Drug Candidate for Treatment of Pulmonary Arterial Hypertension
Ralinepag (APD811) is a next-generation, oral, selective potent, once-daily IP receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). Arena discovered and developed this drug candidate internally. Ralinepag’s potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life, support its application as a potentially best-in-class agent for the treatment of PAH.
Ralinepag is an investigational compound that is not approved for any use in any country.
About Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) is a rare, chronic, progressive, life-threatening disorder characterized by increased pressure in the arteries that carry blood from the heart to the lungs. The increased pressure strains the heart, which can limit physical activity, result in heart failure and reduce life expectancy. Current treatment of PAH falls within four distinct therapeutic classes: endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE-5) inhibitors, prostacyclin analogues and soluble guanylate cyclase (SGc) stimulators. The available therapies have positive effects in PAH, but they do not provide a cure, and in many patients the disease will progress despite treatment.
Following the positive results received in our randomized, double-blind, placebo-controlled Phase 2 clinical trial, Arena has initiated the Phase 3 ADVANCE program.
The comprehensive Phase 3 ADVANCE program is designed to fully elucidate the potentially best-in-class efficacy and safety profile of ralinepag. The program consists of 2 main components to be conducted in 3 trials:
Exercise Capacity Trials
Peak Oxygen Uptake (CPET)
6-Minute Walk Distance (6MWD)
|Drug Candidate||Disease Area||Target||Status||Retained Rights|
|Ralinepag (APD811)||Pulmonary Arterial Hypertension||IP Receptor Agonist||Phase 3 Ongoing||Worldwide, excluding rights granted to Everest Medicines for Greater China & certain other Asian territories|
|Drug Candidate||Ralinepag (APD811)|
|Disease Area||Pulmonary Arterial Hypertension|
|Target||IP Receptor Agonist|
|Status||Phase 3 Ongoing|
|Retained Rights||Worldwide, excluding rights granted to Everest Medicines for Greater China & certain other Asian territories|
Ralinepag has not been approved by the US Food and Drug Administration or any other regulatory agency.