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A bioequivalence study assessing the new formulation F8 compared to the original formulation F1 of tesamorelin

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Trial Profile

A bioequivalence study assessing the new formulation F8 compared to the original formulation F1 of tesamorelin

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Apr 2025

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At a glance

  • Drugs Tesamorelin (Primary)
  • Indications HIV-associated lipodystrophy syndrome
  • Focus Pharmacokinetics

Most Recent Events

  • 08 Apr 2025 According to a Theratechnologies media release, the U.S. Food and Drug Administration (FDA) has approved the Company's Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV (tesamorelin for injection).
  • 26 Nov 2024 According to a Theratechnologies media release, the company announced the resubmission of its sBLA to FDA for the F8 formulation of tesamorelin. The company has filed the resubmission to address concerns raised in the FDA's Complete Response Letter (CRL) to the initial F8 formulation sBLA filing. In the CRL, which was issued in January 2024, the FDA requested clarifications largely related to chemistry, manufacturing and controls (CMC), as well as further information on immunogenicity risk.
  • 06 Feb 2024 According to a Theratechnologies media release, the company has received the Complete Response Letter issued by the U.S. Food and Drug Administration in response to the Companys supplemental Biologics License Application for the F8 formulation of tesamorelin.

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