Definium Therapeutics (Previously known as MindMed.)

The company has developed a compound designed for halting the effects of LSD, working as an off-switch.

DRUG PROGRAMS TARGET: Treatment-resistant depression, major depressive disorder, treatment-resistant depression, opioid use disorder, cognitive impairment associated with schizophrenia and generalized anxiety disorder.

SUBSTANCE FOCUS: Psilocybin, 5-MEO-DMT, Psilocin, DMT, Ibogaine, R-MDMA, LSD.

CLINICAL TRIALS: Yes.

NEWS & PARTNERSHIPS:

2021

The company announced a strategic research collaboration with Sphere Health to collect and analyze multimodal data to improve the understanding of a variety of biomarkers associated with mental illnesses including anxiety and affective disorders.

The company announced a collaboration with Forian to develop best practices for using real-world evidence information to help improve the health and lives of psychiatric patients.

The company joined the Critical Path Institute’s Patient-Reported Outcome Consortium to assist in the development of new approaches to advance medical innovation and regulatory science.

The company announced that it will participate in and financially support the Digital Medicine Society’s Digital Health Measurement Collaborative Community, an effort to develop best practices and streamline the medical field’s approaches to measuring health using digital technologies.

The company announced a partnership with Datavant where MindMed will use Datavant’s privacy-protecting technology to link MindMed’s clinical trial data to external data from both clinical and real-world sources. The company plans to use Datavant’s linking technology across various stages of the drug lifecycle including discovery, clinical development, and commercialization.

The company launched a program to develop R-MDMA for the treatment of social anxiety and functioning in diagnoses, including Autism Spectrum Disorder.

The company executed on a memorandum of understanding regarding the launch of an exclusive collaborative development program with Nextage to optimize the delivery of certain psychedelic drug candidates, leveraging Nextage’s proprietary Brain Targeting Liposome System delivery technology, for which it has an exclusive license. MindMed and Nextage will initially collaborate to optimize the delivery of drug products based on noribogaine and ultimately other ibogaine derivatives and will share development costs and intellectual property arising from the collaboration. Pursuant to the MoU, the parties will jointly pilot the development of a drug product based on noribogaine with the parties sharing the development costs equally. Nextage also granted to MindMed an exclusive, non-transferable, sublicensable license to all intellectual property, and the use of all new data, study results, know-how, arising from the pilot program to make submissions to those regulators whose approval is required in order to market a product. MindMed and Nextage shall each retain all rights to any intellectual property and inventions owned by them prior to the commencement of the pilot program, and to any of their rights unrelated to the pilot program. MindMed and Nextage shall jointly own all new data, study results, and know-how developed from the Pilot Program. If the two companies fail to agree on the further development or application of any jointly owned know-how, whether patentable or not, within 12 months of initiating the pilot program, then each shall be entitled, subject to some conditions, to pursue independently the further development and commercialization of such know-how.

The company announced Project Angie for the advancement of the development of psychedelics, including LSD, to treat pain conditions.

The company entered into a letter of intent to partner with The Chopra Foundation to educate and build public awareness around the use of psychedelic medicines to treat mental illness, remove outdated stigmas, and ultimately research mental wellbeing approaches that can be used in psychedelic related psychotherapy. The two organizations plan to design and conduct research together surrounding altered states of consciousness, psychedelic psychotherapy, and their overall impact on mental wellbeing. Beyond psychedelics, as part of this research, MindMed intends to explore ways for therapists to integrate evidence-based digital therapeutics and digital measurement technology into their routine practice. In addition, MindMed and the Chopra Foundation plan to advance research that targets understanding the role that the mind-body connection, metabolic health, psychedelics, and deeper understandings of consciousness can play into maintenance of overall wellbeing and mental health.

2023

The company entered into a license agreement with Catalent for its Zydis technology for use in the development of MindMed’s lead product candidate MM-120. The agreement gives MindMed exclusive rights for the use of the Zydis technology to develop all salt and polymorphic forms of lysergide in the United States, United Kingdom, and European Union among other key territories.

2024

FDA Breakthrough Therapy Designation for MM120 program for the treatment of generalized anxiety disorder.

The company was included in both the Russell 2000 and Russell 3000 indexes.

The company was included in the Nasdaq Biotechnology Index.

The company was granted an Innovation Passport by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its MM120 orally disintegrating tablet, an optimized form of LSD being developed to treat generalized anxiety disorder (GAD).

2025

The company published Phase 2b results in JAMA demonstrating that a single 100 µg dose of its investigational MM120 (lysergide D-tartrate) produced statistically significant, rapid, and durable improvements in generalized anxiety disorder (GAD) compared to placebo. As the first randomized, placebo-controlled study of its kind, the trial confirmed a clear dose-response relationship, with the 100 µg cohort achieving a 65% clinical response rate and 48% remission rate at Week 12. The treatment was well-tolerated, with adverse events primarily limited to the dosing day and consistent with the expected effects of the drug.

The company presented data at Psych Congress 2025 revealing a high prevalence of suicidal ideation (SI) among individuals with GAD. An analysis of over 75,000 respondents showed that 48% of those with severe GAD reported daily SI, and rates of SI were significantly higher in patients presenting with both GAD and major depressive disorder (MDD). These findings underscore the urgency for improved suicide risk screening in patients with anxiety disorders and support the company’s ongoing clinical focus on developing effective interventions for these high-burden populations.

2026

The company rebranded to Definium Therapeutics from MindMed.

The company launched an educational campaign called Rerouting Minds which was designed to increase awareness and provide scientific context regarding the potential of pharmaceutical-grade LSD in treating severe mental health disorders. By offering information on the history of the substance, its mechanism of action in the brain and current clinical research findings, the company aims to engage healthcare providers, policymakers and advocates to foster an informed understanding of how rigorous psychedelic research may offer a new path forward for patients currently underserved by existing treatment options.

The company published a study in the Journal of Mood and Anxiety Disorders revealing that the prevalence of diagnosed Generalized Anxiety Disorder (GAD) in the US rose from 5.4% in 2020 to 6.6% in 2023, with a three-year cumulative prevalence of 10.3%. The findings, based on healthcare claims data, highlight a growing patient population, disproportionately affecting women, and a significant overlap with Major Depressive Disorder (MDD). By emphasizing that there has been no new drug approval for GAD since 2007 and that existing treatments often involve limiting side effects, the study underscores an urgent clinical need for the more effective and accessible treatment options the company is currently developing.