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    Anxiety research and policy tracker: drugs, trials and guidance

    In 2026 a single dose of DT120, an LSD-based tablet, beat placebo in two phase 3 trials for generalized anxiety disorder, and its developer plans to file for FDA approval in the first half of 2027.[1][2][3] Another candidate, fasedienol for social anxiety, missed its main goal in two phase 3 trials.[4][5] WHO's September 2026 fact sheet puts the number of people with anxiety disorders at 470 million in 2023.[6]

    Editor reviewedStrict sourcingUpdated DevelopingMental health, Health and medicine, Tech policy

    What we know

    • WHO estimates 470 million people had an anxiety disorder in 2023[6]
    • The USPSTF recommends anxiety screening for adults aged 64 or younger (grade B)[19]
    • DT120 met its primary endpoint in two phase 3 GAD trials, Voyage and Panorama[2]
    • DT120 has FDA Breakthrough Therapy designation for GAD and major depressive disorder[12]
    • Fasedienol missed its primary endpoint in PALISADE-3 and PALISADE-4[5]
    • The FDA cleared DaylightRx, the first digital treatment for GAD, in 2024[10]
    • Benzodiazepines carry an FDA boxed warning on abuse, addiction, dependence and withdrawal[24]

    What we don't know yet

    • Whether the FDA will accept an application for DT120, and on what timeline, after the planned pre-NDA meeting
    • How well participants and raters stayed blinded in the DT120 trials, given the drug's strong perceptual effects
    • How long the benefit of a single DT120 dose lasts beyond 12 weeks, and how often repeat doses would be needed
    • Whether fasedienol will get a further phase 3 trial, and whether it would succeed with a different endpoint
    • Whether the reconstituted USPSTF will revisit its anxiety screening recommendation, including for adults aged 65 and older
    Story status

    Story status

    State
    developing
    Started
    2020-09-23
    Timeline entries
    11
    Last entry

    Timeline data (JSON)

    This tracker follows research and policy on anxiety disorders: screening guidance, regulatory actions, late-stage drug trials and new data. It runs to 11 October 2026. WHO now estimates 470 million people had an anxiety disorder in 2023.[6] For background, start with the anxiety crash course.

    This page is general information, not medical advice. Drugs described here as in development are not approved; talk to a clinician about treatment options.

    Where things stand

    Definium Therapeutics, which is developing a GAD drug, says there has been little innovation in generalized anxiety disorder (GAD) treatment for decades and that the last new drug approval for GAD was in 2007.[7] Current guidelines centre on CBT and SSRI or SNRI antidepressants.[8][9] In 2024 the FDA cleared the first digital treatment for GAD, a prescription CBT app.[10]

    The most advanced new drug candidate covered here is DT120, an orally disintegrating tablet of lysergide (LSD) tested earlier under the code MM120.[11] It has FDA Breakthrough Therapy designation for GAD and major depressive disorder.[12]

    DT120 (lysergide): the phase 3 results

    TrialReportedParticipantsHAM-A change at week 12, drug vs placebo
    Phase 2b (JAMA)Oct 2025198 adults, single dose[13]Week 4: 100 µg and 200 µg beat placebo by 5.0 and 6.0 points[13]
    Voyage (phase 3)12 Aug 2026107 per arm[1]-11.6 vs -6.2 (difference 5.4)[1]
    Panorama (phase 3)14 Sep 2026245 enrolled[2]-9.8 vs -4.7 (difference 5.1)[2]

    The Voyage and Panorama figures are topline results announced by the company.[1][2] Definium said adverse events in Voyage were mostly mild to moderate and occurred mainly on the dosing day.[14] Participants in Panorama were monitored for at least 8 hours after dosing.[15] In the earlier phase 2b trial, visual perceptual changes affected 92.5% of people on the 100 µg dose, and most of the paper’s authors were employees of its developer, Mind Medicine (MindMed).[16][17]

    A known challenge for psychedelic trials is “functional unblinding”, where participants can tell from the effects whether they got the drug. Panorama added a 50 µg arm to help reduce it.[18] Definium has scheduled a pre-NDA meeting with the FDA for the fourth quarter of 2026 and expects to file a New Drug Application in the first half of 2027.[3]

    Fasedienol: two misses in social anxiety

    Vistagen’s fasedienol is a nasal spray designed for acute, as-needed use in social anxiety disorder. In December 2025 it failed to beat placebo on distress during a simulated public-speaking challenge in PALISADE-3.[4] In June 2026 it missed its primary and secondary endpoints again in PALISADE-4, which had 238 participants. A post-hoc analysis suggested a benefit in very severe social anxiety, and Vistagen said it would discuss a single further phase 3 trial with the FDA.[5] Post-hoc subgroup findings are hypothesis-generating, not proof of benefit.

