
    Primary Completion
    Apr 2011
    Completion
    Apr 2011
    NCT00325403
  • Phase 3
    Completed

    FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)

    Oral treprostinil (UT-15C) sustained release tablets, Placebo

    Pulmonary Hypertension

    Enrollment
    354
    Start
    Oct 2006
    Primary Completion
    Sep 2008
    Completion
    Dec 2010
    NCT00325442
  • Phase 3
    Withdrawn

    FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

    UT-15C 1 mg, UT-15C 0.25 mg

    Pulmonary Hypertension

    Enrollment
    0
    Start
    Dec 2008
    Primary Completion
    Jan 2009
    Completion
    Jan 2009
    NCT00760916
  • Phase 3
    Completed

    Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension

    UT-15C SR, Placebo

    Pulmonary Hypertension

    Enrollment
    310
    Start
    Jun 2009
    Primary Completion
    Jul 2011
    Completion
    Jul 2011
    NCT00887978
  • Phase 3
    Completed

    An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension

    Oral Treprostinil

    Pulmonary Arterial Hypertension

    Enrollment
    894
    Start
    Jan 2007
    Primary Completion
    Feb 2020
    Completion
    Feb 2020
    NCT01027949
  • Phase 3
    Withdrawn

    Safety and Efficacy of Inhaled Treprostinil in Patients With PAH

    Inhaled treprostinil, Placebo

    Pulmonary Arterial Hypertension

    Enrollment
    0
    Start
    Jun 2012
    Primary Completion
    Dec 2015est.
    Completion
    Jun 2016est.
    NCT01557647
  • Phase 3
    Withdrawn

    Inhaled Treprostinil for PAH: Open-label Extension

    inhaled treprostinil

    Pulmonary Arterial Hypertension

    Enrollment
    0
    Start
    Jun 2012
    Primary Completion
    Dec 2018est.
    Completion
    Dec 2018est.
    NCT01557660
  • Phase 3
    Completed

    Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy

    Treprostinil Diolamine, Placebo

    Pulmonary Arterial Hypertension

    Enrollment
    690
    Start
    Jun 2012
    Primary Completion
    Jun 2018
    Completion
    Jun 2018
    NCT01560624
  • Phase 3
    Completed

    An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

    UT-15C (treprostinil diolamine)

    Pulmonary Arterial Hypertension

    Enrollment
    471
    Start
    Sep 2013
    Primary Completion
    Aug 2021
    Completion
    Aug 2021
    NCT01560637

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