Drugs / Treprostinil
Treprostinil
also known as
UT-15C · Remodulin · Treprostinil sodium · treprostinil diethanolamine · Tyvaso · L606 · LIQ861 · UT-15C SR · +5 more
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed idiopathic pulmonary fibrosis 1 milestone | |||||
| Filed | US (FDA) | Tyvaso | idiopathic pulmonary fibrosis | — | “In June 2026, United Therapeutics submitted a New Drug Application for ralinepag to treat PAH, and a supplemental New Drug Application for nebulized treprostinil to treat IPF,...” unither.com ↗ |
| Filed pulmonary arterial hypertension 4 milestones | |||||
| Filed | US (FDA) | Tyvaso | pulmonary arterial hypertension | 2020-08-17 | “FDA accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution” unither.com ↗ |
| Filed | US (FDA) | Trevyent | pulmonary arterial hypertension | 2019-09-11 | “Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension” unither.com ↗ “We submitted a 505(b)(1) new drug application (NDA) to the FDA for our Trevyent disposable treprostinil pump system in June 2019.” unither.com ↗ |
| Filed | US (FDA) | Remodulin | pulmonary arterial hypertension | 2000-10-16 | “The New Drug Application (NDA) for LIQ861 was submitted to the U.S. Food and Drug Administration (FDA) under the 505(b)(2) regulatory pathway” liquidia.com ↗ “In January 2020 , the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for LIQ861” liquidia.com ↗ “United Therapeutics submitted its New Drug Application (NDA) for Remodulin for PAH to the FDA on October 16, 2000.” unither.com ↗ |
| Filed | Other | Remodulin | pulmonary arterial hypertension | — | “United Therapeutics has submitted marketing applications for Remodulin in France, Switzerland and Australia, with additional European filings to follow approval in France.” unither.com ↗ |
| Filed pulmonary hypertension, primary, 7 3 milestones | |||||
| Filed | US (FDA) | YUTREPIA | pulmonary hypertension, primary, 7 | 2025-03-28 | “NDA resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung...” liquidia.com ↗ “In July 2023 , the Company amended its NDA to add the indication to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).” liquidia.com ↗ |
| Filed | US (FDA) | Tyvaso DPI | pulmonary hypertension, primary, 7 | 2021-04-19 | “In April 2021, we submitted a new drug application ( NDA ) for Tyvaso DPI for pulmonary arterial hypertension ( PAH ) and PH-ILD indications.” unither.com ↗ “Tyvaso DPI™ as United Therapeutics submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA).” mannkindcorp.com ↗ “In April 2021, we submitted an NDA for Tyvaso DPI for pulmonary arterial hypertension ( PAH ) and PH-ILD indications.” unither.com ↗ “In April 2021, we submitted an NDA for Tyvaso DPI for pulmonary arterial hypertension (PAH) and PH-ILD indications.” unither.com ↗ “We resubmitted our NDA in December 2021 and the FDA issued an action date for February 2022.” unither.com ↗ “UNITED THERAPEUTICS ANNOUNCES SUBMISSION OF TYVASO DPI™ NEW DRUG APPLICATION TO FDA” unither.com ↗ |
| Rejected (CRL) | US (FDA) | Tyvaso DPI | pulmonary hypertension, primary, 7 | 2020-11-25 | “has issued a complete response letter (CRL) for the company’s New Drug Application (NDA) for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial...” liquidia.com ↗ “including our response to the Complete Response Letter received in November 2020 , the potential for eventual FDA approval of the NDA for LIQ861” liquidia.com ↗ “In October 2021, we received a complete response letter ( CRL ) from the FDA noting a single deficiency preventing approval of Tyvaso DPI” unither.com ↗ “In October 2021 we received a complete response letter ( CRL ) from the FDA noting a single deficiency preventing approval of Tyvaso DPI” unither.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (3) | US (FDA) | TYVASO | — | 2014-05-20 – 2021-03-31 | fda.gov ↗ |
| Approved | EU (EMA) | Trepulmix | — | 2020-04-03 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | REMODULIN | — | 2004-11-24 – 2006-03-20 | fda.gov ↗ |
| Approved | US (FDA) | REMODULIN | — | 2002-05-21 | fda.gov ↗ |
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EU approved 2020
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07837830 | Sep 2026 → Dec 2027 expected | pulmonary hypertension | Valley Health System | Recruiting | No outcome recorded |
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT05067270 | Oct → Dec 2021 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03950739 | Sep 2019 → Aug 2023 | pulmonary arterial hypertension | United Therapeutics | Completed | Met primary |
| Phase 1 | NCT04041648 | Nov 2018 → Sep 2019 | pulmonary arterial hypertension | Pharmosa Biopharm Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03464864 | Mar → Jun 2018 | pulmonary arterial hypertension | Mannkind Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04675944 | Feb → May 2018 | pulmonary arterial hypertension | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02770521 | May → Jul 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01481974 | Dec 2012 → May 2019 | ischemic disease | Abhinav Humar, MD | Completed | No outcome recorded |
| Phase 1 | NCT01758744 | Dec 2012 → Jul 2016 | chronic obstructive pulmonary disease, pulmonary hypertension | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT01746485 | Jul 2012 | — | United Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01172496 | Aug 2010 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01131845 | May → Sep 2010 | impaired renal function disease, pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00848939 | Dec 2008 → Jan 2010 | systemic sclerosis | United Therapeutics | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT04005469 | Nov 2020 → Jun 2028 expected | ischemic disease | Rhode Island Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03654989 | Jan 2020 → Dec 2021 | ulcer of lower limbs | University Hospital, Grenoble | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03120533 | Jun 2017 → Jun 2019 | systemic sclerosis | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 1/2 | NCT01554540 | Feb 2012 → Oct 2013 | systemic sclerosis | University Hospital, Grenoble | Unknown | No outcome recorded |
