Last reviewed 2026-05-15 · How we verify

Cannabidiol and β-Caryophyllene Patch

Humanitas Clinical and Research Center · Phase 3 active Small molecule

Cannabidiol and β-Caryophyllene Patch is a Cannabinoid and terpene combination Small molecule drug developed by Humanitas Clinical and Research Center. It is currently in Phase 3 development for Chronic pain conditions (specific indication in Phase 3 trial not publicly detailed), Neuropathic pain (potential). Also known as: Levotens Patch.

Cannabidiol and β-caryophyllene work synergistically through cannabinoid and terpene receptors to modulate pain, inflammation, and potentially neuropathic signaling.

Cannabidiol and β-caryophyllene work synergistically through cannabinoid and terpene receptors to modulate pain, inflammation, and potentially neuropathic signaling. Used for Chronic pain conditions (specific indication in Phase 3 trial not publicly detailed), Neuropathic pain (potential).

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 and β-Caryophyllene Patch
Also known as	Levotens Patch
Sponsor	Humanitas Clinical and Research Center
Drug class	Cannabinoid and terpene combination
Target	CB2 receptor, TRPV1, 5-HT1A, GPR55
Modality	Small molecule
Therapeutic area	Pain Management, Neurology, Dermatology
Phase	Phase 3

Mechanism of action

Cannabidiol (CBD) is a non-intoxicating cannabinoid that interacts with multiple targets including TRPV1, 5-HT1A, and GPR55 receptors to reduce inflammation and pain signaling. β-Caryophyllene is a sesquiterpene that acts as a selective CB2 receptor agonist, enhancing anti-inflammatory and analgesic effects. The transdermal patch formulation allows sustained local and systemic delivery of both compounds.

Approved indications

Chronic pain conditions (specific indication in Phase 3 trial not publicly detailed)
Neuropathic pain (potential)

Common side effects

Local skin irritation or erythema at patch site
Dizziness or drowsiness
Dry mouth

Key clinical trials

Therapy With Paravertebral Oxygen-ozone Injections and Topical Cannabidiol and β-Caryophyllene Patch in Neck 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:

Cannabidiol and β-Caryophyllene Patch CI brief — competitive landscape report
Cannabidiol and β-Caryophyllene Patch updates RSS · CI watch RSS
Humanitas Clinical and Research Center portfolio CI

Frequently asked questions about Cannabidiol and β-Caryophyllene Patch

What is Cannabidiol and β-Caryophyllene Patch?

Cannabidiol and β-Caryophyllene Patch is a Cannabinoid and terpene combination drug developed by Humanitas Clinical and Research Center, indicated for Chronic pain conditions (specific indication in Phase 3 trial not publicly detailed), Neuropathic pain (potential).

How does Cannabidiol and β-Caryophyllene Patch work?

Cannabidiol and β-caryophyllene work synergistically through cannabinoid and terpene receptors to modulate pain, inflammation, and potentially neuropathic signaling.

What is Cannabidiol and β-Caryophyllene Patch used for?

Cannabidiol and β-Caryophyllene Patch is indicated for Chronic pain conditions (specific indication in Phase 3 trial not publicly detailed), Neuropathic pain (potential).

Who makes Cannabidiol and β-Caryophyllene Patch?

Cannabidiol and β-Caryophyllene Patch is developed by Humanitas Clinical and Research Center (see full Humanitas Clinical and Research Center pipeline at /company/humanitas-clinical-and-research-center).

Is Cannabidiol and β-Caryophyllene Patch also known as anything else?

Cannabidiol and β-Caryophyllene Patch is also known as Levotens Patch.

What drug class is Cannabidiol and β-Caryophyllene Patch in?

Cannabidiol and β-Caryophyllene Patch belongs to the Cannabinoid and terpene combination class. See all Cannabinoid and terpene combination drugs at /class/cannabinoid-and-terpene-combination.

What development phase is Cannabidiol and β-Caryophyllene Patch in?

Cannabidiol and β-Caryophyllene Patch is in Phase 3.

What are the side effects of Cannabidiol and β-Caryophyllene Patch?

Common side effects of Cannabidiol and β-Caryophyllene Patch include Local skin irritation or erythema at patch site, Dizziness or drowsiness, Dry mouth.

What does Cannabidiol and β-Caryophyllene Patch target?

Cannabidiol and β-Caryophyllene Patch targets CB2 receptor, TRPV1, 5-HT1A, GPR55 and is a Cannabinoid and terpene combination.

Drug class: All Cannabinoid and terpene combination drugs
Target: All drugs targeting CB2 receptor, TRPV1, 5-HT1A, GPR55
Manufacturer: Humanitas Clinical and Research Center — full pipeline
Therapeutic area: All drugs in Pain Management, Neurology, Dermatology
Indication: Drugs for Chronic pain conditions (specific indication in Phase 3 trial not publicly detailed)
Indication: Drugs for Neuropathic pain (potential)
Also known as: Levotens Patch

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing