In Q1 2025, United Therapeutics launched a Phase 3 clinical trial (NCT06237096) to assess a novel implantable system for delivering treprostinil (Remodulin) in patients with pulmonary arterial hypertension (PAH). This open-label, single-arm study seeks to evaluate the safety, tolerability, and mechanical durability of the implantable pump over a 52-week period. The trial will enroll approximately 150 adult participants, marking a strategic effort to improve patient convenience and reduce complications associated with traditional external infusion pumps, such as site infections and mechanical malfunctions. The study follows promising earlier-phase results showing improved patient satisfaction and reduced hospital visits. If successful, this delivery system could extend the market viability of Remodulin by addressing one of the drug’s primary limitations—its burdensome administration. Given increasing competition from oral and inhaled therapies, an implantable formulation could reposition Remodulin as a viable long-term treatment choice, particularly for patients requiring consistent prostacyclin delivery without the drawbacks of external hardware.
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Citation: https://clinicaltrials.gov/study/NCT06237096
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Implications: The launch of this trial signals an effort by United Therapeutics to defend and enhance its Remodulin franchise against oral and combination competitors. If successful, the implantable system could reduce dropout rates and improve quality-of-life metrics, key endpoints in payer negotiations.