Zelira’s Zenivol™, the World’s First Clinically Validated Cannabinoid Medication for Insomnia, Achieves Regulatory Approval in Germany
July 21, 2022
Zelira Therapeutics Ltd
(ASX: ZLD, OTC-QB: ZLDAF), a global leader in the research, development and commercialization of clinically validated cannabinoid medicines, is pleased to announce that its groundbreaking insomnia medication Zenivol
has achieved formal approval from German regulatory authority BfArM to launch in the German medical cannabis market.
is the world’s first and only
, pharmaceutical-grade, cannabis-based sleep medication. Zenivol
‘s clinical research achieved the highest level of scientific review when it was peer reviewed in the
Journal of Sleep
. It is currently available by prescription in
under the country’s legal cannabis regulations.
“The formal approval of Zenivol
by BfArM in
marks a major milestone for Zelira;
is one of the largest global markets for cannabinoid-based medicines, and also one of the highest quality global regulatory markets for pharmaceuticals,” says Zelira CEO Dr.
. “We look forward to working with our partner, Adjupharm, in launching Zenivol
and supporting patients and physicians in treating chronic insomnia in a safe and effective manner. With formal regulatory approval for Zenivol
now received in
, we continue to progress activities to license Zenivol
into other global markets.”
Zelira Therapeutics Ltd (ASX: ZLD, OTCQB: ZLDAF)
is a leading global therapeutic medical cannabinoid company with access to the world’s largest and fastest growing cannabinoid medicine markets. Zelira owns a portfolio of proprietary revenue generating products and a pipeline of candidates undergoing clinical development that are positioned to enter global markets.
The Company is focused on developing branded cannabinoid-based medicines for the treatment of a variety of medical conditions in its Rx business, including insomnia, autism and chronic non-cancer pain.
The Company has two proprietary formulations under the HOPE
brand that are generating revenues in
and have been licensed in
, with other states in the US expected to follow. Zelira is also generating revenue in
from its proprietary and patented Zenivol
, a leading cannabinoid-based medicine for treatment of chronic insomnia. Zenivol
has successfully completed the world’s first Phase
clinical trial for chronic insomnia where it was found to be a safe and effective treatment.
In 2020, Zelira partnered with SprinJene
Natural to develop and commercialize natural and organic oral care products under the SprinjeneCBD brand, as part of Zelira’s OTC business. The SprinjeneCBD toothpaste product is the first of several scientifically formulated, hemp-derived, oral care products containing cannabinoids and based on the proprietary and patented technology of Blackseed oil and Zinc.
The Company conducts its work in partnership with world-leading researchers and organizations including
; the Telethon Kids Institute in
; the University of
; St. Vincent’s Hospital in
; and the Children’s Hospital of
the United States
has more than 30 years of experience as a service provider for the pharmaceutical industry. Since then, the range of products and services has expanded enormously to focus on contract manufacturing for importers of pharmaceuticals in the EU. Adjupharm’s range of services include the production and marketing of pharmaceutical dietary supplements.
In 2018, Adjupharm began pioneering work in the cannabis sector in
and has all the relevant licenses for the contract manufacturing of medical cannabis. Adjupharm uses its experience in the manufacture of medical cannabis to deliver high quality products to pharmacies and pharmaceutical wholesalers. Adjupharm has been a subsidiary of International Medical Cannabis (IMC) since 2019 (
). It combines the best of
: a spirit of innovation, many years of know-how in the cannabis industry, state-of-the-art technologies, security and reliability in deliveries, knowledge of the German market and knowledge of the needs of patients.
View original content to download multimedia:
SOURCE Zelira Therapeutics