# Development of JR-220 (4-Chlorobenzylidenamino-guanidine hydrochloride) as a medication for alcohol dependence

> **NIH NIH U44** · NAPROGENIX, INC · 2024 · $99,510

## Abstract

Abstract
The aim of phase I of the parent cooperative agreement (U44AA026126) was to generate
sufficient data on the pharmacokinetics (PK) and toxicology (Tox) of JR-220 to support an
application for a pre-IND meeting with the FDA. This aim has been successfully accomplished.
The aim of phase II of the parent cooperative agreement is to expand the phase I studies with rat
and a second species (canine) based upon the feedback of the FDA’s pre-IND meeting response
to create a dossier that will be submitted to the FDA in support of IND status for JR-220 as a
medication for treatment of alcohol use disorder (AUD). Neither of these aims has changed from
the original funded application, but the cost to support several GLP/GMP tasks related to these
aims have significantly increased for reasons outside the control of the company. All of these
tasks support the potential value of JR-220 as a medication for AUD and are required for IND
submission. This administrative supplemental proposal is a request for additional funds to cover
the unanticipated increased cost of several key GLP/GMP tasks to be completed that are required
by the FDA to submit the IND application. This administrative supplement proposal includes tasks
previously proposed and accepted by reviewers and NIAAA. The three key tasks with increased
costs are 1) GLP CNS safety study (Neurotoxicity) in rat specifically requested by the FDA in the
pre-IND meeting response, 2) cGMP manufacturing of JR-220 (drug substance), and 3) cGMP
manufacturing of JR-220 capsules (drug product) for clinical trial. This administrative
supplemental request for additional funding under $100K to help cover the incremental
unanticipated cost increase from 2016 to completed these original scope tasks is important for
the successful completion of the overall goal of the parent cooperative agreement to submit the
IND in support of JR-220 as medication for treatment for AUD.

## Key facts

- **NIH application ID:** 10948252
- **Project number:** 3U44AA026126-05S1
- **Recipient organization:** NAPROGENIX, INC
- **Principal Investigator:** Cindy Ann Burklow
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $99,510
- **Award type:** 3
- **Project period:** 2017-08-25 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10948252

## Citation

> US National Institutes of Health, RePORTER application 10948252, Development of JR-220 (4-Chlorobenzylidenamino-guanidine hydrochloride) as a medication for alcohol dependence (3U44AA026126-05S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10948252. Licensed CC0.

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