Recent Updates
Recently added Catalysts

UT-15C

Phase 3

Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |United Therapeutics Corporation|Last Updated: Jan 3, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment551
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01560637An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionPHASE3 COMPLETED 471Sep 11, 2013Aug 12, 2021Jun 2, 2022153 United States, Argentina +21
NCT01934582A Pharmacokinetic Substudy of the TDE-PH-304 ProtocolPHASE3 COMPLETED 13Aug 1, 2013Nov 1, 2013Jan 3, 20241 United States
NCT01588405Remodulin® to Oral Treprostinil TransitionPHASE2 COMPLETED 33Apr 1, 2012Dec 1, 2014May 16, 20166 United States
NCT01477333Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®PHASE2 COMPLETED 18Oct 1, 2011Nov 1, 2013Dec 27, 20236 United States
NCT01131845The Effect of Renal Impairment on the Pharmacokinetics of Oral TreprostinilPHASE1 COMPLETED 16May 1, 2010Sep 1, 2010May 17, 20121 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Adverse Events
Participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years

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.

To Assess the Pharmacokinetics (Mean AM Dose) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).
Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)

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.

To Assess the Pharmacokinetics (Cmax, Cmin) in Subjects During BID Dosing (up to 14 Days Prior to Transitioning to TID Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing Regiment (PK Visit 2)
Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)

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.

To Assess the Pharmacokinetics (AUClast) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose at up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and at up to 35 days after transitioning to TID dosing regiment (PK Visit 2)

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.

Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.
Up to 24 weeks

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.

Change in Hemodynamic Parameters From Baseline to Week 24.
Baseline and 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).

Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24.
Baseline and Week 24

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.

Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24.
Baseline and 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 arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2).

Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24.
Baseline and 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.

Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24.
Baseline and 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 cardiac index (CI).

Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24.
Baseline and 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: pulmonary vascular resistance index (PVRI).

Treprostinil pharmacokinetics in volunteers with varying degrees of renal function following a single oral dose of a 1 mg treprostinil diethanolamine sustained release.
48hrs post dose (60 hours for ESRD)
Secondary Endpoints
Change in 6-Minute Walk Distance From Baseline
Baseline to Week 48
Change in Borg Dyspnea Score From Baseline to Week 48
Baseline to Week 48
Change From Baseline to Week 48 in WHO Functional Class
Baseline to Week 48
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
UT-15CEXPERIMENTALOpen label access
Open label extensionEXPERIMENTAL -
UT-15C SREXPERIMENTAL -
UT-15C SR BIDEXPERIMENTALInitiated at 0.125 mg twice daily (BID), titrated as clinically indicated.
Treprostinil diethanolamineEXPERIMENTAL -
Interventions
NameTypeDescription
UT-15C (treprostinil diolamine)DRUGUT-15C extended release oral tablet three times daily
UT-15C SRDRUG -
treprostinil diethanolamineDRUGOpen label study drug.
Tyvaso Inhalation SolutionDRUGAdministered as at least 9 breaths 4 times daily for at least 4 weeks prior to Baseline
UT-15C SR (treprostinil diethanolamine)DRUGSingle dose, 1 mg UT-15C SR
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites153

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 ...

Countries:United StatesArgentinaAustraliaAustriaBrazilCanadaChileChinaDenmarkFranceGermanyGreeceIndiaIsraelItalyMexicoNetherlandsPolandSingaporeSouth KoreaSwedenTaiwanUnited Kingdom
Unlock Eligibility Criteria