Palmidrol
Small molecule targets PPARA via activation
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07330765 | Jan 2026 → Oct 2027 expected | — | Abdelrahman Gaber Sayed Elkhateeb | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05766969 | Jun → Dec 2023 | diabetic polyneuropathy | Pure Green Pharmaceuticals Inc. | Unknown | No outcome recorded |
| Phase 29 trials · 1 missed | ||||||
| Phase 2 | NCT05126888 | Jun 2026 → Oct 2027 expected | Tourette syndrome | Neurothera Labs Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06273462 | Aug 2024 → Aug 2025 overdue | chronic pain syndrome | Navy Medical Center San Diego | Recruiting | No outcome recorded |
| Phase 2 | NCT06229977 | May 2023 → Jul 2025 | bipolar depression | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT05652907 | Jan → May 2023 | idiopathic mast cell activation syndrome | Quantum Biopharma | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT06063369 | Dec 2022 → Dec 2023 | bipolar depression, major depressive disorder | The Israeli Medical Center for Alzheimer's | Unknown | No outcome recorded |
| Phase 2 | NCT05246670 | May 2022 → Feb 2024 overdue | cancer, chemotherapy-induced neuropathy, hematopoietic and lymphoid cell neoplasm | Academic and Community Cancer Research United | Active not recruiting | Missed primary |
| Phase 2 | NCT04619706 | Dec 2020 → Aug 2021 | COVID-19 | Quantum Biopharma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04091789 | Sep 2019 → Mar 2020 | dysmenorrhea, migraine disorder, mood disorder | Pure Green | Unknown | No outcome recorded |
| Phase 2 | NCT03066193 | Feb 2017 → Jun 2018 | Tourette syndrome | Yale University | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05003453 | Nov 2021 → Jun 2022 | atopic eczema | RDC Clinical Pty Ltd | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05046522 | Sep 2021 → Mar 2023 | migraine disorder | RDC Clinical Pty Ltd | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07013890 | Nov 2022 → Aug 2023 | chronic prostatitis | Clinica Urologica Molinette - Città della Saliute e della Scienza | Completed | No outcome recorded |
| Phase 4 | NCT04853836 | Nov 2020 → Oct 2021 | COVID-19, anosmia | University Of Perugia | Completed | No outcome recorded |
| Phase 4 | NCT04488926 | Jul 2020 → May 2022 | fibromyalgia | Epitech Group SpA | Completed | No outcome recorded |
| Phase 4 | NCT02699281 | Oct 2015 → Jul 2016 | chronic pain syndrome | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07305519 | Apr 2026 → Apr 2027 expected | — | University of Roma La Sapienza | Recruiting | No outcome recorded |
| — | NCT07316660 | Jan → Jun 2026 overdue | — | Benha University | Not yet recruiting | No outcome recorded |
| — | NCT05182697 | Feb 2024 → May 2026 overdue | autism spectrum disorder | Neurothera Labs Inc. | Recruiting | No outcome recorded |
| — | NCT05877170 | Feb 2020 → Aug 2023 | — | University of Catania | Unknown | No outcome recorded |
| — | NCT02645461 | Jan 2014 → Jun 2015 | amyotrophic lateral sclerosis | University of Roma La Sapienza | Completed | No outcome recorded |
| — | NCT02372903 | Oct 2013 → Aug 2015 | chronic pain syndrome, endometriosis | University of Cagliari | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 0 | NCT05480072 Comparator | Nov 2022 → Jan 2025 | substance-related disorder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05317676 Comparator | May 2023 → Dec 2024 | — | University of California, Irvine | Withdrawn | No outcome recorded |
| Phase 4 | NCT05810116 Comparator | May → Dec 2023 | dysmenorrhea | RDC Clinical Pty Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-03-11 | Epitech Group SpA | Results Alzheimer: modulare il sistema immunitario per contrastare la neurodegenerazione epitech.it ↗
Lo studio, condotto su cellule in vitro, ha mostrato che la Palmitoiletanolamide è in grado di migliorare la funzionalità delle cellule dendritiche , elementi chiave nella regolazione delle risposte immunitarie anche a livello cerebrale. |
| 2025-09-18 | Epitech Group SpA | Results Una nuova prospettiva nella gestione della demenza fronto-temporale epitech.it ↗
Oltre al rallentamento della gravità globale, lo studio ha mostrato miglioramenti significativi anche nelle funzioni linguistiche e cognitive dei pazienti. |
| 2025-06-18 | Quantum Biopharma | Regulatory Singular Research Reports on Quantum BioPharma Ltd.'s Strategic Advances and Pipeline Progress issuerdirect.com ↗
Quantum BioPharma has achieved significant progress with its FSD202 program, receiving human ethics review committee (HREC) approval for a Phase 2 clinical trial targeting nociplastic pain in patients with Idiopathic Mast Cell Activation Syndrome (MCAS). |