    Screening and safety policy

    The US Preventive Services Task Force’s 2023 recommendation remains the reference point for US anxiety screening: grade B for adults aged 64 and younger, including pregnant and postpartum people, and an I statement (insufficient evidence) for adults 65 and older.[19][20] As of September 2026 the Task Force had not met for more than a year after its meetings were cancelled, and on 17 September HHS Secretary Robert F. Kennedy Jr. named eight new members.[21][22] See uspstf for how the Task Force works. On safety, the FDA’s 2020 class-wide boxed warning for benzodiazepines warns that dependence can develop within days to weeks of steady use, even as prescribed.[23]

    Next dates to watch

    • Fourth quarter of 2026: Definium’s pre-NDA meeting with the FDA on DT120.[3]
    • First half of 2027: Definium’s planned NDA filing.[3]
    • Vistagen’s FDA discussions on whether fasedienol gets another phase 3 trial.[5]

    Timeline

    10 confirmed1 reported

    1. confirmed

      New USPSTF members named after a year without meetings[21][22]

      The Task Force, which issued the 2023 anxiety screening recommendation, had not met for over a year; HHS Secretary Robert F. Kennedy Jr. named eight new members.

    2. confirmed

      WHO updates anxiety fact sheet to 470 million people[6][26]

      WHO says only about 1 in 4 people who need treatment receive any.

    3. confirmed

      DT120 meets primary endpoint in second phase 3 GAD trial (Panorama)[2][3]

      A 5.1-point placebo-adjusted HAM-A reduction at week 12; Definium scheduled a pre-NDA meeting for late 2026.

    4. reported

      DT120 meets primary endpoint in first phase 3 GAD trial (Voyage)[1][14]

      Company-reported topline results; a single 100 µg dose cut HAM-A scores 5.4 points more than placebo at week 12.

    5. confirmed

      Fasedienol also misses in PALISADE-4[5]

      A post-hoc analysis suggested a nominal benefit in very severe social anxiety; Vistagen planned to discuss a single further trial with the FDA.

    6. confirmed

      Fasedienol misses primary endpoint in PALISADE-3[4]

      Vistagen's nasal spray for acute social anxiety did not beat placebo during a simulated public-speaking challenge.

    7. confirmed

      JAMA publishes phase 2b trial of single-dose MM120 in GAD[13][16]

      The 100 µg and 200 µg doses reduced anxiety scores at week 4 versus placebo; visual perceptual changes were common.

    8. confirmed

      Large trial finds digital meditation cuts employee stress[25]

      1,458 employees at a US academic medical center; effects held at 4 months.

    9. confirmed

      FDA clears DaylightRx, the first digital treatment for GAD[10]

      A prescription CBT app from Big Health for adults aged 22 and older, used alongside usual care.

    10. confirmed

      USPSTF recommends anxiety screening for adults 64 and younger[19][20]

      A new grade B recommendation that includes pregnant and postpartum people; evidence for adults 65 and older was rated insufficient.

    11. confirmed

      FDA requires updated boxed warnings on all benzodiazepines[24][23]

      The warnings cover abuse, addiction, physical dependence and withdrawal reactions.

    Health & medicine

    US Preventive Services Task Force (USPSTF)

    The USPSTF sets the US cancer screening recommendations that shape free coverage. How it grades evidence, what it recommends, and its 2026 overhaul.

    Sources

    · 26 claims from 14 publishers

    Each numbered claim is a statement we checked against the sources listed with it. Tap a number in the text to see its sources in place.

    1. [1]

      Definium Therapeutics reported on 12 August 2026 that its first phase 3 GAD trial, Voyage (107 participants per arm), met its primary endpoint - a single 100 µg dose of DT120 reduced HAM-A anxiety scores by 11.6 points at week 12 versus 6.2 on placebo, a 5.4-point difference. reportedas of 2026-08-12

    2. [2]

      Definium reported on 14 September 2026 that its second phase 3 GAD trial, Panorama (245 participants), met its primary endpoint - a single 100 µg dose of DT120 reduced HAM-A scores by 9.8 points at week 12 versus 4.7 on placebo, a 5.1-point difference. confirmedas of 2026-09-14

    3. [3]

      Definium said in September 2026 that a pre-NDA meeting with the FDA was scheduled for the fourth quarter of 2026 and that it anticipated filing a New Drug Application in the first half of 2027. confirmedas of 2026-09-14

    4. [4]

      Vistagen announced on 17 December 2025 that its PALISADE-3 phase 3 trial of intranasal fasedienol for acute treatment of social anxiety disorder did not show a statistically significant improvement on its primary endpoint, distress during a simulated public-speaking challenge. confirmedas of 2025-12-17

    5. [5]

      Vistagen announced on 30 June 2026 that fasedienol also missed its primary and secondary endpoints in the PALISADE-4 phase 3 trial (238 participants), though a post-hoc analysis suggested a nominal benefit in very severe social anxiety; the company planned to discuss a single further phase 3 trial with the FDA. confirmedas of 2026-06-30

    6. [6]

