Medicinal
Medicinal Products / Medical Devices
Fulderm International Ltd is a Fulhold operating subsidiary based in the UK, which stands at the forefront of pioneering innovation and clinical advancements in the field of Fulvic Acid within dermatology and topical allergology.
Fulhold Inc was established in the USA with a strong commitment to quality, safety, and adhering to regulatory protocols. The company engaged the US FDA for insights in a Pre-IND meeting to provide critical feedback on its drug development program. Backed by approvals from SAHPRA and the Ethics Committees in South Africa, Fulhold currently acts as the sponsor for a Phase 2a clinical trial in South Africa. This trial, involving 60 participants, focuses on evaluating their patented Fulvic Acid (CHD-FA) as a topical treatment for mild to moderate Atopic Dermatitis. Anticipated to yield initial results by early 2024, this trial marks a significant milestone.
Upon the successful completion of the trial and based on positive feedback from the Pre-IND interactions, Fulhold intends to submit an application for Investigational New Drug (IND) approval with the FDA. This step is aimed at initiating a Phase 3 study for Atopic Dermatitis within the United States.
In parallel, Fulderm Sweden AB assumes the role of the Market Authorisation Holder for Reczema, a Class I Medical Device, in the European Union. This topical cream, available in the EU market, complies with the stipulations of the MDR (Medical Device Regulation).
