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Also known as Oral treprostinil (UT-15C) Sustained Release Tablets
treprostinil Sustained Release · 2 trials · 1 indication
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug. The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.
| Arm | Type | Description |
|---|---|---|
| UT-15C (oral treprositnil) | ACTIVE_COMPARATOR | Subjects receive UT-15C (oral treprostinil) twice daily. |
| Placebo | PLACEBO_COMPARATOR | Subjects receive placebo (sugar pill) twice daily. |
| Active | ACTIVE_COMPARATOR | Subjects assigned to active therapy with UT-15C 0.25, 0.5, 1, or 5 mg oral tablets. |
| Placebo Arm | PLACEBO_COMPARATOR | Subjects assigned to placebo 0.25, 0.5, 1, or 5 mg oral tablets. |
| Name | Type | Description |
|---|---|---|
| Oral treprostinil (UT-15C) Sustained Release Tablets | DRUG | Sustained release oral tablet, twice daily |
| Placebo | OTHER | Placebo oral tablet twice daily |
Inclusion Criteria: * Between 12 and 75 years of age, inclusive. * Body weight at least 40 kg with a Body Mass Index \< 45 * PAH that is either idiopathic/heritable; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; ass...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 5 | PHASE3 | selexipag, Macitentan |
| Merck & Co., Inc. | MRK | 8 | PHASE3 | Sotatercept, Riociguat, Frespaciguat |
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag, Tyvaso (treprostinil) |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606, LIQ861 Treprostinil, LIQ861 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | Levosimendan (TNX-103) |
| Inhibikase Therapeutics, Inc. | IKT | 2 | PHASE3 | IKT-001 |
| Roivant Sciences Ltd. | ROIV | 3 | PHASE3 | Mosliciguat |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Tectonic Therapeutic Inc | TECX | 2 | PHASE2 | TX45 |
| Gossamer Bio, Inc. | GOSS | 1 | PHASE3 | Seralutinib |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| IRulya Therapeutics Inc. | IRLA | 1 | PHASE2 | LAM-001 |
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | HS235 |
Treprostinil Sustained Release is an oral tablet being developed for the treatment of pulmonary hypertension, including pulmonary arterial hypertension (PAH). It is a small molecule prostacyclin receptor agonist. The Phase 3 program studied it both as monotherapy and in combination with an endothelin receptor antagonist and/or a phosphodiesterase-5 inhibitor.
Treprostinil Sustained Release targets PTGIR, the prostacyclin receptor. It acts as an agonist at this receptor, meaning it activates the receptor. PTGIR agonism is the mechanism of action for this sustained release oral formulation.
Treprostinil Sustained Release is developed by United Therapeutics Corporation, which trades under the ticker UTHR. The company is the sponsor of the clinical development program for this oral formulation.
Treprostinil Sustained Release is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trials have been completed, and no active trials are currently listed.
Treprostinil Sustained Release has been studied in two completed Phase 3 trials: FREEDOM-C (NCT00325442) and FREEDOM-M (NCT00325403). FREEDOM-C enrolled 354 patients and evaluated the drug in combination with an ERA and/or a PDE-5 inhibitor. FREEDOM-M enrolled 349 patients and evaluated it as monotherapy.
Yes, treprostinil Sustained Release is also known as oral treprostinil (UT-15C) sustained release tablets. These names refer to the same investigational oral formulation developed by United Therapeutics for pulmonary hypertension.