| 2023-11-28 | Clearmind Medicine Inc. | Results Clearmind Medicine Announces Positive Results from its Weight Loss and Metabolic Disorder Program with its Proprietary Psychedelic- Based Treatment clearmindmedicine.com ↗
Similar results were also observed in groups treated by the combination of MEAI and PEA with the most prominent effects being observed when combining MEAI and PEA, particularly at 20 and 10 mg/kg. |
| 2022-09-06 | Quantum Biopharma | Regulatory FDA and Health Canada Clear IND for FSD Pharma to Proceed with Phase 2 Trial of FSD201 for Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome issuerdirect.com ↗
FDA and Health Canada Clear IND for FSD Pharma to Proceed with Phase 2 Trial of FSD201 for Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome |
| 2022-03-17 | Clearmind Medicine Inc. | Results Clearmind Medicine Announces Positive Results on CMND-100 trials clearmindmedicine.com ↗
Clearmind” or the "Company") today announced promising results from two pre-clinical trials which tested suppression of alcohol consumption in mice using its novel psychedelic-based therapeutic CMND-100, whose active pharmaceutical ingredient is MEAI. |
| 2021-05-10 | Quantum Biopharma | Regulatory FSD Pharma Announces Investigational New Animal Drug Filing With the FDA to Treat Dogs With Enteropathy issuerdirect.com ↗
The application has been accepted for review. |
| 2020-10-05 | Quantum Biopharma | Regulatory FSD Pharma Begins Phase 2 Clinical Trial to Evaluate FSD201 for the Treatment of Hospitalized COVID-19 Patients issuerdirect.com ↗
FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN) (“ FSD Pharma ” or the “ Company ”) announced that the U.S. Food and Drug Administration (“ FDA ”) has authorized the initiation of a Phase 2 study for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus (the “ FSD201 COVID-19 Trial ”). |
| 2020-09-28 | Quantum Biopharma | Regulatory FSD Pharma Begins Phase 2 Clinical Trial to Evaluate FSD201 for the Treatment of Hospitalized COVID-19 Patients issuerdirect.com ↗
FSD Pharma Begins Phase 2 Clinical Trial to Evaluate FSD201 for the Treatment of Hospitalized COVID-19 Patients |
| 2020-08-31 | Quantum Biopharma | Regulatory FSD Pharma Announces Phase 2 Clinical Trial IND Filing with the FDA to Treat Patients with COVID-19 issuerdirect.com ↗
FSD Pharma Inc. (CSE:HUGE)(NASDAQ:HUGE)(FRA:0K9A) (" FSD Pharma " or the " Company ") today announced that it has submitted to the U.S. Food and Drug Administration (" FDA" ) an Investigational New Drug Application (IND) for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus (the " FSD201 COVID-19 Trial "). |
| 2020-08-31 | Quantum Biopharma | Regulatory FSD Pharma Announces Phase 2 Clinical Trial IND Filing With The FDA to Treat Patients With COVID-19 issuerdirect.com ↗
FSD Pharma Announces Phase 2 Clinical Trial IND Filing With The FDA to Treat Patients With COVID-19 |
| 2020-06-23 | Quantum Biopharma | Results InvestmentPitch Media Video Discusses FSD Pharma's Report of Favorable Topline Results from Phase 1 First-in-Human Safety and Tolerability Study of Ultra-micronized PEA - Video Available on Investmentpitch.com issuerdirect.com ↗
The study found ultra-micronized PEA to be safe and well tolerated. |
| 2020-06-22 | Quantum Biopharma | Results FSD Pharma Reports Favorable Topline Results from Phase 1 First-in-Human Safety and Tolerability Study of Ultramicronized PEA issuerdirect.com ↗
The study found ultramicronized PEA to be safe and well tolerated. |
| 2020-06-03 | Quantum Biopharma | Regulatory FSD Pharma Receives U.S. FDA Approval to design a Phase 2a Clinical Trial to Treat Patients with Suspected or Confirmed COVID-19 Diagnosis issuerdirect.com ↗
FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN) (FRA: 0K9A) ("FSD Pharma" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has given the company permission to submit an Investigational New Drug Application (IND) for the use of FSD-201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus. |
| 2020-06-03 | Quantum Biopharma | Regulatory FSD Pharma Receives U.S. FDA Approval to Design a Phase 2a Clinical Trial to Treat Patients with Suspected or Confirmed COVID-19 Diagnosis issuerdirect.com ↗
FSD Pharma Receives U.S. FDA Approval to Design a Phase 2a Clinical Trial to Treat Patients with Suspected or Confirmed COVID-19 Diagnosis |
All press releases naming this drug 18 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Palmidrol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05246670 ↗ |
| Known as | AM 3112 | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | CannAmide | “Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily” NCT05182697 ↗ |
| Known as | FSD201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05652907 ↗ |
