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Research, Drug Development & Manufacturing
Research, Drug Development & ManufacturingCompany-Led Drug Development & CommercializationEarly-Stage Translational Research (Pre-Clinical)
Research, Drug Development & ManufacturingCompany-Led Drug Development & Commercialization
Lead program: Pre-clinical

Silo PharmaNasdaq: SILO

2 Drug Candidates

US-listed clinical-stage biotech developing psychedelic and ketamine-based therapies for PTSD and chronic pain. SPC-15 is an intranasal 5-HT4 serotonin receptor agonist for PTSD in IND-enabling GLP studies. SP-26 is a proprietary ketamine implant for fibromyalgia being co-developed with the University of Maryland.

Development Programmes

2

SPC-15

Pre-clinical
PTSDAnxiety Disorders

PTSD / anxiety disorders

Programme Tracker

PTSD

Primary: US (FDA)
Pre-clinicalActive

GLP-compliant IND-enabling toxicology study initiated at Frontage Laboratories (March 2025); key safety study underway (May 2025); 505(b)(2) pathway; FDA follow-up meetings November 2025; IND submission targeted 2025

Milestones

Pre-clinical started

Completed

Actual: Mar 1, 2025

First dosing in GLP-compliant IND-enabling toxicology/toxicokinetics study (Frontage Laboratories)

Why it matters: GLP tox study is the critical IND-enabling step. First dosing confirms the preclinical programme is on track for IND submission in 2025 and potential Phase 1 by end of 2026.

Watch next: Tox study data Q3/Q4 2025; FDA follow-up meetings November 2025; IND filing 2025

Regulatory review accepted

Completed

Actual: Sep 1, 2024

Pre-IND meeting with FDA; 505(b)(2) pathway confirmed for SPC-15

Why it matters: SPC-15 is an intranasal serotonin 5-HT4 receptor agonist — a mechanistically novel PTSD prophylactic (not a classical psychedelic). Pre-IND FDA meeting with 505(b)(2) pathway confirmation is a significant de-risking milestone, as it allows Silo to leverage existing safety data and reduces the full Phase I/II burden.

Recorded Events

Mar 1, 2025: Pre-clinical started

Sep 1, 2024: Regulatory review accepted

Pre-clinical
FibromyalgiaChronic Pain

Fibromyalgia / chronic pain

Programme Tracker

Fibromyalgia

Primary: US (FDA)
Pre-clinicalActive

All endpoints met in minipig fibromyalgia study (April 2025); zero adverse events; sustained plasma levels up to 22 days; peak within 1 hour; 505(b)(2) pathway; joint development agreement for implant device signed November 2024

Milestones

Pre-clinical completed

Completed

Actual: Apr 30, 2025

Minipig fibromyalgia study: all endpoints met, zero adverse events, sustained ketamine plasma levels up to 22 days with 1-hour peak onset

Why it matters: SP-26 is a biodissolvable polymer subcutaneous implant delivering ketamine continuously over weeks — fundamentally different from IV/IM/nasal ketamine that requires clinical visits. Sustained sub-psychedelic plasma levels without repeated dosing addresses the core practical limitation of ketamine for chronic pain. The minipig model is highly translatable.

Watch next: IND-enabling studies and first-in-human dose

Recorded Events

Apr 30, 2025: Pre-clinical completed

Quick Facts

Type
Public Biotech
Ticker
Nasdaq: SILO
Lead Stage
Pre-clinical
Website
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