# Nourexal™: A Novel Bioenergetic Drug to Increase Donor Heart Utilization

> **NIH NIH R44** · NOUR HEART, INC. · 2024 · $1,658,923

## Abstract

PROJECT SUMMARY
In the U.S., over 20,000 heart transplants are needed each year, but fewer than 4,000 procedures are performed
despite the yearly availability of more than 12,000 donors. This gap exists because 6 hearts from every 10
organ donors are unused. The vast majority of eligible donor hearts are rejected because the transport time is
limited to 4 hours. To address this unmet need, Nour Heart developed and patented the bioenergetic
cardioprotective drug, Nourexal™ (Cyclocreatine Phosphate (CCrP)), which was recently granted FDA Orphan
Drug Designation for “Prevention of Ischemic Injury to Enhance Cardiac Graft Recovery and Survival in Heart
Transplantation” (DRU-2015-4951). CCrP enhances myocardial energy stores during ischemia, reduces cell
injury, inhibits inflammation and fibrosis, and restores normal cardiac function after extended cold storage of rat
and dog hearts. Further, injection of CCrP (1.2 gm/kg) into rat donors, protected hearts during harvesting and
allowed prolonged storage for 22 hours with full recovery of surgically grafted hearts for 3 days.
In this two-year Direct-to-Phase II SBIR project, Nour Heart, Inc. (NHI) will prepare and file an Investigational
New Drug (IND) for FDA approval to initiate CCrP Phase I safety trial in human healthy volunteers. Based on
the FDA response to NHI’s Pre-IND application (PIND 125867), we will: 1) produce Good Manufacturing Practice
(GMP) grade CCrP and determine its Chemistry Manufacturing and Controls (CMC) (Aim 1); 2) conduct FDA-
recommended, IND-enabling CCrP preclinical safety studies in rats, dogs, and human unused cadaver donors
(UCDs) (Aim 2) (initial rat studies indicated that CCrP is a safe drug); 3) conduct a pilot in vivo efficacy study in
pigs to confirm the ability of CCrP to safely extend cold storage time of pig hearts to 6 hours before surgically
transplanting the graft into recipient pigs (Aim 3). This pig study will be overseen by Dr. O.H. Frazier at the Texas
Heart Institute to test the therapeutic benefits of our patented “three-step clinical protocol” where CCrP will be
administered only once to heart donors and not to recipients; and 4) prepare CCrP Phase I safety protocol,
investigational brochure, as well as assemble and file Nour Heart’s IND application to the FDA for an indication
for end-stage heart failure patients scheduled for heart transplantation procedures (Aim 4). We expect CCrP to
be safe in rats, dogs, and human unused cadaver donors and can preserve cardiac function in the pig heart
transplantation model. As a novel bioenergetic cardioprotective drug, CCrP will potentially increase the time and
distance that the hearts can be transported, thus extending transplantation to eligible recipient candidates
located outside the current 4-hour transport limit. Upon successful completion of this project, Nour Heart plans
to commercialize CCrP by raising capital to conduct CCrP Phase I safety trial, via two venture capital groups,
who have indicated interes...

## Key facts

- **NIH application ID:** 11003902
- **Project number:** 1R44HL174138-01A1
- **Recipient organization:** NOUR HEART, INC.
- **Principal Investigator:** salwa a elgebaly
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,658,923
- **Award type:** 1
- **Project period:** 2024-09-20 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11003902

## Citation

> US National Institutes of Health, RePORTER application 11003902, Nourexal™: A Novel Bioenergetic Drug to Increase Donor Heart Utilization (1R44HL174138-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11003902. Licensed CC0.

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