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:

Outcomes Trial

Advanced outcomes
Time to Clinical Event (TtCE)


Exercise Capacity Trials

Advanced capacity
Peak Oxygen Uptake (CPET)


Advanced endurance
6-Minute Walk Distance (6MWD)


Visit https://clinicaltrials.gov/ for more information or http://advanceclinicalstudies.com for ADVANCE OUTCOMES.

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.