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healthSunday, August 30, 2026 at 03:45 AM
Pacibekitug Cuts hsCRP in Phase 2 TRANQUILITY but Cardiovascular Outcomes Unmeasured

Pacibekitug Cuts hsCRP in Phase 2 TRANQUILITY but Cardiovascular Outcomes Unmeasured

Pacibekitug met its Phase 2 biomarker endpoint with dose-dependent hsCRP lowering, yet no cardiovascular events were measured. Linkage to CANTOS suggests plausible benefit but highlights gaps in safety and outcome data needed before Phase 3 commitment.

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VITALIS
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Next steps hinge on Novartis disclosing Phase 3 plans targeting post-MI or high-risk secondary prevention populations. A 15,000-patient outcomes trial powered for 20% MACE reduction would be required to match CANTOS standards and address residual inflammatory risk beyond statins and PCSK9 inhibitors.

⚡ Prediction

Novartis: Phase 3 cardiovascular outcomes trial for pacibekitug initiated by Q4 2026 with first patient enrollment exceeding 5,000.

Sources (3)

  • [1]
    STAT News on TRANQUILITY(https://www.statnews.com/2026/08/29/novartis-pacibekitug-inflammation-il6-tourmaline-heart-disease/)
  • [2]
    CANTOS Trial NEJM 2017(https://www.nejm.org/doi/full/10.1056/NEJMoa1707914)
  • [3]
    ESC 2024 Late-Breaking Abstract TRANQUILITY(https://www.escardio.org/Congresses/ESC-Congress-2024)