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Assessing the Safety and Efficacy of SXC-2023 in a Phase 2A Clinical Trial for Cocaine Use Disorder

Award Number: U01DA065419
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2029

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Assessing the Safety and Efficacy of SXC-2023 in a Phase 2A Clinical Trial for Cocaine Use Disorder - Project Abstract: Cocaine use disorder (CUD) is a critical and escalating public health crisis, marked by rising overdose fatalities and a lack of FDA-approved pharmacotherapies. System xc- (Sxc), an astrocytic cystine/glutamate antiporter, is the central nervous system (CNS) target of N-acetylcysteine (NAC) and plays a key role in regulating glutamate homeostasis and antioxidant defenses. While NAC was originally developed for peripheral indications, research by us and many others established that it can activate Sxc in the brain, thereby reversing cocaine-induced disruptions in CNS function. Despite over 80 clinical trials evaluating NAC and Sxc activation for CNS disorders, results have been mixed due to NAC’s poor brain penetration. This project will advance the clinical development of SXC-2023, a novel, brain-penetrant prodrug of NAC specifically designed to overcome the limitations that have restricted NAC’s therapeutic potential in CUD. SXC-2023 addresses this barrier, exhibiting improved CNS bioavailability, favorable pharmacokinetics, and a strong safety profile across six completed trials (n=295). This U01 proposes a two-phase development plan. Aim 1 will finalize GMP manufacturing of SXC-2023 and complete development of a digital health platform that will provide key data in evaluating the efficacy of SXC-2023 across a range of cocaine use in different settings and for different reasons (CUD heterogeneity). Aim 2 will conduct a 12-week, randomized, double-blind, placebo-controlled Phase 2A trial (N=170) to assess the efficacy of once-daily SXC-2023 (800 mg, oral) in preventing relapse following abstinence induction in adults with moderate-to-severe CUD. The primary endpoint is time to relapse; secondary outcomes include safety and drug use patterns, with exploratory assessments of craving, cognition, and stress-related physiology. If successful, this project will establish proof-of-concept for SXC-2023 as a safe and effective treatment for CUD. The approach combines mechanistic precision, digital innovation, and clinical rigor to address a pressing therapeutic gap and inform a potential Phase 2B trial in consultation with the FDA.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $4,240,112 )
2026	2026	MARQUETTE UNIVERSITY	313 N 13TH ST	MILWAUKEE	WI	53233	MILWAUKEE	USA	Drug Use and Addiction Research Programs	000	1	9/4/2026	NEW	$4,240,112
														Subtotal = $4,240,112

Grand Total All Awards = $4,240,112

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Assessing the Safety and Efficacy of SXC-2023 in a Phase 2A Clinical Trial for Cocaine Use Disorder

Award Number: U01DA065419

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2029

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