Clinical Trials

Numerous clinical trials evaluate palmitoylethanolamide across various indications, spanning early feasibility studies, Phase 1 through Phase 4 trials, and non-interventional designs. These studies target chronic pain conditions—such as low back pain, irritable bowel syndrome, and pelvic pain syndromes—alongside metabolic and gastrointestinal inflammatory disorders. Sponsored by academic research centers, public health foundations, and pharmaceutical entities such as Pfizer and Janssen, these investigations encompass completed, actively recruiting, and not yet recruiting protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07609810 NOT_YET_RECRUITING
Ulcerative Colitis (UC)
Ain Shams University
 2026-08-15
NCT07330765 NOT_YET_RECRUITING
Total Knee Replacement
Abdelrahman Gaber Sayed Elkhateeb
 2026-01-13 PHASE1; PHASE2
NCT07772141 RECRUITING
Chronic Low-back Pain
Beni-Suef University
 2026-01-01
NCT07680101 NOT_YET_RECRUITING
Degenerative Joint Disease of Knee; Rheumatoid Arthritis
Universita di Verona
 2026-06
NCT07681063 NOT_YET_RECRUITING
Postoperative Cognitive Dysfunction
Fondazione IRCCS San Gerardo dei Tintori
 2026-06
NCT06717867 RECRUITING
Healthy; Safety
RDC Clinical Pty Ltd
 2025-01-22 PHASE2
NCT07305519 RECRUITING
Preterm Labor
University of Roma La Sapienza
 2026-04-01
NCT07315516 RECRUITING
Sleep Disorder (Disorder); Stress; Anxiety
RDC Clinical Pty Ltd
 2026-04-07 PHASE2
NCT07377409 NOT_YET_RECRUITING
Neuropathic Pain Management; Diabetic Neuropathies, Painful; Palmitoylethanolamide
Azienda di Servizi alla Persona di Pavia
 2026-09-15
NCT06777680 NOT_YET_RECRUITING
Acute Ischemic Stroke AIS
Ospedali Riuniti Trieste
 2025-01
NCT07689214 RECRUITING
Diabete Type 2
University of Roma La Sapienza
 2024-07-17
NCT07316660 NOT_YET_RECRUITING
Pain After Extracorporeal Shock Wave Lithotripsy; Palmitoylethanolamide
Benha University
 2026-01-01
NCT07804758 COMPLETED
PK in Healthy Volunteers; Liposomal Encapsulation; Palmitoylethanolamide
S&R Farmaceutici S.p.A.
 2026-04-13
NCT07359534 RECRUITING
Exercise Recovery
University of Westminster
 2025-03-10
NCT06187090 RECRUITING
Autism; Autism Spectrum Disorder; Autism Spectrum Disorder High-Functioning; Asperger Syndrome; Depressive Symptoms; Anxiety State
University of Udine
 2023-09-01
NCT06273462 UNKNOWN
Chronic Pain
Navy Medical Center San Diego
 2024-08-05 PHASE2
NCT06229977 COMPLETED
Bipolar Depression
Rodrigo Machado-Vieira, MD, PhD, MSc
 2023-05-17 PHASE2
NCT06432569 COMPLETED
Irritable Bowel Syndrome With Diarrhea
University of Padova
 2024-03-08
NCT06694337 COMPLETED
Low Back Pain
Liaquat University of Medical & Health Sciences
 2025-01-28
NCT05480072 COMPLETED
Opioid Use Disorder
Brigham and Women's Hospital
 2022-11-01 EARLY_PHASE1
NCT05877781 UNKNOWN
Dyspepsia and Other Specified Disorders of Function of Stomach
Universitaire Ziekenhuizen KU Leuven
 2021-11-29
NCT05317676 WITHDRAWN
Tibial Fractures; Fibula Fracture; Knee Fracture
University of California, Irvine
 2023-05 PHASE2
NCT06037993 UNKNOWN
Clinical High Risk for Psychosis; Ultra High Risk for Psychosis; Attenuated Psychotic Symptoms
University of Udine
 2022-11-01
NCT07631455 COMPLETED
Autism; Smell Dysfunction; Taste Alterations; Sensorial Disturbance
University of Campania Luigi Vanvitelli
 2024-04-01
NCT05246670 ACTIVE_NOT_RECRUITING
Chemotherapy-Induced Peripheral Neuropathy; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
Academic and Community Cancer Research United
 2022-05-16 PHASE2
NCT05406726 COMPLETED
Osteoarthritis, Knee
University of Maryland, Baltimore
 2023-03-22
NCT06225440 COMPLETED
Wellness, Psychological; Well-Being, Psychological
University of Westminster
 2022-09-01
NCT06063369 UNKNOWN
Bipolar Depression; Major Depressive Disorder
The Israeli Medical Center for Alzheimer's
 2022-12-21 PHASE2
NCT05810116 COMPLETED
Menstrual Pain
RDC Clinical Pty Ltd
 2023-05-19 PHASE4
NCT05766969 UNKNOWN
Diabetic Peripheral Neuropathic Pain
Pure Green Pharmaceuticals Inc.
