Study summary

A once-daily prostacyclin pill cut the risk of worsening by 55%

ADVANCE OUTCOMES trial (ralinepag) · Phase 3 · Topline March 2026; published July 2026, The Lancet; FDA filing planned 2026

55%lower risk of clinical worsening

What was tested

Ralinepag, a once-daily oral drug acting on the prostacyclin receptor (the same pathway as IV and inhaled treprostinil), against placebo, added to background therapy.

What they found

Risk of clinical worsening was 55% lower than with placebo (hazard ratio 0.45).
United Therapeutics planned an FDA application in the second half of 2026.

What it means

Could give an easier once-a-day pill option in a drug class often given by pump or inhaler.

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Last reviewed 2026-11-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.