& development

Clinical trials

Midomafetamine (MDMA) capsules have not been approved by any regulatory agency. The safety and efficacy of midomafetamine have not been established for the treatment of PTSD.

Our development program

At Lykos Therapeutics, we have completed two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of midomafetamine (MDMA) capsules used in combination with psychological intervention versus placebo with psychological intervention in participants diagnosed with severe or moderate to severe post-traumatic stress disorder (PTSD), respectively. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine.1,2

Given the unique properties of MDMA, we plan to explore additional clinical research into the use of MDMA-assisted therapy in other mental health conditions.3

Expanded access

Prior to regulatory approval by the FDA, patients can gain access to an investigational treatment by participating in clinical trials. A clinical trial is a research program conducted with patients to evaluate the safety and efficacy of an investigational drug. In cases where a patient is not able to enroll in a clinical trial or there are no ongoing clinical trials available, doctors may seek a potential pathway called “expanded access” (also known as “compassionate use”) for their patients. Expanded access can allow patients with a serious or life-threatening disease or condition for which there are no comparable or satisfactory therapies to gain access to investigational drugs outside of clinical trials. It’s important to know that investigational drugs have not yet been determined to be safe and effective for their specific use and have not been approved by the FDA for prescription use.

Lykos received FDA authorization to establish an expanded access program for MDMA-assisted therapy for up to 50 patients with PTSD who met specific eligibility criteria. That program has been fully enrolled and is no longer accepting applications. We appreciate the urgent need for new and effective treatments for PTSD and are focused on pursuing FDA approval for MDMA-assisted therapy to help make it more widely available to people with PTSD. Consistent with the 21st Century Cures Act, Lykos may revise this expanded access policy at any time. In the meantime, if you have additional questions about Lykos’ expanded access policy, please contact us at [email protected].

Investigator initiated trials

In addition to conducting our own research on our investigational therapies, we provide support for external clinical research in areas that help discover new opportunities to address unmet medical needs. We will consider applications proposing to investigate midomafetamine (MDMA) capsules. To submit your research concept, please visit our online portal and click on the link below.


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Please email [email protected] with any questions about our IIT program. Read our Privacy Policy.

To learn about any ongoing studies with investigational MDMA-assisted therapy, please visit

1. Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: arandomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021Jun;27(6):1025-1033. doi:10.1038/s41591-021-01336-3.
2. Mitchell JM, Ot’alora MG et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized,placebo-controlled phase 3 trial. Nat Med. 2023 Sept 14 doi: 10.1038/s41591-023-02565-4.
3. Sessa B, Higbed L, NuttD. A Review of 3,4-methylenedioxymethamphetamine (MDMA)-AssistedPsychotherapy. Front Psychiatry. 2019 Mar 20;10:138. doi: 10.3389/fpsyt.2019.00138.