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Soneira

Data updated

1 Drug Candidate

Soneira is a private psychedelic biotech company developing synthetic ibogaine therapies for neuropsychiatric conditions, with a primary focus on traumatic brain injury (TBI). The company has raised $15 million from Sergey Brin's Catalyst4 investment vehicle and is working to advance the first FDA-approvable synthetic ibogaine candidate to clinical trials.

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

Nolan Williams Obituary — Stanford Medicine

Dec 1, 2025 - Press release - Stanford Medicine - SON-001 (Ibogaine + Cardiac Protectant) / SON-001 — TBI / Neuropsychiatric Development

Next known catalyst

Regulatory filing submitted

Timing not specified - SON-001 (Ibogaine + Cardiac Protectant) / SON-001 — TBI / Neuropsychiatric Development - Confidence: 30%

9 sources0 pipeline-linked trials0 pipeline-linked papers

Development Programmes

1

SON-001 (Ibogaine + Cardiac Protectant)

Preclinical

Patent-pending ibogaine formulation co-administered with cardiac-protective agent (magnesium, mexiletine, or other hERG channel modulators) to prevent long QT syndrome. Ibogaine interacts with NMDA, opioid, sigma, and serotonin receptors; increases BDNF/GDNF transcription and cortical dendritic complexity. Primary indication: TBI-associated disabilities in military veterans. Built on Stanford MISTIC study (NCT04313712): 30 SOF veterans, ibogaine 12.1 mg/kg + IV magnesium, published Nature Medicine Jan 2024. Results: PTSD d=2.54, depression d=2.80, anxiety d=2.13 at 1 month; 84% sustained PTSD remission at 12 months. Public Benefit Corporation pledging 1% net profits to indigenous communities.

Programme Tracker

Traumatic Brain Injury (TBI)

Primary: US (FDA)
Pre-clinicalActive

Forecast

Regulatory filing submitted

Pre-clinical stage. No Soneira-sponsored clinical trial registered on ClinicalTrials.gov. No IND filing or FDA pre-IND meeting publicly disclosed. Stanford MISTIC study (NCT04313712, observational, NOT FDA-regulated) provides foundational clinical data. Two patent applications filed jointly with Stanford (Sep 2023). Company path forward unclear after loss of founding advisor Nolan Williams (Oct 2025).

Milestones

data-readout

Completed

Actual: Jan 5, 2024

Stanford MISTIC study results published in Nature Medicine. 30 male Special Operations Forces veterans with mild TBI received oral ibogaine (12.1±1.2 mg/kg) + IV magnesium at clinic in Mexico. PTSD: Cohen's d=2.54 at 1 month (p<0.001). Depression: d=2.80. Anxiety: d=2.13. No unexpected serious adverse events. 12-month follow-up: 84% sustained PTSD remission, 66% depression remission.

Why it matters: Among the largest effect sizes ever reported for any psychiatric intervention. Published in the highest-impact medical journal (Nature Medicine). Establishes ibogaine-magnesium as a potentially transformative treatment for TBI/PTSD in veterans. However, this was an open-label observational study without a control group — RCT data is needed.

Funding milestone

Completed

Actual: Jul 23, 2024

$25M seed round closed. $15M from Catalyst4, Sergey Brin's (Google co-founder) mental health nonprofit. Catalyst4 was established with proceeds from Brin's 2021 sale of $366M in Tesla shares. Additional $10M from undisclosed investors; Satori Capital also listed.

Why it matters: Largest seed round for an ibogaine-focused company. Sergey Brin's involvement brings significant visibility and credibility. $25M provides substantial runway for IND-enabling work and potential Phase 1.

ip-milestone

Completed

Actual: Dec 19, 2024

Two patent applications published jointly with Stanford University: US20240415845A1 (compositions of iboga alkaloids + cardioprotective agents) and US20240100062A1 (treatment methods with brain imaging monitoring). Both challenged by Porta Sophia with third-party prior art submissions contending ibogaine+magnesium co-administration is standard practice per GITA clinical guidelines.

Why it matters: Patent controversy is significant — if prior art challenges succeed, the core IP protecting SON-001 could be invalidated. Co-administration of ibogaine with magnesium is well-documented in clinical practice guidelines. Outcome will determine whether Soneira has a defensible competitive moat.

Company milestone

Completed

Actual: Oct 8, 2025

Nolan R. Williams, M.D. — founding inspiration, advisor, and MISTIC study PI — dies at age 43. Williams was Professor of Psychiatry at Stanford and Director of the Brain Stimulation Lab.

Why it matters: Major loss of the scientific leader whose research underpins SON-001. Williams led the MISTIC study and was co-inventor on both Soneira patents. His absence creates uncertainty about the continuity of the Stanford-Soneira research programme.

Recorded Events

Oct 8, 2025: Company milestone

Dec 19, 2024: ip-milestone

Jul 23, 2024: Funding milestone

Jan 5, 2024: data-readout

Evidence Links

Soneira — Pipeline

company-website - Soneira Inc. PBC - Sep 5, 2025 - Verified

Psychedelic Alpha — Brin Backs Soneira, Patent Questions Loom

industry-media - Psychedelic Alpha - Jul 25, 2024 - Verified

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Quick Facts

Type
Private Biotech
Lead Stage
Preclinical
Website
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