Charlotte’s Web Advances Botanic Drug Candidate for Autism Spectrum Disorder Treatment

Louisville, Colo., February 24, 2025 – Charlotte’s Web Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Phase 1 data and Investigational New Drug (IND) application submitted by DeFloria, Inc., a company in which Charlotte’s Web holds a minority interest. Following the FDA’s clearance, DeFloria is set to initiate its planned Phase 2 clinical trial for AJA001 Oral Solution, a botanical pharmaceutical candidate intended to treat symptoms of autism spectrum disorder (ASD).

According to the accompanying press release, AJA001 leverages Charlotte’s Web’s proprietary full-spectrum cannabidiol (CBD) hemp extract, which is derived from the company’s patented hemp cultivars. The collaboration, which includes Ajna BioSciences PBC alongside Charlotte’s Web, is aiming to develop a treatment for irritability associated with ASD—a condition that currently lacks fully adequate treatment options.

Bill Morachnick, Chief Executive Officer of Charlotte’s Web, commented on the milestone, stating that progressing to Phase 2 of the IND study represents an important step in evolving the company’s expertise from the consumer hemp wellness market into the regulated medical sector. “By leveraging our deep expertise in hemp cultivation and proprietary formulations, we are reinforcing and extending our leadership in hemp wellness from the consumer sector into the regulated medical sector,” Morachnick said.

Dr. Marcel Bonn-Miller, Chief Scientific Officer at Charlotte’s Web and DeFloria board member, described the initiation of Phase 2 as a landmark moment in botanical drug development. He noted that the progression reflects the potential of hemp-based treatments to address the underserved needs of individuals affected by autism spectrum disorder. The upcoming Phase 2 trial will evaluate the safety, tolerability, and effectiveness of AJA001 in adolescents and adults with ASD. Successful outcomes from these studies are expected to shape the design of larger Phase 3 clinical trials, which will be critical for eventual FDA drug approval.

The press release and the corresponding 8-K filing underscore the ongoing commitment by Charlotte’s Web and its partners to expand the applications of hemp extract technology into novel therapeutic areas. The initiative marks a significant step in the evolution of botanical drug development and highlights the potential for hemp-derived compounds to offer new treatment alternatives for patients with ASD.

The information in the filing and press release is provided for informational purposes and is subject to the risks and uncertainties outlined in the company’s regulatory filings.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Charlotte’s Web’s 8K filing here.

About Charlotte’s Web

Charlotte's Web Holdings, Inc is involved in the farming, manufacture, marketing, and sale of hemp-derived cannabidiol (CBD) wellness products. The company's products categories include hemp extract oil tinctures, such as liquid products; gummies; and capsules, CBD topical creams, and lotions, as well as products for pets under the Charlotte's Web, ReCreate, CBD Medic, CBD Clinic, and Harmony Hemp brands.