ArticleAdvances in pharmacological and pharmaceutical sciences2026
Regulatory-Driven Pharmacokinetic and Immunogenicity Study of Siltartoxatug, a Recombinant Native Human Monoclonal Antibody Against Tetanus Toxin, in Cynomolgus Monkeys.
Article in Advances in pharmacological and pharmaceutical sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Siltartoxatug-developed by Trinomab Pharmaceutical Co., Ltd., using its proprietary HitmAb® platform-is the first-in-class recombinant monoclonal antibody drug for urgent prophylaxis of tetanus approved by China National Medical Products Administration in February 2025, which addresses the critical unmet need to substitute blood-derived passive immunization preparations for prevention of tetanus. The nonclinical pharmacokinetic and immunogenicity study of siltartoxatug was designed and conducted in strict compliance with global regulatory guidelines for initiating the first-in-human clinical trials. Herein, we report the comprehensive findings from this study. Twenty-four naive cynomolgus monkeys (
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