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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: 07 May 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

  • 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.
  • 03 Feb 2026 According to AstraZeneca media release, decision from the FDA on the updated application for Saphnelo SC is expected in the first half of 2026.
  • 03 Feb 2026 According to AstraZeneca media release, US Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo (anifrolumab) SC in adult patients with systemic lupus erythematosus (SLE). AstraZeneca subsequently provided the information requested in the CRL and is committed to working with the FDA to progress the application as quickly as possible.

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