| Phase 1/2 | NCT01082484 | Jan 2010 → Jan 2011 | — | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 220 trials · 1 missed | ||||||
| Phase 2 | NCT07177703 | Oct 2025 → Dec 2027 expected | pulmonary arterial hypertension | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07037836 | Sep 2025 → Jul 2027 expected | chronic obstructive pulmonary disease, polycythemia due to hypoxia | Bastiaan Driehuys | Recruiting | No outcome recorded |
| Phase 2 | NCT06969573 | Jun 2025 → Dec 2026 expected | chronic obstructive pulmonary disease | University of Alberta | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05564637 | Mar 2023 → Oct 2024 | interstitial lung disease, pulmonary arterial hypertension | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT03814317 | Jan 2020 → Dec 2025 | interstitial lung disease, pulmonary hypertension, sarcoidosis | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT03884465 | Nov 2019 → Dec 2020 | pulmonary arterial hypertension | Liquidia Technologies, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03016468 | May 2017 → Sep 2018 | pulmonary arterial hypertension | United Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03012646 | Apr 2017 → Apr 2019 | chronic obstructive pulmonary disease, pulmonary hypertension | United Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02769624 | Feb 2017 → Sep 2018 | congenital heart disease | Children's Hospital Medical Center, Cincinnati | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02663895 | Oct 2016 → May 2020 | calcinosis, systemic sclerosis | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT02603068 | Feb 2016 → Apr 2018 | pulmonary fibrosis, pulmonary hypertension | United Therapeutics | Withdrawn | No outcome recorded |
| Phase 2 | NCT02276872 | Dec 2014 → Jul 2017 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01588405 | Apr 2012 → Jul 2014 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01477333 | Oct 2011 → Nov 2013 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00848107 | Sep 2009 → Sep 2011 | systemic sclerosis | United Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT00775463 | May 2009 → Mar 2011 | systemic sclerosis | United Therapeutics | Completed | Missed primary |
| Phase 2 | NCT00705133 | Jul 2008 → Jan 2011 | idiopathic pulmonary fibrosis, pulmonary arterial hypertension | Rajan Saggar | Completed | No outcome recorded |
| Phase 2 | NCT00703339 | Jun 2008 → Dec 2009 | idiopathic pulmonary fibrosis, pulmonary hypertension | Lung Biotechnology PBC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00651885 | Mar 2008 → Dec 2010 | limb ischemia | Ochsner Health System | Completed | No outcome recorded |
| Phase 2 | NCT00445159 | Nov 2006 → ? | limb ischemia | Southern Arizona Vascular Institute | Unknown | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT02633293 | Sep 2016 → Aug 2021 | combined pulmonary fibrosis-emphysema syndrome, interstitial lung disease, pulmonary hypertension | United Therapeutics | Terminated | No outcome recorded |
| Phase 2/3 | NCT01884038 | Jun 2008 → Jun 2010 | — | United Therapeutics | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT00067041 | Mar → Dec 2003 | peripheral vascular disease | United Therapeutics | Terminated | No outcome recorded |
| Phase 325 trials · 5 met primary · 1 missed | ||||||
| Phase 3 | NCT07285655 | Apr 2026 → Jul 2029 expected | pulmonary hypertension owing to lung disease and/or hypoxia | Liquidia Technologies, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06350032 | Jul 2024 → Nov 2028 expected | pulmonary arterial hypertension | AOP Orphan Pharmaceuticals AG | Recruiting | No outcome recorded |
| Phase 3 | NCT05943535 | Oct 2023 → Nov 2027 expected | pulmonary fibrosis | United Therapeutics | Recruiting | No outcome recorded |
| Phase 3 | NCT05255991 | Oct 2022 → Jun 2025 | idiopathic pulmonary fibrosis | United Therapeutics | Completed | Met primary |
| Phase 3 | NCT04905693 | Sep 2022 → Dec 2029 expected | idiopathic pulmonary fibrosis, pulmonary fibrosis | United Therapeutics | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT04691154 | Aug 2021 → Mar 2025 overdue | pulmonary arterial hypertension, pulmonary hypertension owing to lung disease and/or hypoxia | Liquidia Technologies, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04708782 | Jun 2021 → Feb 2026 | idiopathic pulmonary fibrosis | United Therapeutics | Completed | Met primary |
| Phase 3 | NCT03992755 | Jul 2019 → May 2025 overdue | pulmonary hypertension, primary, 6 | Liquidia Technologies, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04062565 | Mar 2019 → Dec 2025 overdue | pulmonary arterial hypertension | University of Arizona | Recruiting | No outcome recorded |
| Phase 3 | NCT03794583 | Dec 2018 → Nov 2022 | chronic obstructive pulmonary disease, pulmonary hypertension | United Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT03496623 | May 2018 → Oct 2022 | chronic obstructive pulmonary disease, pulmonary hypertension | United Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT03043651 | Jan 2018 → Mar 2020 | pulmonary hypertension | United Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT03399604 | Jan 2018 → May 2019 | pulmonary hypertension, primary, 6 | Liquidia Technologies, Inc. | Completed | Met primary |
