Remedi Therapeutics
Preclinical2 active candidates
2 shared indicationsPreclinical peersame regulator: US FDAsimilar active pipeline size
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Lead program: Preclinical
Silo PharmaNasdaq: SILO
CategoriesEarly-Stage Translational Research (Pre-Clinical)Research, Drug Development & Manufacturing
Data updated
2 Drug Candidates
Enterprise Intelligence
Quarterly psychedelic drug-development briefing
Compare indication activity, programme milestones, competitive intensity, and near-term catalysts. Q2 includes quarter-over-quarter changes against the published Q1 baseline.
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
- Active candidates
- 2
- Active programmes
- 2
- Lead stage
- Preclinical
- Forecast coverage
- 2 of 2
All tracked candidates active
All tracked programmes active
Current furthest stage
2 active programmes with forecast fields
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
2SPC-15
Preclinical
PTSD / anxiety disorders
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
CompletedActual: 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
CompletedActual: 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
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
KetaminePreclinical
Fibromyalgia / chronic pain
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
CompletedActual: 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
Evidence Links
Silo SP-26 Ketamine Implant Meets Endpoints in Fibromyalgia Study
Press release - BioSpace / Silo Pharma - Jan 1, 2025 - Verified
Announcement reports SP-26 met all endpoints in a minipig fibromyalgia study.
Silo Pharma SP-26 Pipeline Page
company-website - Silo Pharma - May 24, 2022 - Verified
Pipeline page describes SP-26 as a ketamine-loaded implant for fibromyalgia and chronic pain.
Sever Pharma Expands Partnership with Silo on SP-26
partner-announcement - Sever Pharma Solutions - Aug 14, 2025 - Verified
Partner announcement says Sever will scale extrusion and continue analytical testing for SP-26 controlled-release implant.
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Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.
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Quick Facts
- Type
- Public Biotech
- Ticker
- Nasdaq: SILO
- Lead Stage
- Preclinical
- Website
- Visit