HyBryte Receives Orphan Drug Designation From FDA For Treatment of T Cell Lymphoma

Release Date: 07-Oct-2021

Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient hypericin to treat the T-cell lymphoma disease.  The ingredient is being developed by Soligenix, a company focusing on research and development of rare disease therapeutics.


The FDA's decision to grant and expand this drug signifies an important step and it also gives benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application (NDA), and certain tax credits.


HyBryteandtrade; (SGX301) therapy utilizes safe, visible light for activation. The active ingredient in HyBryteandtrade; is synthetic hypericin. The therapy is currently in the phase3 studies for patients suffering with early stage CTCL

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