Citius Pharmaceuticals

Name

Citius Pharmaceuticals

Legal name

Citius Pharmaceuticals, Inc.

Website

https://citiuspharma.com

Company type

Public

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Specialty Biopharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro industry

PRIMARYHLAIAAAB

Specialty Care Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Branded (Innovator) Pharmaceuticals

SECONDARYHLAIACAM

Infectious Disease Specialty Pharmaceuticals (Non-vaccine)

Healthcare & Life Sciences/Pharmaceuticals/Specialty Pharmaceuticals

Keywords

• Oncology therapeutics
• Biopharmaceutical development
• Targeted immunotherapy
• Antibiotic lock solutions
• Specialty pharmaceuticals

Headquarters

HQ city

Cranford

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Marketing or Sales, Supply Chain, Personnel, Operations

Revenue model

1. LYMPHIR Product Sales: Revenue generated from commercial sales of LYMPHIR (denileukin diftitox-cxdl) following FDA approval and December 2025 U.S. launch. The product achieved $5.6 million in net revenue for H1 FY2026 with approximately 80% gross margins, representing the company's first revenue-generating period.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

Citius Pharmaceuticals is a late-stage biopharmaceutical company that develops, manufactures, and commercializes first-in-class critical care therapeutics. Its lead product LYMPHIR (denileukin diftitox-cxdl) is an FDA-approved engineered IL-2-diphtheria toxin fusion protein for relapsed/refractory cutaneous T-cell lymphoma commercially launched in the U.S. in December 2025. The pipeline includes Mino-Lok antibiotic lock therapy for catheter salvage, Halo-Lido topical hemorrhoid therapy, and an i-MSC stem cell platform for acute respiratory distress syndrome.

Product overview

Citius Pharmaceuticals is a late-stage biopharmaceutical company with a diversified pipeline of critical care products. The company's portfolio includes LYMPHIR (denileukin diftitox-cxdl), an FDA-approved targeted immunotherapy for cutaneous T-cell lymphoma; Mino-Lok, an antibiotic lock solution for salvaging infected catheters; Halo-Lido, a topical hemorrhoid treatment in late-stage development; and a stem cell platform using engineered i-MSCs for respiratory conditions. The company operates through its majority-owned subsidiary Citius Oncology, which commercializes LYMPHIR.

Differentiator

Problem solved

Functional benefit

Brands

• LYMPHIR: FDA-approved targeted immune therapy (denileukin diftitox-cxdl) for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL).
• Mino-Lok
• Halo-Lido
• Stem Cell Platform (i-MSCs)

Products and services

• LYMPHIR (denileukin diftitox-cxdl) FDA-approved engineered IL-2-diphtheria toxin fusion protein (immunotoxin) for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL), including mycosis fungoides and Sézary Syndrome, after at least one prior systemic therapy. The drug targets both malignant T-cells and immunosuppressive regulatory T-cells (Tregs). Sold to oncology specialty centers, academic cancer centers, and community infusion centers.
• Mino-Lok Investigational antibiotic lock solution combining minocycline, edetate (disodium EDTA), and ethyl alcohol for salvaging infected central venous catheters in patients with catheter-related bloodstream infections (CRBSIs) and central line-associated bloodstream infections (CLABSIs). Demonstrated 100% catheter salvage rate in Phase 2b trial. Targeted to hospitals, oncology treatment centers, and dialysis centers serving cancer and hemodialysis patients.
• Halo-Lido (CITI-002) Proprietary topical prescription formulation combining halobetasol (high-potency corticosteroid) and lidocaine (anesthetic) for symptomatic relief of hemorrhoids. If approved, would be the first FDA-approved prescription product for hemorrhoids in the United States. Targeted to primary care physicians, gastroenterologists, proctologists, and colorectal surgeons.
• i-MSC Stem Cell Platform Next-generation engineered induced mesenchymal stem cells (i-MSCs) derived from induced pluripotent stem cells (iPSCs) under cGMP using a patented synthetic, non-immunogenic, non-viral mRNA reprogramming technique. Targeted to treatment of acute respiratory distress syndrome (ARDS) and other acute inflammatory respiratory disorders. Developed through majority-owned subsidiary NoveCite Inc.

Quantifiable outcome

• 24% objective response rate (ORR) in heavily pre-treated gynecologic cancer patients with LYMPHIR + pembrolizumab combination, including 33% ORR in endometrial cancer patients previously treated with checkpoint inhibitors
• +4 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Eight partnerships are on record, tiered core.

