This section highlights FDA-related milestones and regulatory updates for drugs developed by Atai Beckley (ATAI).
Over the past two years, Atai Beckley has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
COMP360, EMP-01, BPL-003, VLS-01, and ELE-101. 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.
COMP360 FDA Regulatory Timeline and Events
COMP360 is a drug developed by Atai Beckley 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:
- April 24, 2026
- Indication:
- Treatment-resistant depression
Announcement
Compass Pathways plc announced the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling review request and selected COMP360, Compass' proprietary formulation of synthetic psilocybin, for the Commissioner's National Priority Voucher (CNPV) program for treatment-resistant depression (TRD).
AI Summary
Compass Pathways announced the U.S. Food and Drug Administration granted its request for a rolling submission and review of a New Drug Application (NDA) for COMP360, Compass’s proprietary synthetic psilocybin, based on Phase 3 trial data. The FDA also selected COMP360 for the Commissioner’s National Priority Voucher (CNPV) program for treatment-resistant depression (TRD). The rolling review allows Compass to submit sections of the NDA as they become ready, which can help speed the overall regulatory assessment.
The CNPV designation highlights COMP360 as a priority candidate for TRD and could accelerate progress toward patients if approved. Compass said the award boosts momentum and that it is confident and ready to deliver for patients. CEO Nath noted that people with TRD often endure long periods of suffering with few options, and the company has advanced commercial preparations to bring this potential treatment to those in need.
Read Announcement- Drug:
- COMP360
- Announced Date:
- February 16, 2026
- Indication:
- Treatment-resistant depression
Announcement
Compass Pathways plc announced that tomorrow it will report new clinical data from two ongoing Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD).
AI Summary
Compass Pathways plc said it will report new clinical data tomorrow from two ongoing Phase 3 trials testing COMP360, its synthetic proprietary psilocybin formulation, for treatment-resistant depression (TRD). The updates will cover outcomes and safety findings from both studies and are expected to clarify COMP360’s therapeutic profile in people whose depression has not responded to standard treatments.
Phase 3 trials are the final large studies before possible regulatory decisions, so these results could influence Compass’s development plans, timelines and discussions with health authorities. Investors, clinicians and patient groups will be watching for evidence of symptom improvement, durability of response, and any side effect patterns. Positive findings could expand treatment options for people with severe, persistent depression.
Compass, headquartered in London with offices in New York, will stream the announcement live; a replay will be available for 30 days after the event.
Read Announcement- 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
EMP-01 FDA Regulatory Timeline and Events
EMP-01 is a drug developed by Atai Beckley 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:
- April 22, 2026
- Indication:
- For the Treatment of Social Anxiety Disorder
Announcement
AtaiBeckley Announces Expanded Phase 2a Results For EMP-01 In Adults With Social Anxiety Disorder That Demonstrate Clinically Meaningful And Consistent Improvements Across Clinician-Rated Symptoms, Patient-Reported Experience And Real-World Behavioral Outcomes
Read Announcement- Drug:
- EMP-01
- Announced Date:
- February 26, 2026
- Indication:
- For the Treatment of Social Anxiety Disorder
Announcement
AtaiBeckley Inc announced topline results from its exploratory, double‑blind, placebo‑controlled, first-in-patient Phase 2a study (NCT06693609) evaluating EMP‑01 (oral R‑MDMA) in adults with Social Anxiety Disorder (SAD).
AI Summary
AtaiBeckley Inc. reported topline results from an exploratory, double‑blind, placebo‑controlled, first‑in‑patient Phase 2a study (NCT06693609) evaluating EMP‑01 (oral R‑MDMA) in adults with Social Anxiety Disorder (SAD). With respect to the trial’s primary objective, EMP‑01 demonstrated a favorable and manageable safety and tolerability profile. No serious adverse events were observed, and there were no treatment‑emergent suicidal behaviors or intent. Most adverse events were mild or moderate and resolved without intervention.
On the Clinical Global Impression–Improvement (CGI‑I) scale, 49% of patients receiving EMP‑01 were rated “very much improved” or “much improved,” compared with 15% in the placebo group — a 34‑percentage‑point difference. That effect corresponds to a Number Needed to Treat (NNT) of 2.95 (95% CI: 1.84–7.42), signaling a clinically meaningful level of global improvement for EMP‑01 and supporting further study of this oral treatment for SAD.
Read Announcement- Drug:
- EMP-01
- Announced Date:
- December 11, 2025
- Indication:
- For the Treatment of Social Anxiety Disorder
Announcement
Atai Beckley announced that the United States Patent and Trademark Office has granted a new patent covering EMP-01 (oral R-MDMA), further strengthening the company's intellectual property estate and long-term exclusivity for the program.
AI Summary
Atai Beckley announced that the U.S. Patent and Trademark Office granted patent No. 12,492,178 covering EMP-01, its oral R‑MDMA candidate. The patent protects the drug substance itself and is expected to provide exclusivity through 2043. It covers a highly crystalline, thermodynamically stable HCl salt form of (R)-MDMA that has high aqueous solubility and low hygroscopicity. Those form-specific attributes can ease formulation development, drug product manufacture, and storage, and they protect critical drug substance features that support the company’s strategy to develop differentiated mental health therapies.
The company says the patent strengthens its intellectual property estate and long-term position for EMP-01. Atai Beckley is expanding its global patent portfolio to back clinical development and potential commercialization. The firm is advancing an exploratory Phase 2 study of EMP-01 in adults with social anxiety disorder and expects topline Phase 2a data in the first quarter of 2026. Management views the patent as reinforcing its science and long-term commitment to building durable innovation.
Read Announcement- Drug:
- EMP-01
- Announced Date:
- May 13, 2025
- Target Action Date:
- Q1 2026
- Estimated Target Date Range:
- January 1, 2026 - March 31, 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- 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
BPL-003 FDA Regulatory Timeline and Events
BPL-003 is a drug developed by Atai Beckley 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:
- April 8, 2026
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
AtaiBeckley Inc announced peer-reviewed Phase 2a results (NCT05660642) in CNS Drugs demonstrating that a single intranasal dose of BPL-003 (mebufotenin benzoate), which holds FDA Breakthrough Therapy Designation, achieved rapid and sustained reductions in MADRS scores from baseline in participants with treatment-resistant depression (TRD) who remained on stable SSRI therapy throughout the study (n=12).
AI Summary
AtaiBeckley Inc. reported peer‑reviewed Phase 2a results (NCT05660642) published in CNS Drugs showing that a single intranasal dose of BPL‑003 (mebufotenin benzoate) produced rapid and sustained reductions in MADRS scores from baseline in 12 participants with treatment‑resistant depression (TRD) who remained on stable SSRI therapy. The small, controlled study tested two dose cohorts (10 mg and 12 mg, n=6 each).
By Day 2, 66.7% of participants in both the 10 mg and 12 mg cohorts met criteria for an antidepressant response. Durable responses were observed at Day 85, with 83% (5/6) responding in the 10 mg group and 66.7% (4/6) in the 12 mg group. These findings suggest rapid onset and lasting benefit after a single dose.
AtaiBeckley says Phase 3 initiation is on track for Q2 2026, supporting further development of BPL‑003 for TRD.Read Announcement
- Drug:
- BPL-003
- Announced Date:
- March 17, 2026
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
AtaiBeckley Inc. announced the peer-reviewed publication of results from its ongoing four-part Phase 2a study (NCT05660642) evaluating BPL-003 (mebufotenin benzoate nasal spray) in patients with treatment-resistant depression (TRD).
AI Summary
AtaiBeckley Inc. announced the peer‑reviewed publication of results from its ongoing four‑part Phase 2a study (NCT05660642) assessing BPL‑003 (mebufotenin benzoate nasal spray) in patients with treatment‑resistant depression (TRD). The company said the published article reports findings from the trial, which is designed to evaluate safety and signals of benefit for BPL‑003 in this difficult‑to‑treat population.
The trial has four cohorts; Parts 1–3 results were previously disclosed, and the first patient has now been dosed in Part 4. That cohort is testing a two‑dose induction regimen (8 mg + 8 mg) of BPL‑003 in TRD patients who remain on defined antidepressant therapy. Initial data from Part 4 are expected in the fourth quarter of 2026.
AtaiBeckley framed the peer‑reviewed publication as an important step in advancing BPL‑003’s clinical development and said it will continue to report data as the study progresses.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- March 10, 2026
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
AtaiBeckley Inc. today highlighted key clinical, regulatory, and operational milestones from its 2026 Virtual Investor Day, including the advancement of BPL‑003 (mebufotenin benzoate nasal spray) toward Phase 3 initiation in Q2 2026 following a successful End-of-Phase 2 meeting with the FDA.
AI Summary
AtaiBeckley Inc. used its 2026 Virtual Investor Day to highlight clinical and regulatory milestones, notably advancing BPL‑003 (mebufotenin benzoate nasal spray) toward Phase 3. Following a successful End‑of‑Phase 2 meeting with the FDA, the company plans two parallel Phase 3 trials to start in Q2 2026 and continues to hold Breakthrough Therapy Designation.
BPL‑003’s positive Phase 2b topline results showed rapid antidepressant effects by Day 2 after a single dose, durable improvements maintained up to eight weeks, and higher response and remission rates sustained for an additional eight weeks after a second dose in the open‑label extension.
