Lead program: Preclinical

Silo PharmaNasdaq: SILO

Data updated June 27, 2026

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.

Pipeline Intelligence

Developer Momentum

Programme tracker

Active candidates: 2
Active programmes: 2
Lead stage: Preclinical
Forecast coverage: 2 of 2

Latest sourced update

Sever Pharma Expands Partnership with Silo on SP-26

Aug 14, 2025 - partner-announcement - Sever Pharma Solutions - SP-26

Next known catalyst

Regulatory filing submitted

Timing not specified - SPC-15 / SPC-15 IND-Enabling Programme (PTSD) — Columbia University licence - Confidence: 40%

9 sources0 pipeline-linked trials0 pipeline-linked papers

Development Programmes

SPC-15

Preclinical

PTSD Anxiety Disorders

PTSD / anxiety disorders

Programme Tracker

PTSD

Primary: US (FDA)

Pre-clinicalActive

Forecast

Regulatory filing submitted

SPC-15 remains in IND-enabling work for PTSD/stress-induced anxiety, with GLP safety work at Frontage and public 2025 plans for IND submission and potential 2026 Phase 1.

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

(Press release)[Verified]Silo Advances SPC-15 Toward First-in-Human Trial(Press release)[Verified]

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.

Silo completes FDA pre-IND meeting for SPC-15 PTSD programme(Press release)[Verified]Silo Pharma Fact Sheet - SPC-15(company-presentation)[Verified]

Recorded Events

Mar 1, 2025: Pre-clinical started

Sep 1, 2024: Regulatory review accepted

Evidence Links

Silo Advances SPC-15 Toward First-in-Human Trial

Press release - BioSpace / Silo Pharma - Jan 1, 2025 - Verified

Announcement says a key GLP-compliant safety study for SPC-15 was initiated at Frontage Laboratories.

Silo Pharma Fact Sheet - SPC-15

company-presentation - Silo Pharma - Mar 1, 2025 - Verified

Fact sheet describes SPC-15 as a nose-to-brain intranasal formulation for PTSD and stress-induced anxiety disorders.

Silo Plans SPC-15 IND Submission and Potential Phase 1 in 2026

industry-media - Quiver Quantitative - Jul 1, 2025 - Verified

Coverage reports SPC-15 IND submission plans and potential 2026 Phase 1 trial if preclinical results are favorable.

Silo completes FDA pre-IND meeting for SPC-15 PTSD programme

Press release - Silo Pharma / BioSpace - Sep 10, 2024 - Verified

Release reports completion of FDA pre-IND meeting for SPC-15, proposal submitted for FDA 505(b)(2) regulatory pathway, and alignment toward IND submission for first-in-human trials.

SP-26

Ketamine

Preclinical

Fibromyalgia Chronic Pain

Fibromyalgia / chronic pain

Programme Tracker

Fibromyalgia

Primary: US (FDA)

Pre-clinicalActive

Forecast

preclinical-data

SP-26 remains a preclinical ketamine-loaded implant programme for fibromyalgia/chronic pain, with 2025 minipig endpoint data and Sever Pharma scale-up work.

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

(Press release)[Verified]Silo SP-26 Ketamine Implant Meets Endpoints in Fibromyalgia Study(Press release)[Verified]

Recorded Events

Apr 30, 2025: Pre-clinical completed