Lykos Therapeutics
| Company type | Public benefit corporation |
|---|---|
| Industry | Pharmaceutical |
| Founded | 2014 |
| Founder | Rick Doblin |
| Headquarters | United States |
Area served | Worldwide |
Key people | Michael Mullette (CEO), Rick Doblin (Founder) |
| Products | MDMA-assisted psychotherapy treatments |
| Owner | Multidisciplinary Association for Psychedelic Studies (MAPS) |
Number of employees | ~100 (prior to August 2024 layoffs) |
| Website | lykostherapeutics |
Lykos Therapeutics, previously known as the MAPS Public Benefit Corporation (MAPS PBC), operates as a public benefit corporation focused on developing MDMA ("ecstasy") for therapeutic applications. Established in 2014 and primarily owned by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the organization adopted the name Lykos Therapeutics in January 2024.
Development program for MDMA-assisted psychotherapy
Initially, MAPS raised $140 million to support its MDMA treatment development for PTSD but did not meet its full funding targets, leading to a strategic pivot. After rebranding to Lykos Therapeutics, the company obtained an additional $100 million in capital. Founder Rick Doblin recognized that exclusive reliance on philanthropic contributions was inadequate. Although initially following an "anti-patent" approach, MAPS PBC filed patent applications in December 2022 concerning MDMA particle sizes; these patents were published in June 2024 but ultimately rejected by the USPTO in January 2025, denying patent protection.
In December 2023, Lykos finalized Phase III clinical trials for MDMA-assisted psychotherapy targeting post-traumatic stress disorder (PTSD) and filed a New Drug Application (NDA) with the United States Food and Drug Administration (FDA). The trial outcomes showed marked superiority over placebo, with remission rates between 67% and 71% for MDMA-assisted therapy compared to 32% to 48% for placebo-assisted therapy.
FDA denial of MDMA approval and ensuing developments
In June 2024, an FDA advisory committee consisting of 11 members overwhelmingly opposed approval of MDMA-assisted psychotherapy for PTSD, voting 9-2 against its efficacy and 10-1 doubting that benefits outweighed risks. Issues raised included concerns about functional unblinding, cardiovascular risks associated with MDMA, limited data on abuse potential, and allegations of professional bias. The psychedelic-focused media outlet Psymposia faced accusations of attempting to sway the hearing, though these assertions remain contested. Despite having approved the phase 3 trial design back in 2017, the FDA adhered to the panel’s guidance and rejected Lykos Therapeutics' NDA in August 2024, requesting additional evidence on safety and efficacy, including a third phase 3 trial. Doblin and Lykos contended that many FDA requirements could be fulfilled using existing datasets combined with post-market studies.
Subsequent to the FDA’s rejection, three scientific articles authored by MAPS and Lykos researchers on MDMA-assisted psychotherapy were withdrawn from Psychopharmacology due to ethical breaches involving misconduct by an unlicensed therapist during a Canadian phase 2 trial. Although MAPS and Lykos had disclosed these issues publicly and to regulators years earlier, they initially did not exclude related data from their analyses. In response, MAPS terminated its relationship with the therapist and strengthened ethical policies prohibiting sexual relationships between patients and therapists.
In August 2024, Lykos Therapeutics announced a workforce reduction affecting approximately 75% of its nearly 100 employees; concurrently, founder Rick Doblin stepped down from its board but continued his role at MAPS. CEO Amy Emerson resigned in September 2024 and was succeeded by Michael Mullette. By January 2025, five additional board members departed and were replaced by new appointees.
Despite these challenges, Lykos reported constructive discussions with the FDA during meetings held in October 2024 and January 2025, maintaining progress toward regulatory approval for MDMA-assisted psychotherapy. Doblin remains hopeful about eventual FDA endorsement but expects the process may extend over several more years. In January 2025, billionaire investor Antonio Gracias—formerly on Tesla’s board and known as an associate of Elon Musk—proposed a $100 million investment aimed at assuming control of Lykos Therapeutics and strengthening its collaboration with MAPS to advance FDA approval efforts. Doblin has expressed support for this proposal. By March 2025, reports indicated that Gracias’ acquisition and subsequent leadership transition back to Doblin were underway.
Market competition
Multiple firms are actively pursuing the development of MDMA-assisted psychotherapy targeting PTSD and various other psychiatric disorders. Nevertheless, as of late 2024, none have obtained official regulatory authorization. Companies such as MindMed and Tactogen are investigating different entactogen compounds beyond MDMA or its racemic form, with the goal of enhancing both safety profiles and therapeutic effectiveness in psychiatric applications.
See also
- List of investigational hallucinogens and entactogens
- Psychedelic therapy
- I Feel Love: MDMA and the Quest for Connection in a Fractured World
- Usona Institute
External links
- Lykos Therapeutics official website
- POD 108: Rachel Nuwer on the history of MDMA (including FDA advisory panel vote) - The Hamilton Morris Podcast
- POD 110: MDMA psychiatrist Dr. Casey Paleos on the FDA's rejection of MDMA - The Hamilton Morris Podcast
- POD 115: MDMA researcher Dr. Ingmar Gorman on Lykos Phase III - The Hamilton Morris Podcast