Tampa, Florida, U.S., October 8, 2026
Psilera Inc., a biopharmaceutical company developing next-generation neuroplastogens and psychedelic-inspired therapies, has announced the initiation of Phase 2 of its National Institutes of Health (NIH)-supported research program investigating potential treatments for alcohol use disorder (AUD). The research is supported through the Small Business Innovation Research (SBIR) program and funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The program focuses on exploring the potential of non-hallucinogenic psilocybin derivatives to reduce alcohol consumption and advance new approaches to addiction treatment. The milestone follows the completion of Phase 1 of the grant-supported research, with Psilera reporting promising preclinical findings and anticipating a Phase 1a clinical trial in 2027.
Psilera Advances NIH-Funded Addiction Research
Psilera began the first phase of its NIH-supported research program in October 2025. Following the completion of this phase, the company received the green light to initiate Phase 2 of the grant-funded work, allowing the research program to progress toward further investigation of potential treatments for alcohol use disorder. The research is being conducted in collaboration with Dr. Danielle Gulick at the University of South Florida, with a focus on evaluating the effects of non-hallucinogenic psilocybin derivatives on alcohol consumption in preclinical models. According to Psilera, the research team has observed promising results in reducing alcohol consumption in vivo, supporting continued investigation of these compounds.
Jackie von Salm, Ph.D., Chief Scientific Officer of Psilera, highlighted the importance of continued NIH support in exploring the therapeutic potential of non-hallucinogenic compounds for addiction disorders. The company aims to investigate whether these candidates can offer a different approach to addressing the biological mechanisms associated with addictive behaviors. The research remains at the preclinical stage. Initiating Phase 2 of the NIH grant does not mean that Psilera has begun a Phase 2 human clinical trial. Instead, it represents the next phase of the grant-supported research program intended to generate further evidence ahead of clinical development.
Non-Hallucinogenic Compounds Target Alcohol Use Disorder
Alcohol use disorder is a medical condition characterized by difficulty controlling or stopping alcohol consumption despite negative effects on health, relationships, work, or other aspects of life. The condition exists across a spectrum of severity and can involve persistent vulnerability to relapse. It can also be associated with lasting changes in brain function that affect reward processing, behavior, and decision-making. Psilera is investigating neuroplastogens, a class of compounds being studied for their potential to promote changes in neural connections and brain function. Traditional psychedelic compounds have attracted scientific interest for their potential effects on neural plasticity, but their hallucinogenic effects can present practical challenges for therapeutic development and clinical use.
By exploring non-hallucinogenic derivatives of psilocybin, Psilera aims to investigate whether potentially useful neuroplastic effects can be achieved without the characteristic hallucinogenic experience associated with traditional psychedelics. The research could help clarify whether this approach has potential in addiction-related conditions, including AUD. However, the company’s reported preclinical findings do not establish that these compounds are effective or safe treatments for people with alcohol use disorder. Further research is required to understand their mechanisms, appropriate dosing, safety profile, and potential clinical benefits.
Psilera Prepares for Planned Clinical Development
The company has stated that its grant-supported research has advanced its preclinical work ahead of an anticipated Phase 1a clinical trial in 2027. Before any candidate can become an established treatment, clinical studies must evaluate safety and tolerability in humans and determine whether further testing is justified. Psilera’s broader pipeline includes PSIL-006, a candidate designed to deliver neuroplastic effects without the limitations associated with traditional psychedelic side effects. The company’s research strategy focuses on developing next-generation compounds for conditions where existing treatment approaches may leave significant unmet medical needs. The NIH-supported AUD program represents one component of Psilera’s efforts to translate neuroscience research into potential therapeutic candidates. Continued preclinical investigation may help determine which compounds merit advancement into clinical studies, although the timing and progression of any trial will depend on research findings and applicable regulatory requirements. The initiation of Phase 2 of the NIH grant marks a research milestone rather than proof of clinical efficacy. Future studies will be needed to establish whether Psilera’s non-hallucinogenic compounds can provide a safe and effective treatment option for people affected by alcohol use disorder.
Source: Psilera press release



