FDA approves IND for clinical trial evaluating CBD-based drug

By Jenni Spinner contact

- Last updated on GMT

(Feodora Chiosea/iStock via Getty Images Plus)
(Feodora Chiosea/iStock via Getty Images Plus)

Related tags: CBD, Opioid, Opioid epidemic, Fda, IND, phase I

The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientific’s Nantheia ATL5, a candidate for treating opioid use disorder.

Biotech pharmaceutical firm Ananda Scientific has announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for a clinical study evaluating Nantheia ATL5. The candidate uses cannabidiol (CBD) with the company’s proprietary delivery technology as an adjunctive treatment for opioid use disorder.

According to Ananda Scientific representatives, the study is planned to take place at the Jane and Terry Semel Institute for Neuroscience and Human Behavior at the University of California-Los Angeles (UCLA).

Sohail Zaidi, CEO, of Ananda Scientific

Sohail Zaidi, CEO of Ananda Scientific, said the IND approval is the latest in a line of promising developments for the company’s offerings.

This is the fourth IND approval for our investigational drug Nantheia product line, and it further re-enforces our vision of developing CBD as a therapeutic for a number of key indications​,” Zaidi said. “This clinical study at UCLA is an important component of our clinical development efforts focused on opioid addiction, where a non-addictive therapy is a significant unmet need; we are excited to be working with the UCLA team and look forward to this trial advancing​.”

This particular trial is being led by principal investigators (PIs)

Edythe London, Jane and Terry Semel Institute at David Geffen School of Medicine, UCLA

; and Richard De La Garza, Professor of Psychiatry and Biobehavioral Sciences at the Jane and Terry Semel Institute at David Geffen School of Medicine UCLA. Additionally, funding for the trial reportedly is coming from the National Institute on Drug Abuse (NIDA).

PI London said, “The approval of the IND for this important clinical trial is a key milestone for our ongoing research into therapeutic alternatives for opioid use disorder and reversal of the effects of the opioid epidemic.”

Richard De La Garza, Jane and Terry Semel Institute at David Geffen School of Medicine, UCLA

With the IND approved we are now moving quickly to get the trial underway​,” added De La Garza.

Related news

Related products

show more

ODM and CDASH in CRF design

ODM and CDASH in CRF design

Formedix | 15-Aug-2022 | Technical / White Paper

The lesser-known Operational Data Model (ODM) standard is often overlooked as it's not required by any regulators. So, why should you be interested...

dPCR Case Study

dPCR Case Study

CellCarta | 08-Aug-2022 | Case Study

Streamline your adoptive cell therapy program with digital PCR. Our team has a unique expertise in digital and quantitative PCR to support you in ensuring...

Standardizing data with NCI controlled terminology

Standardizing data with NCI controlled terminology

Formedix | 18-Jul-2022 | Technical / White Paper

The use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND...

Related suppliers

Follow us


View more