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A Phase 3 Study of the Safety of Trogarzo Administered as an Undiluted "IV Push" Over a Reduced Interval in Clinically Stable HIV-1 Infected Trogarzo Experienced Patients

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Trial Profile

A Phase 3 Study of the Safety of Trogarzo Administered as an Undiluted "IV Push" Over a Reduced Interval in Clinically Stable HIV-1 Infected Trogarzo Experienced Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Oct 2025

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At a glance

  • Drugs Ibalizumab (Primary) ; Ibalizumab (Primary) ; Ibalizumab
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors TaiMed Biologics

Most Recent Events

  • 08 Sep 2025 Number of treatment arms increased from 3 to 5 by the addition of 2 more experimental arms. Primary end-points are updated to remove 4 PJ and 1 safety primary end-points.
  • 06 Mar 2024 Results assessing the safety and efficacy of IV and IM administration of Ibalizumab for the treatment of HIV-1 infection in heavily treatment experienced (HTE) people with HIV, presented at the 31st Conference on Retroviruses and Opportunistic Infections 2024
  • 28 Feb 2024 According to a Theratechnologies media release, the FDA has issued a refusal to file letter (RTF) to a supplemental Biologics License Application (sBLA) filed by Theratechnologies Inc. for an intramuscular (IM) method of administration for maintenance dosing of Trogarzo (ibalizumab-uiyk). The RTF followed a preliminary review of sBLA by FDA, which found that application did not include data agency required to establish a pharmacokinetic bridge between IM and IV administration.

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