CEO Srinivas Rao said the FDA’s supportive feedback enables the Phase 3 push and that BPL‑003 could reshape treatment for treatment‑resistant depression. External experts at the event also noted that shorter in‑clinic sessions and intermittent dosing could broaden patient access and align with existing clinic infrastructure.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- March 3, 2026
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
AtaiBeckley Inc. announced a successful End‑of‑Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of BPL‑003, the Company's proprietary intranasal formulation of mebufotenin benzoate, for treatment‑resistant depression (TRD).
AI Summary
AtaiBeckley Inc. announced a successful End‑of‑Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration about BPL‑003, the company’s investigational intranasal formulation of mebufotenin benzoate for treatment‑resistant depression (TRD). The company said the meeting confirmed the FDA’s interest in the program and clarified regulatory expectations for moving forward.
According to AtaiBeckley, the FDA provided feedback on key elements of late‑stage development, including design considerations for pivotal studies, appropriate clinical endpoints, safety monitoring, and data needed to support a future marketing submission. The agency also discussed manufacturing and quality data that will be required as the program advances.
AtaiBeckley plans to use the FDA’s guidance to finalize Phase 3 plans and prepare regulatory filings. The company said the productive meeting helps define a clearer path toward potential approval and, if successful, a new treatment option for people with TRD.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- November 10, 2025
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
Atai Beckley announced positive topline results from the open-label extension (OLE) study of its Phase 2b clinical trial (NCT05870540) of BPL-003 in patients with treatment-resistant depression (TRD).
AI Summary
Atai Beckley reported positive topline results from the open-label extension (OLE) of its Phase 2b trial of BPL-003 (mebufotenin benzoate nasal spray) in treatment-resistant depression. A 12 mg dose given eight weeks after an initial 0.3 mg, 8 mg or 12 mg dose was generally well tolerated and produced rapid, clinically meaningful antidepressant effects that lasted up to eight weeks. Of 126 eligible patients, 107 entered the OLE.
Efficacy findings showed mean MADRS score reductions at Day 57 of 14.0 points for those who initially received 0.3 mg and 22.3 points for those who initially received 8 mg. In the pooled active-dose group (initial 8 mg or 12 mg, n=60) the mean reduction was 19.0 points. Overall OLE responder and remission rates at Day 57 were 81% and 67%; in the pooled active group, responder rate was 63% and remission 48%.
Safety was consistent with prior studies: most adverse events were mild or moderate and transient (nausea, headache, site discomfort, blood pressure increases, anxiety). One drug-related serious event resolved with monitoring. Average readiness-for-discharge was within two hours, supporting an intermittent-dose treatment model of two doses eight weeks apart with effects lasting up to four months.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- October 16, 2025
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
atai Life Sciences announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).
AI Summary
atai Life Sciences announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to BPL-003 (mebufotenin benzoate) nasal spray for adults with treatment-resistant depression (TRD). This designation recognizes BPL-003’s potential to improve symptoms more than current therapies.
BPL-003 is an intranasal formulation designed to produce fast relief from a single dose. In a Phase 2b study, adults with TRD saw significant reductions within 24 hours and effects lasting eight weeks. Most patients left 90 minutes after dosing, fitting into a two-hour session.
The Breakthrough Therapy designation provides intensive FDA guidance and may shorten review timelines. atai and Beckley Psytech plan Phase 3 trials in early 2026. They say this milestone brings new hope to adults whose depression resisted other treatments.
Read Announcement- Drug:
- BPL-003
- Announced Date:
- September 23, 2025
- Indication:
- In Patients With Treatment Resistant Depression
Announcement
atai Life Sciences announced positive data from a proof-of-concept study investigating a two-dose induction regimen of BPL-003 (intranasal mebufotenin benzoate), in patients with treatment-resistant depression (TRD).
AI Summary
atai Life Sciences announced positive data from its open-label Phase 2a study of BPL-003, an intranasal mebufotenin benzoate, in treatment-resistant depression (TRD) patients. In the trial, 13 patients received an 8 mg dose followed by a 12 mg dose two weeks later. Twelve patients were evaluable.
After the first dose, patients showed a mean 13.3-point MADRS score drop at Day 2 and a 12.9-point drop at Day 8. One week after the second dose, scores fell by 19.0 points, with effects lasting through 12 weeks (13.7-point drop).
The second dose improved response and remission rates: remission rose from 25% after the first dose to 50% by Week 8 and stayed at 42% at Week 12. BPL-003 was well tolerated, with only mild or moderate side effects and no serious events.
These findings will guide atai’s Phase 3 clinical program for BPL-003 in TRD patients.
Read Announcement- 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
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 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
VLS-01 FDA Regulatory Events
VLS-01 is a drug developed by Atai Beckley 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
ELE-101 FDA Regulatory Events
ELE-101 is a drug developed by Atai Beckley 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
- Target Action Date:
- H2 2024
- Estimated Target Date Range:
- July 1, 2024 - December 31, 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
Free ATAI Stock Alerts