BRC Therapeutics Announces Investigational New Drug Application for BRC-002 Cleared by FDA

Clearance will accelerate development of a therapeutic for Complex Regional Pain Syndrome (CRPS)

There are currently no approved treatment options for CRPS in the United States

MONTEREY, Calif., April 28, 2026 /PRNewswire/ -- BRC Therapeutics (BRC), a pharmaceutical company developing therapeutics for neurological and inflammatory diseases, announced today that the company can proceed with a Phase I study to further establish safety of BRC-002 in healthy volunteers.

BRC-002 is a first-in-class investigational product aiming to address pain and other symptoms of Complex Regional Pain Syndrome (CRPS). The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for the treatment of CRPS to BRC-002. BRC-002 is a multimodal botanical drug composed of prescription-grade cannabinoids at defined and proprietary ratios.

CRPS is a debilitating chronic pain condition that has very few treatment options available. The condition lasts on average for a year but can persist for five years or longer in many patients. In addition to intense pain, individuals with CRPS can suffer from depression, anxiety, and sleep disorders. Currently, there is no approved treatment for CRPS in the United States, highlighting the critical need for new therapeutic approaches.

"We are thrilled to announce yet another milestone for BRC Therapeutics. The IND clearance for BRC-002 by the FDA reinforces our commitment to help these patients whose lives are so heavily impacted by pain. CRPS patients often feel frustrated, out of treatment options and desperate for relief that allows them to live a life not constantly dictated by pain. We have dedicated ourselves to accelerating the development of BRC-002 and are now one step closer to supporting these patients in need." said George Hodgin, CEO and founder of BRC.

BRC Therapeutics (BRC) is a pharmaceutical company focused on developing innovative therapeutics to deliver relief from pain and other symptoms in chronic conditions. BRC's medicines are multimodal and contain cannabinoids at defined ratios. BRC has developed a pipeline of investigational prescription medicines addressing neurological and inflammatory conditions. Two investigational products are currently being tested in clinical trials for Complex Regional Pain Syndrome (CRPS) and Aromatase Inhibitor-Induced Arthralgia (AIIA). BRC is registered with the Drug Enforcement Administration and is based in Monterey, CA.

To learn more about BRC, visit https://brctherapeutics.com/.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks, uncertainties and assumptions, including without limitation statements about the development, use, benefits and effects of BRC Therapeutics' (BRC) therapeutic product candidate and related technology, future plans for the BRC's business and growth, expected plans with respect to clinical trials, including the number of patients enrolled and timing of patient enrollment. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "design," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements. The forward-looking statements made herein speak only as of the date of this press release and, unless otherwise required by law, BRC does not undertake any obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

SOURCE BRC Therapeutics