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Low-Dose Cannabidiol
Low-Dose Cannabidiol is a Cannabinoid Small molecule drug developed by Wayne State University. It is currently in Phase 3 development for Anxiety disorders, Epilepsy, Neuroinflammatory conditions. Also known as: EPIDIOLEX®.
Low-dose cannabidiol modulates endocannabinoid signaling and reduces neuroinflammation through CB1/CB2 receptor interactions and non-receptor pathways.
Low-Dose Cannabidiol has been studied for various conditions, including fractures, seizures, acute radicular back pain, and musculoskeletal pain, in clinical trials. It is a small molecule that functions as a cannabinoid CB1 receptor negative allosteric modulator, which is a specific mechanism of action.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | Low-Dose Cannabidiol |
|---|---|
| Also known as | EPIDIOLEX® |
| Sponsor | Wayne State University |
| Drug class | Cannabinoid |
| Target | CB1 receptor, CB2 receptor, 5-HT1A receptor, TRPV1 channel |
| Modality | Small molecule |
| Therapeutic area | Neurology, Psychiatry, Immunology |
| Phase | Phase 3 |
Mechanism of action
Cannabidiol (CBD) is a non-intoxicating cannabinoid that interacts with cannabinoid receptors and multiple other molecular targets including serotonin receptors, TRPV1 channels, and adenosine receptors. At low doses, it exerts anti-inflammatory, anxiolytic, and neuroprotective effects by modulating endocannabinoid tone and reducing neuroinflammatory cascades. The low-dose formulation is designed to optimize therapeutic benefit while minimizing potential adverse effects associated with higher CBD exposures.
Approved indications
- Anxiety disorders
- Epilepsy
- Neuroinflammatory conditions
Common side effects
- Fatigue
- Diarrhea
- Changes in appetite
- Headache
- Drug-drug interactions via CYP3A4 inhibition
Key clinical trials
- Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder (PHASE3)
- Safety and Pharmacokinetics of Cannabidiol in Healthy Volunteers (PHASE1)
- Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving (PHASE2, PHASE3)
- A Study of Atorvo+™ in Healthy Adult Participants (PHASE1)
- Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement (PHASE3)
- Cannabidiol After Multi-Trauma for Pain and Opioid Therapy (PHASE2)
- CBD-Microglia PET Study (EARLY_PHASE1)
- Cannabidiol and Management of Endometriosis Pain (PHASE3)
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:
- Low-Dose Cannabidiol CI brief — competitive landscape report
- Low-Dose Cannabidiol updates RSS · CI watch RSS
- Wayne State University portfolio CI
Frequently asked questions about Low-Dose Cannabidiol
What is Low-Dose Cannabidiol?
How does Low-Dose Cannabidiol work?
What is Low-Dose Cannabidiol used for?
Who makes Low-Dose Cannabidiol?
Is Low-Dose Cannabidiol also known as anything else?
What drug class is Low-Dose Cannabidiol in?
What development phase is Low-Dose Cannabidiol in?
What are the side effects of Low-Dose Cannabidiol?
What does Low-Dose Cannabidiol target?
Related
- Drug class: All Cannabinoid drugs
- Target: All drugs targeting CB1 receptor, CB2 receptor, 5-HT1A receptor, TRPV1 channel
- Manufacturer: Wayne State University — full pipeline
- Therapeutic area: All drugs in Neurology, Psychiatry, Immunology
- Indication: Drugs for Anxiety disorders
- Indication: Drugs for Epilepsy
- Indication: Drugs for Neuroinflammatory conditions
- Also known as: EPIDIOLEX®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing