Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ralinepag · 3 trials · 11 indications
The safety and tolerability of ralinepag will be evaluated by the Number of subjects with treatment-emergent adverse events
Clinical worsening events are defined as death, nonelective hospital admission for worsening PAH (further defined in clinical study protocol), initiation of parenteral or inhaled prostacyclin pathway agent for treatment of worsening PAH, disease progression (further defined in clinical study protocol), or unsatisfactory long-term clinical response (further defined in clinical study protocol).
Pulmonary vascular resistance was collected by right heart catheterization (RHC).
Cardiac output was collected by right heart catheterization (RHC).
Cardiac index was collected by right heart catheterization (RHC).
Mean pulmonary arterial pressure was collected by right heart catheterization (RHC).
| Arm | Type | Description |
|---|---|---|
| Ralinepag | EXPERIMENTAL | Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablets (oral) |
| Oral Ralinepag | EXPERIMENTAL | Ralinepag immediate-release (IR) capsules of 10, 20, 30, 40, and 100 mcg or extended-release (XR) tablets of 50, 250, and 400 mcg for oral administration. |
| Name | Type | Description |
|---|---|---|
| Ralinepag | DRUG | Active |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 2. Subjects who are willing and able to comply with scheduled visits, treat...
Ralinepag is an investigational small molecule being developed for pulmonary arterial hypertension (PAH). It is designed to treat PAH by targeting the prostacyclin receptor. Ralinepag is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Ralinepag targets the prostacyclin receptor (PTGIR) and acts as an agonist. By activating this receptor, it aims to produce effects relevant to treating pulmonary arterial hypertension. The drug is being studied for its potential to improve treatment outcomes in PAH patients.
Ralinepag is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's efficacy and safety for pulmonary arterial hypertension.
Ralinepag is in Phase 3 clinical development for pulmonary arterial hypertension. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 3 program includes studies evaluating its efficacy, safety, and long-term outcomes.
Ralinepag has been studied in clinical trials including NCT02279745, a completed Phase 2 long-term safety and efficacy study, and NCT03626688, a completed Phase 3 efficacy and safety study. An open-label extension trial, NCT03683186, is enrolling by invitation to evaluate long-term safety and efficacy.
Ralinepag is a distinct investigational compound and is not known to be the same as any other marketed drug. It is a small molecule prostacyclin receptor agonist being developed specifically for pulmonary arterial hypertension, with no alternative names reported.