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With several pulmonary arterial hypertension (PAH) medicines already on the market, United Therapeutics is hoping to add ralinepag to the list after a Phase III readout showed the once-daily oral prostacyclin agonist significantly lowered the risk of clinical worsening events. The company plans to submit a filing to the FDA in the second half.The ADVANCE OUTCOMES trial enrolled 687 patients, most of whom were already receiving standard background therapy. Roughly 80% were on dual therapy, and 70% were classified as World Health Organization/New York Heart Association Functional Class II at baseline.Subjects randomised to ralinepag experienced a 55% reduction in the risk of the first adjudicated clinical worsening event versus placebo, meeting the primary endpoint. Clinical worsening was broadly defined as death, nonelective hospitalisation for worsening PAH, starting a parenteral or inhaled prostacyclin agent, disease progression, or unsatisfactory long-term response.Ralinepag works by activating prostacyclin receptors on pulmonary artery endothelial and smooth muscle cells to trigger downstream conversion of ATP to cAMP. United says ralinepag is six to eight times more potent at increasing cAMP levels than the active metabolite of Johnson & Johnson's Uptravi (selexipag). That elevated intracellular cAMP acts on pathways implicated in PAH progression to promote vasodilation and inhibit vascular remodeling, according to the company."It binds the [prostacyclin] receptor very tightly and has a really long half-life," noted Leigh Peterson, head of product development, during the company's recent earnings call, "so this translates to the once-a-day dosing and potentially more tolerability."The drug succeeded on key secondary endpoints as well. At week 28, ralinepag increased the odds of achieving clinical improvement by 47% versus placebo, alongside statistically significant gains in six-minute walk distance and reductions in NT-proBNP, a biomarker of cardiac strain. Safety outcomes were in line with known prostacyclin-related adverse events, and no new safety signals emerged. Full details will be shared at an upcoming conference."With its extended-release profile and pharmacokinetic characteristics that mimic the steady-state exposure of parenteral therapy, ralinepag provides disease-mitigating capabilities that target underlying PAH pathology and achieve impressive clinical benefits," said Derek Solum, senior director of product development and global lead for ADVANCE OUTCOMES.United already has several PAH therapies in its portfolio that vary by route and mechanism. These include drugs based on the synthetic prostacyclin analogue treprostinil; namely, Remodulin, given by infusion; Tyvaso, via dry-powder inhaler; and oral Orenitram. It also markets Adcirca (tadalafil), an oral PDE5 inhibitor for PAH.If approved, ralinepag would enter a market that has been reshaped by Merck & Co.'s Winrevair (sotatercept), an injectable activin signaling inhibitor whose sales have gone from $419 million in 2024 to $1.4 billion last year (see – Spotlight On: Merck & Co.'s fastest selling drugs in 2025 and Physician Views Results: Merck & Co.'s Winrevair set to move upstream).

MONDAY, March 2, 2026 — A chocolate male enhancement product is being pulled from store shelves after federal health officials found it contains a hidden prescription drug. The company — USALESS.COM , based in Brooklyn, New York — is recalling its product called Rhino Choco VIP 10X, according to an alert from the U.S. Food and Drug Administration (FDA). Testing found the supplement contains Tadalafil , the active ingredient in the prescription drug Cialis , which is used to treat erectile dysfunction . The drug was not listed on the product’s label. The recall pertains to the company’s 10-gram, 12-piece chocolate supplement, sold in a black box with an expiration date of October 2027. The product was sold online and in retail stores. Tadalafil can be dangerous for some people. It may interact with nitrate medications and could “lower blood pressure to dangerous levels,” the FDA said. People with diabetes , high blood pressure, high cholesterol or heart disease often take nitrate medications, which makes the hidden ingredient especially risky. "The product has been immediately removed from our online store until we are certain that the problem has been corrected," USALESS.com said. Folks who purchased the product are being asked to stop using it and return it to the store for a full refund. This is not the first warning about similar products. In 2018, the FDA advised consumers not to buy or use “Rhino”-branded male enhancement products after reports of hidden drugs and health problems. Consumers with questions may call 800-872-5377 or send email to 409749@email4pr.com. Sources U.S. Food and Drug Administration, Feb. 27, 2026