Funded Projects

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Project #	Project Title Sort descending	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
1UG3NS127943-01 Show Summary	Oral N2O Therapy in Treating Acute Vaso-Occlusive Pain in Sickle Cell Disease	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	Hillhurst Biopharmaceuticals, Inc.	GOMPERTS, EDWARD (contact); BELCHER, JOHN D; SIMONE, DONALD	Montrose, CA	2022
NOFO Title: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) NOFO Number: RFA-NS-21-010 Summary: Inhaled nitrous oxide, N₂O, is used in emergency departments in Europe to treat pain associated with sickle cell disease as well as for labor, painful fractures, and to manage serious gynecological pain. It is not a viable therapeutic option for home use for reasons such as poor dosing control, potential inhalation equipment issues, and variability in patient ventilation and lung absorption. This project seeks to optimize, characterize, and develop an oral formulation of N₂O that could be used by patients at home for unpredictable and severe episodes of pain associated sickle cell disease. Once developed, the new oral formulation of N₂O will be evaluated to determine whether it or an optimized version is ready for more clinical testing.
1UG3NS128148-01A1 Show Summary	Peripherally Restricted Non-Addictive Cannabinoids for Cancer Pain	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	UNIVERSITY OF CALIFORNIA LOS ANGELES	SPIGELMAN, IGOR (contact); CAHILL, CATHERINE M; FAULL, KYM FRANCIS; SCHMIDT, BRIAN L; SPOKOYNY, ALEXANDER MICHAEL	Los Angeles, CA	2023
NOFO Title: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) NOFO Number: RFA-NS-21-010 Summary: Oral cancer pain is debilitating and difficult to treat, in part because even the most effective available pain remedies are limited by side effects. Opioid-based pain medications have several side effects including dependence and tolerance, in which the body gets used to a medicine so that either more medicine is needed or different medicine is needed. Another side effect is hyperalgesia, in which people taking opioids become more sensitive to certain painful stimuli and may misuse the drugs and risk addiction. This project will evaluate lab-made versions of cannabinoid molecules known to block pain signals in nerve cells, but which cannot enter the brain to cause neurological side effects. The research aims to advance promising versions of the molecules to testing in human research participants.
1R61NS127271-01A1 Show Summary	Planning Study for the Development of Sigma 2 Ligands as Analgesics	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	UNIVERSITY OF KENTUCKY	TIDGEWELL, KEVIN JOSEPH (contact); KOLBER, BENEDICT J	Lexington, KY	2023
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed) NOFO Number: RFA-NS-21-029 Summary: Natural products, which are substances found in nature and made by living organisms, have been used in the past as good sources for developing new medications. Natural products isolated from marine bacteria that attach to the pain-signaling protein sigma-2 receptor (also known as transmembrane protein 97 [TMEM97]), may serve as a starting point to create new, non-opioid pain medications. This project will use chemistry and biology approaches to refine such natural products as a treatment for neuropathic pain.
1R61NS131307-01 Show Summary	Preclinical Assessment of a Novel Systemic Drug Candidate for Osteoarthritic Pain	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	UNIVERSITY OF SOUTHERN CALIFORNIA	EVSEENKO, DENIS	Los Angeles, CA	2023
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional) NOFO Number: PAR-20-092 Summary: Osteoarthritis is a degenerative joint disease marked by progressively worsening chronic joint pain that affects function and quality of life. Non-opioid, alternative medications are needed for people with this condition. Joint inflammation, damage, and pain involve signaling through the interleukin-6/glycoprotein 130 pathway. This project will test blocking this pathway in rodents with a new molecule with improved drug-like properties, toward developing an oral medication for osteoarthritis.
1R34NS126030-01 Show Summary	Profiling the human gut microbiome for potential analgesic bacterial therapies	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	HOLOBIOME, INC.	STRANDWITZ, PHILIP PETER (contact); GILBERT, JACK ANTHONY	Cambridge, MA	2021
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed) NOFO Number: RFA-NS-21-016 Summary: Disruptions in make-up of the microbiome are associated with disorders characterized by chronic pain and inflammation, such as rheumatoid arthritis and fibromyalgia. The gut microbiome has immune and metabolic effects, and human gut-derived bacteria may be a source of novel, safe, and non-addictive pain treatments. However, connections between gut and pain signals, known as the “gut–pain axis,” are still poorly understood. This study aims to identify human-gut-native bacteria that i) interact with known pain targets in lab studies, ii) test their activity and analgesic/anti-inflammatory potential in an animal model, and iii) develop a computational approach to predict microbial-genetic effects on pain signals.
