116-Patient Repurposing Clinical Trial

Montefiore Medical Center is conducting a Phase 2 trial (NCT07109817), DETOXp, in New York, USA, enrolling 116 breast cancer patients. Recruitment is ongoing, with an estimated start date of June 2026, primary completion in September 2029, and overall completion in September 2030. The trial is a triple-blind, randomized study in which patients receiving 12 weeks or more of first- to third-line paclitaxel- or docetaxel-based neoadjuvant or adjuvant therapy will receive either desloratadine 5mg orally every other day or a placebo. Stratification by taxane class and platinum-based combination controls for variations in chemotherapy and their impact on outcomes.

Repurposing an Allergy Drug as a Neuroinflammation Inhibitor

Desloratadine, the active ingredient in Clarinex and Aerius, is a long-acting histamine H1 receptor (HRH1) antagonist. It was approved in the U.S. on December 21, 2001, for allergic rhinitis and chronic idiopathic urticaria, and authorized in the European Union on January 15, 2001, with brand licensing and U.S. packaging managed by Organon (OGN). This trial explores a repurposing strategy to reduce neuroinflammation via HRH1 and pathways involving 5-HT2A, c-Fos, NLRP3, and IL-1β to prevent taxane-induced peripheral neuropathy (TIPN). While it is marketed for allergy indications, this is the first Phase 2 trial to evaluate its preventive potential in humans for TIPN.

Validating Patient-Reported Outcomes and Biomarkers

The primary endpoint is the change in FACT-GOG-NTX neurotoxicity scores and PRO-CTCAE-based neuropathy and pain scores after 12 weeks of chemotherapy. Quality of life, inflammatory and anti-inflammatory cytokines, and gut microbiome composition will also be analyzed to link clinical outcomes with mechanisms of action. If the preventive signals observed in animal models are replicated in patients, it could provide evidence to reduce the need for taxane dose reduction, delay, or discontinuation due to sensory disturbances. However, as results are not yet published, efficacy assessment will depend on the 12-week patient-reported outcomes and inter-group differences once disclosed.

Targeting a Market Without Preventive Standard of Care

ASCO guidelines recommend duloxetine as the only pharmacological option for established painful chemotherapy-induced peripheral neuropathy (CIPN), but its efficacy is limited and no preventive agents are recommended. Competing approaches such as cold and compression therapies reduced grade 2 or higher neuropathy in the 122-patient POLAR randomized trial but have not become standard in routine care. The global CIPN neuropathic pain market is projected to grow from USD 1.2741 billion in 2025 to USD 2.5383 billion in 2033. If a low-cost oral generic proves effective in prevention, convenience and accessibility could be advantages, but weak patent protection and limited pricing power would make commercial value contingent on indication patents and formulation strategies.