Drugs in development · updated 11 November 2026
Epidiolex: clinical trials and development status
As of 11 November 2026 Epidiolex is in 8 active clinical trials (recruiting or ongoing, phases I–III) for 10 diseases. The most advanced phase is III.
Authorisation
- EU yes, since 19 Sep 2019 (EMA)
- Italy yes (EU authorisation)
- Germany yes (EU authorisation)
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
A phytocannabinoid derived from Cannabis species, which is devoid of psychoactive activity, with analgesic, anti-inflammatory, antineoplastic and chemopreventive activities. Upon administration, cannabidiol (CBD) exerts its anti-proliferative, anti-angiogenic and pro-apoptotic activity through various mechanisms, which likely do not involve signaling by cannabinoid receptor 1 (CB1), CB2, or vanilloid receptor 1. CBD stimulates endoplasmic reticulum (ER) stress and inhibits AKT/mTOR signaling, thereby activating autophagy and promoting apoptosis. In addition, CBD enhances the generation of reactive oxygen species (ROS), which further enhances apoptosis. This agent also upregulates the expression of intercellular adhesion molecule 1 (ICAM-1) and tissue inhibitor of matrix metalloproteinases-1 (TIMP1) and decreases the expression of inhibitor of DNA binding 1 (ID-1). This inhibits cancer cell invasiveness and metastasis. CBD may also activate the transient receptor potential vanilloid type 2 (TRPV2), which may increase the uptake of various cytotoxic agents in cancer cells.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Mucopolysaccharidosis III | II–III | 1 | NCT06333041 |
| Opioid-related disorders | III | 1 | NCT07148206 |
| Autism spectrum disorder | II | 1 | NCT04517799 |
| Autistic Disorder | II | 1 | NCT04517799 |
| Brain stem infarction | II | 1 | NCT07778810 |
| Knee osteoarthritis | II | 1 | NCT06234631 |
| Rotator cuff tear | I–II | 1 | NCT06381791 |
| Seizures | I | 1 | NCT07918469 |
| Tobacco smoking | I | 1 | NCT07001930 |
| Tobacco use disorder | I | 1 | NCT07001930 |
Everything on Epidiolex
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 11 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.