NWPharmaTech CHR-P Research Programme

Programme Room

Inside the CHR-P programme

What the programme has done, what it plans and what is still unknown, with the source behind each statement. NWPT-SM32300 is investigational; its effectiveness has not been established.

Explore the programme

Research topics and development stages, not a schedule. Dates appear only where records give them; see dated milestones.

What the labels mean

Work status (each stage)

Background
Existing research that frames the programme. Not programme activity.
Completed
Programme activity recorded as completed, with its date.
In progress (reported)
Work that company records report as under way, with the date of the report.
Proposed
Planned research described in company records. Its design may change.
Open question
Not yet known. The panel says what research would answer it.

Source type (each source)

Published research
Peer-reviewed articles, reviews and funder study reports.
Published guidance
National clinical guidelines.
Registry information
Entries in public trial registries (ClinicalTrials.gov, ISRCTN).
Company records
NWPharmaTech records and website pages; not independently published.

  1. Stage 1 · Clinical need

    Why people at clinical high risk are a research priority

    Link to this topic
    Work status
    Background Existing research; not programme activity
    Sources used
    Published research Published guidance

    The question

    What is known about people who meet criteria for clinical high risk of psychosis (CHR-P), and what care is recommended today?

    What is known

    • CHR-P is not a diagnosis of psychosis or schizophrenia, and most people in this group do not develop psychosis.
    • An updated meta-analysis estimated that about one in four people identified as CHR-P (pooled estimate, 25%) developed psychosis within three years.
    • In England, psychological therapy is the recommended first step. NICE advises against antipsychotics to prevent psychosis in this group.
    • No preventive intervention has been shown to work better than the others.

    What further research would establish

    Larger, well-designed trials in this group. For each intervention studied so far, the trials are few and small.

    Translucent glass panels forming a sequence of thresholds in a light room.
    Conceptual illustration — not a clinical pathway.
    What supports this? 4 sources

    1. Salazar de Pablo et al. — probability of transition to psychosis (updated meta-analysis), JAMA Psychiatry

      Evidence library entry Original source: DOI Original source: PubMed

      Relates to
      The CHR-P field — no specific medicine
      Source type
      Published research
      Library assessment
      Established
      Source date
      Published 2021
      Limitations
      The pooled estimate and the separate Kaplan–Meier series are different analyses and are not combined. Estimates span services and criteria; individual risk varies.

    2. NICE CG155 — psychosis and schizophrenia in children and young people

      Evidence library entry Original source: NICE

      Relates to
      The CHR-P field — no specific medicine
      Source type
      Published guidance
      Library assessment
      Established
      Source date
      Published 23 January 2013; last updated 26 October 2016
      Limitations
      Applies in England; guidance differs elsewhere.

    3. NICE CG178 — psychosis and schizophrenia in adults

      Evidence library entry Original source: NICE

      Relates to
      The CHR-P field — no specific medicine
      Source type
      Published guidance
      Library assessment
      Established
      Source date
      Published 12 February 2014; last updated 4 September 2026
      Limitations
      Applies in England; guidance differs elsewhere.

    4. Davies et al. — network meta-analysis of preventive interventions, World Psychiatry

      Evidence library entry Original source: DOI Original source: PubMed

      Relates to
      The CHR-P field — no specific medicine
      Source type
      Published research
      Library assessment
      Established; inconclusive result
      Source date
      Published 2018
      Limitations
      Few, small trials per intervention.

  2. Stage 2 · Formulation

    An oral softgel designed for a poorly water-soluble medicine

    Link to this topic
    Work status
    Completed Completed before Phase 1 dosing in 2025
    Sources used
    Published research Company records

    The question

    Is a fixed-strength micellar softgel a suitable way to give cannabidiol by mouth?

    What is known

    • Cannabidiol dissolves poorly in water. Taken by mouth while fasting, only about 6% of a dose is estimated to reach the bloodstream, and food changes absorption markedly (research on other CBD products).
    • NWPT-SM32300 is a 300 mg softgel whose contents are designed to disperse into very small droplets in the gut.
    • The final formulation and GMP clinical supply were completed before Phase 1 dosing in 2025 (company records).

