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.
Select a button below to view the list of FDA events for that drug.
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:
- March 10, 2026
- Indication:
- For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Announcement
Citius Oncology, Inc and majority‑owned subsidiary of Citius Pharmaceuticals, Inc announced positive topline results from a completed investigator‑initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators.
AI Summary
Citius Oncology, Inc. and its majority‑owned subsidiary of Citius Pharmaceuticals, Inc. announced positive topline results from a completed investigator‑initiated Phase 1 trial led by University of Pittsburgh investigators. The dose‑escalation, non‑chemotherapy study tested LYMPHIR combined with pembrolizumab in patients with relapsed or refractory gynecologic cancers and aimed to identify a recommended dose for a Phase 2 study.
In 25 evaluable patients, investigators observed no unexpected safety signals or serious immune‑related adverse events at any dose level. Company leadership noted a favorable safety profile and sustained disease control that suggest LYMPHIR may boost pembrolizumab’s anti‑tumor activity and merits further study.
Among 21 evaluable patients, the trial showed a 24% objective response rate and a 48% clinical benefit rate (complete or partial response, or stable disease ≥6 months). Full safety and efficacy data will be presented at an international cancer conference later this year.
The use of LYMPHIR in this study was investigational and outside its approved indication. The Phase 1 trial was not powered to prove efficacy, so no definitive conclusions about long‑term outcomes or comparative effectiveness can be drawn.
Read Announcement- Drug:
- LYMPHIR
- Announced Date:
- March 4, 2026
- Indication:
- For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Announcement
Citius Oncology, Inc. and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. announced positive topline safety and efficacy results from an investigator‑initiated Phase 1 trial evaluating LYMPHIR™ (E7777, denileukin diftitox‑cxdl) administered prior to commercial CD19‑directed CAR‑T therapy in patients with high‑risk relapsed or refractory diffuse large B‑cell lymphoma (DLBCL).
AI Summary
Citius Oncology, a majority‑owned subsidiary of Citius Pharmaceuticals, reported positive topline safety and efficacy from an investigator‑initiated Phase 1 trial testing LYMPHIR (E7777) before commercial CD19 CAR‑T therapy in high‑risk relapsed or refractory diffuse large B‑cell lymphoma (DLBCL). The trial was led by Dr. Veronika Bachanova at the University of Minnesota and City of Hope and was presented at the 2026 ASTCT & CIBMTR meetings.
Topline results showed an 86% overall response rate, including 57% complete responses and 29% partial responses. LYMPHIR was well tolerated and no dose‑limiting toxicities were observed. The Phase 1 approach aimed to augment lymphodepletion before CAR‑T by targeting IL‑2‑receptor‑expressing regulatory T cells to possibly boost CAR‑T anti‑tumor activity.
The study was small and not powered to prove efficacy, so no conclusions about long‑term benefit can be drawn. Investigators said the safety and pharmacodynamic signals support larger trials to test whether extended LYMPHIR use can enhance CAR‑T outcomes in high‑risk DLBCL.
Read Announcement- Drug:
- LYMPHIR
- Announced Date:
- December 1, 2025
- Indication:
- For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Announcement
Citius Oncology, Inc. announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl).
AI Summary
Citius Oncology, Inc. announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl), a targeted IL‑2 receptor-directed fusion protein for adults with relapsed or refractory Stage I–III cutaneous T‑cell lymphoma (CTCL) after at least one prior systemic therapy. The company said LYMPHIR is now available nationwide through specialty distributors and that healthcare providers can find prescribing and access information at www.lymphirhcp.com.
Clinical data from a pivotal Phase 3 study showed an objective response rate of 36.2%, with 84% of evaluable patients experiencing a reduction in skin tumor burden. Median time to response was 1.4 months, and the drug showed activity against severe itch (pruritus). Citius said LYMPHIR was not associated with cumulative toxicity in the trials.
Commercial support includes a permanent J‑code (J9161) to help reimbursement, inclusion in NCCN Guidelines (Category 2A), payer and provider programs, international distribution plans, and a patient assistance program called Citius Advantage. Important safety risks include capillary leak syndrome, visual changes, infusion reactions, and liver enzyme elevations; providers should follow monitoring and management guidance.
Read Announcement- Drug:
- LYMPHIR
- Announced Date:
- October 16, 2025
- Target Action Date:
- Q4 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Announcement
Citius Oncology, Inc announced it has finalized an exclusive agreement with EVERSANA®, a leading provider of global commercialization services, to support the anticipated fourth quarter 2025 U.S.
AI Summary
Citius Oncology, Inc. announced it has finalized an exclusive agreement with EVERSANA® to support the anticipated U.S. commercialization of LYMPHIR™ in the fourth quarter of 2025. Under this Master Service Agreement, EVERSANA will act as Citius Oncology’s sole commercialization partner, preparing the company for a smooth market entry.
EVERSANA’s integrated services will cover both pre- and post-launch operations, including medical information, pharmacovigilance, revenue cycle management, program management, data and analytics, and channel management. As launch preparations advance, additional support services will be added to optimize performance and patient access.
Leonard Mazur, Chairman and CEO of Citius Oncology, described the agreement as a transformative milestone that leverages EVERSANA’s infrastructure and oncology expertise to scale efficiently, ensure timely market access, de-risk execution, and create long-term shareholder value. Greg Skalicky, President of EVERSANA, said the partnership reflects their shared mission to deliver innovative cancer treatments to patients in need.
Read Announcement- Drug:
- LYMPHIR
- Announced Date:
- October 7, 2025
- Indication:
- For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Announcement
Citius Oncology, Inc. announced it is actively engaging with regional distribution partners to make LYMPHIR™ (denileukin diftitox-cxdl) available to eligible patients through country-specific Named Patient Programs (NPPs) in Europe, South America and the Middle East.
Read Announcement- Drug:
- LYMPHIR
- Announced Date:
- August 22, 2025
- Indication:
- For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Announcement
Citius Oncology, Inc the oncology-focused subsidiary of Citius Pharmaceuticals, Inc announced that it has deployed an innovative AI platform to support its commercial team with advanced data analytics and insights ahead of the anticipated launch of LYMPHIR™, a novel therapy for cutaneous T-cell lymphoma (CTCL).
AI Summary
Citius Oncology, the cancer-focused subsidiary of Citius Pharmaceuticals, has rolled out a new artificial intelligence platform to boost its commercial team’s work before the anticipated launch of LYMPHIR™, an innovative treatment for cutaneous T-cell lymphoma (CTCL). The system offers advanced data analytics and insights to help the salesforce engage with healthcare providers at the right time and with the right information.
The proprietary AI uses company-defined rules and machine learning to spot patterns in treatment and diagnosis. It then highlights doctors whose patients may benefit most from LYMPHIR and continually refines its recommendations as new real-world U.S. claims data and marketing results are added. This feedback loop sharpens targeting accuracy over time.
By combining robust data analysis with clinical expertise, Citius Oncology aims to sharpen decision-making, streamline its lean commercial operations, accelerate provider education, and ultimately improve patient care and access to the new CTCL therapy.
Read Announcement- 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
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
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