THERAPY DOSSIER · th-ad8ccda0826d

Co-ultramicronised palmitoylethanolamide and luteolin (co-ultraPEALut, 10:1)

Nutraceutical · Co-ultramicronized palmitoylethanolamide + luteolin (PEA-LUT); PEA is a PPAR-alpha-active fatty acid amide

Not approved Suggest a correction

Evidence & regulatory context

Mechanism: Co-ultramicronized palmitoylethanolamide + luteolin (PEA-LUT); PEA is a PPAR-alpha-active fatty acid amide
Target: Not recorded
Injury models: Spinal cord injury · Fracture · Other
Reported indication: Not recorded
First approval: Not recorded
Development stage: In trials, not approved
ChEMBL record: CHEMBL417675 ↗
ChEMBL max phase: 3 / 4 (development scale, not regulatory approval)
Synonyms: Palmitoylethanolamide; PEA; PEA-LUT; co-ultraPEALut
Note: Not recorded

Clinical trials 6

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT04489017 ↗PHASE2completed

Palmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia (RCT)

Frontotemporal Dementia

Enrolment: 50 · Results not recorded

NCT01370720 ↗PHASE2unknown

Micronised PEA + Polydatin on Intestinal Inflammation in IBS

Irritable Bowel Syndrome

Enrolment: 60 · Results not recorded

NCT06777680 ↗NAnot yet recruiting

Palmitoylethanolamide and Luteolin on Early Functional Recovery in Acute Stroke Patients Treated with Thrombectomy

Acute Ischemic Stroke

Enrolment: 60 · Results not recorded

NCT05311852 ↗NAcompleted

PEA Co-ultramicronized With Luteolin (PEA-LUT) on Frontal Lobe Functions in Long Covid

COVID-19 · Cognitive Deficit

Enrolment: 34 · Results not recorded

NCT02372903 ↗NAcompleted

Efficacy of Palmitoylethanolamide-polydatin on Chronic Pelvic Pain in Endometriosis

Endometriosis

Enrolment: 30 · Results not recorded

NCT05867693 ↗NAunknown

Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome: RCT

Irritable Bowel Syndrome

Enrolment: 70 · Results not recorded

Preclinical evidence 3

3 studies reported at therapy level; 3 evidence entries itemised.

PMID 26143261 ↗2015Reported benefit

The Association of Palmitoylethanolamide with Luteolin Decreases Autophagy in Spinal Cord Injury.

MouseSpinal cord injuryCompressionCD1Malen = 30 mice per group across four groupsIntraperitoneal1 mg/kg1 and 6 h after injury

Model: Spinal cord compression at T6 to T7 by an aneurysm clip with a 24 g closing force following T5 to T8 laminectomy

Injury increased Beclin-1 and MAP-LC3 and reduced p62; co-ultraPEALut reduced Beclin-1 and MAP-LC3, restored p62, reduced co-localisation with neuronal and astrocytic markers and improved tissue structure, indicating inhibition of excessive autophagy. No percentage magnitudes were reported.

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.88. Machine-extracted fields require source verification.

PMID 28594885 ↗2017Reported benefit

Effect of a new formulation of micronized and ultramicronized N-palmitoylethanolamine in a tibia fracture mouse model of complex regional pain syndrome.

MouseFractureTibiaCD1Malen = n = 10 per group across 4 groupsOral300 mg/kg micronized PEA plus 600 mg/kg ultramicronized PEA…First dose 1 hour after fracture surgery

Model: Closed distal tibia fracture of the right hindlimb with casting for 28 days, a model of complex regional pain syndrome type I

Oral PEA-MPS started 1 h after tibia fracture and continued for 28 days reduced mechanical and thermal nociception and subjective pain, and improved callus formation, bone density and fracture healing. It lowered mast cell density, NGF, TNF-alpha, IL-1beta, nitrotyrosine, PAR and Bax while raising…

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.95. Machine-extracted fields require source verification.

PMID 28676456 ↗2017Reported benefit

Palmitoylethanolamide and Polydatin combination reduces inflammation and oxidative stress in vascular injury.

MouseOtherC57BL/630 mg/kg

Model: Complete ligation of the left carotid artery for 14 days (neointimal hyperplasia model of vascular injury)

PEA/PLD 30 mg/kg reduced vessel damage, adhesion molecule expression, proinflammatory cytokine production, iNOS and PAR formation, NF-kappaB expression and apoptosis activation after carotid ligation.

Extraction: extract · Supplied extraction confidence: 0.65. Machine-extracted fields require source verification.

Loading the evidence…