Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UT-15C · 9 trials · 4 indications
All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final visit. The overall summary of AEs includes the number of subjects with any AE, the number of subjects with any study drug-related AEs, the number of subjects with AEs leading to study drug withdrawal, the number of subjects with any serious AEs, the number of subjects with any severe AEs, and the number of subjects with any study drug-related severe/serious AEs. AEs were coded using the Medical Dictionary for Regulatory Activities.
The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.
The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.
The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.
Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current 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 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies).
Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm).
Heart rate was assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2).
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included cardiac index (CI).
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: pulmonary vascular resistance index (PVRI).
The effects of 12-week treatment with different doses of UT-15C on peak TPRI during exercise will be evaluated by comparing the change from Baseline to Week 12 at peak wattage on a pairwise basis between treatment groups. The primary measure of efficacy was the change from Baseline to Week 12 in peak TPRI during exercise assessed 3 to 6 hours after the subject's morning dose of UT-15C to obtain measurements at peak concentrations of treprostinil. The equation used to determine the Total Pulmonary Resistance Index (TPRI) (mmHg/\[L/min/m\^2\]) is Mean Pulmonary Artery Pressure (PAPm)/ Cardiac Index (CI).
Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2
| Arm | Type | Description |
|---|---|---|
| UT-15C | EXPERIMENTAL | Open label access |
| Open label extension | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Identical placebo tablets to UT-15C, doses were titrated in the same manner |
| UT-15C SR | EXPERIMENTAL | Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID. |
| UT-15C SR BID | EXPERIMENTAL | Initiated at 0.125 mg twice daily (BID), titrated as clinically indicated. |
| Dose Group 1 | ACTIVE_COMPARATOR | UT-15C 0.25 mg twice daily |
| Dose Group 2 | ACTIVE_COMPARATOR | UT-15C 1.25 mg twice daily |
| Dose Group 3 | ACTIVE_COMPARATOR | UT-15C individual Maximum Tolerated Dose |
| Comparison 1 | ACTIVE_COMPARATOR | UT-15C 1 mg alone |
| Comparison 2 | ACTIVE_COMPARATOR | UT-15C 1 mg plus ethanol (simultaneously) |
| Comparison 3 | ACTIVE_COMPARATOR | UT-15C 1 mg administered 1 hour before ethanol |
| Comparison 4 | ACTIVE_COMPARATOR | UT-15C 1 mg administered 1 hour after ethanol |
| Treprostinil diethanolamine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| UT-15C (treprostinil diolamine) | DRUG | UT-15C extended release oral tablet three times daily |
| UT-15C SR | DRUG | - |
| treprostinil diethanolamine | DRUG | Open label study drug. |
| Placebo | DRUG | - |
| Tyvaso Inhalation Solution | DRUG | Administered as at least 9 breaths 4 times daily for at least 4 weeks prior to Baseline |
| UT-15C | DRUG | oral |
| ethanol | OTHER | Absolut 100 vodka |
| UT-15C SR (treprostinil diethanolamine) | DRUG | Single dose, 1 mg UT-15C SR |
Inclusion Criteria: * Participated in United Therapeutics Study TDE-PH-310 * All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag |
| Merck & Co., Inc. | MRK | 6 | PHASE3 | Riociguat |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Johnson & Johnson | JNJ | 4 | PHASE3 | Selexipag |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | TNX-103 |
| Inhibikase Therapeutics, Inc. | IKT | 1 | PHASE3 | IKT-001 |
| Gossamer Bio, Inc. | GOSS | 2 | PHASE3 | Seralutinib |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| Tectonic Therapeutic Inc | TECX | 1 | PHASE2 | TX000045- Dose A, TX000045- Dose B |
| Abbott Laboratories | ABT | 1 | N/A | Undisclosed |
UT-15C is an investigational oral small molecule being studied for pulmonary arterial hypertension (PAH), pulmonary hypertension, and in healthy volunteers. It is a sustained-release formulation of treprostinil, a prostacyclin analog. UT-15C is in clinical development by United Therapeutics Corporation and is not yet approved.
UT-15C is a sustained-release oral formulation of treprostinil, a prostacyclin analog. Treprostinil works by mimicking prostacyclin, a naturally occurring molecule that dilates pulmonary arteries and inhibits platelet aggregation. This mechanism helps reduce pulmonary arterial pressure in patients with pulmonary arterial hypertension.
UT-15C is developed by United Therapeutics Corporation, a biotechnology company traded on NASDAQ under the ticker UTHR. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with pulmonary arterial hypertension and in healthy volunteers.
UT-15C is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. Completed trials include Phase 1 pharmacokinetic studies and a Phase 2 study, but the drug remains in early-stage clinical development.
UT-15C has been studied in several completed clinical trials. NCT01131845 evaluated the effect of renal impairment on oral treprostinil pharmacokinetics. NCT01477333 studied adding UT-15C SR to PAH patients receiving Tyvaso. NCT01746485 examined three times daily dosing, and NCT02318758 assessed interaction with ethanol in healthy volunteers.
UT-15C is a sustained-release oral formulation of treprostinil. The drug's active ingredient is treprostinil, which is also the active ingredient in other formulations. UT-15C is designed for oral administration with sustained release properties, distinguishing it from other treprostinil products.