      WHO estimates that 470 million people had an anxiety disorder in 2023, making anxiety disorders the most common of all mental disorders, and that about 5.8% of the global population currently has one. confirmedas of 2026-09-15

    7. [7]

      Definium states that the last new drug approval for GAD occurred in 2007. reportedas of 2026-09-14

    8. [8]

      For GAD with marked functional impairment or no response to low-intensity help, NICE recommends offering either a high-intensity psychological intervention or drug treatment, based on preference, because there is no evidence either is better. confirmedas of 2026-10-11

    9. [9]

      NICE recommends that people with GAD who choose drug treatment be offered an SSRI, considering sertraline first because it is the most cost-effective; if it does not work, an alternative SSRI or an SNRI. confirmedas of 2026-10-11

    10. [10]

      In September 2024 the FDA cleared Big Health's DaylightRx, a prescription app delivering CBT, as the first FDA-cleared digital treatment for generalized anxiety disorder, for adults aged 22 and older as an adjunct to usual care. confirmedas of 2024-09-05

    11. [11]

      Definium Therapeutics' Panorama study, registered under the code MM120-301, tested DT120, an orally disintegrating tablet of lysergide (LSD). confirmedas of 2026-09-14

    12. [12]

      DT120 has FDA Breakthrough Therapy designation for GAD and major depressive disorder, according to Definium. confirmedas of 2026-09-14

    13. [13]

      In a phase 2b trial published in JAMA in October 2025, 198 adults with moderate to severe GAD received a single dose of MM120 (lysergide) or placebo; the 100 µg and 200 µg doses reduced anxiety scores at week 4 versus placebo (by 5.0 and 6.0 points), while 25 µg and 50 µg did not reach significance. confirmedas of 2025-10-21

    14. [14]

      Definium said DT120 was generally well tolerated in Voyage, with adverse events mostly mild to moderate, transient and on the dosing day, and that participants took an average of 6.4 hours to meet end-of-session discharge criteria. reportedas of 2026-08-12

    15. [15]

      In Panorama, participants were monitored for at least 8 hours on the dosing day and took an average of 6.2 hours to meet end-of-session criteria on the 100 µg dose. confirmedas of 2026-09-14

    16. [16]

      In the MM120 phase 2b trial, visual perceptual changes were the most common adverse events, occurring in 92.5% of participants on 100 µg and 10.3% on placebo; nausea and headache were also common. confirmedas of 2025-10-21

    17. [17]

      Most authors of the MM120 phase 2b JAMA paper were employees of the drug's developer, Mind Medicine (MindMed) Inc. confirmedas of 2025-10-21

    18. [18]

      Panorama included a 50 µg arm intended to help reduce functional unblinding, in which participants can guess their treatment from its perceptual effects. confirmedas of 2026-09-14

    19. [19]

      In a final recommendation dated 20 June 2023, the USPSTF recommended screening for anxiety disorders in adults aged 64 or younger, including pregnant and postpartum people (grade B); it was a new recommendation. confirmedas of 2023-06-20

    20. [20]

      The USPSTF concluded that evidence is insufficient to assess the balance of benefits and harms of anxiety screening in adults aged 65 or older (I statement). confirmedas of 2023-06-20

    21. [21]

      As of September 2026 the USPSTF had not met for more than a year after its meetings were cancelled by HHS Secretary Robert F. Kennedy Jr. confirmedas of 2026-09-17

    22. [22]

      On 17 September 2026 Kennedy named eight new USPSTF members, with pediatric hematologist-oncologist Seth Corey as chair; most are specialists, a departure from the panel's generalist make-up. confirmedas of 2026-09-17

    23. [23]

      The FDA says physical dependence on benzodiazepines can develop when they are taken steadily for several days to weeks, even as prescribed, and that stopping abruptly or reducing the dose too quickly can cause withdrawal reactions including seizures. confirmedas of 2020-09-23

    24. [24]

      In September 2020 the FDA required the Boxed Warning for all benzodiazepine medicines to be updated to address the serious risks of abuse, addiction, physical dependence and withdrawal reactions. confirmedas of 2020-09-23

    25. [25]

      In a randomised trial of 1,458 employees of a US academic medical center with mild to moderate stress, a digital meditation programme (10 minutes a day for 8 weeks) reduced perceived stress versus a waiting list (Cohen's d 0.85), with improvement maintained at 4 months (d 0.71). confirmedas of 2025-01-02

    26. [26]

      WHO says only about 1 in 4 people who need treatment for an anxiety disorder (27.6%) receive any, citing World Mental Health Surveys in 21 countries. confirmedas of 2026-09-15

    Revision history (1)
    1. Page created.

    Created Oct 11, 2026. Last reviewed by an editor on Oct 11, 2026. Next scheduled review: Dec 31, 2026.

    Cite this page

    "Anxiety research and policy tracker: drugs, trials and guidance." ContentLora, updated Oct 11, 2026. https://contentlora.com/events/anxiety-tracker

    Spotted an error? Suggest a correction or emailcorrections@contentlora.com.

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