Citius Pharmaceuticals' subsidiary Citius Oncology has signed an exclusive distribution agreement with Uniphar to enable access to Lymphir (denileukin diftitox-cxdl) in selected European countries.

The agreement focuses on expanding Lymphir’s international access via country-specific managed access programmes, where permitted by local regulations.

Under the terms, Uniphar will act as the exclusive distributor for Lymphir in the designated territories.

The product will only be provided through managed access programmes, not constituting marketing authorisation or a commercial launch outside the US.

Citius Oncology will supply the finished product and continue to offer support under this partnership.

The agreement follows the company’s previous arrangements for exclusive distribution in the Middle East, Turkey, Southern Europe, and the Balkans.

Citius Pharmaceuticals chairman and CEO Leonard Mazur said: “This agreement with Uniphar builds on the momentum of our international expansion efforts and reflects our commitment to partnering with experienced organisations that have deep regional expertise and proven execution capabilities.

“As our third international distribution agreement, this partnership further strengthens our ability to responsibly expand access to Lymphir for patients with limited treatment options, while continuing to lay the groundwork for long-term global growth.”

Lymphir is a targeted immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) Stage I-III, given after at least one prior systemic therapy.

Denileukin diftitox-cxdl received regulatory approval in Japan in 2021 for CTCL and peripheral T-cell lymphoma.

Citius acquired commercialisation rights in most global markets (except India, Japan, and parts of Asia) later that year. The FDA approved Lymphir in December 2025.

In August 2024, Citius Pharmaceuticals concluded the merger of its wholly-owned oncology subsidiary with TenX Keane Acquisition, forming the new entity Citius Oncology.