5-HT2C receptor antagonists(Serotonin 2c (5-HT2c) receptor antagonists), MTNR1A agonists(Melatonin receptor 1A agonists), MTNR1B agonists(Melatonin receptor 1B agonists)

Therapeutic Areas

Nervous System DiseasesOther DiseasesEndocrinology and Metabolic Disease

Active Indication

Generalized anxiety disorderDepressive Disorder, MajorDepressive Disorder+ [1]

Inactive Indication

Autistic DisorderBipolar I disorderBrain Injuries+ [3]

Originator Organization

Les Laboratoires Servier SAS

Active Organization

Les Laboratoires Servier SAS

Fujian Medical University

Alto Neuroscience, Inc.

+ [2]

Inactive Organization

Bharat Institute of TechnologyInstitut de Recherches Internationales ServierServier (Ireland) Industries Ltd.

+ [7]

License Organization

Sanofi (China) Investment Co. Ltd.

Laboratorios Farmaceúticos Rovi SA

Novartis AG

+ [2]

Drug Highest PhaseApproved

First Approval Date

European Union (19 Feb 2009),

Depressive Disorder, Major

RegulationPaediatric investigation plan (European Union)

Structure/Sequence

Molecular FormulaC15H17NO2

InChIKeyYJYPHIXNFHFHND-UHFFFAOYSA-N

CAS Registry138112-76-2

164

Clinical Trials associated with Agomelatine

CTIS2025-522967-13-00

/ RecruitingPhase 4IIT

A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.

Start Date10 Aug 2026

Sponsor / Collaborator

Fundación para la Investigación Biomédica del Hospital

IRCT20090117001556N164

/ SuspendedPhase 2/3IIT

The effect of Agomelatine as an adjuvant therapy on the improvement of negative symptoms in patients with chronic schizophrenia: A randomized, double-blind, placebo-controlled trial

Start Date23 Sep 2025

Sponsor / Collaborator

Tehran University of Medical Sciences

ACTRN12625000575437

/ CompletedPhase 1

Part A: Phase 1, Single- Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Agomelatine in Healthy Participants.

Start Date08 Jul 2025

Sponsor / Collaborator-

100 Clinical Results associated with Agomelatine

100 Translational Medicine associated with Agomelatine

100 Patents (Medical) associated with Agomelatine

1,212

Literatures (Medical) associated with Agomelatine

01 Nov 2026·JOURNAL OF AFFECTIVE DISORDERS

Investigating the effects of antidepressants on measures of insulin resistance in major depressive disorder: A systematic review

Review

Author: Zheng, Yang Jing ; McIntyre, Roger S ; Guillen-Burgos, Hernan F ; Le, Gia Han ; Teopiz, Kayla ; Dri, Christine E ; Wong, Sabrina

BACKGROUND:

Persons with depression are disproportionately at risk for developing insulin resistance. Replicated evidence indicates that insulin resistance blunts acute antidepressant response; however, some antidepressants exacerbate insulin resistance risk. Herein, we aim to comprehensively evaluate previous literature reporting on the effects of antidepressants on measures of insulin resistance with the view to disaggregate class- and drug-specific effects.

METHODS:

A systematic search on PubMed, Ovid and Scopus (inception-July 2025) was conducted, with a manual search of Google Scholar and reference lists. Two reviewers (S.W. and G.H.L.) independently screened studies. Clinical trials investigating FDA-approved antidepressants on a validated measure of insulin resistance were included. Studies were assessed using the National Institute of Health quality assessment tools.

RESULTS:

Select tricyclic antidepressants (i.e., nortriptyline, amitriptyline, imipramine) were associated with acute and long-term disruptions in insulin sensitivity. SSRIs were not associated with acute alterations in insulin sensitivity. Preliminary evidence suggests agomelatine and bupropion are metabolically neutral and may improve insulin resistance in persons with diabetes mellitus. SNRIs do not adversely affect glucose-insulin signaling in the long-term. There was a paucity of studies reporting the effects of other antidepressant classes and agents.

CONCLUSION:

The effect of antidepressants on mechanisms mediating insulin sensitivity is mixed, with a relatively limited body of evidence currently available. While select SSRIs and tricyclic antidepressants may adversely affect glucose-insulin homeostasis, conclusions remain preliminary. The development of novel antidepressants may provide an opportunity to optimize psychiatric and metabolic outcomes. Identifying mechanisms contributing to insulin resistance could inform future discovery and development of antidepressants.

01 Sep 2026·INTERNATIONAL IMMUNOPHARMACOLOGY

Corrigendum to “Agomelatine improves streptozotocin-induced diabetic nephropathy through melatonin receptors/SIRT1 signaling pathway” [Int. Immunopharmacol. 115 (2023) 109646]

Author: Soliman, Eman ; Elshazly, Shimaa M ; Hassan, Arwa A ; Mahmoud, Nevertyty M

01 Sep 2026·JOURNAL OF APPLIED TOXICOLOGY

Agomelatine Alleviates Methotrexate‐Induced Lung Injury by Concurrently Inhibiting CD45/CD68‐Positive Immune Cell Infiltration and Modulating the BAX/BCL2 Apoptosis Pathway

Article

Author: Pekgöz, Şakir ; Şahin, Melda ; Usta, Zafer ; Özmen, Özlem ; Kara, Yağmur

ABSTRACT:

Methotrexate (MTX)‐induced pulmonary toxicity severely limits its clinical use and effective preventive strategies are lacking. This study evaluated the protective effects of agomelatine (AGO), a melatonergic antidepressant, against MTX‐induced lung injury, focusing on its dual‐pathway action targeting both immune cell infiltration and apoptotic signaling. Thirty‐two female Wistar rats were assigned to: Control, AGO (20 mg/kg/day, p.o., 7 days), MTX (single i.p. dose, 20 mg/kg), and MTX + AGO groups. Lung tissues were examined by histopathology, immunohistochemistry (CD45 + , CD68 + ), and RT‐qPCR (BAX, BCL2). MTX administration caused marked pulmonary damage (histopathological score: 2.75 ± 0.25, p < 0.001), significant infiltration of CD45 + leukocytes and CD68 + macrophages and an elevated BAX/BCL2 ratio (3.5 ± 0.4 vs. 1.0 ± 0.2 in Control, p < 0.001). AGO cotreatment significantly ameliorated these alterations via its dual activity, lowering the histopathological score (1.25 ± 0.25, p < 0.01), reducing CD45 + /CD68 immunopositivity, and restoring the BAX/BCL2 ratio toward cell survival (1.4 ± 0.3, p < 0.01 vs. MTX). These findings provide integrated immunohistochemical and molecular evidence supporting the concurrent modulation of immune cell infiltration and apoptotic signaling by AGO in MTX‐induced lung injury. Given its established clinical use and favorable safety profile, AGO may represent a potential adjunctive candidate to reduce the risk of MTX‐related pulmonary complications, through concurrent targeting of immune and apoptotic pathways.

News (Medical) associated with Agomelatine

13 Aug 2026

·www.biospace.com

Alto Neuroscience Reports Second Quarter 2026 Financial Results and Recent Business Highlights