| Phase 3 | NCT03037580 | Aug 2017 → Dec 2019 | diastolic heart failure, pulmonary hypertension | United Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT03055234 | Jun 2017 → Dec 2021 | pulmonary hypertension | United Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02865733 | Aug 2016 → Dec 2018 | pulmonary hypertension | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 3 | NCT01560637 | Sep 2013 → Aug 2021 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT01560624 | Jun 2012 → Jun 2018 | pulmonary arterial hypertension | United Therapeutics | Completed | Met primary |
| Phase 3 | NCT01557660 | Jun 2012 → Dec 2018 | pulmonary arterial hypertension | United Therapeutics | Withdrawn | No outcome recorded |
| Phase 3 | NCT01557647 | Jun 2012 → Dec 2015 | pulmonary arterial hypertension | United Therapeutics | Withdrawn | No outcome recorded |
| Phase 3 | NCT00887978 | Jun 2009 → Jul 2011 | pulmonary hypertension | United Therapeutics | Completed | Missed primary |
| Phase 3 | NCT01416636 | Mar 2009 → Nov 2016 | chronic thromboembolic pulmonary hypertension | SciPharm SàRL | Completed | Met primary |
| Phase 3 | NCT01027949 | Jan 2007 → Feb 2020 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00060996 | Feb 2003 → Sep 2004 | limb ischemia, peripheral vascular disease, restless legs syndrome, ulcer of lower limbs | United Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT00004497 | Oct 1998 → Sep 2000 | pulmonary hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 420 trials · 1 met primary | ||||||
| Phase 4 | NCT07759804 | Sep 2026 → May 2027 expected | pulmonary arterial hypertension | Liquidia Technologies, Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT07112183 | Oct 2025 → Sep 2028 expected | Raynaud disease | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06317805 | Dec 2023 → Jun 2027 expected | pulmonary arterial hypertension | AOP Orphan Pharmaceuticals AG | Recruiting | No outcome recorded |
| Phase 4 | NCT05203510 | Oct 2022 → Apr 2026 overdue | pulmonary arterial hypertension | United Therapeutics | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03835676 | May 2019 → Jun 2025 | pulmonary hypertension | Magdi H. Yacoub | Unknown | No outcome recorded |
| Phase 4 | NCT03497689 | Jan 2019 → May 2022 | pulmonary arterial hypertension | United Therapeutics | Completed | Met primary |
| Phase 4 | NCT02882126 | Jun 2017 → Jun 2021 | pulmonary arterial hypertension | United Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT02893995 | Feb 2017 → Apr 2018 | pulmonary arterial hypertension | United Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT06605326 | Jan 2015 → Sep 2024 | heart failure, pulmonary arterial hypertension, pulmonary hypertension owing to lung disease and/or hypoxia | Guangzhou Institute of Respiratory Disease | Completed | No outcome recorded |
| Phase 4 | NCT01615627 | Jul 2012 → Feb 2019 | pulmonary arterial hypertension | Jewish General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02847260 | Apr 2012 → Mar 2014 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT01268553 | Aug 2010 → Oct 2016 | pulmonary arterial hypertension | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00741819 | Sep 2008 → Mar 2010 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT00643604 | Mar 2008 → Jan 2010 | pulmonary arterial hypertension | United Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00458042 | Mar → Nov 2007 | pulmonary arterial hypertension | United Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00439946 | Feb 2007 → Sep 2009 | pulmonary arterial hypertension | United Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00373360 | Sep 2006 → Jan 2008 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT03055221 | Jun 2005 → Feb 2014 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT00494533 | Mar → Oct 2005 | pulmonary arterial hypertension | United Therapeutics | Terminated | No outcome recorded |
| Phase 4 | NCT00058929 | Oct 2002 → Aug 2005 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase not applicable3 trials · 1 missed | ||||||
| — | NCT07844213 | Aug 2022 → Jul 2025 | congenital heart disease | China National Center for Cardiovascular Diseases | Completed | No outcome recorded |
| — | NCT02498444 | Sep 2015 → Dec 2020 | univentricular heart | Stanford University | Terminated | Missed primary |
| — | NCT01980979 | Nov 2013 → Dec 2015 | congenital heart disease | University of California, Los Angeles | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy12 trials | ||||||
| Phase 0 | NCT02583789 Comparator | May 2016 → Dec 2021 | Raynaud disease | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1 | NCT06193031 Background | Nov → Dec 2015 | — | Insmed Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT02178566 Comparator | Aug 2015 → Jan 2019 | chronic obstructive pulmonary disease | Inova Health Care Services | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02261883 Comparator | Jul 2015 → Sep 2022 | pulmonary hypertension, neonatal | United Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02370095 Comparator | Feb 2015 → Oct 2017 | adult acute respiratory distress syndrome | University of North Carolina, Chapel Hill | Terminated | No outcome recorded |
| Phase 2/3 | NCT02630316 Comparator | Feb 2017 → Dec 2019 | combined pulmonary fibrosis-emphysema syndrome, interstitial lung disease, pulmonary hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02999906 Comparator | Oct 2017 → Dec 2021 | pulmonary arterial hypertension | United Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT00760916 Comparator | Dec 2008 → Jan 2009 | pulmonary hypertension | United Therapeutics | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00325442 Comparator | Oct 2006 → Sep 2008 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00325403 Comparator | Oct 2006 → Apr 2011 | pulmonary hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT01305252 Comparator | Jul 2010 → Sep 2014 | pulmonary arterial hypertension | Stanford University | Completed | No outcome recorded |