 2023-06-05 PHASE1; PHASE2
NCT05867693 UNKNOWN
Irritable Bowel Syndrome
University of Roma La Sapienza
 2023-04-19
NCT06040164 Not yet recruiting
PreDiabetes|Diabetes Mellitus Type 2|Obesity|Oral Dysbiosis|Mouth Disease
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
 2023-10-01 --
NCT07013890 COMPLETED
Chronic Prostatitis (CP); Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Prostatitis/ Pelvic Pain Syndrome
Clinica Urologica Molinette - Città della Saliute e della Scienza
 2022-11-02 PHASE4
NCT05753111 COMPLETED
Muscle Recovery; Muscle Soreness
KU Leuven
 2023-02-16
NCT05046522 COMPLETED
Migraine
RDC Clinical Pty Ltd
 2021-09-01 PHASE3
NCT04489017 COMPLETED
Frontotemporal Dementia
I.R.C.C.S. Fondazione Santa Lucia
 2019-06-01 PHASE2
NCT05984771 COMPLETED
Diabetic Neuropathies; Diabetes Mellitus; Dietary Supplement
Aristotle University Of Thessaloniki
 2021-01-10
NCT05003453 COMPLETED
Eczema, Atopic
RDC Clinical Pty Ltd
 2021-11-29 PHASE2; PHASE3
NCT04912921 COMPLETED
Inflammation; COVID19
Arizona State University
 2020-10-20
NCT04488926 COMPLETED
Fibromyalgia
Epitech Group SpA
 2020-07-16 PHASE4
NCT05311852 COMPLETED
Fatigue; Cognitive Deficit; COVID-19; Neurophysiologic Abnormality
Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy
 2021-08-16
NCT05242718 COMPLETED
Immunity Disorders
Immunoflex Therapeutics Inc.
 2021-01-10
NCT04568876 COMPLETED
Covid19
Epitech Group SpA
 2020-10-23 PHASE4
NCT05849792 Completed
Exercise|Physical Fitness|Depression|Adult ALL|Psychological
University of Cadiz|Consejería de Salud y Familia (Junta de Andalucía)|Institute of Biomedical research and innovation of Cádiz (INIBICA)
 2019-09-01 Not Applicable
NCT03066193 COMPLETED
Tourette Syndrome
Yale University
 2017-02-01 PHASE2
NCT03564379 Completed
Healthy
Janssen Research & Development LLC
 2018-06-12 Phase 1
NCT04088084 COMPLETED
Glaucoma
Fondazione IRCCS Policlinico San Matteo di Pavia
 2015-03-09 PHASE2
NCT02699281 COMPLETED
Chronic Pain
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
 2015-10 PHASE4
NCT02372903 COMPLETED
Endometriosis; Chronic Pelvic Pain
University of Cagliari
 2013-10
NCT02645461 COMPLETED
Amyotrophic Lateral Sclerosis
University of Roma La Sapienza
 2014-01
NCT01491191 UNKNOWN
Chronic Post-operative Pain
University of Modena and Reggio Emilia
 2012-01
NCT01370720 UNKNOWN
Irritable Bowel Syndrome
MARIA CRISTINA COMELLI
 2010-02 PHASE2
NCT01092845 Completed
Healthy|Sleep
Pfizer
 2010-04 Phase 1
NCT01370720 Unknown status
Irritable Bowel Syndrome
MARIA CRISTINA COMELLI|CM&D Pharma Limited
 2010-02 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-07-14)

Check the Palmitoylethanolamide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Palmitoylethanolamide is an endogenous fatty acid amide that selectively binds and activates peroxisome proliferator-activated receptor-alpha (PPAR-α), suppressing pro-inflammatory cascades, mast cell degranulation, and neuroinflammatory cytokine signaling. This targeted anti-inflammatory and neuroprotective activity provides the mechanistic foundation for its clinical evaluation in mitigating chronic pain, neuropathic low back pain, and gastrointestinal inflammatory disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.