| Known as | Impulsin | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | Levagen+ | “Subjects will receive PEA (Levagen+) 600 capsules mg twice daily (BID) orally from Day 1 to Day 21” NCT05480072 ↗1“Palmitoylethanolamide sold as Levagen +” NCT05046522 ↗ |
| Known as | Loramine p 256 | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | mPEA | “micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules” NCT04488926 ↗ |
| Known as | N(2-hydroxyethyl) palmitide | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | NSC-23320 | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | Palmdrol prodes | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | Palmidrol component of sci-110 palmitoylethanolamide | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | Palmitamide mea | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | Palmitic acid monoethanolamide | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | Palmitic monoethanolamide | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | Palmitoylethanolamide | “Palmitoylethanolamide (PEA) is a bioactive lipid mediator similar to endocannabinoids (eCBs) that has been observed to have anti-inflammatory, analgesic, anticonvulsant,...” NCT05877170 ↗22“A sublingual tablet containing 30 mg of cannabidiol (CBD), 1 mg tetrahydrocannabinol (THC), 97 mg palmitoylethanolamide (PEA), and a 0.2 mg combination of myrcene,...” NCT04091789 ↗ “SCI-110 - a softgel capsule containing Dronabinol and Palmitoylethanolamide (PEA) in the following doses: 2.5mg Dronabinol+400mg PEA, 5mg Dronabinol+400mg PEA and 10mg Dronabinol+400mg.” NCT05126888 ↗ “The studies evaluated the following interventions: systemic corticosteroids plus intranasal corticosteroid/mucolytic/decongestant and palmitoylethanolamide plus luteolin.” PMID 36062970 ↗ Sep 2022 “A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol and Palmitoylethanolamide for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet” NCT05766969 ↗ “Effect of Palmitoylethanolamide (PEA) Compared to a Placebo on Acute Menstrual Pain in an Adult Population - a Double-blind, Crossover, Randomised Controlled Trial.” NCT05810116 ↗ “Palmitoylethanolamide (PEA), an endogenous bioactive lipid, exerts anti-inflammatory and mast-cell-stabilizing properties” NCT07305519 ↗ “Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes” NCT04488926 ↗ “One of the most widely studied NAEs is the analgesic endocannabinoid compound, palmitoylethanolamide (PEA).” NCT07330765 ↗ “Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily” NCT05182697 ↗ |
| Known as | PEA | “Palmitoylethanolamide (PEA) is a bioactive lipid mediator similar to endocannabinoids (eCBs) that has been observed to have anti-inflammatory, analgesic, anticonvulsant,...” NCT05877170 ↗10“A sublingual tablet containing 30 mg of cannabidiol (CBD), 1 mg tetrahydrocannabinol (THC), 97 mg palmitoylethanolamide (PEA), and a 0.2 mg combination of myrcene,...” NCT04091789 ↗ “SCI-110 - a softgel capsule containing Dronabinol and Palmitoylethanolamide (PEA) in the following doses: 2.5mg Dronabinol+400mg PEA, 5mg Dronabinol+400mg PEA and 10mg Dronabinol+400mg.” NCT05126888 ↗ “Palmitoylethanolamide (PEA) is a naturally occurring substance in the body with anti-inflammatory and pain-relieving properties and has been shown to be safe in previous studies.” NCT07316660 ↗ “Effect of Palmitoylethanolamide (PEA) Compared to a Placebo on Acute Menstrual Pain in an Adult Population - a Double-blind, Crossover, Randomised Controlled Trial.” NCT05810116 ↗ “Palmitoylethanolamide (PEA) is an endogenous widely distributed N-acylethanolamina involved in neuroinflammation and pain-generating processes.” NCT02699281 ↗ “Palmitoylethanolamide (PEA), an endogenous bioactive lipid, exerts anti-inflammatory and mast-cell-stabilizing properties” NCT07305519 ↗ “One of the most widely studied NAEs is the analgesic endocannabinoid compound, palmitoylethanolamide (PEA).” NCT07330765 ↗ “Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily” NCT05182697 ↗ “Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin” NCT02372903 ↗ “Palmitoylethanolamide (PEA)” NCT06229977 ↗ |
| Known as | Pea (chemical) | ChEMBL registry synonym — accepted as the source's own label CHEMBL417675 ↗ |
| Known as | umPEA | “micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules” NCT04488926 ↗ |
| Action | Activate | “PEA has potent immunoregulatory and anti-inflammatory effects by directly activating PPAR-α” NCT06063369 ↗ |
| Modality | Small molecule | “Palmitoylethanolamide (PEA) is a naturally occurring fatty acid amide” NCT06273462 ↗ |
| Route | Other | “Palmitoylethanolamide 600 mg twice daily for 10 days sublingually” NCT02372903 ↗ |
| Target | PPARA | “interacting with peroxisome proliferator-activated receptor alpha (PPAR-α)” NCT06273462 ↗ |