This section highlights FDA-related milestones and regulatory updates for drugs developed by Definium Therapeutics (DFTX).
Over the past two years, Definium Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DT120 and MM120. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
DT120 ODT FDA Regulatory Events
DT120 ODT is a drug developed by Definium Therapeutics for the following indication: For Major Depressive Disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DT120 ODT
- Announced Date:
- May 12, 2026
- Indication:
- For Major Depressive Disorder
Announcement
Definium Therapeutics, Inc. announced that the first patient has been dosed in Ascend, its second Phase 3 study evaluating DT120 ODT (lysergide tartrate) for the treatment of major depressive disorder (MDD).
AI Summary
Definium Therapeutics, Inc. said the first patient has been dosed in Ascend, its second Phase 3 study of DT120 ODT (lysergide tartrate) for major depressive disorder (MDD). The trial will test whether the 100 microgram orally disintegrating tablet can reduce depression symptoms better than placebo. Researchers will measure the main outcome by looking at changes in the Montgomery-Åsberg Depression Rating Scale, or MADRS, at Week 6. Ascend follows earlier Phase 2b results in generalized anxiety disorder, which suggested DT120 may also have antidepressant effects. The study includes a 12-week double-blind period, and the company expects topline results in 2027. If successful, the trial could add important evidence for DT120 as a possible treatment option for people with MDD.
Read Announcement
MM120 FDA Regulatory Timeline and Events
MM120 is a drug developed by Definium Therapeutics for the following indication: For Generalized Anxiety Disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MM120
- Announced Date:
- September 4, 2025
- Indication:
- For Generalized Anxiety Disorder
Announcement
Mind Medicine announced that JAMA has published full results from the Company's positive Phase 2b study of MM120 (lysergide D-tartrate, LSD) in 198 adults with moderate-to-severe GAD.
AI Summary
Mind Medicine announced that JAMA has published full results from its positive Phase 2b study of MM120 (lysergide D-tartrate, LSD) in 198 adults with moderate-to-severe generalized anxiety disorder. This was the first randomized, placebo-controlled trial to test a single LSD dose as monotherapy across four levels (25, 50, 100, 200 µg) without any study-related psychotherapy.
The study showed a clear dose-response relationship on the Hamilton Anxiety Rating Scale after one administration, with improvements lasting through 12 weeks. MM120 at 100 µg was identified as the optimal dose, delivering a 7.6-point greater reduction in anxiety scores versus placebo at week 4 and yielding a 65% clinical response rate and 48% remission rate at week 12.
MM120 was generally well tolerated. Most treatment-related adverse events were mild to moderate, transient, and occurred on dosing day, matching the expected perceptual effects of LSD. These findings support ongoing pivotal trials of MM120.
Read Announcement- Drug:
- MM120
- Announced Date:
- April 15, 2025
- Indication:
- For Generalized Anxiety Disorder
Announcement
Mind Medicine announced that the first patient has been dosed in its Phase 3 Emerge study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment of MDD.
AI Summary
Mind Medicine (MindMed) has begun dosing the first patient in its Phase 3 Emerge study, which is testing MM120 Orally Disintegrating Tablet (ODT) – a pharmaceutically optimized form of LSD – for treating Major Depressive Disorder (MDD). In this trial, participants will receive a single 100 µg dose of MM120 ODT or a placebo, and researchers will assess changes in depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 6.
The study plans to enroll approximately 140 participants across the United States. The trial builds on promising results from a prior Phase 2b study, where significant improvements in depression scores were observed with MM120 ODT. Topline data from the 12-week double-blind period of the study is expected in the second half of 2026, highlighting the potential of this new treatment option for MDD.
Read Announcement- Drug:
- MM120
- Announced Date:
- March 6, 2025
- Indication:
- For Generalized Anxiety Disorder
Announcement
Mind Medicine (MindMed) Inc. provided an update on business highlights.
AI Summary
Mind Medicine (MindMed) Inc. provided an update on its business highlights, showcasing key milestones and progress toward future growth. The company raised approximately $250 million in 2024 through two equity financings and ended the year with cash and cash equivalents of $273.7 million. This strong financial base is expected to support operations into 2027 and beyond the first Phase 3 topline data readout for its MM120 Orally Disintegrating Tablet (ODT) in generalized anxiety disorder (GAD).
MindMed also announced significant advancements in its clinical programs. Dosing has begun in the Phase 3 Voyage and Panorama studies for MM120 ODT in GAD, with anticipated topline data in 2026. In addition, the company is on track to initiate Emerge, its first Phase 3 trial in major depressive disorder (MDD), in the first half of 2025.
Read Announcement- Drug:
- MM120
- Announced Date:
- January 30, 2025
- Indication:
- For Generalized Anxiety Disorder
Announcement
Mind Medicine (MindMed) Inc announced that the first patient has been dosed in Panorama, its second Phase 3 study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment generalized anxiety disorder (GAD).
