This section highlights FDA-related milestones and regulatory updates for drugs developed by atai Life Sciences (ATAI).
Over the past two years, atai Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BPL-003, COMP360, ELE-101, EMP-01, and VLS-01. 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.
BPL-003 FDA Regulatory Timeline and Events
BPL-003 is a drug developed by atai Life Sciences for the following indication: In Patients With Treatment Resistant Depression.
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:
- BPL-003
- Announced Date:
- July 1, 2025
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
atai Life Sciences and Beckley Psytech Limited jointly announced positive topline results from the eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 (intranasal mebufotenin (5-MeO-DMT) benzoate) in patients with treatment-resistant depression (TRD).
AI Summary
Atai Life Sciences and Beckley Psytech Limited recently announced positive topline results from an eight-week, quadruple-masked Phase 2b clinical trial. The study evaluated the efficacy and safety of a single dose of BPL-003—a nasal spray formulation of mebufotenin benzoate—in patients with treatment-resistant depression. Both the 8 mg and 12 mg doses showed rapid and statistically meaningful reductions in depressive symptoms compared to a 0.3 mg active control, with improvements noticeable as early as Day 2 and maintained through Week 8. The trial met its primary endpoint, along with all key secondary endpoints, and demonstrated a strong safety profile as most adverse events were mild or moderate.
Based on these results, the 8 mg dose has been selected for advancement into Phase 3 clinical development. This achievement further strengthens the strategic partnership between atai Life Sciences and Beckley Psytech as they work together to develop a global leader in in-clinic, psychedelic-based mental health therapies.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- May 20, 2025
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
atai Life Sciences announced positive topline data from Part 2 of Beckley Psytech's Phase 2a study (NCT05660642) of BPL-003 (mebufotenin benzoate), for treatment-resistant depression (TRD).
AI Summary
Atai Life Sciences announced positive topline data from Part 2 of Beckley Psytech’s Phase 2a study (NCT05660642) evaluating BPL-003 (mebufotenin benzoate) for treatment-resistant depression. In this study, a single dose of BPL-003 was given alongside selective serotonin reuptake inhibitors (SSRIs) to 12 patients with moderate-to-severe depression who had not responded to at least two previous treatments. The results showed rapid and durable antidepressant effects lasting up to three months after dosing, with a mean reduction of 18 points in the Montgomery-Asberg Depression Rating Scale observed as early as the day after dosing. BPL-003 was well-tolerated by patients, and they were discharged within an average of less than two hours after dosing. These promising results suggest that BPL-003 could offer a commercially scalable approach to alleviate treatment-resistant depression.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- March 5, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
atai Life Sciences announced that Topline results from the core stage of the Phase 2b clinical trial are expected in mid-2025
AI Summary
Atai Life Sciences announced important progress in its global Phase 2b clinical trial for BPL-003, a treatment for patients with treatment-resistant depression. The trial's core stage is an eight-week, quadruple-masked and dose-finding study, designed to test the safety and effectiveness of a single dose of the drug. About 196 patients are enrolled at 38 sites across six countries, and they are being evaluated using standard depression rating scales. The trial examines both medium (8mg) and high (12mg) doses compared to a very low dose.
The company expects topline results from this core stage in mid-2025. These results will be a key milestone in assessing BPL-003’s potential to deliver rapid and lasting antidepressant effects, which could transform treatment options for individuals facing difficult-to-treat depression.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- March 5, 2025
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
atai Life Sciences announced the completion of patient enrollment in the eight-week, double-blind, core stage of the global Phase 2b clinical trial evaluating BPL-003 (mebufotenin benzoate) in patients with treatment-resistant depression (TRD).
AI Summary
Atai Life Sciences announced it has completed patient enrollment in the eight-week, double-blind core stage of its global Phase 2b trial testing BPL-003 (mebufotenin benzoate) for treatment-resistant depression. The trial is evaluating how a single dose of either 8mg or 12mg of BPL-003 compares to a sub-perceptual dose for both safety and effectiveness. Patients with moderate-to-severe depression who have not responded to at least two prior treatments are enrolled at 38 sites across six countries.
Earlier Phase 2a studies suggested that a single dose of BPL-003 can lead to rapid and lasting antidepressant effects, with many patients recovering quickly enough to be discharged from the clinic in less than two hours. Topline results of the Phase 2b core stage are expected in mid-2025, offering further insight into the drug’s potential impact on treatment-resistant depression.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- January 28, 2025
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
atai Life Sciences announced positive topline results from Beckley Psytech's Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe alcohol use disorder (AUD).
