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A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

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Trial Profile

A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

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

Latest Information Update: 29 Jul 2026

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At a glance

  • Drugs Anifrolumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms TULIP-SC
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 27 Apr 2026 Results presented in the AstraZeneca media release.
  • 27 Apr 2026 According to an AstraZeneca media release, based on the data from the trial the U.S FDA has approved anifrolumab-fnia in the US for self-administration as a once-weekly autoinjector, the SAPHNELO Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.
  • 13 Apr 2026 According to an AstraZeneca Canada media release, Health Canada has granted a Notice of Compliance (NOC) for Saphnelo (anifrolumab injection) for subcutaneous self-administration via a single-use autoinjector for adult patients with active, autoantibody positive systemic lupus erythematosus (SLE) in addition to standard therapy. The approval by Health Canada was based on positive results from the interim analysis of the Phase III TULIP-SC trial.

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