Developer · United States

Engrail Therapeutics, Inc.

Privately held clinical-stage neuroscience company headquartered in San Diego, California, founded by Vikram Sudarsan (President and CEO) and describing itself as applying 'precision chemistry and pharmacology' to neuropsychiatric and neurodevelopmental disease. It acquired NeuroCycle Therapeutics in February 2021 to build its subtype-selective GABA-A franchise, and licensed elesclomol from the Texas A&M University System for disorders of mitochondrial copper metabolism. Pipeline: ENX-102 (GABA-A alpha-2/3/5 positive allosteric modulator, Phase 2 in generalized anxiety disorder — its most advanced asset), ENX-104 (D2/D3 autoreceptor antagonist, Phase 1, anhedonic major depressive disorder), ENX-105 (D2/D3/D4 antagonist with 5-HT1A and 5-HT2A agonism, PTSD and mood disorders), and ENX-103/ENX-203 (copper ionophore, Menkes disease). It closed an oversubscribed $157M Series B on 2024-03-19 co-led by F-Prime Capital, Forbion and Norwest Venture Partners, bringing total capital raised to more than $220M. Being private, it files nothing with the SEC, so its disclosure cadence is limited to press releases and conference presentations.

engrail.com ↗

1compound
1program
1indication
Phase 1lead asset

Phase distribution

  • Phase 11

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Deals & partnerships

  • Mar 19, 2024FinancingEngrail Therapeutics closes oversubscribed $157M Series BEngrail closed an oversubscribed $157 million Series B financing co-led by new investors F-Prime Capital, Forbion and Norwest Venture Partners, with participation from RiverVest Venture Partners, Red Tree Venture Capital, funds managed by abrdn Inc., Ysios Capital, Longwood Fund, Eight Roads Ventures and founding investor Pivotal Life Sciences, bringing total capital raised since inception to more than $220 million. The company said proceeds would advance its pipeline through multiple stages of clinical development across anxiety disorders, depression, post-traumatic stress disorder and rare neurodegenerative disease.ENX-104source ↗

Catalysts · 2 upcoming · 1 reported

  • No guidance — study completed 26 Nov 2025, topline undisclosedAnticipated

    ENX-104forMajor depressive disorderTopline data

    Topline from the Phase 1 multiple-ascending-dose study of ENX-104 in 48 patients with major depressive disorder with anhedonia (NCT07253324) — safety, tolerability, PK and pharmacodynamics, the first data in the target population. Completed 26 November 2025; nothing disclosed.

    NCT07253324source ↗

  • No guidance — study completed 2 Sep 2025, results undisclosedAnticipated

    ENX-104forMajor depressive disorderFull results

    D2/D3 receptor occupancy results from the Phase 1 PET study of single-dose ENX-104 in 10 healthy volunteers (NCT07253272) — the dose-to-occupancy relationship that would anchor Phase 2 dose selection against the intended 10-50% occupancy window. Completed 2 September 2025; nothing disclosed.

    NCT07253272source ↗

Recently reported

  • 2026-05-01met

    ENX-104forMajor depressive disorderFull results

    First-in-human single-ascending-dose results for ENX-104 presented at ASCP 2026: safe and well tolerated at all 5 dose levels with no serious or severe adverse events, dose-proportional plasma exposure, sustained central target engagement (dose-related decreases in adaptive tracking lasting >=48 h) and prolactin-confirmed peripheral D2/D3 antagonism.

    source ↗

Recent activity

  • May 1, 2026ReadoutENX-104·Major depressive disordermetFirst-in-human single-ascending-dose results for ENX-104 presented at ASCP 2026: safe and well tolerated at all 5 dose levels with no serious or severe adverse events, dose-proportional plasma exposure, sustained central target engagement (dose-related decreases in adaptive tracking lasting >=48 h) and prolactin-confirmed peripheral D2/D3 antagonism.source ↗
  • Nov 26, 2025Phase changeENX-104·Major depressive disorderPhase 1Actual primary completion and study completion of the multiple-ascending-dose study in anhedonic MDD (NCT07253324, 48 participants enrolled, actual), following completion of the PET occupancy study on 2025-09-02. The Phase 1 patient work is therefore finished, with no topline disclosed. Phase remains phase_1 and status remains active: no Phase 2 study is registered or announced, and the subsequent tablet-versus-solution bridging study (NCT07472361, Feb-Mar 2026) is itself Phase 1.source ↗
  • Feb 17, 2025Phase changeENX-104·Major depressive disorderPhase 1First dosing in the target patient population: the multiple-ascending-dose study in participants with major depressive disorder with anhedonia (NCT07253324, ENX-104-003) started 2025-02-17 at four MAC Clinical Research sites in England, and the D2/D3 PET receptor-occupancy study in healthy volunteers (NCT07253272, ENX-104-002) started a week later on 2025-02-24 at Parexel London. Both dates are ACTUAL start dates on ClinicalTrials.gov — but note that neither study was registered until November 2025, so no contemporaneous public disclosure of this transition existed.source ↗
  • Sep 18, 2024Phase changeENX-104·Major depressive disorderPhase 1Engrail announced initiation of the ENX-104 clinical program — a randomized, double-blind, placebo-controlled single ascending dose study in up to 48 healthy adult volunteers (cohorts of 8: 6 active, 2 placebo), with safety and tolerability as the primary objective plus PK and dopamine-related pharmacodynamic biomarkers. This is the compound's first-in-human entry and the only dated public marker of the preclinical-to-Phase 1 transition; the actual first-dose date was not disclosed, so this announcement date is an upper bound. The study is not registered on ClinicalTrials.gov.source ↗

Competitive landscape

Other companies developing against Engrail Therapeutics, Inc.'s targets or indications.