Axsome Therapeutics, Inc.

Axsome Therapeutics is a clinical-stage biopharmaceutical company whose product development pipeline relies on animal testing as a standard component of regulatory compliance. The company’s public filings and regulatory submissions explicitly reference conducting animal studies as part of the preclinical testing required for FDA approval. For example, the prescribing information for its approved drug AUVELITY includes warnings based on findings from animal studies, and FDA review documents for its product AXS-05 detail specific repeat-dose toxicity studies in mice.

This reliance on animal testing is inherent to its business model of developing central nervous system therapeutics. The company’s annual reports state that its drug candidates must undergo preclinical laboratory tests and animal studies in accordance with FDA Good Laboratory Practice regulations. While the available evidence does not specify the scale or internal protocols of Axsome’s animal testing, its regulatory filings confirm that animal data is a foundational element of its product development and submission process.