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A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study

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Trial Profile

A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Jan 2026

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary) ; Anagrelide
  • Indications Essential thrombocythaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms SURPASS ET
  • Sponsors PharmaEssentia Corporation

Most Recent Events

  • 12 Jan 2026 According to a PharmaEssentia Corporation media release, The FDA's review of supplemental Biologics License Application to expand the ropeginterferon alfa-2b-njft (BESREMi) label to include patients with ET is ongoing.
  • 25 Dec 2025 According to a PharmaEssentia Corporation media release, based on positive head-to-head phase 3 results from this trial, the company has submitted a supplemental BLA seeking BESREMi label expansion for essential thrombocythemia (ET).
  • 24 Nov 2025 Results presented in the PharmaEssentia Corporation Media Release.

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