This is the study progress hub — a static summary of programme status. It is not the interactive Programme Room (tracked separately; not on public nav yet).
The programme
The study: progress and evidence
Where the NWPT-SM32300 study programme stands, what has been completed, and the sources behind each statement.
Summary
As of
- What the study is intended to investigate
- Whether NWPT-SM32300, an investigational oral cannabidiol medicine, shows a dose response, changes symptoms, and is safe and tolerable in people at clinical high risk of psychosis.
- Current stage
- Phase 2B study: Planned. Not recruiting. Protocol being finalised.
- Completed so far
- Phase 1 study in 14 healthy volunteers: completed 10 December 2025; database locked 11 March 2026; analysis outputs delivered 30 March 2026.
- Next milestone
- Finalisation of the Phase 2B protocol, reported as in progress in February 2026. No date has been announced.
Public synopsis
Programme informationThe planned Phase 2B study will evaluate dose response, symptoms, safety and tolerability of NWPT-SM32300 in people at clinical high risk of psychosis. It follows a completed Phase 1 study in healthy volunteers, which looked at how the body absorbs and handles the medicine and at short-term tolerability.
The Phase 2B study is not recruiting. It can start only after regulatory and research ethics approval.
Proposed design
Population and aims
Source and version: NWPharmaTech, September 2026
- Population: people at clinical high risk of psychosis.
- Aims: dose response, symptoms, safety and tolerability.
Milestones
Statuses are Planned, In progress or Completed. Dates are exact where a record gives one; otherwise we say what the record states.
| Milestone | Status | Date | Source |
|---|---|---|---|
| Phase 1: first participants consented | Completed | Phase 1 study records (NW PharmaTech) | |
| Phase 1: last study activity | Completed | Phase 1 study records (NW PharmaTech) | |
| Phase 1: database locked | Completed | NWPharmaTech records (not published) | |
| Phase 2B: protocol finalised | In progress | As reported 23 February 2026 | NWPharmaTech records (not published) |
| Milestone | Status | Date | Source |
|---|---|---|---|
| Final formulation and GMP clinical supply for Phase 1 | Completed | Before Phase 1 dosing (2025) | NWPharmaTech records (not published) |
| Phase 1 analysis outputs delivered | Completed | NWPharmaTech records (not published) |
No funding milestones have been published.
Registrations
The completed Phase 1 study is registered on two public registries. Both entries describe the same study: a single-dose, three-period crossover study of NW300EMCBD (the development code for NWPT-SM32300) in healthy adults aged 18 to 55, sponsored by NWPharmaTech Ltd.
| Study | Registry | Identifier |
|---|---|---|
| Phase 1 | ClinicalTrials.gov | NCT07186283 |
| Phase 1 | ISRCTN | ISRCTN25163383 |
Sponsor and oversight
In clinical trial law, the sponsor is the organisation that takes responsibility for starting, managing and financing a study. NWPharmaTech Ltd was the sponsor of the Phase 1 study.
Phase 1 study (completed)
- Sponsor: NWPharmaTech Ltd.
- Pre-specified stopping rules, including stopping if one participant had a serious reaction possibly related to the study medicine, or two had severe reactions.
- No data monitoring committee was used.
- Statistical outputs were produced by an external biostatistics provider under documented quality testing.
Phase 2B study (planned)
Oversight arrangements for the Phase 2B study have not yet been published.