AI Summary
Atai Life Sciences announced promising topline results from Beckley Psytech’s Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe alcohol use disorder. The study tested a single dose of BPL-003, a synthetic intranasal 5-MeO-DMT benzoate formulation, combined with relapse prevention cognitive behavioral therapy.
The results showed meaningful and sustained reductions in alcohol use over 12 weeks. On average, patients’ daily alcohol consumption dropped from 9.3 to 2.2 units, with heavy drinking days declining from 56% to 13%, and days of abstinence rising from 33% to 81%. Notably, 50% of the participants maintained complete abstinence throughout the study. The treatment was well-tolerated, and no serious or severe adverse events were reported, suggesting that BPL-003 may provide a safe and durable therapeutic option for those struggling with alcohol use disorder.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- April 24, 2024
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
Atai Life Sciences announced that Dosing Of First Patient In Part 2 Of Beckley Psytech's Phase 2a Study Exploring BPL-003 Adjunctive To SSRIs In Patients With Treatment Resistant Depression
Read Announcement
COMP360 FDA Regulatory Events
COMP360 is a drug developed by atai Life Sciences for the following indication: Treatment-resistant depression.
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:
- COMP360
- Announced Date:
- June 23, 2025
- Indication:
- Treatment-resistant depression
Announcement
Compass Pathways plc announced that the successful achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD).
AI Summary
Compass Pathways plc announced that the Phase 3 COMP005 trial has successfully met its primary endpoint. In this study, a single 25 mg dose of COMP360—a synthetic, proprietary formulation of psilocybin—showed a statistically significant and clinically meaningful reduction in depression symptoms compared to a placebo. The trial measured changes using the Montgomery‑Åsberg Depression Rating Scale (MADRS), with a mean difference of -3.6 (p < 0.001) at week 6, marking an important milestone in the treatment of treatment-resistant depression.
An independent safety board confirmed that there were no unexpected safety issues or imbalances in suicidal thoughts between the COMP360 and placebo groups. These positive results will soon be reviewed with the FDA, and the company continues to enroll patients in a second Phase 3 trial, COMP006, to gather further data on the treatment’s efficacy and safety.
Read Announcement- Drug:
- COMP360
- Announced Date:
- May 8, 2024
- Indication:
- Treatment-resistant depression
Announcement
Compass Pathways plc announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD).
Read Announcement
ELE-101 FDA Regulatory Events
ELE-101 is a drug developed by atai Life Sciences for the following indication: Treatment of mental health disorders.
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:
- ELE-101
- Announced Date:
- June 20, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- Treatment of mental health disorders
Announcement
atai Life Sciences announced that Results are expected in H2 2024.
AI Summary
Atai Life Sciences announced an update on its clinical trial for ELE-101, a new intravenous (IV) formulation of psilocin designed to treat major depressive disorder (MDD). The trial is in its Phase 2a stage, where 6 to 12 patients with MDD will receive a single IV dose. The treatment is expected to have a consistent and controlled effect with a shorter treatment time, around two hours.
The study builds on early Phase 1 results that showed ELE-101 was well-tolerated with no serious side effects and a predictable dose response. Atai highlighted that the full results of this trial are expected to be available in the second half of 2024. This progress represents an important step toward a new, scalable treatment for depression.
Read Announcement- Drug:
- ELE-101
- Announced Date:
- June 20, 2024
- Indication:
- Treatment of mental health disorders
Announcement
atai Life Sciences announced an update on Beckley Psytech's Phase 1/2a trial of ELE-101 (NCT05434156) for people living with MDD, with initial results from Phase 1 and the dosing of the first patients in the Phase 2a part of the study.
AI Summary
Atai Life Sciences announced an update on Beckley Psytech’s Phase 1/2a trial of ELE-101, a synthetic psilocin formulation designed for efficient, short-duration treatment of Major Depressive Disorder (MDD). Initial results from Phase 1 indicated that ELE-101 was well-tolerated and had a predictable, dose-proportional pharmacokinetic profile without serious adverse events when administered to healthy participants. Based on these promising findings, the study selected a dose for the Phase 2a part, which now begins dosing the first patients. This open-label phase will assess the safety, tolerability, subjective effects, and potential efficacy of a single intravenous dose of ELE-101 in 6-12 MDD patients, with clinical results expected in the second half of 2024. The approach may provide a rapid, consistent treatment option for depression, reducing variability among patients.
