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A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Phase III Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Phase III Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2025

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At a glance

  • Drugs Siltartoxatug (Primary) ; Tetanus immune globulin
  • Indications Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors Trinomab Biotech; Zhuhai Trinomab Pharmaceutical

Most Recent Events

  • 01 Dec 2025 According to the Zhuhai Trinomab Pharmaceutical media release, approved for marketing through the priority review and approval procedure by China NMPA. This product is indicated for emergency prophylaxis of tetanus in adults.It is a recombinant anti-tetanus toxin monoclonal antibody, which provides passive immunity primarily by binding to the AB fragment of tetanus toxin.
  • 20 Nov 2025 According to Trinomab Pharmaceuticalmedia release, Trinomab Biotech has changed its name to Zhuhai Trinomab Pharmaceuticals.
  • 01 Aug 2025 Primary endpoint (Proportion of participants with an increase of anti-tetanus neutralizing antibody titers ( titers) over protective level) has been met, as per results published in the Nature Medicine.

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