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Also known as Ralinepag
APD811 · 4 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).
Measurements of PVR from right heart catheterization were obtained prior to Day 1 of the dose titration period and at the end of the maintenance period (Week 22), approximately 4 hours after the last dose of study drug.
The 6MWT was conducted according to the modified guidelines issued by the American Thoracic Society prior to Day 1 of the dose titration period and at the end of the maintenance period (Week 22).
| 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. |
| APD811 | EXPERIMENTAL | Multiple dose titration to maximum tolerated dose. |
| Name | Type | Description |
|---|---|---|
| Ralinepag | DRUG | Active |
| Placebo | DRUG | Placebo |
| APD811 | DRUG | - |
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...
Top 13 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| 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 |
| Johnson & Johnson | JNJ | 4 | PHASE3 | selexipag, Macitentan |
| 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 |
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | HS235 |
APD811 is being developed for the treatment of pulmonary arterial hypertension, a condition characterized by high blood pressure in the arteries of the lungs. It is an investigational small molecule therapy from United Therapeutics Corporation and has not been approved for any indication.
APD811 is being developed by United Therapeutics Corporation, a biotechnology company traded on the Nasdaq under the ticker symbol UTHR. The company is responsible for the clinical development and regulatory strategy for this investigational therapy.
APD811 is in the NDA/BLA stage, meaning United Therapeutics has submitted or is preparing a New Drug Application or Biologics License Application for regulatory review. The drug has completed a Phase 2 clinical trial and is not yet approved.
APD811 has been studied in one completed Phase 2 clinical trial, NCT02279160, titled "Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension." The trial enrolled 61 participants across the United States, Australia, Bulgaria, Czechia, Hungary, Poland, Romania, Serbia, and Spain.
No, APD811 is not FDA approved. It is an investigational drug currently in the NDA/BLA stage of development. United Therapeutics has not received marketing authorization for APD811 for any indication, including pulmonary arterial hypertension.