| — | NCT05572996 Background | — | combined pulmonary fibrosis-emphysema syndrome, interstitial lung disease, pulmonary hypertension | Ferrer Internacional S.A. | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 70
| Date | Issuer | Release |
|---|---|---|
| 2026-09-03 | Liquidia Technologies, Inc. | Regulatory FDA Grants Fast Track Designation to YUTREPIA® for the Treatment of Raynaud's Phenomenon Associated with Systemic Sclerosis liquidia.com ↗
Liquidia Corporation (Nasdaq: LQDA), a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases, today announced that the U.S. Food and Drug Administration ( FDA ) has granted Fast Track designation to YUTREPIA® (treprostinil) inhalation powder for the treatment of Raynaud's phenomenon associated with systemic sclerosis (SSc-RP). |
| 2026-09-02 | United Therapeutics | Regulatory United Therapeutics Corporation Announces FDA Acceptance of Supplemental New Drug Application for Nebulized Tyvaso® to Treat Idiopathic Pulmonary Fibrosis unither.com ↗
United Therapeutics Corporation (Nasdaq: UTHR ), a public benefit corporation, today announced that the FDA has accepted the supplemental New Drug Application ( sNDA ) for nebulized Tyvaso ® (treprostinil) Inhalation Solution to treat IPF. |
| 2026-08-28 | United Therapeutics | Results United Therapeutics Presents Data at The European Society of Cardiology Congress 2026 and The European Respiratory Society International Congress 2026 unither.com ↗
Early and Rapid Treprostinil Titration Improves Right Ventricular Ejection Fraction at 12 Months in Pulmonary Arterial Hypertension: ARTISAN Interim Analysis |
| 2026-05-18 | United Therapeutics | Results United Therapeutics Corporation Announces TETON-1 Study of Tyvaso Published in The New England Journal of Medicine and Presented at ATS 2026 unither.com ↗
In combined analyses of TETON-1 and TETON-2 — also included in the NEJM publication and presented at ATS — nebulized Tyvaso achieved statistically significant treatment effects across the primary and most secondary efficacy endpoints |
| 2026-04-30 | Mochida Pharmaceutical Company, Ltd. | Regulatory Announcement of Application for Manufacturing and Marketing Approval in Japan of MD-712, a Treatment for PAH and PH-ILD mochida.co.jp ↗ |
| 2026-04-20 | United Therapeutics | Results United Therapeutics Corporation Presents New Data Spanning Pulmonary Hypertension Treatment, Lung Donor Expansion, and Xenotransplantation at ISHLT 2026 unither.com ↗
An interim analysis from the ARTISAN study indicates that early, high-dose treatment with treprostinil reduced afterload, improved right ventricular function, and reversed cardiac remodeling in pulmonary arterial hypertension ( PAH ) |
| 2026-03-30 | United Therapeutics | Results United Therapeutics Corporation Announces TETON-1 Pivotal Study of Tyvaso® Meets Primary Endpoint for Treatment of Idiopathic Pulmonary Fibrosis, Exceeding Impressive Treatment Effect Seen in TETON-2 unither.com ↗
Nebulized Tyvaso ® (treprostinil) Inhalation Solution demonstrated superiority over placebo for the change in absolute forced vital capacity by 130.1 mL and reduced the risk of clinical worsening in patients with idiopathic pulmonary fibrosis, with positive results observed across all subgroups |
| 2026-03-11 | United Therapeutics | Results United Therapeutics Corporation Announces Full Results of TETON-2 Phase 3 Clinical Trial Published in The New England Journal of Medicine unither.com ↗
The study met its primary efficacy endpoint, with nebulized Tyvaso demonstrating statistically significant improvement in absolute FVC relative to placebo from baseline to week 52 in an IPF population broadly treated with background therapy. |
| 2025-09-02 | United Therapeutics | Results United Therapeutics Corporation Announces TETON-2 Pivotal Study of Tyvaso® Meets Primary Endpoint for the Treatment of Idiopathic Pulmonary Fibrosis unither.com ↗
Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL (Hodges-Lehmann estimate, p <0.0001) from baseline to week 52 in patients with IPF. |
| 2025-08-12 | Liquidia Technologies, Inc. | Results Liquidia Corporation Reports Second Quarter 2025 Financial Results and Provides Corporate Update liquidia.com ↗
Positive interim data from ASCENT trial reinforces YUTREPIA’s tolerability and efficacy profile in PH-ILD with median improvement in six-minute walk distance of 31.5 meters at Week 16 |
| 2025-05-23 | Liquidia Technologies, Inc. | Regulatory U.S. FDA Approves Liquidia’s YUTREPIA™ (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) liquidia.com ↗
FDA’s approval of YUTREPIA paves the way for prescribers to add a new treatment option for patients with PAH and PH-ILD |
| 2025-03-28 | Liquidia Technologies, Inc. | Regulatory Liquidia Corporation Announces FDA Acceptance of New Drug Application Resubmission for YUTREPIA™ (treprostinil) Inhalation Powder liquidia.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). |
| 2024-11-13 | Liquidia Technologies, Inc. | Regulatory Liquidia Corporation Reports Third Quarter 2024 Financial Results and Provides Corporate Update liquidia.com ↗
Received tentative approval from the FDA for YUTREPIA™ (treprostinil) inhalation powder for both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) |
| 2024-08-19 | Liquidia Technologies, Inc. | Regulatory U.S. FDA Grants Tentative Approval of YUTREPIA™ (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) liquidia.com ↗
Tentative approval indicates that YUTREPIA has met all regulatory standards for quality, safety and efficacy required for approval in the United States but must await the expiration of regulatory exclusivity of a competing product before final approval can be granted. |
| 2024-01-25 | Liquidia Technologies, Inc. | Regulatory Liquidia Corporation Provides Update on New Drug Application for YUTREPIA™ (treprostinil) inhalation powder liquidia.com ↗ |
