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Lead program: Preclinical
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Xylo Bio

Also known as: Psylo

Data updated

1 Drug Candidate

Xylo Bio (formerly Psylo) is an Australian-US biotech developing next-generation neuroplasticity-promoting therapeutics for mental health. Founded in 2021 by Josh Ismin and Sam Banister in Sydney, the company has labs at the University of Colorado Boulder and the University of New South Wales. Its lead candidate PSYLO-100X is a non-hallucinogenic compound designed for home administration without clinical supervision, advancing through IND-enabling studies toward first-in-human trials. Xylo has raised $14.2M including an $8M seed round in June 2024 from Tenmile, Focalpoint Partners, and Palo Santo.

Pipeline Intelligence

Developer Momentum

Programme tracker
Active candidates
1

All tracked candidates active

Active programmes
1

All tracked programmes active

Lead stage
Preclinical

Current furthest stage

Forecast coverage
1 of 1

1 active programme with forecast fields

Latest sourced update

Xylo Bio Company Site

Jun 26, 2026 - company-website - Xylo Bio - XYL-1001 (formerly PSYLO-100X)

Next known catalyst

No next milestone forecast yet.

4 sources0 pipeline-linked trials0 pipeline-linked papers

Development Programmes

1

XYL-1001 (formerly PSYLO-100X)

Preclinical

Depression, anxiety, ruminative disorders — non-hallucinogenic 5-HT2A-selective neuroplastogen

Programme Tracker

Major Depressive Disorder (MDD)

Primary: US (FDA)
Pre-clinicalActive

XYL-1001 remains in IND-enabling/manufacturing scale-up, with Xylo reporting rebrand/pipeline progress in 2025 and first-in-human trials planned around mid-2026.

Milestones

Pre-clinical completed

In progress

Manufacturing scale-up initiated; preclinical efficacy data (antidepressant-like effects, neuroplasticity, pro-cognitive) reported

Why it matters: Positive preclinical data and manufacturing progress support the mid-2026 FIH timeline. The non-hallucinogenic, 5-HT2A-selective, 5-HT2B-sparing profile is the key differentiator in a crowded neuroplastogen field.

Watch next: IND-enabling tox completion and FDA IND filing

Funding milestone

Completed

Actual: Jun 3, 2024

First close on $8M Series Seed financing announced at BIO Conference San Diego

Why it matters: The $8M seed funds IND-enabling studies and manufacturing scale-up for XYL-1001 (then PSYLO-100X). Xylo Bio's computationally enhanced drug discovery platform identified XYL-1001 as a non-hallucinogenic 5-HT2A-selective neuroplastogen that avoids 5-HT2B activation (reducing cardiac risk) while preserving antidepressant-like efficacy and pro-cognitive effects in preclinical models.

Watch next: IND filing and FIH study initiation mid-2026

Company milestone

Completed

Actual: Jan 1, 2025

Rebranded from Psylo to Xylo Bio; key board appointments; restructured as US Delaware C-corp

Why it matters: US reincorporation and rebrand position the company for US IND filing and institutional fundraising. Board appointments signal expansion from academic origins toward clinical-stage drug development.

Recorded Events

Jan 1, 2025: Company milestone

Jun 3, 2024: Funding milestone

Evidence Links

Xylo Bio Company Site

company-website - Xylo Bio - Jun 26, 2026 - Verified

Company site describes Xylo next-generation targeted neurotherapeutics and pipeline direction.

Psylo Announces First Close on 8M Series Seed Financing

Press release - PRNewswire / Psylo - Jun 3, 2024 - Verified

Series seed announcement supports PSYLO-100X as flagship non-hallucinogenic 5-HT2A agonist advancing toward clinical development.

Psylo Rebrands as Xylo with Pipeline Progress

Press release - PRNewswire / Xylo Bio - Jan 1, 2025 - Verified

Rebrand announcement says XYL-1001 manufacturing scale-up has begun and first-in-human clinical trials are planned for mid-2026.

Xylo Bio March 2025 Newsletter

company-update - Xylo Bio - Mar 1, 2025 - Verified

Newsletter describes XYL-1001 as a non-hallucinogenic, 5-HT2A-selective neuroplastogen advancing toward clinical trials.

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Quick Facts

Type
Private Biotech
Founded
2021
Lead Stage
Preclinical
Website
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