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Palmitoylethanolamide (PALMIDROL)
Palmitoylethanolamide (generic name: PALMIDROL) is a drug. It is currently in Phase 3 development.
Palmitoylethanolamide works by binding to the G-protein coupled receptor 55, which helps regulate inflammation and pain.
Palmitoylethanolamide is a small molecule with the synonyms AM 3112, FSD-201, IMPULSIN, LEVAGEN, LORAMINE P 256, and N(2-HYDROXYETHYL) PALMITIDE. It has been studied in clinical trials for various conditions, including Autism Spectrum Disorder, Inflammation, COVID-19, Dermatologic Disorders, and Injury Due to Laser.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | PALMIDROL |
|---|---|
| Target | Cannabinoid receptor 2, Cannabinoid receptor 1, G-protein coupled receptor 55 |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 3 |
Mechanism of action
Imagine your body's pain and inflammation response like a fire alarm. When the alarm is triggered, it sends a signal to the brain, which can lead to pain and discomfort. Palmitoylethanolamide helps to turn off the fire alarm by binding to a specific receptor, reducing the signal sent to the brain and alleviating pain and inflammation.
Approved indications
Common side effects
Key clinical trials
- Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids) in Diabetic Subjects With Neuropathic Pain. (NA)
- Training Health Recovery and Improvement Via Levagen+® Evaluation (NA)
- Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial
- Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty (PHASE1,PHASE2)
- Palmitoylethanolamide vs Ibuprofen for Pain After ESWL (NA)
- Sleep and Stress Study (PHASE2)
- The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth: (NA)
- Nutritional Supplement for Treating Chemotherapy Induced Neuropathy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Palmitoylethanolamide CI brief — competitive landscape report
- Palmitoylethanolamide updates RSS · CI watch RSS
Frequently asked questions about Palmitoylethanolamide
What is Palmitoylethanolamide?
How does Palmitoylethanolamide work?
What is the generic name of Palmitoylethanolamide?
What development phase is Palmitoylethanolamide in?
What does Palmitoylethanolamide target?
Related
- Target: All drugs targeting Cannabinoid receptor 2, Cannabinoid receptor 1, G-protein coupled receptor 55
- Therapeutic area: All drugs in Pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing