ZYN001 – THC Pro-Drug Patch

Being Developed in Fibromyalgia and Peripheral Neuropathic Pain

ZYN001 is a  pro-drug of THC that enables effective transdermal delivery via a patch. A Phase 1 clinical program for ZYN001 was initiated in the first half of 2017. ZYN001 is patent-protected through 2031. Learn more about pro-drugs.

Addressing Limitations of Current Treatments

Challenge: Oral administration
Oral administration can lead to limitations in safety and efficacy including low bioavailability, inconsistent plasma levels and significant first-pass liver metabolism. (First-pass liver metabolism refers to the process by which the liver breaks down therapeutics ingested directly or indirectly through the gastrointestinal system, such as through oral or oral mucosal delivery methods, allowing only a small amount of drug to be absorbed into the circulatory system.)

Potential Benefit of ZYN001:
Transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and potentially allowing for a lower dose to achieve efficacy and better tolerability profile.

Challenge: THC delivered orally causes high peak levels of THC in the blood, leading to increased psychoactive side effects

Potential Benefit of ZYN001:
ZYN001 may have an improved tolerability profile because of more consistent blood levels with fewer peaks and valleys.

Challenge: Oral THC is dosed multiple times a day

Potential Benefit of ZYN001:
ZYN001 may provide once-daily dosing with an easy-to-apply patch.

Challenge: Botanically derived cannabinoids
Botanical cannabinoids create significant challenges for drug manufacturers because of the natural resources and security measures required to grow Cannabis, as well as the strict batch controls required by regulatory agencies in pharmaceutical manufacturing.

Potential Benefit of ZYN001:
Our product candidates are synthetically manufactured per FDA/CGMP regulations. We believe synthetic manufacturing provides consistent potency and eliminates impurities in the product.


What Is a Pro-Drug?

Pro-drugs are drugs administered in an inactive or less active form and designed to enable more effective delivery, and then converted into a different form through a normal metabolic process.

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Fibromyalgia

Fibromyalgia is a chronic health problem that causes pain throughout the body and other symptoms such as fatigue and cognitive (memory or thought) problems. Approximately 5.6 million patients in the US battle fibromyalgia.

Fibromyalgia patient resources


Peripheral Neuropathic Pain

Neuropathic pain is defined as pain initiated or caused by a primary lesion or dysfunction of the central or peripheral nervous systems. In patients with peripheral neuropathic pain, the pain is a symptom of another disease that has caused nerve damage—such as a herniated disc (lower back pain), diabetes (diabetic neuropathy), cancer (neuropathic cancer pain), or herpes zoster infection (postherpetic neuralgia)—but it is recognized as a clinical condition on its own. Because the damage does not involve the brain or spinal cord, the resulting neuropathic pain is defined as peripheral. Approximately 14.0 million patients in the US battle peripheral neuropathic pain.

Peripheral neuropathic pain patient resources