| 2023-11-07 | Liquidia Technologies, Inc. | Regulatory Liquidia Corporation Reports Third Quarter 2023 Financial Results and Provides Corporate Update liquidia.com ↗
PDUFA goal date to add PH-ILD indication to YUTREPIA label is January 24, 2024 |
| 2023-09-25 | Liquidia Technologies, Inc. | Regulatory FDA Accepts Submission to Add PH-ILD to YUTREPIA™ Label liquidia.com ↗ |
| 2023-07-27 | Liquidia Technologies, Inc. | Regulatory Liquidia Submits Amendment to Add PH-ILD Indication to Tentatively Approved NDA for YUTREPIA™ (treprostinil) Inhalation Powder liquidia.com ↗
Liquidia Corporation (NASDAQ: LQDA) announced today the submission of an amendment to the tentatively approved new drug application (NDA) for YUTREPIA™ (treprostinil) inhalation powder to add the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). |
| 2022-10-31 | United Therapeutics | Results United Therapeutics Announces Top Line Data From the EXPEDITE Study of Remodulin Induction Prior to Orenitram Therapy unither.com ↗
A short induction of Remodulin ® (treprostinil) injection allowed study subjects to reach double the typical doses of Orenitram ® (treprostinil) extended-release tablets than patients who did not have a Remodulin induction |
| 2022-08-01 | Liquidia Technologies, Inc. | Results Liquidia Announces the Publication of Long-Term Clinical Data from Completed INSPIRE Study in the Journal Pulmonary Circulation liquidia.com ↗
YUTREPIA can be safely titrated using a dry powder inhaler to doses comparable to 24 breaths of Tyvaso, indicating that a wide range of therapeutic doses can be more easily administered in just a few breaths compared to nebulizers |
| 2022-06-09 | Liquidia Technologies, Inc. | Results Liquidia Announces Presentation at the 2022 Pulmonary Hypertension Association (PHA) International Conference liquidia.com ↗
The data presented today help demonstrate that YUTREPIA™ can provide a clinically meaningful improvement in quality of life whether starting a prostacyclin therapy for the first time or transitioning from another inhaled form. |
| 2022-05-24 | United Therapeutics | Regulatory United Therapeutics Announces FDA Approval of Tyvaso DPI™ unither.com ↗
Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD. |
| 2022-05-24 | Mannkind Corporation | Regulatory MannKind’s Technosphere® Inhalation Platform Utilized in FDA-Approved Tyvaso DPI™ mannkindcorp.com ↗ |
| 2022-05-16 | Pharmosa Biopharm Inc. | Results L606 Poster presented at 2022 ATS Conference com.tw ↗
Inhaled liposomal treprostinil (L606) provides extended release and stable plasma concentration as demonstrated in healthy adult volunteers. |
| 2022-04-06 | United Therapeutics | Results United Therapeutics Announces the Publication of Tyvaso DPI™ BREEZE Clinical and Long-term Data in the Journal Pulmonary Circulation unither.com ↗
In subjects with PAH, transition from Tyvaso ® to Tyvaso DPI™ demonstrated safety and tolerability with significant improvements in six-minute walk distance, device preference and satisfaction, and patient reported outcomes |
| 2022-02-24 | Mannkind Corporation | Regulatory Update on Tyvaso DPI™ New Drug Application mannkindcorp.com ↗
MannKind has now learned that the FDA considers the response to be a major amendment to the NDA, thereby extending to May 2022 the FDA’s deadline to complete its review of the pending NDA. |
| 2021-11-08 | Liquidia Technologies, Inc. | Regulatory FDA Grants Tentative Approval for Liquidia’s YUTREPIA™ (Treprostinil) Inhalation Powder liquidia.com ↗
Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) granted tentative approval for YUTREPIA™ (treprostinil) inhalation powder, previously referred to as LIQ861. |
| 2021-10-21 | United Therapeutics | Results United Therapeutics Details New Data Presented at CHEST Annual Meeting 2021 unither.com ↗
Tyvaso DPI™ BREEZE pharmacokinetic data demonstrate similar exposure and lower variability for Tyvaso DPI compared with Tyvaso |
| 2021-10-18 | United Therapeutics | Regulatory United Therapeutics Provides an Update on the Progress of the Tyvaso DPI™ New Drug Application unither.com ↗
On Friday, October 15, 2021 , the FDA issued a complete response declining to approve the NDA at this time. |
| 2021-10-18 | Mannkind Corporation | Regulatory Progress Update on Tyvaso DPI™ New Drug Application mannkindcorp.com ↗
The FDA declined to approve the NDA at this time, noting only one deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil drug substance, the active ingredient of Tyvaso DPI. |
| 2021-09-07 | United Therapeutics | Results United Therapeutics Presents Tyvaso DPI™ BREEZE Clinical Data At The European Respiratory Society International Congress 2021 unither.com ↗
United Therapeutics Corporation (Nasdaq: UTHR) today presented new clinical data from the BREEZE study evaluating Tyvaso DPI™ (treprostinil) in patients with pulmonary arterial hypertension (PAH) at the European Respiratory Society (ERS) International Congress 2021. |
| 2021-06-30 | United Therapeutics | Results United Therapeutics Announces The Lancet Respiratory Medicine Publication Of Post-Hoc Analysis Of FVC Change From The Tyvaso® INCREASE Study unither.com ↗
The analysis demonstrated that inhaled treprostinil was associated with improvements in FVC compared to placebo over 16 weeks. |
| 2021-06-16 | United Therapeutics | Regulatory United Therapeutics Announces FDA Acceptance of Tyvaso DPI™ New Drug Application For Priority Review unither.com ↗
“The acceptance of the Tyvaso DPI NDA for review represents an important regulatory step toward offering this meaningful new product to both PAH and PH-ILD patients,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. |
| 2021-06-16 | Mannkind Corporation | Regulatory MannKind and United Therapeutics Achieve a Major Milestone in the Development of Tyvaso DPI™ With New Drug Application Acceptance From the FDA mannkindcorp.com ↗ |
| 2021-06-02 | Liquidia Technologies, Inc. | Regulatory Liquidia Announces FDA Acceptance of New Drug Application Resubmission for LIQ861 (treprostinil) Inhalation Powder liquidia.com ↗
Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH). |
| 2021-05-10 | Liquidia Technologies, Inc. | Regulatory Liquidia Resubmits New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension liquidia.com ↗
Liquidia Corporation (NASDAQ: LQDA) announced today that on May 7, 2021 , it resubmitted its New Drug Application (NDA) for LIQ861 for the treatment of pulmonary arterial hypertension (PAH). |
| 2021-04-19 | United Therapeutics | Regulatory United Therapeutics Announces Submission of Tyvaso DPI™ New Drug Application to FDA unither.com ↗
UNITED THERAPEUTICS ANNOUNCES SUBMISSION OF TYVASO DPI™ NEW DRUG APPLICATION TO FDA |
| 2021-04-19 | Mannkind Corporation | Regulatory Mannkind and United Therapeutics Reach a Milestone in the Development of Tyvaso DPI™ With New Drug Application Submitted to the FDA mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) and United Therapeutics (Nasdaq: UTHR) reached a milestone today in the development of Tyvaso DPI™ as United Therapeutics submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA). |
| 2021-04-01 | United Therapeutics | Regulatory United Therapeutics Announces FDA Approval and Launch of Tyvaso® for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease unither.com ↗
United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has approved Tyvaso® (treprostinil) Inhalation Solution for the treatment of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. |
| 2021-04-01 | Mannkind Corporation | Regulatory United Therapeutics Announces FDA Approval and Launch of Tyvaso® for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease mannkindcorp.com ↗ |
| 2021-02-01 | Alembic Pharmaceuticals Ltd. | Regulatory 12th February, 2021, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that its wholly-owned subsidiary Alembic Global Holding SA has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Treprostinil Injection, 20 mg/20 ml (1 mg/ml ), 50 mg/20 ml (2.5 mg/ml ), 100 mg/20 ml (5 mg/ml ), and 200 mg/20 ml (10 mg/ml ), Multiple-Dose Vials. |
| 2021-01-31 | Mannkind Corporation | Results United Therapeutics Announces BREEZE Study of Investigational Tyvaso DPI™ Meets Primary Objective mannkindcorp.com ↗ |
| 2021-01-28 | United Therapeutics | Results United Therapeutics Announces BREEZE Study of Investigational Tyvaso DPI™ Meets Primary Objective unither.com ↗
United Therapeutics Corporation (Nasdaq: UTHR) announced today that that the BREEZE study of Tyvaso DPI (inhaled treprostinil) met its primary objective of demonstrating safety and tolerability in patients with pulmonary arterial hypertension (PAH) transitioning from Tyvaso (treprostinil) Inhalation Solution. |
| 2021-01-13 | United Therapeutics | Results United Therapeutics Announces New England Journal of Medicine Publication of the INCREASE Study Evaluating Tyvaso® in Pulmonary Hypertension Associated with Interstitial Lung Disease unither.com ↗
Additionally, patients treated with Tyvaso experienced significant improvements in other clinically meaningful outcomes, including a decreased risk of clinical worsening, an improvement in forced vital capacity, and a reduction in exacerbation of underlying lung disease. |
| 2020-12-09 | United Therapeutics | Regulatory United Therapeutics Receives FDA Orphan Drug Designation For Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis unither.com ↗
United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). |
| 2020-11-25 | Liquidia Technologies, Inc. | Regulatory Liquidia Receives Complete Response Letter from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension liquidia.com ↗
In the CRL, the FDA stated that it is unable to approve the NDA at this time. |
| 2020-10-22 | United Therapeutics | Results United Therapeutics Highlights Poster Presentations from the Recent CHEST 2020 Meeting unither.com ↗
Clinical study data suggests Tyvaso® improved forced vital capacity, an important measure of lung function, in patients with pulmonary hypertension associated with interstitial lung disease |
| 2020-09-01 | Alembic Pharmaceuticals Ltd. | Regulatory 7th September, 2020, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that its wholly owned subsidiary Alembic Global Holdings SA has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Treprostinil Injection, 20 mg/20 ml (1 mg/ml ), 50 mg/20 ml (2.5 mg/ml ), 100 mg/20 ml (5 mg/ml ), and 200 mg/20 ml (10 mg/ml ), Multiple-Dose Vials. |
| 2020-08-17 | United Therapeutics | Regulatory United Therapeutics Announces U.S. FDA Filing Acceptance Of Supplemental New Drug Application For Tyvaso® For Pulmonary Hypertension Associated With Interstitial Lung Disease unither.com ↗ |
| 2020-08-05 | Liquidia Technologies, Inc. | Results Liquidia Releases Exploratory Endpoint Data from INSPIRE Study at the American Thoracic Society (ATS) Annual Meeting liquidia.com ↗
The data from the INSPIRE study were made available via a prerecorded poster session and showed results from standard measures used to evaluate clinical symptoms and functional ability, which were exploratory endpoints and not subject to formal statistical analysis. |
| 2020-04-30 | Liquidia Technologies, Inc. | Results Liquidia Releases Final LIQ861 Results from Pivotal Phase 3 INSPIRE Study in Patients with Pulmonary Arterial Hypertension liquidia.com ↗
today announced that it has released final safety and tolerability results from the two-month endpoint of the pivotal phase 3 INSPIRE trial that evaluated LIQ861 in patients with pulmonary arterial hypertension (PAH). |
