Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APD811 · 1 trial · 1 indication
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 |
|---|---|---|
| APD811 | EXPERIMENTAL | Multiple dose titration to maximum tolerated dose. |
| Placebo | PLACEBO_COMPARATOR | Multiple dose titration to maximum tolerated dose. |
| Name | Type | Description |
|---|---|---|
| APD811 | DRUG | - |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Males or females aged 18-75 years, inclusive * Symptomatic WHO Group 1 PAH classified by one of the following subgroups: * Idiopathic pulmonary arterial hypertension (IPAH); * Heritable pulmonary arterial hypertension (HPAH); * Drugs and toxins induced; * Associated p...
| 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 |
APD811 is an investigational small molecule being developed for the treatment of Pulmonary Arterial Hypertension (PAH), a form of high blood pressure in the arteries of the lungs. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
APD811 is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for Pulmonary Arterial Hypertension.
APD811 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is not yet available as a marketed therapy for Pulmonary Arterial Hypertension.
APD811 has one completed Phase 2 clinical trial registered as NCT02279160, titled 'Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension.' The trial enrolled 61 participants and was conducted in the United States, Australia, Bulgaria, Czechia, Hungary, Poland, Romania, Serbia, and Spain.
APD811 is the investigational name for this compound developed by United Therapeutics. No alternative names have been reported for this drug in the available clinical trial information. It is distinct from other PAH therapies and is being studied as a potential new treatment option.