– ALTO-207 development expanded: an additional Phase 3 trial evaluating ALTO-207 as monotherapy in treatment-resistant depression (TRD) is now planned, alongside the ongoing potentially registrational Phase 2b trial; topline Phase 2b data on track for 2H 2027 – – Independent investigator-led study results published in Nature Medicine reinforce the dopaminergic mechanism underlying ALTO-207, demonstrating significant effects on anhedonia (Hedges' g=0.62, p=0.006) – – Approximately $100 million financing completed in July 2026; pro forma cash of approximately $338 million expected to fund planned operations through 2030 – MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- $anro #cns --Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today reported financial results for the quarter ended June 30, 2026, and highlighted recent progress across its pipeline of clinical-stage product candidates. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “The second quarter further strengthened the case for ALTO-207 and our conviction in the opportunity ahead of it,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “The Nature Medicine publication of PRIME-PRAXOL provides another independent, peer-reviewed dataset showing that dopaminergic treatment produces large effects in depression, and, just as importantly, a reminder of the tolerability challenge that ALTO-207 is designed to address. With enrollment in our potentially registrational Phase 2b trial tracking as planned and pro forma cash of approximately $338 million, we are now positioned to pursue ALTO-207 in both the adjunctive and monotherapy settings, broadening the potential label and the commercial opportunity, with expected runway through 2030.” Second Quarter and Recent Pipeline Highlights ALTO-207: Independent Nature Medicine publication reinforces mechanism; monotherapy Phase 3 trial added to development plan ALTO-207 is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist with demonstrated antidepressant effect across multiple independent trials, and ondansetron, a selective 5-HT3 receptor antagonist. The fixed-dose combination is designed to enable rapid titration to higher pramipexole doses by mitigating the dose-limiting nausea and vomiting associated with pramipexole. This combination approach — and its use to enable higher pramipexole dosing in the treatment of depression — is the subject of Alto's issued method-of-treatment patent estate described below. ALTO-207 is being developed to address the significant unmet medical need in TRD, which is estimated to affect approximately 7 million adults in the United States. In June 2026, results from PRIME-PRAXOL — an independent, randomized, double-blind, placebo-controlled trial conducted by investigators at Lund University, Sweden — were published in Nature Medicine. Adults with major depressive disorder (MDD), dysthymia, or bipolar depression and clinically significant anhedonia received flexible-dose pramipexole or placebo added to ongoing treatment for nine weeks, followed by a six-month open-label extension. The trial met its primary endpoint, with pramipexole reducing anhedonia significantly more than placebo on the Snaith–Hamilton Pleasure Scale (SHAPS) (mean difference −4.04; 95% CI −6.89 to −1.18; p=0.006; Hedges' g=0.62). Significant improvements were also observed on independent measures of anhedonia (DARS; p=0.008) and apathy (AES-S; p<0.001), and improvements were maintained through the six-month open-label period. In an exploratory analysis included in the publication, an MDD diagnosis was significantly associated with greater SHAPS improvement at week 9 relative to dysthymia (p=0.038). In an additional analysis of the trial data not included in the publication, the MDD subgroup showed a larger effect on SHAPS at week 9 (Hedges' g=0.99) and a larger effect on the Hamilton Depression Rating Scale (HDRS-6) (Hedges' g=0.64). Consistent with prior studies, adverse events were common in the pramipexole arm despite slow titration, including nausea in approximately 60% of participants — the dose-limiting tolerability constraint that the ALTO-207 fixed-dose combination is designed to address. These findings are consistent with the broader body of evidence supporting ALTO-207, including the PAX-D study conducted by the University of Oxford and published in The Lancet Psychiatry (Cohen's d=0.87 versus placebo at 12 weeks in TRD) and a meta-analysis of pramipexole in depression (Hedges' g=0.64, p<0.001). The broad development program for ALTO-207, collectively the PACE program ( P ramipexole-ondansetron A ssessment of C linical E fficacy in depression), remains on track across three large, well-controlled clinical trials; PACE-1 Trial (Phase 2b adjunctive TRD trial): Enrollment in the ongoing, potentially registrational, Phase 2b trial of ALTO-207 as an adjunctive treatment in approximately 178 adults with TRD is on track with topline data expected in 2H 2027. MADRS is the primary endpoint in the trial, which is aligned with FDA standards in depression and supports the potential for the trial to contribute to a future registrational package alongside the planned Phase 3 trials. PACE-2 Trial (Phase 3 adjunctive TRD trial): Alto remains on track to initiate its Phase 3 trial of ALTO-207 as adjunctive treatment in TRD by early 2027, following alignment with the FDA on the planned trial design. The Phase 3 trial is designed to run in parallel with the ongoing Phase 2b trial rather than await its topline data, an approach Alto believes can meaningfully accelerate the path to a potential NDA submission. PACE-3 Trial (Phase 3 monotherapy TRD trial): In July 2026, Alto announced plans to accelerate and expand the clinical development of ALTO-207, including an additional planned Phase 3 trial evaluating ALTO-207 as monotherapy in TRD. The Company believes a monotherapy dataset, alongside the planned adjunctive Phase 3 trial, could support a broader label and expand the addressable population for ALTO-207 if approved. Alto expects to initiate this trial in the second half of 2027 pending alignment with the FDA. Alto's patent estate covering ALTO-207 includes multiple method-of-treatment patents protecting the use of ondansetron to mitigate pramipexole-related side effects to enable higher pramipexole dosing in the treatment of depression. Together with the Company's broader estate of issued and pending patents, Alto expects patent coverage of ALTO-207 through at least the mid-2040s. ALTO-300 and ALTO-100: Phase 2b trials on track Enrollment remains ongoing in the Phase 2b trials of ALTO-300 in MDD and ALTO-100 in bipolar depression (BPD), conducted under the enhanced eligibility review and patient data quality procedures the Company implemented earlier this year, which continue to perform as intended. Topline data remain expected in 1H 2027 for the ALTO-300 Phase 2b MDD trial and mid-2027 for the ALTO-100 Phase 2b BPD trial. Corporate Highlights In July 2026, Alto completed an underwritten registered direct offering of 3,776,436 shares of common stock at $26.48 per share, for gross proceeds of approximately $100.0 million and net proceeds of approximately $94.6 million. The Company intends to use the proceeds, together with existing cash, to accelerate and expand the clinical development of ALTO-207, including the additional planned Phase 3 monotherapy trial in TRD, and for general working capital purposes. In June 2026, Alto was added to the Russell 2000® Index and the broad-market Russell 3000® Index, effective June 29, 2026, as part of the 2026 Russell US Indexes reconstitution. In May 2026, Alto appointed Andrew Miller, Ph.D., founder of Karuna Therapeutics, to its Board of Directors. During his tenure, Dr. Miller was CEO, COO, and led research and development at Karuna through its acquisition by Bristol Myers Squibb, and brings extensive neuropsychiatric drug development and company-building experience to Alto. Expected Upcoming Milestones Early 2027 — ALTO-207 PACE-2 (Phase 3 adjunctive TRD) trial initiation 1H 2027 — ALTO-300 Phase 2b MDD trial topline data Mid-2027 — ALTO-100 Phase 2b BPD trial topline data 2H 2027 — ALTO-207 PACE-1 (Phase 2b adjunctive TRD) trial topline data 2H 2027 — ALTO-207 PACE-3 (Phase 3 monotherapy TRD) trial initiation Second Quarter 2026 Financial Highlights Cash Position: As of June 30, 2026, the Company had cash, cash equivalents, and restricted cash of approximately $244.2 million, compared to approximately $177.0 million as of December 31, 2025. Giving effect to the net proceeds of the July 2026 offering, the Company's pro forma cash position following the offering was approximately $338 million. R&D Expenses: Research and development expenses for the quarter ended June 30, 2026, were $22.1 million, as compared to $13.1 million for the same period in 2025. G&A Expenses: General and administrative expenses for the quarter ended June 30, 2026, were $7.0 million, as compared to $5.6 million for the same period in 2025. Net Loss: The Company incurred a net loss of $27.6 million for the quarter ended June 30, 2026, as compared to a net loss of $17.7 million for the same period in 2025. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in treatment-resistant depression, major depressive disorder, bipolar depression, schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X . Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “look forward,” “may,” “on track,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations with regard to the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform (“Platform”); statements regarding patient compliance and the effectiveness of Alto’s clinical trial execution measures, including its eligibility review and patient and data quality procedures, and the impact of those measures on patient and data quality and the timing of trial readouts; statements regarding Alto’s expectations for the design, timing, and results of its Phase 2b and planned Phase 3 trials of ALTO-207; Alto’s expectations with regard to the design and results of its research and development programs and clinical trials, including the timing of enrollment and the timing and availability of data from such trials; Alto’s clinical and regulatory development plans for its product candidates, including the timing or likelihood of regulatory filings and approvals for its product candidates and regulatory alignment; Alto’s business strategy, financial position, including anticipated cash runway, and the sufficiency of its financial resources to fund its operations through expected milestones; and other statements that are not historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of Alto’s product candidates; the risk that Alto may not realize the intended benefits of its Platform or its eligibility review and patient and data quality procedures; availability and timing of results from clinical trials; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that clinical trials may have unsatisfactory outcomes; the risk that Alto’s projections regarding its financial position and expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in Alto’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and other filings Alto may make with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto's Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website. ALTO NEUROSCIENCE, INC. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share amounts) (unaudited) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development $ 22,108 $ 13,124 $ 42,402 $ 23,098 General and administrative 7,021 5,558 13,865 11,260 Total operating expenses 29,129 18,682 56,267 34,358 Loss from operations (29,129 ) (18,682 ) (56,267 ) (34,358 ) Other income (expense): Interest income 2,112 1,683 3,673 3,510 Interest expense (491 ) (646 ) (1,036 ) (1,244 ) Loss on debt extinguishment — — — (681 ) Other, net (130 ) (61 ) (245 ) (102 ) Total other income, net 1,491 976 2,392 1,483 Net loss $ (27,638 ) $ (17,706 ) $ (53,875 ) $ (32,875 ) Other comprehensive income (loss): Change in fair value attributable to instrument specific credit risk — 22 7 156 Foreign currency translation 4 (5 ) (12 ) (24 ) Total other comprehensive income (loss) $ 4 $ 17 $ (5 ) $ 132 Comprehensive loss $ (27,634 ) $ (17,689 ) $ (53,880 ) $ (32,743 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.65 ) $ (0.65 ) $ (1.34 ) $ (1.21 ) Weighted-average number of common shares outstanding, basic and diluted 42,813 27,072 40,179 27,061 ALTO NEUROSCIENCE, INC. Selected Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) June 30, December 31, 2026 2025 Cash, cash equivalents, and restricted cash $ 244,233 $ 176,984 Total assets 254,066 184,689 Total liabilities 34,817 33,547 Accumulated deficit (255,509 ) (201,634 ) Contacts Investor & Media Contact: Nick Smith investors@altoneuroscience.com media@altoneuroscience.com

Phase 2Executive ChangePhase 3Financial StatementClinical Result

03 Aug 2026

·www.biospace.com

Seaport Therapeutics Reports Second Quarter 2026 Financial Results and Highlights Recent Corporate and Clinical Progress

Enrollment in Phase 2b BUOY-1 trial of GlyphAllo ™ in major depressive disorder (MDD) is on track with topline data expected in 1H 2027 Phase 1 driving simulation trial of GlyphAllo on track to report topline data in 2H 2026 Following positive data from completed Phase 1 proof-of-concept trial of GlyphAgo ™ , Company plans to initiate Phase 2a trial in patients with generalized anxiety disorder (GAD) and sleep disturbance in 2H 2026, and Phase 2b trial in patients with GAD in 1H 2027 Glyph2BLSD ™ , a novel non-hallucinogenic neuroplastogen, is on track to complete first-in-human-enabling studies by the end of 2027 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Upsized IPO in May generated $260.0 million in gross proceeds; $427.3 million in cash, cash equivalents, and investments as of June 30, 2026, expected to fund operations into 2029 BOSTON--(BUSINESS WIRE)-- Seaport Therapeutics, Inc. , (Nasdaq: SPTX) (“Seaport” or the “Company”), a clinical-stage therapeutics company that is inventing and developing novel neuropsychiatric medicines, today announced financial results for the second quarter of 2026 and highlighted recent corporate and clinical progress. “The second quarter of 2026 was marked by two major milestones for Seaport – positive results from our Phase 1 proof-of-concept trial of GlyphAgo and the successful completion of our IPO,” said Daphne Zohar, Co-Founder and Chief Executive Officer at Seaport Therapeutics. “We believe the GlyphAgo Phase 1 data package significantly derisks future clinical development of this program, and we expect to initiate Phase 2 development of GlyphAgo in generalized anxiety disorder in the second half of this year. "In parallel, we are executing on two clinical trials of our lead product candidate, GlyphAllo, including the Phase 2b BUOY-1 trial in patients with major depressive disorder, and the Phase 1 driving simulation trial in healthy volunteers. Both trials are on track, and we look forward to data from the driving simulation trial in the coming months, ahead of topline data from BUOY-1 in the first half of next year. “With the data that continue to emerge from psychedelics in neuropsychiatry, including LSD, we are excited about the potential of Glyph2BLSD, which is designed to harness the pharmacology of a psychedelic without causing a ‘trip,’ and may therefore avoid limitations of psychedelics, including the need for supervised administration. “With a strong balance sheet and cash runway through multiple important clinical data readouts for our two lead programs, we are well-positioned to advance our pipeline through key inflection points and develop novel treatments for the hundreds of million people living with depression and anxiety.” Recent Business Updates and Anticipated Milestones GlyphAllo (SPT-300 or Glyph Allopregnanolone) Program for Patients with Major Depressive Disorder (MDD) Enrollment on Track in Phase 2b BUOY-1 Trial in MDD. Seaport is actively enrolling patients in BUOY-1, a two-arm, global, randomized, double-blind, placebo-controlled, potentially registration-enabling Phase 2b trial investigating the safety and efficacy of GlyphAllo in patients with MDD with or without anxious distress. Topline data from the BUOY-1 trial are expected in the first half of 2027. Phase 1 Driving Simulation Trial in Healthy Volunteers is On Track - Topline data Expected in 2H 2026. This randomized, double-blind, placebo-controlled Phase 1 trial is designed to evaluate the potential impact of multiple dose levels of GlyphAllo on simulated driving performance in healthy volunteers. In this trial, GlyphAllo is dosed in the evening, and simulated driving performance is assessed the following morning, approximately nine hours following GlyphAllo administration, as is typical in driving simulation trials. Topline data from the driving simulation trial are expected in the second half of 2026, in advance of the expected topline readout of the BUOY-1 trial. Presented Overview of the GlyphAllo Development Program at the Main Session of the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. In May 2026, Seaport presented oral and poster presentations highlighting the key clinical data generated in the Phase 1 and Phase 2a clinical trials of GlyphAllo and the design of the ongoing Phase 2b BUOY-1 trial of GlyphAllo in patients with MDD with or without anxious distress. GlyphAgo (SPT-320 or Glyph Agomelatine) Program for Patients with Generalized Anxiety Disorder (GAD) Positive Proof-of-Concept Topline Results from Completed Phase 1 Trial in Healthy Volunteers In April 2026, Seaport reported positive topline results from the head-to-head crossover and single-ascending dose (SAD) portions of the trial. In the head-to-head crossover portion of the trial, GlyphAgo demonstrated a statistically significant 6.8-fold increase in bioavailability compared to unmodified agomelatine in healthy volunteers, exceeding the program’s two-fold target to mitigate liver exposure. GlyphAgo also showed significantly lower (10-fold) pharmacokinetic variability compared to unmodified agomelatine. In June 2026, Seaport reported positive topline results from the multiple-ascending dose (MAD) portion of the trial. Data from the MAD portion of the trial showed that seven-day dosing of GlyphAgo achieved therapeutic exposures of agomelatine at doses projected to avoid liver enzyme elevations and reduce or eliminate the need for liver function testing that has previously limited agomelatine’s clinical use. Across all dose levels in all portions of the trial, GlyphAgo was well-tolerated, with no serious or severe adverse events, no liver-related AEs, and no clinically significant changes in liver-related laboratory parameters, including ALT, AST, or bilirubin. The complete Phase 1 data package supported dose selection and advancement of GlyphAgo into two parallel Phase 2 trials in patients with GAD. Company Plans to Initiate a Phase 2a Proof-of-Pharmacology Trial in the Second Half of 2026. This randomized, double-blind trial of two dose levels of GlyphAgo is designed to demonstrate proof-of-pharmacology by characterizing the potential benefits of GlyphAgo on sleep, including objective measures of sleep architecture, in patients with GAD and sleep disturbance. Topline data from this trial are expected in early 2028. Company Plans to Initiate a Phase 2b Trial in the First Half of 2027. This randomized, double-blind, placebo-controlled, potentially registration-enabling trial is designed to evaluate the efficacy and safety of GlyphAgo in patients with GAD. Topline data from this trial are expected by year-end 2028. Preclinical and Discovery Programs Glyph2BLSD (SPT-348 or Glyph 2-bromo-LSD) Program on Track. Seaport is developing Glyph2BLSD for neuropsychiatric and headache disorders with significant unmet need. Glyph2BLSD is a non-hallucinogenic neuroplastogen designed to harness the pharmacology of a psychedelic without the hallucination, or “trip.” Completion of first-in-human-enabling studies is expected by year-end 2027. Corporate Upsized IPO Raising $260.0M Completed. In May 2026, Seaport closed its initial public offering (IPO), in which the Company raised gross proceeds of $260.0 million, before deducting underwriting discounts, commissions, and other offering expenses. The net proceeds from the offering together with the Company’s current cash, cash equivalents and investments are expected to support Seaport’s current operating plans into 2029, which includes multiple anticipated topline data readouts, including the Phase 2b BUOY-1 trial of GlyphAllo in patients with MDD, the Phase 2a trial of GlyphAgo in patients with GAD and sleep disturbance, and the Phase 2b trial of GlyphAgo in patients with GAD. Sharon Mates, Ph.D. Appointed to Board of Directors in April 2026. Dr. Mates served as Co-Founder, Chairman, and Chief Executive Officer of Intra-Cellular Therapies, Inc., which she co-founded in 2002, until its acquisition by Johnson & Johnson (J&J) for $14.6 billion in 2025. Second Quarter 2026 Financial Results Cash Position: Cash, cash equivalents, and investments totaled $427.3 million as of June 30, 2026. Seaport expects its cash, cash equivalents, and investments to support its current operating plans into 2029. R&D Expenses: Research and development (R&D) expenses were $24.6 million for the quarter ended June 30, 2026, as compared with $13.4 million for the quarter ended June 30, 2025. The increase in R&D expenses of $11.2 million was primarily due to increases in clinical development expenses of GlyphAllo and GlyphAgo as they advanced into later stage development. G&A Expenses: General and administrative (G&A) expenses were $41.2 million for the quarter ended June 30, 2026, as compared with $5.1 million for the quarter ended June 30, 2025. The increase in G&A expenses of $36.1 million was primarily due to one-time, non-cash stock-based compensation costs related to the successful completion of the Company’s IPO, as described in its previous SEC filings, and additional equity grants issued under the Company’s 2024 and 2026 Equity Plans. Net Loss: Net loss was $62.6 million for the second quarter of 2026, as compared to a net loss of $15.1 million for the second quarter of 2025. The increase in net loss was primarily due to one-time, non-cash stock-based compensation costs related to the successful completion of the Company’s IPO, as described in its previous SEC filings, and additional equity grants issued under the Company’s 2024 and 2026 Equity Plans. About Seaport Therapeutics Seaport Therapeutics (Nasdaq: SPTX) is a clinical-stage therapeutics company focused on inventing and developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders. Through its differentiated approach, the Company identifies clinically validated mechanisms with established efficacy and safety which had historically been limited by high first-pass metabolism, low bioavailability, and/or side effects. Seaport applies its proprietary Glyph™ platform to overcome those limitations and invent innovative oral therapies. With an experienced team of industry leaders, Seaport has a proven track record in neuropsychiatry drug discovery and development and delivering successful business outcomes. Seaport aims to develop novel, leading treatment options that will make a significant impact for patients and their families. For more information, please visit . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding our product candidates, including the ongoing Phase 2b trial of GlyphAllo, enrollment status and anticipated timing of topline data in the first half of 2027, the Phase 1 driving simulation trial for GlyphAllo in healthy volunteers and timing of results in the second half of 2026, the completed Phase 1 trial of GlyphAgo, results related thereto, and the anticipated Phase 2a proof-of-pharmacology trial (initiating in the second half of 2026) and the Phase 2b trial (initiating in the first half of 2027) and related data in 2028, preclinical and clinical development activities and timelines, including preclinical and first-in-human-enabling activities for Glyph2BLSD (SPT-348), and our expectations regarding uses of capital, expenses and financial results, including the expected cash runway and financial performance. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect Seaport’s business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities; risks that interim results are not predictive of final results in a clinical trial, Seaport’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Seaport’s ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Seaport’s intellectual property protections; and risks related to the competitive landscape for Seaport’s product candidates; as well as other risks described in “Risk Factors,” in Seaport’s Quarterly Report on Form 10-Q for the three months ended March 31, 2026 filed with the Securities and Exchange Commission (SEC), as well as subsequent filings with the SEC. Seaport expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Seaport uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. Seaport Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development (including non-cash stock-based compensation expense of $0.9 million and $0.6 million for three months ended June 30, 2026 and 2025, respectively and $1.8 million and $1.1 million for six months ended June 30, 2026 and 2025, respectively) $ 24,619 $ 13,409 $ 46,049 $ 23,944 General and administrative (including non-cash stock-based compensation expense of $36.0 million and $1.2 million for three months ended June 30, 2026 and 2025, respectively and $37.6 million and $2.3 million for six months ended June 30, 2026 and 2025, respectively) 41,189 5,061 47,302 10,711 Total operating expenses 65,808 18,470 93,351 34,655 Loss from operations (65,808 ) (18,470 ) (93,351 ) (34,655 ) Total other income, net 3,459 3,527 6,113 6,618 Loss before income taxes (62,349 ) (14,943 ) (87,238 ) (28,037 ) Income tax provision 251 134 770 165 Net loss $ (62,600 ) $ (15,077 ) $ (88,008 ) $ (28,202 ) Net loss per share, basic and diluted $ (1.78 ) $ (6.40 ) $ (4.60 ) $ (12.05 ) Weighted-average common shares outstanding, basic and diluted 35,236,214 2,356,777 19,118,049 2,340,431 Seaport Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (In thousands) (Unaudited) June 30, December 31, 2026 2025 Cash, cash equivalents and investments $ 427,260 $ 233,653 Working capital $ 266,501 $ 210,448 Total assets $ 441,681 $ 249,009 Total stockholders' equity (deficit) $ 422,602 $ (92,545 ) Contacts Seaport Therapeutics Media Contact: Shannon Costello Vice President, Communications publicrelations@seaporttx.com Investor Contact: Adam Bero, Ph.D. Vice President, Head of Investor Relations ir@seaporttx.com

Phase 2Phase 1Clinical ResultFinancial StatementASCO

09 Jun 2026

·www.biospace.com

PureTech Founded Entity Seaport Therapeutics Reports Positive Multiple-Ascending Dose Data from Phase 1 Proof-of-Concept Trial of GlyphAgo™ in Healthy Volunteers

BOSTON--(BUSINESS WIRE)-- PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, notes that its Founded Entity, Seaport Therapeutics, announced positive data from the multiple-ascending dose (MAD) portion of its Phase 1 proof-of-concept clinical trial evaluating repeat dosing of GlyphAgo™ (SPT-320), a novel, Glyphed oral prodrug of agomelatine, in healthy volunteers. Repeat dosing of GlyphAgo demonstrated a safety, tolerability, and pharmacokinetic (PK) pro with previously reported single-ascending dose (SAD) and crossover data, supporting its planned advancement of GlyphAgo into two parallel Phase 2 trials in patients with generalized anxiety disorder (GAD). Seaport expects to initiate a Phase 2a proof-of pharmacology trial in the second half of 2026. This randomized, double-blind trial of two dose levels of GlyphAgo is designed to demonstrate proof-of-pharmacology by characterizing the potential benefits of GlyphAgo on sleep, including objective measures of sleep architecture, in patients with GAD and sleep disturbance. Topline data from this trial are expected in early 2028. Seaport also expects to initiate a Phase 2b trial of GlyphAgo in the first half of 2027. This randomized, double-blind, placebo-controlled, potentially registration-enabling trial is designed to evaluate the efficacy and safety of GlyphAgo in patients with GAD. Topline data from this trial are expected by the end of 2028. The GlyphAgo program and the underlying Glyph platform were initially advanced at PureTech, applying the Company’s strategy of identifying clinically validated pharmacology and overcoming key limitations through targeted innovation. The Glyph platform and related programs are now being advanced by PureTech’s Founded Entity, Seaport Therapeutics. The full text of the announcement from Seaport is as follows: Seaport Therapeutics Reports Positive Multiple-Ascending Dose Data from Phase 1 Proof-of-Concept Trial of GlyphAgo™ in Healthy Volunteers Repeat dosing of GlyphAgo confirms favorable safety, tolerability, and pharmacokinetics observed across the Phase 1 program, with no liver-related adverse events observed New data demonstrate seven-day dosing of GlyphAgo achieved therapeutic exposures of agomelatine at doses projected to avoid liver enzyme elevations and reduce or eliminate the need for liver function testing Results support dose selection and planned advancement into two parallel Phase 2 trials in patients with generalized anxiety disorder BOSTON, June 8, 2026 -- Seaport Therapeutics, Inc. , (Nasdaq: SPTX) (“Seaport” or the “Company”), a clinical-stage therapeutics company that is inventing and developing novel neuropsychiatric medicines, today announced positive data from the multiple-ascending dose (MAD) portion of its Phase 1 proof-of-concept clinical trial evaluating repeat dosing of GlyphAgo™ (SPT-320), a novel, Glyphed oral prodrug of agomelatine, in healthy volunteers. Repeat dosing of GlyphAgo demonstrated a safety, tolerability, and pharmacokinetic (PK) pro with previously reported single-ascending dose (SAD) and crossover data, supporting its planned development in patients with generalized anxiety disorder (GAD). The MAD data showed that seven-day dosing of GlyphAgo achieved therapeutic exposures of agomelatine at doses that reduce liver exposure and are projected to avoid liver enzyme elevations and reduce or eliminate the need for liver function testing that has previously limited agomelatine’s clinical use. GlyphAgo AUC 0-24 and Cmax increased dose-dependently over the range of doses studied, and agomelatine exposures following GlyphAgo administration in the MAD portion were consistent with data from the SAD and crossover portions of the trial. There was no unmodified agomelatine arm in the MAD portion. Across all dose levels evaluated, GlyphAgo was well tolerated, with no serious or severe adverse events, no liver-related adverse events, and no clinically significant changes in liver-related laboratory parameters observed, further supporting observations from the SAD and crossover cohorts. “We are enthusiastic about the data from our Phase 1 program for GlyphAgo, where we’ve now observed consistent safety, tolerability, and PK across all cohorts,” said Daphne Zohar, Co-Founder and Chief Executive Officer of Seaport Therapeutics. “We believe these results substantially derisk our future clinical development approach and strengthen the differentiated pro GlyphAgo. The complete Phase 1 data package further validates our Glyph platform and supports the advancement of GlyphAgo into two parallel Phase 2 trials as we work to bring a new treatment option to patients with generalized anxiety disorder who have not had a new medicine approved in almost 20 years.” The Phase 1 proof-of-concept trial, which included 174 participants, was conducted in multiple parts to evaluate the safety, tolerability, and PK of GlyphAgo and to compare the PK of GlyphAgo to agomelatine alone. The trial included SAD and MAD cohorts, as well as a crossover portion (including both food-effect and within-participant comparison between GlyphAgo and agomelatine), using both open-label and placebo-controlled designs. In the previously reported results from the head-to-head crossover portion of the trial, GlyphAgo demonstrated a 6.8-fold increase in bioavailability of agomelatine compared with orally administered unmodified agomelatine. GlyphAgo also showed significantly lower (10-fold) PK variability compared to unmodified agomelatine. The crossover portion included participants who were taking estrogen-containing oral contraceptives that are known to increase agomelatine exposure due to liver drug-drug interaction. In contrast, GlyphAgo exposure was unaffected by oral contraceptives, further supporting the ability of GlyphAgo to bypass first-pass liver metabolism. GlyphAgo demonstrated a 9.6 to 14.5-fold increase in dose-normalized exposure compared to agomelatine in a separate SAD portion of the trial in which no participants were on oral contraceptives. Seaport expects to initiate a Phase 2a proof-of pharmacology trial in the second half of 2026. This randomized, double-blind trial of two dose levels of GlyphAgo is designed to demonstrate proof-of-pharmacology by characterizing the potential benefits of GlyphAgo on sleep, including objective measures of sleep architecture, in patients with GAD and sleep disturbance. Topline data from this trial are expected in early 2028. Seaport also expects to initiate a Phase 2b trial of GlyphAgo in the first half of 2027. This randomized, double-blind, placebo-controlled, potentially registration-enabling trial is designed to evaluate the efficacy and safety of GlyphAgo in patients with GAD. Topline data from this trial are expected by the end of 2028. Seaport plans to present additional analyses from the Phase 1 trial at future upcoming scientific meetings. About GlyphAgo ™ (SPT-320 or Glyph Agomelatine) GlyphAgo is a novel, “Glyphed” oral prodrug of agomelatine, a clinically validated anti-anxiety and antidepressant that is approved for the treatment of GAD in Australia and Major Depressive Disorder in Australia and the European Union. Using Seaport’s proprietary Glyph™ platform, GlyphAgo is designed to enhance lymphatic absorption and avoid first-pass liver metabolism, thereby enhancing oral bioavailability and reducing side effects. By leveraging an alternative absorption pathway via the intestinal lymphatic system used by dietary fats, GlyphAgo is designed to increase systemic exposure of agomelatine, enabling exposure levels of agomelatine that are effective in GAD but at a lower dose that reduces liver exposure and reduces or eliminates the need for liver function testing. Based on the data generated to date, Seaport believes GlyphAgo has the potential to become a leading treatment for GAD. About Seaport Therapeutics Seaport Therapeutics (Nasdaq: SPTX) is a clinical-stage therapeutics company focused on inventing and developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders. Through its differentiated approach, the Company identifies clinically validated mechanisms with established efficacy and safety which had historically been limited by high first-pass metabolism, low bioavailability, and/or side effects. Seaport applies its proprietary Glyph™ platform to overcome those limitations and invent innovative oral therapies. With an experienced team of industry leaders, Seaport has a proven track record in neuropsychiatry drug discovery and development and delivering successful business outcomes. Seaport aims to develop novel, leading treatment options that will make a significant impact for patients and their families. For more information, please visit . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding our product candidates, preclinical and clinical development activities and timelines, including projected data announcements, and our expectations for future operations and financial performance. These statements include, among other things, Seaport Therapeutics’ expectations regarding the concurrent Phase 2 trials of GlyphAgo (SPT-320), including the expected trial design and the timing of topline data. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect Seaport Therapeutics’ business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities; Seaport Therapeutics’ ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Seaport Therapeutics’ ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Seaport Therapeutics’ intellectual property protections; and risks related to the competitive landscape for Seaport Therapeutics’ product candidates; as well as other risks described in “Risk Factors,” in Seaport Therapeutics’ Registration Statement on Form S-1 filed with the Securities and Exchange Commission (SEC), as well as subsequent filings with the SEC. Seaport Therapeutics expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Seaport uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. About PureTech Health PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a proven, capital-efficient R&D model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. This strategy has produced dozens of therapeutic candidates, including three that have received U.S. FDA approval. By identifying, shaping, and de-risking these high-conviction assets, and scaling them through dedicated structures backed by external capital, we accelerate their path to patients while creating sustainable value for shareholders. For more information, visit or connect with us on LinkedIn and X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to those related to Seaport's development plans for its pipeline of neuropsychiatric therapeutics based on the Glyph™ Platform, the potential of GlyphAgo™ (SPT-320™ or Glyph Agomelatine) and the Glyph platform, the broader applicability of the platform, the addressable market for Seaport's product candidates, if approved, potential benefits to patients, and Seaport's and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Contacts PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 puretech@fticonsulting.com US Media Justin Chen jchen@tenbridgecommunications.com

Phase 1Clinical ResultPhase 2

100 Deals associated with Agomelatine

External Link

KEGG	Wiki	ATC	Drug Bank
D02578	Agomelatine	N06AX22	DB06594

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Generalized anxiety disorder	Australia	Servier Laboratories (Australia) Pty Ltd.	09 Aug 2010
Depressive Disorder, Major	European Union	Servier (Ireland) Industries Ltd.	19 Feb 2009
Depressive Disorder, Major	European Union	Les Laboratoires Servier SAS	19 Feb 2009
Depressive Disorder, Major	Iceland	Les Laboratoires Servier SAS	19 Feb 2009
Depressive Disorder, Major	Iceland	Servier (Ireland) Industries Ltd.	19 Feb 2009
Depressive Disorder, Major	Liechtenstein	Servier (Ireland) Industries Ltd.	19 Feb 2009
Depressive Disorder, Major	Liechtenstein	Les Laboratoires Servier SAS	19 Feb 2009
Depressive Disorder, Major	Norway	Les Laboratoires Servier SAS	19 Feb 2009
Depressive Disorder, Major	Norway	Servier (Ireland) Industries Ltd.	19 Feb 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bipolar I disorder	Phase 3	Austria	Institut de Recherches Internationales Servier	01 May 2006
Bipolar I disorder	Phase 3	Austria	Laboratorios Servier SL	01 May 2006
Obsessive-Compulsive Disorder	Phase 2	Israel	Institut de Recherches Intern Servier	01 May 2010
Kidney Failure, Chronic	Phase 1	United States	Novartis Pharmaceuticals Corp.	01 Mar 2011
Autistic Disorder	Clinical	United States	Nectid, Inc.	17 Aug 2012
Pain	Clinical	United States	Nectid, Inc.	17 Aug 2012
Depressive Disorder	IND Approval	China	Xinwen Biomedical Technology (Jiashan) Co., Ltd.	14 May 2024
Parkinson Disease	Preclinical	China	Fujian Medical University	30 Nov 2025
Brain Injuries	Preclinical	India	Bharat Institute of Technology	10 Jun 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04589143 (Pubmed \| BMC Med)	Phase 4	Depressive Disorder, Major	123	Agomelatine	ktdczryncz(vjzvhiqxpj): P-Value = 0.90	Negative	05 Mar 2025
				Placebo
NCT05922878 (BusinessWire) Manual	Phase 2	Depressive Disorder, Major	87	ALTO-300	fvcnhvxkxi(bfelsqmaha) = the development of novel precision medicines for neuropsychiatric disorders, today announced a favorable outcome from the planned interim analysis for the Phase 2b trial of ALTO-300 as an adjunctive treatment for patients with major depressive disorder (MDD). xioljlmbsz (znuzzpueea )	Positive	12 Feb 2025
NCT05118750 \| NCT05157945 (Corporate Publications) Manual	Phase 2	Depressive Disorder, Major	239	ALTO-300 (biomarker-characterized patients)	apensnttfy(wvzxadfxqd) = iftjkiscng argwaifxyn (rkwtbyydfk ) View more	Positive	04 Dec 2023
ISRCTN57507360 (Pubmed \| J Clin Psychiatry)	Phase 3	Depressive Disorder, Major	222	Agomelatine	cabnroguwp(rlouuqtqly) = etlioxuljk giukqxtkfe (ympsfsaxse )	Positive	01 Jun 2013
				Placebo	cabnroguwp(rlouuqtqly) = zedxhdsmsi giukqxtkfe (ympsfsaxse )
NCT03977441 (Pubmed \| J Clin Psychiatry)	Phase 4	Depressive Disorder, Major	332	Agomelatine 25-50 mg/day	wimujmmhpr(zekjblrptb) = rjmegualxa wmbqbcsjal (zulbikqmov )	Positive	01 Nov 2007
				Venlafaxine 75-150 mg/day	wimujmmhpr(zekjblrptb) = bdgqznoypa wmbqbcsjal (zulbikqmov )

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