Neurala Biosciences
Neurala Biosciences is a Melbourne-based clinical-stage biotech developing second-generation DMT–harmala alkaloid neuromedicines for mental health and addiction. Emerging from over a decade of research at the University of Melbourne, their Phase 1 proof-of-concept study was published in Scientific Reports (2025). Lead candidate NBX-100 targets substance use disorder; NBX-200 targets depressive illness.
Development Programmes
2NBX-100 (Oral DMT + Harmala Alkaloids)
DMTSecond-generation oral DMT–harmala alkaloid combination with proprietary structural refinements. Medium duration (3–5 hrs). Phase 1 PoC (1st gen) completed at St Vincent's Melbourne (9 HVs, MEQ-30 ~76, published in Scientific Reports). GMP drug product completed Jan 2026. Phase 1 PK/PD study approved at CMAX Clinical Research (Adelaide). Phase 2a planned for AUD + chronic depression ($2M AU govt grant).
Programme Tracker
Major Depressive Disorder (MDD)
Completed. Phase 1 proof-of-concept with first-generation DMT-harmala formulation. Results published in Scientific Reports (Nature Portfolio) early 2025.
Milestones
Efficacy data
CompletedActual: Jun 1, 2024
Phase 1 PoC completed: 9 healthy volunteers, 17 dosing sessions at St Vincent's Hospital Melbourne. Botanically derived purified DMT + 3 harmala alkaloids. MEQ-30 scores ~76, 5D-ASC ~56 — exceeding published psilocybin and LSD benchmarks. Well tolerated, no serious adverse events.
Why it matters: First controlled clinical data for a pharmaceutical-grade oral DMT-harmala (pharmahuasca) formulation. The 3-5 hour duration aligns with standard therapy sessions, unlike IV DMT (15 min) or psilocybin (6-8 hrs). Intensity metrics exceeding psilocybin/LSD benchmarks suggest potent therapeutic potential.
publication
CompletedActual: Feb 1, 2025
Phase 1 results published in Scientific Reports. Acute experience intensity correlated with persisting psychological benefits.
Why it matters: Peer-reviewed publication in a high-impact Nature journal builds scientific credibility and supports regulatory submissions for the second-generation NBX-100 formulation.
Recorded Events
Feb 1, 2025: publication
Jun 1, 2024: Efficacy data
Alcohol Use Disorder (AUD)
HREC and TGA regulatory approvals granted. GMP drug product final release testing completed Jan 2026. All clinical and CRO contracts in place. Phase 1 PK/PD study at CMAX Clinical Research (Adelaide) commencing. Second-generation formulation with proprietary harmala alkaloid refinements.
Milestones
manufacturing
CompletedActual: Jan 15, 2026
GMP drug product for NBX-100 (2nd gen) completed final release testing. Second-generation formulation incorporates proprietary structural refinements to harmala alkaloids.
Why it matters: GMP manufacturing completion is the last prerequisite before Phase 1 dosing can begin. The proprietary harmala modifications differentiate NBX-100 from generic pharmahuasca formulations and strengthen the IP position.
regulatory-milestone
CompletedActual: Feb 1, 2026
HREC (Human Research Ethics Committee) and TGA regulatory approvals granted for Phase 1 PK/PD study at CMAX Clinical Research, Adelaide.
Why it matters: Dual approval (ethics + regulatory) clears NBX-100 for first-in-human dosing of the second-generation formulation. Australian CTN scheme allows faster trial initiation than FDA IND process.
Company milestone
CompletedActual: Feb 24, 2026
Spyros Papapetropoulos, MD, PhD appointed Board Chair. Former President & CEO of Neuphoria Therapeutics (Nasdaq: NEUP); 20+ years CNS drug development experience; 170+ publications.
Why it matters: Appointment of a seasoned CNS drug development executive with Nasdaq CEO experience signals preparation for later-stage clinical development and potential US expansion. Papapetropoulos' IND/NDA submission experience is critical for future FDA interactions.
Recorded Events
Feb 24, 2026: Company milestone
Feb 1, 2026: regulatory-milestone
Jan 15, 2026: manufacturing
Evidence Links
company-website - Neurala Biosciences - Verified
investor - Tin Alley Ventures - Verified
government - LaunchVic - Verified
NBX-200 (Intranasal DMT + Harmala)
DMTSecond-generation intranasal DMT–harmala formulation, short duration (30–50 min), for chronic depressive illness. GMP formulation development by Ab Initio Pharma (Sydney), funded by Australian government grant.
Programme Tracker
Major Depressive Disorder (MDD)
GMP formulation development and manufacturing by Ab Initio Pharma (Sydney). Funded by Australian government grant. Regulatory-grade drug product being developed for future Phase 1 study.
Milestones
manufacturing
In progressActual: Feb 16, 2026
Ab Initio Pharma (Sydney) engaged to support GMP manufacturing and development of NBX-200, funded by Australian government grant. Formulation development aligned with regulatory requirements for future clinical studies.
Why it matters: Dedicated GMP manufacturing partner and government co-funding de-risks NBX-200 development. Intranasal DMT-harmala (30-50 min) would offer the shortest controlled psychedelic experience in clinical development — ideal for clinic-based dosing without full-day sessions.
Recorded Events
Feb 16, 2026: manufacturing
Quick Facts
- Type
- Private Biotech
- Lead Stage
- Phase I
- Website
- Visit