1U44NS115732-01 Show Summary	Selective Kv7.2/3 activators for the treatment of neuropathic pain	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	KNOPP BIOSCIENCES, LLC	SIGNORE, ARMANDO (contact); RESNICK, LYNN	Pittsburgh, PA	2019
NOFO Title: HEAL Initiative: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain NOFO Number: RFA-NS-19-020 Summary: The development of non-addictive pain therapeutics can help counter opioid addiction and benefit patients, including those who suffer from neuropathic pain, in particular diabetic neuropathic pain (DNP). This project’s goal is to develop a safe, efficacious, and non-addictive small-molecule drug that activates Kv7 voltage-gated potassium channels to address overactive neuronal activity in DNP. Researchers will discover Kv7 activators that favor Kv7 isoforms altered in DNP and found in dorsal root ganglia, decrease off-target side effects observed with the use of earlier non-biased Kv7 activators, and optimize the absorption, distribution, metabolism, excretion, and toxicity profiles of these activators. This screening paradigm is intended to establish a clinic-ready, well-tolerated, and widely effective product to treat neuropathic pain.
1U19NS126038-01 Show Summary	Site-directed RNA editing of Nav1.7 as a novel analgesic	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	MARINE BIOLOGICAL LABORATORY, WOODS HOLE	ROSENTHAL, JOSHUA J C (contact); DIB-HAJJ, SULAYMAN D; DUSSOR, GREGORY O; EISENBERG, ELI	New Haven, CT	2021
NOFO Title: HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development (U19 Clinical Trial Not Allowed) NOFO Number: RFA-NS-21-015 Summary: Opioids are widely used pain treatments, despite their relative ineffectiveness for chronic pain and their high potential for misuse and addiction. There is thus an urgent need for alternative, non-addictive pain treatments. Genetic and functional studies of human pain disorders and animal models of pain have validated Nav1.7, a voltage-gated sodium channel as an attractive target for new pain treatments. Currently available blockers of these channels can sometimes provide symptomatic relief for patients but have worrisome side effects affecting the brain and heart. This study aims to develop and validate an innovative site-directed RNA editing strategy that will offer the ability to create new versions of molecules to block Nav1.7, toward establishing a novel, non-addictive approach to treat chronic pain.
1R34NS126032-01 Show Summary	Stem cell-loaded microgels to treat discogenic low back pain	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	CEDARS-SINAI MEDICAL CENTER	SHEYN, DMITRIY	Los Angeles, CA	2021
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed) NOFO Number: RFA-NS-21-016 Summary: Pain caused by the degeneration of discs between vertebrae in the spine makes up a significant proportion of all chronic low back pain conditions. Although opioids are prescribed as treatments for this chronic condition, they often do not provide effective pain management, and currently there are no treatments that target the underlying disc disease. Notochordal cells mature into the cells that make up discs between vertebrae. Preliminary studies have shown that notochordal cells can be made from induced pluripotent stem cells, offering a potential replacement for diseased cells between discs. This study aims to develop a novel treatment for painful disc degeneration using a microgel/microtissue embedded with human notochordal cells made in the lab from induced pluripotent stem cells.
1R34NS126036-01 Show Summary	Synthesis of peripherally active CB1 agonists as analgesics	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	ST. LOUIS COLLEGE OF PHARMACY	MAJUMDAR, SUSRUTA (contact); DROR, RON ; GEREAU, ROBERT W	St. Louis, MO	2021
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed) NOFO Number: RFA-NS-21-016 Summary: Current medications for chronic pain are largely ineffective and rely heavily on opioids, one contributor to the nation’s opioid crisis. The endocannabinoid system that consists of cannabinoid receptors (CB1R and CB2R) and their endogenous ligands is a natural pathway in the human body and has emerged as an alternative target for developing new pain medications with few side effects. Current molecules that bind to CB1R in the brain and spinal cord have psychoactive side effects, limiting their therapeutic use for treating chronic pain. This study aims to develop new molecules to bind to CB1R tightly and selectively, are metabolically stable, and are also unable to enter the brain.
1RF1NS135580-01 Show Summary	Validation of Prenatal Rabbit Hypoxia Ischemia as a Model of Cerebral Palsy-Induced Pain	Preclinical and Translational Research in Pain Management	Development and Optimization of Non-Addictive Therapies to Treat Pain	NINDS	UNIVERSITY OF RHODE ISLAND	QUINLAN, KATHARINA ANN (contact); DETLOFF, MEGAN R	Kingston, RI	2023
NOFO Title: HEAL Initiative: Development and Validation of Non-Rodent Mammalian Models of Pain (R01 Clinical Trial Not Allowed) NOFO Number: RFA-NS-22-070 Summary: Cerebral palsy (CP), the leading cause of childhood disabilities in the United States, refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. The experience of pain is one of the most common, poorly understood, and inadequately treated conditions in CP, impairing health and quality of life for both patients and caregivers. To understand why pain and motor dysfunction occur together, a model that accurately replicates both is needed. This project will validate an established, rabbit model of CP motor dysfunction for use in studying and developing effective treatments for CP-associated pain.