• University of Pittsburgh Medical Center (UPMC)coreStrategic or Co-development Partner · 1 June 2026Investigator-initiated Phase 1 trial evaluating LYMPHIR in combination with pembrolizumab in patients with recurrent or refractory gynecologic malignancies. Study demonstrated 24% overall response rate and 33% ORR in endometrial cancer patients previously treated with checkpoint inhibitors.
• University of Minnesota and City of HopecoreStrategic or Co-development Partner · 4 March 2026Investigator-initiated Phase 1 trial evaluating LYMPHIR administered prior to CAR-T therapy in high-risk relapsed/refractory diffuse large B-cell lymphoma patients. Study demonstrated 86% overall response rate with 57% complete responses and strong one-year survival rates.
• UnipharcoreChannel Partner/ Reseller/ Distributor · 1 December 2025European distribution agreement for LYMPHIR with Uniphar, a leading international healthcare services company. LYMPHIR being made available through Named Patient Programs across 19 markets including Southern Europe, Middle East, and additional European territories. Initial shipment completed April 29, 2026.
• McKesson CorporationcoreChannel Partner/ Reseller/ Distributor · 20 October 2025U.S. distribution agreement with McKesson for LYMPHIR commercial launch. This alliance completed Citius Oncology's distribution network with all three largest U.S. pharmaceutical distributors to ensure broad access to the therapy.
• EVERSANAcoreImplementation/ SI/ Consulting Partner · 17 October 2025Exclusive agreement with EVERSANA to support U.S. commercialization of LYMPHIR for Q4 2025 launch. EVERSANA provides integrated services for market entry and launch readiness including commercial analytics, market access, and distribution support.
• Eisai Co. Ltd.coreStrategic or Co-development Partner · 1 September 2021Citius acquired exclusive license to develop and commercialize late-stage cancer immunotherapy (LYMPHIR) for which Dr. Reddy's Laboratories SA (in association with Eisai) was completing a fully-enrolled Phase 3 pivotal trial in persistent or recurrent CTCL. Eisai retained responsibility for completing the Pivotal trial and associated CMC activities through BLA filing with FDA. LYMPHIR approved by FDA in August 2024.
• Brooklyn ImmunoTherapeutics (formerly Novellus Therapeutics)coreStrategic or Co-development Partner · 1 January 2020Partnered to create NoveCite Inc., a majority-owned subsidiary of Citius focused on developing, manufacturing, and commercializing a unique induced mesenchymal stem cell (i-MSC) platform for treatment of acute respiratory distress syndrome (ARDS), including COVID-19 related cases. Novellus acquired by Brooklyn ImmunoTherapeutics in July 2021.
• MD Anderson Cancer CentercoreStrategic or Co-development Partner · 1 January 2016Licensed worldwide rights to Mino-Lok, the first and only product in development to salvage infected Central Venous Catheters. Also acquired worldwide license for Mino-Wrap in January 2019, potentially the first product for prevention of infections associated with post-mastectomy implants. Both products were developed by clinicians and technologists at MD Anderson.

Scale indicators14 records

Recent moves1 record

Emerging players

• Athersys: Athersys developed MultiStem cell therapy for ARDS and stroke, a partial overlap with Citius's i-MSC platform. Both are early-stage cell therapy companies pursuing allogeneic stem cell approaches for critical care indications with similar regulatory and manufacturing risk profiles.
• Fortress Biotech: Fortress Biotech is a small specialty pharma holding company developing and commercializing multiple products across oncology, infectious disease, and rare diseases. Its diversified pipeline and partnership-driven commercialization model parallels Citius's multi-asset strategy.

Broad incumbents

• Spectrum Pharmaceuticals: Spectrum is a specialty oncology pharmaceutical company commercializing hematology and oncology products through specialty distribution. It shares Citius's profile of branded specialty injectable biologics targeting smaller oncology indications with hospital-channel distribution.
• Eagle Pharmaceuticals: Eagle Pharmaceuticals is a specialty injectable pharmaceutical company focused on oncology and critical care, with a comparable product profile of branded hospital-administered therapies and similar small-cap public profile. Like Citius, Eagle commercializes differentiated specialty products through hospital and specialty pharmacy channels.

Direct peers

• Mesoblast: Mesoblast is a cell therapy company developing mesenchymal stem cell therapies for inflammatory conditions including ARDS, directly comparable to Citius's i-MSC platform. Both companies pursue allogeneic stem cell approaches for respiratory and inflammatory critical care indications.
• Verastem Oncology: Verastem is a small-cap oncology-focused biopharma commercializing targeted therapies for hematologic malignancies and solid tumors. It is a direct peer in micro-cap oncology specialty pharma, with similar pipeline breadth and commercialization challenges.
• Soligenix: Soligenix is a late-stage specialty biopharma developing products in oncology and infectious disease with a similar small-cap, multi-asset profile. Its diversified pipeline of critical care products mirrors Citius's structure across multiple specialty therapeutic areas.
• Innate Pharma: Innate Pharma develops antibody-based immunotherapies for cancer including lacutamab for CTCL, a direct competitor to LYMPHIR in the relapsed/refractory CTCL indication. Innate's CTCL focus and immunology-oncology platform make it a directly comparable peer for Citius's lead asset.
• Acrotech Biopharma: Acrotech is a specialty oncology company developing and commercializing differentiated therapeutics for rare and difficult-to-treat cancers. Its focus on niche oncology indications and specialty distribution channels is closely aligned with Citius's LYMPHIR commercial model.
• Tarsus Pharmaceuticals: Tarsus is a specialty pharma that recently launched its first FDA-approved product (Xdemvy) targeting a niche indication, sharing Citius's profile of a small-cap specialty pharma with one recently approved product and a broader specialty pipeline.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/citiuspharma
• LinkedInlinkedin.com/company/citius-pharmaceuticals-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Subsidiaries2 records

Funding overview

Funding rounds20 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Citius Pharmaceuticals