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Terran Biosciences is a New York-based drug discovery platform company developing transformative therapeutics for neurological and psychiatric diseases. Founded by CEO Samuel Clark, the company holds over 200 patent applications covering novel formulations of psychedelic compounds including LSD, DMT, psilocybin, and MDMA, and operates clinical programs in schizophrenia and depression. Its AI-enabled neuromelanin MRI software platform NM-101 has received FDA clearance.

Development Programmes

3

Idazoxan XR (Alpha-2 Adrenergic Antagonist)

Phase I

Enantiomerically pure extended-release idazoxan (alpha-2 adrenergic antagonist). Licensed exclusively from Pierre Fabre (June 2023). Previously tested in 1,000+ patients. Phase 2 PoC showed ~2x symptom improvement vs antipsychotic alone. Solves historical 3-4x daily dosing with once-daily XR formulation. Indications: schizophrenia (adjunctive) + Alzheimer's disease.

Programme Tracker

Neurocognitive Disorders

Primary: US (FDA)
Phase IActive

Phase 1 safety, tolerability, and PK study in ~150 healthy volunteers (NCT05727189). Testing R-idazoxan XR, S-idazoxan XR, and racemic idazoxan XR. First cohort dosed; early PK confirms once-daily profile. Five clinical drug product forms manufactured to Phase 3 standards.

Milestones

partnership

Completed

Actual: Jun 15, 2023

Exclusive worldwide license from Pierre Fabre for idazoxan and portfolio of alpha-2 adrenergic antagonists. Terran completes key development milestones: once-daily XR formulation, first cohort dosed in Phase 1, early PK analysis confirms target profile.

Why it matters: Idazoxan has 1,000+ patient safety database from prior studies and Phase 2 PoC showing ~2x symptom improvement. Extended-release formulation solves the dosing frequency problem that previously limited clinical utility. Pierre Fabre deal provides global rights.

Recorded Events

Jun 15, 2023: partnership

TerXT (Xanomeline + Trospium Prodrugs)

Pre-clinical

Next-generation muscarinic agonist approach: novel prodrugs of xanomeline (M1/M4 agonist) + trospium (muscarinic antagonist). Once-daily oral + multi-month LAI injectable formulation. 505(b)(2) pathway leveraging Cobenfy (KarXT) safety/efficacy database. NOT a psychedelic compound.

Programme Tracker

Neurocognitive Disorders

Primary: US (FDA)
Pre-clinicalActive

Phase 1 PK bridging trials announced May 2024. No NCT registered yet. 505(b)(2) filing can only occur after Cobenfy's 5-year exclusivity expires (~2029). Attended BIO Investment & Growth Summit March 2026.

Milestones

Company milestone

Completed

Actual: May 20, 2024

Terran announces TerXT development: combination prodrugs of xanomeline and trospium with once-daily oral and multi-month LAI injectable formulations. Will pursue accelerated 505(b)(2) approval pathway leveraging Cobenfy's (KarXT) clinical database.

Why it matters: TerXT addresses Cobenfy's key limitations: twice-daily dosing and food restrictions. Once-daily oral + LAI injectable could significantly improve adherence in schizophrenia — a population with notoriously low medication compliance. 505(b)(2) pathway dramatically reduces development cost and timeline.

Recorded Events

May 20, 2024: Company milestone

Eplivanserin + Volinanserin (5-HT2A Antagonist Psychedelic Combos)

Pre-clinical

Selective 5-HT2A antagonists (eplivanserin, volinanserin) licensed from Sanofi (Apr 2022) + deuterated volinanserin from Concert Pharmaceuticals (Mar 2022). Phase 3-tested compounds (15,000+ patients, 100+ trials). Fixed-dose combos with psychedelics (psilocybin, LSD) block hallucinations while preserving therapeutic neuroplasticity. Also: monotherapy for Parkinson's psychosis; "trip terminator" tool. UMB exclusive license for combo patents.

Programme Tracker

Major Depressive Disorder (MDD)

Primary: US (FDA)
Pre-clinicalActive

Preclinical combo development. Eplivanserin and volinanserin have extensive Phase 3 safety databases (15,000+ patients). Exclusive license from University of Maryland Baltimore (Mar 2022) for psilocybin + 5-HT2A antagonist combination patents and data. 200+ patent applications across 30+ families covering prodrugs of psilocin, LSD, 2C-B, methylone, long-acting MDMA, oral DMT, 5-MeO-DMT.

Milestones

partnership

Completed

Actual: Apr 1, 2022

Exclusive worldwide license from Sanofi for eplivanserin and volinanserin (selective 5-HT2A antagonists). Concert Pharmaceuticals deuterated volinanserin portfolio also acquired (March 2022). UMB psilocybin + 5-HT2A antagonist combination patent portfolio exclusively licensed.

Why it matters: Three licensing deals in one month assemble the full toolkit for non-hallucinogenic psychedelic therapy: 5-HT2A antagonists with 15,000-patient safety databases, deuterated variants for improved PK, and academic IP covering the combination concept. Positions Terran to develop "psychedelic therapy without the trip."

ip-milestone

Completed

Actual: Jan 1, 2024

Terran receives notice of allowance for four US patents including world's first new salts and polymorphs of psilocybin (psilocybin HCl, psilocybin edisylate). Psilocybin DMF filed with FDA. 200+ total patent applications across 30+ patent families.

Why it matters: New psilocybin salts + FDA DMF filing enables future 505(b)(2) pathways for psilocybin products once any psilocybin compound receives approval. Combined with the 5-HT2A antagonist portfolio, this creates the IP foundation for non-hallucinogenic psilocybin therapy.

Recorded Events

Jan 1, 2024: ip-milestone

Apr 1, 2022: partnership

Evidence Links

Terran Biosciences — Website

company-website - Terran Biosciences - Verified

Psychedelic Alpha — Terran Patent Strategy Analysis

industry-media - Psychedelic Alpha - Verified

Quick Facts

Type
Private Biotech
Founded
2017
Lead Stage
Phase I
Website
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