| 2020-04-23 | United Therapeutics | Results United Therapeutics Announces Additional Results From FREEDOM-EV Study Showing The Hemodynamic And Risk Status Reduction Benefits Of Orenitram Treatment In Patients With Pulmonary Arterial Hypertension unither.com ↗
Orenitram demonstrated improvement in hemodynamic parameters and risk status, important indicators of long-term outcomes in PAH patients, in presentations at recent scientific conferences |
| 2020-04-08 | Liquidia Technologies, Inc. | Regulatory Liquidia Announces FDA Acceptance of New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension liquidia.com ↗
the U.S. Food and Drug Administration (FDA) accepted for review the Company’s New Drug Application (NDA) seeking marketing approval for LIQ861 for the treatment of pulmonary arterial hypertension (PAH) |
| 2020-02-26 | United Therapeutics | Results United Therapeutics Corporation Reports Fourth Quarter and Full Year 2019 Financial Results unither.com ↗
INCREASE study of Tyvaso® in PH-ILD meets primary and secondary endpoints |
| 2020-02-24 | United Therapeutics | Regulatory United Therapeutics and DEKA Announce Additional FDA Clearance Related to the Unity Subcutaneous Delivery System for Remodulin® unither.com ↗
This additional 510(k) clearance enables cassettes to be prefilled with Remodulin by contracted specialty pharmacies in order to improve convenience for patients. |
| 2020-01-27 | Liquidia Technologies, Inc. | Regulatory Liquidia Submits New Drug Application for LIQ861 (treprostinil) inhalation powder to U.S. Food and Drug Administration for the Treatment of Pulmonary Arterial Hypertension (PAH) liquidia.com ↗
today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for LIQ861. |
| 2019-10-21 | United Therapeutics | Regulatory United Therapeutics Announces FDA Approval Of Updated Label For Orenitram Reflecting Results Of FREEDOM-EV Study unither.com ↗
The FDA-approved labeling has now been updated to indicate that Orenitram delays disease progression when used in conjunction with an approved oral background PAH therapy. |
| 2019-09-11 | United Therapeutics | Regulatory United Therapeutics Announces FDA Acceptance Of Trevyent New Drug Application For Review unither.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH). |
| 2019-06-05 | Liquidia Technologies, Inc. | Results Liquidia Announces Clinical Update on INSPIRE; Targeting NDA Filing for LIQ861 in Late 2019 liquidia.com ↗
Post-hoc analysis showed that plasma levels of treprostinil were tightly correlated to the LIQ861 dose delivered. |
| 2019-04-03 | Liquidia Technologies, Inc. | Results Liquidia Technologies Presents Phase 3 Trial Data for LIQ861 at the ISHLT 39th Annual Meeting & Scientific Sessions liquidia.com ↗
Liquidia Technologies, Inc. (Nasdaq: LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of LIQ861, announced today additional detailed safety and exploratory endpoint findings at the two-month timepoint for the Phase 3 INSPIRE trial. |
| 2019-03-11 | Liquidia Technologies, Inc. | Results Liquidia’s LIQ861 Meets Primary Endpoint in Pivotal Phase 3 INSPIRE Study in Patients with Pulmonary Arterial Hypertension liquidia.com ↗
Initial analysis indicates the study has met its primary endpoint of safety and tolerability of LIQ861 at the two-month timepoint. |
| 2019-01-31 | United Therapeutics | Results Survival Data From FREEDOM-EV Study of Orenitram Presented at the Pulmonary Vascular Research Institute Annual World Congress unither.com ↗
Orenitram decreased the risk of adjudicated clinical worsening events by 26% compared to placebo (p=0.0391). |
| 2019-01-07 | Liquidia Technologies, Inc. | Results Liquidia Technologies Reports Positive Interim LIQ861 Safety Data on 109 Patients from Pivotal INSPIRE Trial liquidia.com ↗
LIQ861 was observed to be well-tolerated at the two-week timepoint in PAH patients. |
| 2018-08-08 | United Therapeutics | Results United Therapeutics Announces FREEDOM-EV Study Of Orenitram Meets Primary Endpoint unither.com ↗
today announced that preliminary analysis indicates that the FREEDOM-EV clinical study of Orenitram® (treprostinil) extended-release tablets in patients suffering from pulmonary arterial hypertension (PAH) has met its primary endpoint of delayed time to first clinical worsening event. |
| 2018-07-31 | United Therapeutics | Regulatory United Therapeutics Announces FDA Approval Of The Implantable System For Remodulin® unither.com ↗
today announced approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for the use of Remodulin (treprostinil) Injection in the Implantable System for Remodulin® (ISR). |
| 2018-06-07 | Mannkind Corporation | Results MannKind Successfully Completes Phase 1 Trial of Treprostinil Technosphere for Pulmonary Arterial Hypertension Advancing Development to Next Phase mannkindcorp.com ↗ |
| 2018-05-31 | Camurus AB | Results Camurus announces positive topline results from Phase 1 study of long-acting treprostinil for the treatment of pulmonary arterial hypertension camurus.com ↗
Results from the study showed that CAM2043 provided a dose-proportional treprostinil plasma exposure and release profile suitable for weekly, or less frequent, dosing. |
| 2018-01-25 | Liquidia Technologies, Inc. | Results Liquidia Presents Positive LIQ861 Results at the Annual World Congress of the Pulmonary Vascular Research Institute liquidia.com ↗
LIQ861 was well-tolerated at all doses tested, with a proportional dose response in pharmacokinetics. |
| 2017-10-23 | United Therapeutics | Regulatory United Therapeutics Announces FDA Approval Of Third Generation Nebulizer For The Tyvaso® Inhalation System unither.com ↗
today announced approval by the U.S. Food and Drug Administration (FDA) of a new inhalation device, called the TD-300/A, for use with Tyvaso® (treprostinil) Inhalation Solution (Tyvaso). |
