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Cannabidiol (CBD) Extract
Cannabidiol (CBD) Extract is a Cannabinoid receptor modulator Small molecule drug developed by Milton S. Hershey Medical Center. It is currently in Phase 3 development for Seizure disorders (epilepsy), Anxiety disorders, Chronic pain and inflammation. Also known as: Hemp Supplement.
Cannabidiol modulates endocannabinoid signaling and multiple receptor pathways to reduce inflammation, anxiety, and seizure activity.
Cannabidiol modulates endocannabinoid signaling and multiple receptor pathways to reduce inflammation, anxiety, and seizure activity. Used for Seizure disorders (epilepsy), Anxiety disorders, Chronic pain and inflammation.
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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 (CBD) Extract |
|---|---|
| Also known as | Hemp Supplement |
| Sponsor | Milton S. Hershey Medical Center |
| Drug class | Cannabinoid receptor modulator |
| Target | CB1 receptor, CB2 receptor, 5-HT1A receptor, TRPV1 receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology, Psychiatry, Immunology |
| Phase | Phase 3 |
Mechanism of action
CBD acts as a negative allosteric modulator of CB1 and CB2 cannabinoid receptors and interacts with serotonin (5-HT1A), vanilloid (TRPV1), and glycine receptors. These interactions produce anti-inflammatory, anxiolytic, and anticonvulsant effects without the psychoactive properties of THC. The exact therapeutic mechanism varies by indication but generally involves modulation of neuroinflammation and excitatory neurotransmission.
Approved indications
- Seizure disorders (epilepsy)
- Anxiety disorders
- Chronic pain and inflammation
Common side effects
- Fatigue
- Diarrhea
- Changes in appetite
- Hepatotoxicity
- Drug-drug interactions via CYP3A4/CYP2C19 inhibition
Key clinical trials
- EFFECTS OF A FULL SPECTRUM CANNABIS EXTRACT WITH DIFFERENT DOSES OF CBD AND THC ON THE MODULATION OF FIBROMYALGIA: A PILOT, MULTICENTER, OPEN LABEL CLINICAL TRIAL (FRIDINHA) (PHASE1, PHASE2)
- CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy (PHASE1)
- Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden (PHASE2)
- Cannabidiol and Alcohol Use Disorder Phenotypes (PHASE2)
- Pharmacokinetic Evaluation of a Natural CBD Extract (NA)
- Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study (PHASE1, PHASE2)
- Efficacy and Safety of Revodiol Calming Cream® in Atopic Dermatitis. (NA)
- Tolerability and Efficacy of CBD Extract for RLS Treatment (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 (CBD) Extract CI brief — competitive landscape report
- Cannabidiol (CBD) Extract updates RSS · CI watch RSS
- Milton S. Hershey Medical Center portfolio CI
Frequently asked questions about Cannabidiol (CBD) Extract
What is Cannabidiol (CBD) Extract?
How does Cannabidiol (CBD) Extract work?
What is Cannabidiol (CBD) Extract used for?
Who makes Cannabidiol (CBD) Extract?
Is Cannabidiol (CBD) Extract also known as anything else?
What drug class is Cannabidiol (CBD) Extract in?
What development phase is Cannabidiol (CBD) Extract in?
What are the side effects of Cannabidiol (CBD) Extract?
What does Cannabidiol (CBD) Extract target?
Related
- Drug class: All Cannabinoid receptor modulator drugs
- Target: All drugs targeting CB1 receptor, CB2 receptor, 5-HT1A receptor, TRPV1 receptor
- Manufacturer: Milton S. Hershey Medical Center — full pipeline
- Therapeutic area: All drugs in Neurology, Psychiatry, Immunology
- Indication: Drugs for Seizure disorders (epilepsy)
- Indication: Drugs for Anxiety disorders
- Indication: Drugs for Chronic pain and inflammation
- Also known as: Hemp Supplement
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing