Citius Pharmaceuticals, a biopharmaceutical company focusing on critical care products, recently reported a productive Type C meeting with the U.S. Food and Drug Administration (FDA) regarding their Phase 3 clinical trial of Mino-Lok®. The meeting, held on November 25, 2024, centered on discussing the trial’s results in patients with central line-associated infections or catheter-related bloodstream infections, as well as laying out a pathway towards approval.
During the meeting, the FDA provided clear and actionable guidance to Citius Pharmaceuticals, emphasizing the support for a potential New Drug Application (NDA) submission for Mino-Lok. Discussions encompassed a broad spectrum of topics essential to the NDA process, including clinical efficacy and safety data, in-vitro testing, and regulatory considerations.
Mino-Lok is a novel antibiotic lock solution designed to treat patients with catheter-related bloodstream infections and offers an alternative to catheter removal. If approved, Mino-Lok could significantly reduce healthcare costs, mitigate patient risks, and enhance clinical outcomes for individuals requiring central venous catheters.
Citius Pharmaceuticals remains dedicated to advancing the Mino-Lok program and will continue to provide updates on regulatory and clinical developments as they unfold.
Citius Pharmaceuticals, Inc. is also known for its recent FDA approval of LYMPHIR™, a targeted immunotherapy for cutaneous T-cell lymphoma, in August 2024. Additionally, the company’s late-stage pipeline includes CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief. Citius Pharma continues to engage with the FDA to outline the next steps for these programs alongside Mino-Lok.
Investors and individuals interested in further information can reach out to Ilanit Allen, via [email protected] or contact the media representative Greg Salsburg at [email protected].
This press release may contain forward-looking statements. Risks and uncertainties that could impact Citius Pharmaceuticals are outlined in their SEC filings, emphasizing caution against placing undue reliance on forward-looking statements. The company disclaims any obligation to publicly release updates or revisions to forward-looking statements.
This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Citius Pharmaceuticals’s 8K filing here.
About Citius Pharmaceuticals
Citius Pharmaceuticals, Inc, a late-stage pharmaceutical company, engages in the development and commercialization of critical care products focusing on oncology products, anti-infectives products in adjunct cancer care, prescription products, and stem cell therapy. It is developing five proprietary products comprising LYMPHIR, an engineered IL-2 diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma, which is in Phase 3 clinical trial; Mino-Lok, an antibiotic lock solution to treat patients with catheter-related bloodstream infections by salvaging the infected catheter, which is in Phase 3 clinical trial; Halo-Lido, a corticosteroid-lidocaine topical formulation that intends to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids that is in clinical Phase 2b trial; Mino-Wrap, a liquifying gel-based wrap for reduction of tissue expander infections following breast reconstructive surgeries; and NoveCite, a mesenchymal stem cell therapy for the treatment of acute respiratory disease syndrome.
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