Read Announcement
EMP-01 FDA Regulatory Events
EMP-01 is a drug developed by atai Life Sciences for the following indication: For the Treatment of Social 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:
- EMP-01
- Announced Date:
- May 13, 2025
- Indication:
- For the Treatment of Social Anxiety Disorder
Announcement
atai Life Sciences announced that the first patient has been dosed in the exploratory Phase 2 study of EMP-01 (R-3,4-methylenedioxy-methamphetamine (R-MDMA)) for the treatment of social anxiety disorder (SAD).
AI Summary
Atai Life Sciences announced that the first patient has been dosed in an exploratory Phase 2 clinical trial for EMP-01, an oral form of R-MDMA, aimed at treating social anxiety disorder (SAD). The study is randomized, double-blind, and placebo-controlled, and will enroll about 60 adult patients. It is designed to evaluate the safety, tolerability, and potential efficacy of EMP-01 in treating social anxiety.
In this Phase 2 trial, patients will receive two administrations of either EMP-01 or a placebo, spaced four weeks apart, with their symptoms monitored for six weeks after the first dose. Previous Phase 1 findings showed that EMP-01 has a unique, dose-dependent effect profile similar to classical psychedelics. The study highlights a promising new approach in addressing an important unmet need in the treatment of SAD.
Read Announcement- Drug:
- EMP-01
- Announced Date:
- May 13, 2025
- Estimated Event Date Range:
- January 1, 2026 - March 31, 2026
- Target Action Date:
- Q1 2026
- Indication:
- For the Treatment of Social Anxiety Disorder
Announcement
atai Life Sciences announced that Topline data anticipated in the first quarter of 2026
AI Summary
Atai Life Sciences has initiated a Phase 2 clinical study of EMP-01, an oral formulation of R-MDMA, to treat social anxiety disorder (SAD). The study is randomized, double-blind, and placebo-controlled, enrolling around 60 adults to evaluate the treatment’s safety, tolerability, and potential to improve social anxiety symptoms. EMP-01 previously showed a unique, dose-dependent effect profile in a Phase 1 trial that resembled classical psychedelics rather than racemic MDMA. This research is important as SAD affects millions and current treatment options are limited. Topline data from this study are anticipated in the first quarter of 2026, which will provide critical insights into EMP-01’s efficacy and its potential role in addressing the unmet needs within mental health care.
Read Announcement
VLS-01 FDA Regulatory Events
VLS-01 is a drug developed by atai Life Sciences for the following indication: For Treatment-Resistant Depression.
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:
- VLS-01
- Announced Date:
- March 17, 2025
- Indication:
- For Treatment-Resistant Depression
Announcement
atai Life Sciences Recent Corporate Highlights
AI Summary
Atai Life Sciences recently shared several key corporate highlights aimed at advancing mental health treatments. The company dosed the first patient in its Phase 2 Elumina trial for VLS-01, a buccal film formulation of DMT designed for treatment-resistant depression, with topline data expected in the first quarter of 2026. They also initiated a Phase 2 clinical trial for EMP-01, an oral R-MDMA formulation being tested for social anxiety disorder, anticipating similar data timing.
In addition, Beckley Psytech completed patient enrollment in the Phase 2b study of BPL-003, an intranasal mebufotenin benzoate for treatment-resistant depression, with topline results expected by mid-2025. Furthermore, the company successfully raised net proceeds of $59.2 million through an equity offering, extending its operational runway into 2027.
Read Announcement- Drug:
- VLS-01
- Announced Date:
- March 11, 2025
- Indication:
- For Treatment-Resistant Depression
Announcement
atai Life Sciences announced that the first patient has been dosed in the Phase 2 Elumina trial of VLS-01, atai's proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, in people suffering from treatment-resistant depression (TRD).
AI Summary
Atai Life Sciences has reached an important milestone by dosing the first patient in its Phase 2 Elumina trial. This study is assessing VLS-01, the company’s innovative oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) that is applied to the buccal surface. Designed as a rapid-acting antidepressant, VLS-01 aims to provide robust and durable relief for people suffering from treatment-resistant depression—a condition affecting close to 100 million people globally.
The trial is a multi-center, double-blind, randomized, placebo-controlled study that will evaluate the safety, tolerability, and efficacy of VLS-01. With a treatment plan that involves repeated dosing within a two-hour interventional psychiatry model, top-line results are expected in the first quarter of 2026, marking a potential breakthrough in mental health care.
Read Announcement
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