Drug intelligence / Profile preview

Mucomel

Development stage
Unknown
Lead developer
Spherium Biomed
Modality
Small Molecules
Administration
Oral, Topical
01

Overview

Mucomel (SP13004) is a high-dose melatonin mucoadhesive oral gel developed by Spherium Biomed (now part of Ferrer) for the prevention and treatment of oral mucositis in cancer patients receiving chemo-radiotherapy or bio-radiotherapy. The drug works through a disease-modifying mechanism that restores the natural defense mechanism of mucosal integrity by protecting cells from oxidative stress and inflammation. It was developed under an exclusive license from the University of Granada, based on research identifying melatonin's protective role against mucosal damage. Clinical Phase I/IIa trials in head and neck cancer patients demonstrated that Mucomel significantly reduced the incidence and duration of severe oral mucositis. The formulation is designed to adhere to the oral mucosa, providing a local protective barrier and delivering the active ingredient directly to the affected tissue.

Brand names
Mucomel
Other names
Melatonin oral gel
02

Targets

MTNR1A (MT1)

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