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Cannabidiol oral solution
Cannabidiol oral solution is a Cannabinoid Small molecule drug developed by University of California, San Diego. It is currently in Phase 3 development for Seizures associated with Dravet syndrome, Seizures associated with Lennox-Gastaut syndrome, Seizures associated with tuberous sclerosis complex. Also known as: Placebo, Arvisol.
Cannabidiol modulates endocannabinoid signaling and multiple other pathways to reduce seizure activity and provide neuroprotective effects.
Cannabidiol modulates endocannabinoid signaling and multiple other pathways to reduce seizure activity and provide neuroprotective effects. Used for Seizures associated with Dravet syndrome, Seizures associated with Lennox-Gastaut syndrome, Seizures associated with tuberous sclerosis complex.
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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 | Cannabidiol oral solution |
|---|---|
| Also known as | Placebo, Arvisol |
| Sponsor | University of California, San Diego |
| Drug class | Cannabinoid |
| Target | Multiple targets including TRPV1, 5-HT1A, GPR55, and endocannabinoid system modulation |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Cannabidiol (CBD) is a non-intoxicating cannabinoid that interacts with multiple molecular targets including TRPV1 channels, 5-HT1A receptors, and GPR55, while also modulating endocannabinoid tone. Its anticonvulsant properties are thought to arise from enhancement of GABAergic inhibition, reduction of excitatory glutamatergic transmission, and anti-inflammatory effects in the central nervous system. The exact mechanism remains incompletely understood but involves both cannabinoid receptor-dependent and receptor-independent pathways.
Approved indications
- Seizures associated with Dravet syndrome
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with tuberous sclerosis complex
Common side effects
- Somnolence
- Diarrhea
- Fatigue
- Decreased appetite
- Elevated liver transaminases
- Rash
- Insomnia
Key clinical trials
- Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder (PHASE2)
- CBD for Pain Following Orthopedic Shoulder Surgery (PHASE1, PHASE2)
- Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
- A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex (PHASE4)
- Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution (PHASE4)
- A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex (PHASE4)
- A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures (PHASE1)
- Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden (PHASE2)
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:
- Cannabidiol oral solution CI brief — competitive landscape report
- Cannabidiol oral solution updates RSS · CI watch RSS
- University of California, San Diego portfolio CI
Frequently asked questions about Cannabidiol oral solution
What is Cannabidiol oral solution?
How does Cannabidiol oral solution work?
What is Cannabidiol oral solution used for?
Who makes Cannabidiol oral solution?
Is Cannabidiol oral solution also known as anything else?
What drug class is Cannabidiol oral solution in?
What development phase is Cannabidiol oral solution in?
What are the side effects of Cannabidiol oral solution?
What does Cannabidiol oral solution target?
Related
- Drug class: All Cannabinoid drugs
- Target: All drugs targeting Multiple targets including TRPV1, 5-HT1A, GPR55, and endocannabinoid system modulation
- Manufacturer: University of California, San Diego — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Seizures associated with Dravet syndrome
- Indication: Drugs for Seizures associated with Lennox-Gastaut syndrome
- Indication: Drugs for Seizures associated with tuberous sclerosis complex
- Also known as: Placebo, Arvisol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing