Solvonis Therapeutics (Formerly Awakn Life Sciences) is a clinical-stage biotechnology company developing therapeutics to treat addiction, with a near-term focus on Alcohol Use Disorder. Protocols are licensed out to clinics around the world.
FACILITIES:
CLINICAL TRIALS: Yes.
DRUG PROGRAMS TARGET: Alcohol use disorder and substance abuse.
SUBSTANCE FOCUS: Ketamine
NEWS & PARTNERSHIPS:
2020
The company signed a binding investment agreement to acquire a controlling interest in Mandala Therapy, the UK-based psychedelic clinical practice run by acclaimed author, researcher and consultant psychiatrist, Dr. Ben Sessa. Dr. Sessa will become Awakn’s Chief Medical Officer and will open the UK’s first psychedelic-assisted psychotherapy clinic soon. As part of the agreement, Dr. Sessa is also building training pathways that will open access for psychiatrists and psychologists across the country.
The company joined Drug Science and its mission, DS was founded by David Nutt in 2010 in the UK and works to provide evidence for widespread application of psychedelic drugs within public health models. Its aim is to break the barriers of 50 years of medical censorship by creating a rational and enlightened approach to psychedelic research and clinical treatment. The group shall be designing campaigns that will ultimately lead to the rescheduling of all psychedelic drugs for research and medical purposes.
2021
The company acquired exclusive rights to the data from the phase IIa Bristol Imperial MDMA in Alcoholism Study from Imperial College London.
The company acquired Axonklinikken, a leading ketamine-assisted psychotherapy clinic in Oslo, Norway. Axon will be renamed Awakn Clinics Oslo and will serve as the Nordic hub from which Awakn plans to expand its clinical network across the region.
The company announced that the findings from its phase 2 A/B psychotherapy intervention study “Ketamine in the Reduction of Alcoholic Relapse” was published in the American Journal of Psychiatry.
The company announced a lease of 10 years for a 5,000 sq ft 8 treatment room clinic, its 2nd clinic in the UK, in London.
The company appointed Evotec as its new chemical entity research partner and the selection of David Nutt as the program lead.
The company launched Awakn Digital, a unit focused on using advanced analytics to improve the effectiveness of psychedelic-assisted psychotherapy in treating addiction. The company also deepened its partnership with the University of Exeter to apply the latest developments in digital, technology and innovation in healthcare to tackle addiction. The agreement deepens the partnership by establishing a framework for the two organisations to work together to use advanced data analytics to improve the effectiveness of ketamine-assisted psychotherapy in treating addiction. The first project will use a pattern classifier to detect identity shifts following ketamine treatment in Awakn clinics. The project builds on the work of Dr Koschate-Reis who holds an EPSRC Innovation Fellowship “Psychological Identity in a Digital World” and has been working on developing digital signatures of identity shift in recovery in people with problematic substance use in collaboration with local drug and alcohol services.
The company initiated the first study ever investigating ketamine in gambling addiction.
The company acquired proprietary research data on next generation candidate MDMA and Ketamine molecules from Prof. David Nutt’s Equasy Enterprises. Professor Nutt was also named Head of Research to lead Awakn’s next generation psychedelic molecule development programme.
2022
The company expanded into the US with its first licensing partnership agreement with Revitalist. The agreement will enable Revitalist to treat clients with Awakn’s proprietary ketamine-assisted therapy for the treatment of AUD. Awakn will provide access to its proprietary therapeutics and training to Revitalist practitioners and Revitalist will pay Awakn an annual fee and a revenue share per treatment.
The company signed its 2nd licensing partnership agreement with Wellbeings and expands commercial operations into Canada. The agreement will enable Wellbeings to treat their patients with Awakn’s proprietary ketamine-assisted therapy for the treatment of AUD as a co-morbidity for pain. Under the terms of the license agreement with Wellbeings, Awakn will provide access to its proprietary therapeutics for AUD and training to Wellbeings practitioners and in Wellbeings will pay Awakn an annual subscription and a revenue share per treatment.
The company signed its 3rd licensing partnership agreement in North America with Nushama, bringing the company’s Ketamine-assisted therapy treatment for AUD to Nushama’s clinic in New York City. Awakn will provide access to its proprietary therapeutics and training to Nushama practitioners and Nushama will pay Awakn an annual fee and a revenue share per treatment.
The company’s phase III trial in partnernership with the University of Exeter which explores the use of ketamine-assisted therapy for the treatment of severe AUD will be delivered across 7 NHS sites in the UK and is the first psychedelic phase III trial to ever receive government funding as NIHR approved grant funding for 66% of the costs of the approximately 3.75 million CAD in total.
The company announced the signing of a 5-year lease for its 2nd clinic, a 1,400 sq ft 3-treatment room clinic in Trondheim, Norway.
The company signed a 5-year lease for a larger, 6-treatment room clinic in Oslo, replacing the existing clinic in Oslo and providing the potential to perform research and clinical trials on site.
The company signed a 12-month option agreement with a leading drug development, manufacturing, and delivery systems company to in-license a proprietary formulation and route of administration for ketamine.
The company signed a drug development agreement with Catalent, the agreement will focus on investigating a market-ready proprietary formulation and optimized delivery route for MDMA Zydis orally disintegrating tablet technology. The agreement will allow Awakn to conduct feasibility studies using Zydis technology for addiction, including substance and behavioural addictions, as well as other mental health disorders, including anxiety, depression, post-traumatic stress disorder and eating disorders.
The company secured funding from Innovate UK to identify the quickest and most cost-effective route to market in both the UK and the US for Awakn’s lead program – proprietary ketamine-assisted therapy for treating AUD. Awakn’s activities will be delivered in collaboration with Veristat.
The company received an ethical committee approval to expand its existing ketamine study beyond gambling disorder to include binge eating disorder, compulsive sexual behavior and internet gaming disorder.
The company signed a Memorandum of Understanding with MAPS where Awakn will explore a data licensing agreement with MAPS to support Awakn’s Phase 2b and planned Phase 3 studies for MDMA-assisted therapy for AUD in Europe. Awakn and MAPS will also assess a partnership to secure marketing authorization/regulatory approval for the ethical commercialization of MDMA-assisted therapy for the treatment of AUD in Europe.
Professor Morgan, Awakn’s Head of Ketamine-Assisted Therapy for Addiction was named one of the 16 most influential women shaping the future of psychedelics by Insider.
2023
The company sold the company operating its London clinic to Awakn Via Amitis and announced an agreement with the same for the exclusive license of selected elements of Awakn’s healthcare services intellectual property within the UK and a non-exclusive license for Awakn Kare within the UK, in consideration for a share of Awakn London Limited’s revenue being payable to Awakn.
The company sold its 2 clinics businesses in Norway which were sold in a management buyout meaning Awakn exits from its healthcare services enabling the company to solely focus on its biotechnology research and development programs. Awakn will receive a fee from the new owners for the acquisition of both clinics and executed an agreement with the new owners for the license of selected elements of Awakn’s healthcare services intellectual property and a license for Awakn Kare in Norway, Awakn will in turn receive a share of revenue from the clinics on an ongoing basis.
Dr. Ben Sessa resigned from his role as Head of Psychedelic Medicine at Awakn and agreed to transfer his 49% stake of Awakn Bristol Limited which operates Awakn Clinics Bristol, to Awakn Life Sciences, resulting in the company ownning 100% of the clinic.
The company signed its 4th licensing partnership agreement in North America with with Ken Starr MD Wellness Group, an addiction treatment facility in California. This is the first licensing partnership Awakn has signed with a dedicated addiction treatment provider. Awakn will provide access to, and training for its proprietary therapeutics package ‘Awakn Kare’ to Ken Starr practitioners and Ken Starr MD Wellness Group will pay Awakn a fee and a revenue share per treatment.
The company announced that the UK Medicines and Healthcare products Regulatory Agency has granted Awakn an Innovation Passport as part of the Innovative Licensing and Access Pathway for its proprietary ketamine-assisted therapy for the treatment of Severe Alcohol Use Disorder.
The company signed its first licensing partnership agreement in Europe with a Portuguese healthcare consortium currently operating in stealth-mode. The agreement will support the Portuguese partner’s strategy to launch a new chain of medical-psychedelic clinics in Portugal, with the first location in Lisbon. Awakn will provide the Portuguese partner with an exclusive license for the use of its clinical protocols for the treatment of AUD, Anxiety, Depression, Eating Disorders and PTSD in Portugal for a period of 10 years. Awakn will train the Portuguese partner’s clinicians in the delivery of these protocols and will provide ongoing strategic, operational, risk management and marketing support.
2024
The company announced it has signed a global licensing agreement with LTS Lohmann Therapie-Systemeor a proprietary S-ketamine formulation, administered sublingually via an oral thin film. Awakn will have global exclusivity of its use in the treatment of Addiction, Anxiety Disorders, and Eating Disorders. The licensing agreement includes terms related to milestone payments, royalties, and commercial manufacturing of the drug product by LTS.
The company announced the launch of a licensing partnership agreement in North America with RivusWellness and Research Institute, based in Oklahoma City. Awakn provides access to its proprietary therapeutics and training to the Rivus practitioners and Rivus will pay Awakn an annual fee and a revenue share per treatment.
The company announced a collaboration agreement with Graft Polymer focused on developing Awakn’s novel aminoindane new chemical entity series program. The collaboration involves the joint development and potential commercialization of the Aminoindane NCEs, with an initial phase focused on completing certain pre-clinical research activities. Graft will initially contribute £300,000 and expertise in novel drug delivery systems to potentially enhance the bioavailability and improve the pharmacokinetics of the Aminoindane NCEs. Awakn will contribute intellectual property, relevant small molecule development expertise, and management resources. Future funding of the collaboration is intended to be split equally between Awakn and Graft, and Awakn has agreed to grant Graft a royalty of initially 40% of the future net income generated by the Aminoindane NCEs, such royalty to be adjusted based on the actual proportional split between the parties of future funding.
The company selected Eurofins Discovery to conduct initial in vitro pharmacology testing for the company’s aminoindane series.
The company announced a new partnership with the University of Nottingham to conduct in vivo testing of its aminoindane series as part of its preclinical program. The research will explore the therapeutic potential of Awakn’s aminoindane, or psychoactive, series in enhancing social cognition and pro-social behaviors, particularly for trauma-related mental health disorders such as PTSD.
The company entered into a binding letter to acquire Awakn Life Sciences.
After the binding LOI, Graft Polymer, a company focused on polymer technology decided to shift its business entirely toward biotech and therapeutics for mental health and addiction and changed their name to Solvonis Therapeutics.
2025
The company announced the initiation of an AI-supported drug discovery program drug focused on its proprietary central nervous system compound library which it acquired from its acquisition of Awakn Life Sciences. The new programme will apply AI and computational modelling techniques to enable data-driven asset prioritisation, structure–activity relationship analysis and translational hypothesis generation with the objective of accelerating the identification and optimisation of high-value development candidates within the library and it will firstly focus on indications in depression and stimulant use disorders.
The company’s AI-discovered drug candidate, SVN-015, was accepted into the US National Institute on Drug Abuse’s Addiction Treatment Discovery Program, where NIDA will fully fund and conduct preclinical safety and efficacy evaluations for the treatment of methamphetamine and cocaine use disorders.
The company received an allowance with no objections or rejections for US patent 18/838,986 – Bridged Ring Compounds and Their Therapeutic Use as CNS Agents. The claims cover composition of matter and methods of use for a family of novel morpholine-class compounds, originally developed by Awakn Life Sciences.
The company secured £1 M through 3 of its largest existing shareholders, with the capital raised for lead identification and early-stage candidate validation in two core therapeutic areas: major depressive disorder (MDD) and stimulant use disorder.
The company secured £1.25 M involving a group of institutional and strategic investors with the capital raised for enabling the company to broaden its R&D scope to include neurology, deepening its work across the three strategic pillars of addiction, psychiatry, and neurology.
The company announced the acceptance of SVN-015 into the U.S. National Institute on Drug Abuse (NIDA) Addiction Treatment Discovery Program. This marks Solvonis’ formal expansion into stimulant use disorders, a major public health crisis with no currently approved pharmacological treatments.
2026
Solvonis received a Notice of Allowance from the USPTO for a series of compounds within its SVN-SDN-14 PTSD discovery program, providing a vital intellectual property foundation as the company works to develop best-in-class serotonin, dopamine, and noradrenaline modulators.
The company announced the expansion of its investigational compound SVN-015 into the treatment of depression, following positive results in preclinical rodent models. The compound, a novel Serotonin-Dopamine Reuptake Inhibitor (SDRI), demonstrated antidepressant-like activity comparable to the established gold-standard SSRI, fluoxetine, after 14 days of once-daily dosing. By targeting pathways linked to mood regulation, motivation, and reward processing, the company intends to develop SVN-015 as a once-daily oral therapy for patients who do not respond adequately to traditional SSRIs, specifically addressing symptoms like anhedonia and reduced motivation.
The company has selected SVN-114 as the lead candidate for its SVN-SDN-14 PTSD discovery program. This decision follows successful preclinical studies conducted by Evotec SE, which confirmed that the compound provides balanced modulation of serotonin (SERT), dopamine (DAT) and noradrenaline (NET), key neurotransmitters involved in social behavior and emotional regulation. By targeting pathways associated with trust and empathy, the company aims to develop SVN-114 as a therapy that helps patients rebuild interpersonal relationships and engage more effectively in psychotherapy.
The company was granted US patent 12,590,077 by the USPTO covering a monoamine modulator compound series from its PTSD discovery program. As a composition of matter patent, this provides the strongest level of protection by covering the actual underlying molecules, rather than just their use or manufacture. This grant builds upon the company’s January 2026 patent allowance and further strengthens the intellectual property foundation surrounding the SVN-114 lead candidate.
The company was granted US patent 12,595,269 by the USPTO covering a chemically distinct monoamine modulator series from its proprietary PTSD discovery program. This composition of matter patent secures exclusive rights to the underlying molecules—designed to modulate serotonin, dopamine and noradrenaline transporters and is expected to remain in force until February 2043.