This section highlights FDA-related milestones and regulatory updates for drugs developed by Citius Pharmaceuticals (CTXR).
Over the past two years, Citius Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LYMPHIR and Mino-Lok. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LYMPHIR - FDA Regulatory Timeline and Events
LYMPHIR is a drug developed by Citius Pharmaceuticals for the following indication: For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYMPHIR
- Announced Date:
- August 8, 2024
- Indication:
- For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Announcement
Citius Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
AI Summary
Citius Pharmaceuticals, Inc. announced that the U.S. FDA has approved LYMPHIR™ (denileukin diftitox-cxdl), a new immunotherapy for treating relapsed or refractory cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. This innovative treatment is unique because it specifically targets the interleukin-2 (IL-2) receptor on both malignant T-cells and regulatory T-cells. The approval comes after positive results from a Phase 3 study that showed a 36% overall response rate, with 84% of patients experiencing a reduction in skin disease and rapid improvement in symptoms, such as severe itching. With no cumulative toxicity observed, LYMPHIR provides a promising new option for patients with CTCL. The company plans to launch the therapy in the U.S. market within the next five months, offering new hope and treatment alternatives for this challenging condition.
Read Announcement- Drug:
- LYMPHIR
- Announced Date:
- April 11, 2024
- Indication:
- For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Announcement
Citius Pharmaceuticals, Inc. announced that the University of Minnesota Masonic Cancer Center intends to expand their ongoing investigator-initiated Phase 1 trial of LYMPHIR™ (denileukin diftitox) in combination with FDA-approved CAR-T products for the treatment of B-cell lymphomas.
AI Summary
Citius Pharmaceuticals, Inc. announced that the University of Minnesota Masonic Cancer Center will expand its ongoing Phase 1 trial of LYMPHIR™ (denileukin diftitox) combined with FDA-approved CAR-T therapies for treating B‐cell lymphomas. This investigator-initiated study, led by Dr. Veronika Bachanova, is now including a second site at City of Hope in Duarte, CA, where Dr. Matthew Mei will serve as the principal investigator. The trial is designed to determine the maximum tolerated dose of LYMPHIR when used to augment lymphodepletion before CAR-T therapy. Researchers are interested in understanding whether transient depletion of regulatory T-cells by LYMPHIR in the tumor microenvironment can enhance CAR-T-based anti-tumor activity. The expansion to City of Hope, an NCI-designated center, underlines the scientific community’s interest in exploring effective, innovative combinations for patients with relapsed or refractory B-cell lymphomas.
Read Announcement
Mino-Lok - FDA Regulatory Timeline and Events
Mino-Lok is a drug developed by Citius Pharmaceuticals for the following indication: Catheter-related bloodstream infections (CRBSIs).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Mino-Lok
- Announced Date:
- November 25, 2024
- Indication:
- Catheter-related bloodstream infections (CRBSIs)
Announcement
Citius Pharmaceuticals, Inc. announced that the Company held a constructive in-person Type C meeting with the U.S. Food and Drug Administration (FDA).
AI Summary
Citius Pharmaceuticals, Inc. recently held a constructive in-person Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the future regulatory pathway for its novel catheter lock solution, Mino-Lok®. During the meeting, the FDA provided clear and actionable guidance on key topics such as clinical efficacy, safety data, and other regulatory requirements. This guidance outlines a pathway that supports a future New Drug Application (NDA) submission for Mino-Lok®, which is designed to salvage central venous catheters in patients suffering from infections. The collaborative discussion focused on addressing the FDA’s inquiries about the clinical trial data and steps necessary to advance the product toward potential approval. Citius Pharmaceuticals expressed strong encouragement from the meeting and remains committed to the advancement of Mino-Lok® as a promising treatment for critical catheter-related infections.
Read Announcement- Drug:
- Mino-Lok
- Announced Date:
- May 29, 2024
- Indication:
- Catheter-related bloodstream infections (CRBSIs)
Announcement
Citius Pharmaceuticals, Inc. announced that it will host an investor call on Monday, June 3, 2024 at 8:30 am ET to discuss the topline results of its Phase 3 Trial of Mino-Lok antibiotic lock solution.
AI Summary
Citius Pharmaceuticals, Inc. announced that it will host an investor call on Monday, June 3, 2024, at 8:30 AM Eastern Time. During the call, CEO Leonard Mazur and members of the management team will discuss the topline results of the Phase 3 Trial of its Mino-Lok antibiotic lock solution. The trial focuses on the use of Mino-Lok to treat catheter-related bloodstream infections. After their presentation, there will be a question and answer session where investors can ask for more detailed information about the trial and its implications for the company’s product pipeline. The call will be accessible via both U.S. toll-free and international dial-in numbers, and a webcast will be available, with a replay viewable on the company’s website for 90 days following the event.
Read Announcement- Drug:
- Mino-Lok
- Announced Date:
- May 21, 2024
- Indication:
- Catheter-related bloodstream infections (CRBSIs)
Announcement
Citius Pharmaceuticals, Inc announced positive topline results of its pivotal Phase 3 clinical trial of Mino-Lok®, a novel antibiotic lock solution designed to salvage catheters in patients with central line-associated infections (CLABSI) or catheter-related bloodstream infections (CRBSI)..
AI Summary
Citius Pharmaceuticals announced positive topline results from its pivotal Phase 3 clinical trial for Mino-Lok®, a new antibiotic lock solution designed to salvage catheters in patients with central line-associated or catheter-related bloodstream infections. The trial met its primary endpoint with a statistically significant delay in catheter failure (p=0.0006), meaning patients receiving Mino-Lok experienced longer catheter survival compared to the control group that received standard anti-infective treatments. Additionally, secondary outcomes showed a statistically significant improvement in overall treatment success, with a greater percentage of patients retaining their catheters (p=0.0025). The trial results suggest that Mino-Lok is well-tolerated and could offer a non-invasive alternative to catheter removal and replacement, potentially setting a new standard of care for patients with these serious bloodstream infections.
Read Announcement