AI Summary
Mind Medicine (MindMed) Inc. announced that the first patient has been dosed in Panorama, its second Phase 3 trial evaluating MM120 ODT. This unique formulation of LSD is being studied as a potential treatment for generalized anxiety disorder (GAD). The trial will examine the efficacy and safety of a 100 µg dose compared to a placebo, with the main result measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) score at week 12.
The Panorama study plans to enroll about 250 participants across sites in the United States and Europe. This trial builds on positive results from the earlier Phase 2b study, indicating a rapid and sustained response in patients with GAD. Topline data from the initial 12-week period is expected in the second half of 2026, representing a promising development in addressing the unmet medical needs for GAD treatment.
Read Announcement- Drug:
- MM120
- Announced Date:
- December 16, 2024
- Indication:
- For Generalized Anxiety Disorder
Announcement
Mind Medicine (MindMed) Inc announced that the first patient has been dosed in its Phase 3 Voyage study of MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD) for the treatment of GAD. .
AI Summary
Mind Medicine (MindMed) Inc. announced that the first patient has been dosed in its Phase 3 Voyage study. This trial is evaluating MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD), for the treatment of generalized anxiety disorder (GAD). The study is designed as a 52-week clinical trial with two parts. The first part is a 12-week, randomized, double-blind, placebo-controlled period where the primary endpoint is to measure changes in anxiety using the Hamilton Anxiety Rating Scale (HAM-A) at week 12. Approximately 200 participants will be enrolled in the United States. The study builds on positive results from a Phase 2b trial, and researchers expect the data from the 12-week period to be available in the first half of 2026, marking a significant step forward in exploring new treatment options for GAD.
Read Announcement- Drug:
- MM120
- Announced Date:
- December 5, 2024
- Indication:
- For Generalized Anxiety Disorder
Announcement
Mind Medicine announced that MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD), has been granted an Innovation Passport for the potential treatment of GAD under ILAP by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
AI Summary
Mind Medicine has announced that its pharmaceutically optimized formulation of lysergide D-tartrate (LSD), known as MM120 ODT, has been granted an Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). This designation is part of the Innovative Licensing and Access Pathway (ILAP) and is designed to speed up the development process and improve patient access to new treatments. The Innovation Passport provides access to several development tools, including an accelerated 150-day review for the Marketing Authorization Application and additional opportunities for input from regulatory stakeholders. The designation highlights MM120 ODT's potential as a treatment for generalized anxiety disorder (GAD), a condition that remains underdiagnosed and underserved. Mind Medicine’s efforts aim to offer a new therapeutic option for patients with GAD by bringing innovative, more effective treatment solutions to market faster.
Read Announcement- Drug:
- MM120
- Announced Date:
- July 17, 2024
- Indication:
- For Generalized Anxiety Disorder
Announcement
Mind Medicine (MindMed) Inc. announced the issuance of a new patent by the United States Patent and Trademark Office (USPTO) covering MM120 (lysergide).
AI Summary
Mind Medicine (MindMed) Inc. recently announced that the United States Patent and Trademark Office issued a new patent (USPN 12,036,220) covering its innovative MM120 ODT formulation. This patent secures the company's unique form of lysergide, detailing its pharmaceutical formulation, methods of manufacturing, and treatment procedures. Notably, it extends MindMed's intellectual property protection for MM120 until 2041.
The MM120 ODT formulation uses Catalent’s Zydis® ODT fast-dissolve technology, which is designed to provide faster absorption, improved bioavailability, and reduced gastrointestinal side effects. According to the company, these benefits could lead to a unique clinical profile and offer significant advantages for patients. MindMed's strategy aims to protect MM120 across multiple therapeutic options, highlighting its potential in treating generalized anxiety disorder and other brain health disorders.
Read Announcement- Drug:
- MM120
- Announced Date:
- June 20, 2024
- Indication:
- For Generalized Anxiety Disorder
Announcement
Mind Medicine announced the completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of MM120 (lysergic acid diethylamide [LSD] D-tartrate) into pivotal trials for the treatment of adults with GAD.
AI Summary
Mind Medicine Inc. announced that it has successfully completed the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). During the meeting, the company and the FDA reached an agreement on the requirements for moving forward with Phase 3 clinical trials of MM120, a formulation of lysergic acid diethylamide (LSD) D-tartrate. These pivotal trials will evaluate MM120’s potential for treating adults with generalized anxiety disorder (GAD), a condition that affects millions in the U.S. and around the world.
With the alignment on development strategy, Mind Medicine is on track to launch its Phase 3 program in the second half of 2024. This milestone marks an important step toward offering a new therapeutic option for those suffering from GAD.
Read Announcement
