Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops critical care products, a sector that inherently relies on animal testing for regulatory compliance and product development. Its lead asset, Mino-Lok, is an antibiotic lock solution for catheter-related bloodstream infections that has undergone FDA review. The FDA's complete response letter in July 2023 required Citius to incorporate enhanced product testing, a process that typically includes preclinical animal studies to demonstrate safety and efficacy. As a clinical-stage biopharma company, its entire pipeline of repurposed and 505(b)(2) drugs would be subject to standard FDA-mandated animal testing protocols before advancing to human trials. The company's operations and funding are structured around this development model.

While specific, publicly disclosed details of Citius's animal testing protocols are not found in the provided evidence, the company's sector and regulatory pathway confirm its engagement in this practice. The business model of acquiring, developing, and commercializing therapies for serious conditions is fundamentally built on a preclinical research phase that utilizes animal models. This places the company within the scope of the animal_testing exclusion.