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HealthQuiet 4d · day 10

Definium's LSD therapy clears second late-stage anxiety trial

DT120 reduced anxiety scores by 9.8 points vs. 4.7 for placebo, paving the path to FDA filing in early 2027.

newest coverage 3d agosummary written 9d ago8 pieces NewswiresGoogle NewsReddit

What to know

  • DT120, a 100-microgram LSD tablet, reduced anxiety scores by 9.8 points versus 4.7 for placebo in a 245-patient trial, with benefits appearing by day two.
  • This is Definium's second successful late-stage anxiety trial; a third trial showed efficacy for depression, positioning the company to seek FDA approval for both indications.
  • CEO Robert Barrow cited the dual success as strengthening the regulatory case, noting that about a dozen other GAD programs have failed for approval.
  • Definium plans to file its FDA marketing application in the first half of 2027; the company's stock has nearly tripled this year amid broader investor enthusiasm for psychedelic therapies.

“Higher efficacy on the 100-microgram dose versus the 50-microgram one 'gives us obviously an easier discussion (with regulators).'”

Robert Barrow, CEO, Definium Therapeutics · Jerusalem Post ↗

Definium Therapeutics Company developing DT120Robert Barrow CEO, Definium TherapeuticsGavin Clark-Gartner Analyst, Evercore ISI

Definium's LSD therapy clears second late-stage anxiety trial
Jerusalem Post

How it unfolded 3 developments, newest first · click a bar or a number to jump articles

Peak 2 pieces in 3h at Sep 14, 9 AM; 8 pieces over 10 days (7 articles · 1 post) Sep 14, 6 AM — 1 piece · 1 article — Newswires 1Sep 14, 9 AM — 2 pieces · 2 articles — Newswires 2Sep 14, 12 PM — quietSep 14, 3 PM — 2 pieces · 2 articles — Google News 2Sep 14, 6 PM — quietSep 14, 9 PM — quietSep 15, 12 AM — quietSep 15, 3 AM — quietSep 15, 6 AM — 1 piece · 1 post — Reddit 1Sep 15, 9 AM — quietSep 15, 12 PM — quietSep 15, 3 PM — quietSep 15, 6 PM — quietSep 15, 9 PM — quietSep 16, 12 AM — quietSep 16, 3 AM — quietSep 16, 6 AM — quietSep 16, 9 AM — quietSep 16, 12 PM — 1 piece · 1 article — Newswires 1Sep 16, 3 PM — quietSep 16, 6 PM — quietSep 16, 9 PM — quietSep 17, 12 AM — quietSep 17, 3 AM — quietSep 17, 6 AM — quietSep 17, 9 AM — quietSep 17, 12 PM — quietSep 17, 3 PM — quietSep 17, 6 PM — quietSep 17, 9 PM — quietSep 18, 12 AM — quietSep 18, 3 AM — quietSep 18, 6 AM — quietSep 18, 9 AM — quietSep 18, 12 PM — quietSep 18, 3 PM — quietSep 18, 6 PM — quietSep 18, 9 PM — quietSep 19, 12 AM — quietSep 19, 3 AM — quietSep 19, 6 AM — quietSep 19, 9 AM — quietSep 19, 12 PM — quietSep 19, 3 PM — quietSep 19, 6 PM — quietSep 19, 9 PM — quietSep 20, 12 AM — quietSep 20, 3 AM — quietSep 20, 6 AM — quietSep 20, 9 AM — 1 piece · 1 article — Newswires 1Sep 20, 12 PM — quietSep 20, 3 PM — quietSep 20, 6 PM — quietSep 20, 9 PM — quietSep 21, 12 AM — quietSep 21, 3 AM — quietSep 21, 6 AM — quietSep 21, 9 AM — quietSep 21, 12 PM — quietSep 21, 3 PM — quietSep 21, 6 PM — quietSep 21, 9 PM — quietSep 22, 12 AM — quietSep 22, 3 AM — quietSep 22, 6 AM — quietSep 22, 9 AM — quietSep 22, 12 PM — quietSep 22, 3 PM — quietSep 22, 6 PM — quietSep 22, 9 PM — quietYesterday, 12 AM — quietYesterday, 3 AM — quietYesterday, 6 AM — quietYesterday, 9 AM — quietYesterday, 12 PM — quietYesterday, 3 PM — quietYesterday, 6 PM — quietYesterday, 9 PM — quietToday, 12 AM — quietToday, 3 AM — quietToday, 6 AM — quiet 1–3
Sep 15Sep 16Sep 17Sep 18Sep 19Sep 20Sep 21Sep 22now · 7:48 AM ET
  1. 3

    Definium stock rises on trial success

    Share prices climbed following the announcement, continuing a year of strong investor enthusiasm for psychedelic-based therapies that has nearly tripled Definium's stock value since the start of 2026.

    1. 2 outlets Definium's LSD-based drug lowers anxiety in second successful late-stage study

      first by Jerusalem Post, 9d ago · also Seeking Alpha

      1 more headline
  2. 2

    Analyst calls results unusually consistent for neuropsych field

    Evercore ISI analyst Gavin Clark-Gartner praised the three back-to-back successful trials as exceptional for the category, noting this consistency is atypical in neuropsychiatric drug development.

    “It is really fascinating to see 3 back-to-back trials that show shockingly consistent benefits – this is just not something you normally see in the neuropsych field.”
    — Gavin Clark-Gartner
  3. background

    CEO Barrow highlights regulatory advantage of dual-trial success — Definium's CEO said having two confirming studies addresses attribution questions and gives an easier regulatory discussion, noting that about a dozen GAD programs have failed for approval. He also observed that patients could guess their assignment despite the lower dose arm designed to mitigate unblinding.

  4. 1

    Definium releases second successful anxiety trial results

    In a 245-patient trial, a single 100-microgram dose of DT120 reduced anxiety scores by 9.8 points after 12 weeks, compared with 4.7 points for placebo. Benefits appeared as early as day two and sustained through week 12. The 50-microgram dose also showed efficacy but less than the 100-microgram dose.

    “A single 100-microgram dose of DT120, a fast-dissolving tablet of lysergide, or LSD, reduced scores on an anxiety scale by 9.8 points after 12 weeks, compared with a 4.7-point decline for placebo.”
    — Definium Therapeutics

    1. 2 outlets first by STAT, 9d ago · also Yahoo Finance · read ↗

    2. 1 outlet LSD-based Drug Lowers Anxiety in Second Successful Late-stage Study

      first by Medscape, 10d ago

  5. background

    Definium announces first successful late-stage anxiety trial for DT120 — The company reported that DT120 significantly reduced anxiety symptoms in its initial late-stage study for generalized anxiety disorder.

  6. background

    DT120 succeeds in depression treatment late-stage study — Definium disclosed that the LSD-based drug also showed efficacy in treating depression in another late-stage trial, positioning the company to pursue a broad label for both GAD and depression.