Sun 1334H offers an advantageous pharmacological and safety profile compared to the currently marketed antihistamines.

In preclinical studies, Sun 1334H showed efficacy as a potent antihistamine and selective H1 blocker with fast onset and long duration of action. Sun 1334H also showed good anti-inflammatory activity.

A two year long carcinogenicity study in animal models, with the oral formulation of Sun 1334H, as a part of chronic toxicity studies, has been completed and the initial results are quite encouraging.

On account of the cardiac toxicity seen with oral antihistamines, the USFDA requires submission of safety data on thorough QT studies (TQT studies) at very high doses. The pilot TQT studies with the oral Sun 1334H formulation are ongoing, and the initial results seem to be favorable.

Phase III studies of the oral Sun1334H will commence once the data from the TQT studies is completely analyzed and found acceptable.

Sun 1334H is also being studied for ophthalmic conditions like pink eye or allergic conjunctivitis. In preclinical studies as we had previously shared, a 0.3% solution of Sun 1334H eye drop as showed a good inhibition of allergen and histamine induced conjunctivitis on once a day dosing. Chronic toxicity for the eyedrop formulations is ongoing. In a Phase I study conducted in India with the eyedrops, it was found to be well tolerated by healthy volunteers. A Phase II study ( Conjunctival Allergen Challenge), is ongoing in the US.