AbbVie has entered into a significant option agreement with startup Gilgamesh Pharmaceuticals, paying $65 million upfront for rights to develop next-generation psychiatric medicines based on neuroplastogen compounds. The deal structure includes potential milestone payments and option fees totaling up to $1.95 billion, marking one of the largest commitments to psychedelic-derived therapies by a major pharmaceutical company.
Novel Approach to Psychiatric Drug Development
The partnership centers on Gilgamesh's neuroplastogen platform, which aims to harness the therapeutic mechanisms of psychedelic medicines while eliminating the psychoactive effects that complicate clinical administration. Unlike traditional psychedelics such as LSD and psilocybin, these compounds are designed to improve neuroplasticity—the brain's ability to respond to changes—without causing hallucinations that require carefully controlled clinical settings.
"Significant unmet need remains for people living with psychiatric disorders and we know that to innovate in this field, we need to pursue novel technologies and approaches," said Jonathon Sedgwick, AbbVie's global head of discovery research. "We look forward to working with Gilgamesh's world-class team to advance the development of novel neuroplastogens and pave the way for additional treatment approaches in psychiatry."
Gilgamesh's Clinical Pipeline
Gilgamesh's drug discovery platform combines behavioral assessment, artificial intelligence, medical imaging, and electrophysiology to refine the biological activity of psychoactive molecules. The company's lead program, GM-1020, is a small-molecule NMDA receptor channel blocker currently in Phase 2a clinical development for major depressive disorder. This oral compound could provide an alternative to Johnson & Johnson's intranasally-administered Spravato (esketamine), which generated over $1 billion in sales last year.
The pipeline also includes GM-2505, a short-acting serotonin 5-HT2A agonist in Phase 2 trials for major depressive disorder. According to the company, GM-2505 demonstrated the ability to quickly, effectively and durably treat the most common form of depression in recent study results. Additional compounds under development include GM-5022, an oral neuroplastogen being evaluated for anxiety and depression, and GM-3009, an ibogaine analogue designed for improved safety in treating PTSD, traumatic brain injury, and substance use disorders.
Market Momentum for Psychedelic Therapies
The AbbVie-Gilgamesh partnership reflects growing pharmaceutical industry interest in psychedelic-based treatments. Joshua Schimmer, an analyst at Cantor Fitzgerald, described psychedelics as "one of the most important waves of innovation we're seeing today in biotech," noting their "transformational" potential across mental health disorders.
Recent clinical successes have bolstered investor confidence. Compass Pathways announced in June that a single dose of its psilocybin therapy significantly reduced symptoms of treatment-resistant depression in a late-stage clinical trial. Following news of the AbbVie-Gilgamesh discussions, shares of publicly traded psychedelics companies including Cybin, Mind Medicine, and GH Research rose 3% to 5%, while Atai Life Sciences and Compass Pathways saw gains exceeding 10%.
Regulatory Environment and Commercial Validation
The regulatory landscape for psychedelic therapies continues to evolve favorably. The FDA issued guidance for psychedelic drug developers in 2023, and current leadership including FDA Commissioner Martin Makary and HHS Secretary Robert F. Kennedy Jr. support accelerated testing and potential approval of these treatments.
Johnson & Johnson's Spravato has increasingly validated the commercial potential of this therapeutic class. RBC Capital Markets analysts noted that the psychedelic space is "approaching a tipping point" as late-stage clinical readouts approach and Spravato tracks toward $2 billion in annual sales.
AbbVie's Neuroscience Strategy
This partnership represents AbbVie's continued expansion into neuroscience research. The company recently completed a $9 billion acquisition of Cerevel Therapeutics for a schizophrenia therapy, invested $1.4 billion in a Johnson & Johnson-backed startup focused on brain drug technology, and took a $355 million stake in a biotech developing genetic medicines for neurological disorders.
The Gilgamesh collaboration follows the startup's successful fundraising, including a $27 million Series A in 2021 and a $39 million Series B the following year. While the specific target indications remain undisclosed, both companies confirmed the focus on mood and anxiety disorders, areas with substantial unmet medical need.
Gavin Clark-Gartner, an analyst at Evercore ISI, noted that while Spravato's success has helped de-risk psychedelic drug research, emerging biotechs will likely need to build upon the commercial infrastructure Johnson & Johnson established. "It is not necessarily flipping a switch and a one-for-one translation from Spravato to a lot of these other therapies," he cautioned.
