Ralinepag XR is a Small Molecule owned by United Therapeutics, and is involved in 11 clinical trials, of which 7 were completed, and 4 are ongoing.

Ralinepag (APD-811) acts as PGI2 receptor agonist. The drug candidate binds to the prostacyclin receptor (IP) located on the surface of platelets and vascular smooth muscle cells. The IP receptor is a G-protein coupled receptor that upon activation by drug candidate, stimulates the formation of cyclic adenosine monophosphate (cAMP). Prostacyclin counteracts the vasoconstrictor and pro-thrombotic activity of endothelin. The drug candidate by agonizing PGI2 receptor regulates vascular smooth muscle tone and thereby slows disease progression and improves exercise tolerance in PAH patients.

The revenue for Ralinepag XR is expected to reach a total of $6.7bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ralinepag XR NPV Report.

Ralinepag XR was originated by Arena Pharmaceuticals and is currently owned by United Therapeutics. Everest Medicines is the other company associated in development or marketing of Ralinepag XR.

Ralinepag XR Overview

Ralinepag (APD-811) is under development for the treatment of pulmonary arterial hypertension (PAH). It is a next-generation drug that is administered through oral route. It acts by targeting PGI2 receptor. It is developed based on GPCR-based drug discovery technology.

United Therapeutics Overview

United Therapeutics develops and commercializes innovative pharmaceutical products for the treatment of cardiovascular disorders, particularly pulmonary arterial hypertension, and infectious diseases. The company’s products consist of prostacyclin analogues including Remodulin (treprostinil) injection; Tyvaso (treprostinil) inhalation solution; and Orenitram (treprostinil). Adcirca (tadalafil) is a phosphodiesterase type 5 (PDE-5) inhibitor and Unituxin (dinutuximab), a monoclonal antibody for oncologic applications, are the other products. Its product candidates include monoclonal antibodies (mAbs), glycobiology antiviral agents and cell-based therapies. The company also develops engineered lungs for transplantation in pre-clinical stage. It manufactures products in its facility in Silver Spring, Maryland. It markets its products in the US, Europe, South America and Israel. United Therapeutics is headquartered in Silver Spring, Maryland, the US.

The company reported revenues of (US Dollars) US$1,685.5 million for the fiscal year ended December 2021 (FY2021), an increase of 13.6% over FY2020. In FY2021, the company’s operating margin was 32.8%, compared to an operating margin of 39.3% in FY2020. In FY2021, the company recorded a net margin of 28.2%, compared to a net margin of 34.7% in FY2020. The company reported revenues of US$516 million for the third quarter ended September 2022, an increase of 10.5% over the previous quarter.

Quick View – Ralinepag XR

Report Segments
  • Innovator
Drug Name
  • Ralinepag XR
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
Key Companies
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.