| 2016-02-18 | United Therapeutics | Regulatory United Therapeutics Receives Paragraph IV Notice Letter For Orenitram unither.com ↗
United Therapeutics Corporation (NASDAQ: UTHR) announced receipt of a Paragraph IV Certification Notice Letter on February 18, 2016 from Actavis Laboratories FL, Inc. (Actavis) advising that Actavis has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting approval to market a generic version of the 2.5 mg strength of Orenitram® (treprostinil) Extended-Release Tablets. |
All press releases naming this drug 119 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 119 releases opens the full record — a long page | ||
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 104 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | treprostinil | “This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous...” NCT01588405 ↗90“The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release \[SR\] tablets) to...” NCT01477333 ↗ “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...” NCT00760916 ↗ “Remodulin (treprostinil sodium), a prostacyclin analog, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo.” NCT00458042 ↗ “Treprostinil diolamine (oral treprostinil) is an orally available prostacyclin analog that was developed for the treatment of pulmonary arterial hypertension.” PMID 24603117 ↗ Mar 2014 “Treprostinil is a stable prostacyclin analog approved for the treatment of pulmonary arterial hypertension (PAH) as parenteral or inhaled therapy.” PMID 23669822 ↗ Sep 2013 “Liposomal Treprostinil Inhalation Suspension (L606)” NCT04691154 ↗ |
| Known as | iTRE | “evaluated the safety and efficacy of inhaled treprostinil (iTRE) in this patient population.” PMID 38811045 ↗ Jun 2024 |
| Known as | L606 | “The primary objective of this study is to evaluate the Pharmacokinetics, Safety and Tolerability of L606 (Liposomal Treprostinil) Inhalation Solution in Single Ascending Dose...” NCT04041648 ↗ |
| Known as | LIQ861 | “This study will look at safety and tolerability of LIQ861 (treprostinil) inhalation powder in adults with pulmonary arterial hypertension (PAH, WHO Group 1) who switch from...” NCT07759804 ↗2“Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients” NCT03992755 ↗ “inhaled dry powder treprostinil (LIQ861)” NCT03884465 ↗ |
| Known as | Remodulin | “Remodulin (treprostinil sodium), a prostacyclin analog, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo.” NCT00458042 ↗8“Remodulin® (treprostinil sodium), a stable analogue of prostacyclin” NCT00643604 ↗ “Remodulin® (treprostinil sodium) Injection” NCT00060996 ↗ “Remodulin (treprostinil sodium) Injection” NCT00067041 ↗ “Remodulin (treprostinil sodium)” NCT00494533 ↗ |
| Known as | treprostinil diethanolamine | “A Randomized, Single-Center, Placebo Controlled Study To Assess the Safety of UT-15C (Treprostinil Diethanolamine) Sustained Release (SR) in Patients Undergoing an...” NCT00651885 ↗4“A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral...” NCT01172496 ↗ “This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma.” NCT00775463 ↗ “Oral UT-15C (Treprostinil Diethanolamine)SR Tablets” NCT00445159 ↗ “UT-15C SR (treprostinil diethanolamine)” NCT01131845 ↗ |
| Known as | treprostinil diolamine | “METHODS: We examined 19 circulating vascular, angiogenic, and inflammatory biomarkers in 124 patients with scleroderma and DU who participated in a randomized controlled trial...” PMID 31858338 ↗ Dec 20191“UT-15C (treprostinil diolamine)” NCT01560637 ↗ |
| Known as | Treprostinil sodium | “Generic treprostinil sodium + Standard of Care (Double Oral)” NCT06317805 ↗8“Remodulin® (treprostinil sodium) Injection” NCT00060996 ↗ “Remodulin (treprostinil sodium) Injection” NCT00067041 ↗ “Remodulin (treprostinil sodium)” NCT00494533 ↗ “Drug: Treprostinil sodium” NCT01416636 ↗ |
| Known as | Tyvaso | “Participants will receive inhaled Treprostinil (Tyvaso nebulizer), 6 µg per breath, administered four times daily for 4 weeks.” NCT07037836 ↗3“Participants receive inhaled treprostinil (Tyvaso) in addition to standard disease-specific care.” NCT07837830 ↗ “Tyvaso (treprostinil) inhalation solution” NCT01477333 ↗ |
| Known as | Tyvaso DPI | “BREEZE: Open-label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension.” PMID 35514770 ↗ Apr 2022 |
| Known as | UT-15 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00004497 ↗ |
| Known as | UT-15C | “A Randomized, Single-Center, Placebo Controlled Study To Assess the Safety of UT-15C (Treprostinil Diethanolamine) Sustained Release (SR) in Patients Undergoing an...” NCT00651885 ↗9“This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have...” NCT01560637 ↗ “A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral...” NCT01172496 ↗ “This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma.” NCT00775463 ↗ “Oral treprostinil (UT-15C), a synthetic prostacyclin analog that inhibits platelet aggregation, induces vasodilation, and suppresses smooth muscle proliferation.” NCT02583789 ↗ “Oral treprostinil (UT-15C) Sustained Release Tablets” NCT00325403 ↗ “Oral treprostinil (UT-15C) sustained release tablets” NCT07112183 ↗ “Oral treprostinil (UT-15C) sustained release tablets” NCT00325442 ↗ “randomized (1:1 oral treprostinil (UT-15C): placebo)” NCT01560624 ↗ “Oral UT-15C (Treprostinil Diethanolamine)SR Tablets” NCT00445159 ↗ |
| Known as | UT-15C SR | “This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203,...” NCT01027949 ↗2“A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral...” NCT01172496 ↗ “UT-15C SR (treprostinil diethanolamine)” NCT01131845 ↗ |
| Known as | UT-15C sustained release (SR) | “This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous...” NCT01588405 ↗ |
| Modality | Other / unclassified | “a prostacyclin analog” NCT00458042 ↗ |
| Route | Subcutaneous | “continuous subcutaneous infusion of either UT-15 or placebo for 12 weeks” NCT00004497 ↗ |