Zelira’s Zenivol(TM), the World’s First Clinically Validated Cannabinoid Medication for Insomnia, Achieves Regulatory Approval in Germany

<br /> Zelira’s Zenivol™, the World’s First Clinically Validated Cannabinoid Medication for Insomnia, Achieves Regulatory Approval in Germany<br />

PR Newswire



July 21, 2022

/PRNewswire/ —

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

clinically validated

, 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.

Oludare Odumosu

. “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



Washington D.C.

, 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

Curtin University




Western Australia

; the Telethon Kids Institute in


; the University of

Western Australia

, in


; St. Vincent’s Hospital in

Melbourne, Australia

; and the Children’s Hospital of


(CHOP) in

the United States


Adjupharm GmbH

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.

Media Contact (Zelira Therapeutics):

GVM Communications

Brenda Loughery

[email protected]

Gia Morón

[email protected]

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SOURCE Zelira Therapeutics

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