    What further research would establish

    Whether this formulation gives more consistent absorption than other CBD products. Phase 1 measured absorption; its results have not been published. How much reaches the brain has not been measured.

    Gloved hands arranging translucent softgel prototypes and lipid formulation materials on a bright workbench.
    Conceptual editorial image of exploratory formulation work — not the programme’s manufacture or product.
    What supports this? 3 sources

    1. Perucca and Bialer — oral cannabidiol bioavailability (review), CNS Drugs

      Evidence library entry Original source: DOI Original source: PubMed

      Relates to
      Other CBD products — not NWPT-SM32300
      Source type
      Published research
      Library assessment
      Established
      Source date
      Published 2020
      Limitations
      Review of other CBD preparations; figures vary between studies.

    2. Taylor et al. — Phase 1 study of purified CBD, including a food-effect arm, CNS Drugs

      Evidence library entry Original source: DOI Original source: PubMed

      Relates to
      Other CBD products — not NWPT-SM32300
      Source type
      Published research
      Library assessment
      Established
      Source date
      Published 2018
      Limitations
      Healthy volunteers; a different CBD product. A published correction exists.

    3. Study progress — final formulation and GMP clinical supply

      Website page

      Relates to
      NWPT-SM32300 programme
      Source type
      Company records
      Record date
      Before Phase 1 dosing (2025); exact date not available
      Website page reviewed
      23 September 2026
      Limitations
      NWPharmaTech records; not published.

  3. Stage 3 · Phase 1

    Phase 1 in healthy volunteers: absorption and short-term tolerability

    Link to this topic
    Work status
    Completed Study activity ended 10 December 2025; results not yet published
    Sources used
    Registry information Company records
    Registrations
    NCT07186283 · ISRCTN25163383

    The question

    How does the body absorb and handle NWPT-SM32300 after single doses, and how well is it tolerated in the short term, compared with a licensed cannabidiol oral solution?

    What is known

    • 14 healthy adult volunteers; randomised, open-label, three-period crossover.
    • Sponsor of the Phase 1 study: NWPharmaTech Ltd (as registered).
    • It was not a study of whether NWPT-SM32300 works.
    • Study activity ended on 10 December 2025. Results have not yet been published.

    What further research would establish

    The Phase 1 results, once published, would show how NWPT-SM32300 was absorbed and tolerated after single doses. Effectiveness in people at clinical high risk would need a separate study, such as the planned Phase 2B.

    Conceptual cyan and amber investigational softgel on a dark background.
    Conceptual illustration of the investigational softgel — not a product photograph.
    What supports this? 2 sources

    1. Phase 1 registration: NCT07186283 and ISRCTN25163383

      Evidence library entry Original source: ClinicalTrials.gov Original source: ISRCTN

      Relates to
      NWPT-SM32300 programme
      Source type
      Registry information
      Library assessment
      Programme information
      Source date
      Registered 2025; exact registration date not available
      Limitations
      Healthy volunteers and single doses: measures absorption and short-term tolerability, not effectiveness in clinical high risk of psychosis.

    2. Study progress — Phase 1 milestones

      Website page

      Relates to
      NWPT-SM32300 programme
      Source type
      Company records
      Record dates
      27 August 2025 to 30 March 2026
      Website page reviewed
      23 September 2026
      Limitations
      Database lock and analysis dates come from NWPharmaTech records (not published).

  4. Stage 4 · Protocol

    Finalising the Phase 2B protocol

    Link to this topic
    Work status
    In progress (reported) Reported as in progress on 23 February 2026
    Sources used
    Company records

    The question

    What will the final design of the planned Phase 2B study be, including its primary outcome details?

    What is known

    • Finalisation of the Phase 2B protocol was reported as in progress on 23 February 2026 (company records).
    • Primary outcome details are being finalised.
    • No completion date has been announced.

    What further research would establish

    The finalised protocol, including its primary outcome, would establish exactly what the planned Phase 2B study measures. The study can start only after regulatory and research ethics approval.

    Conceptual programme pipeline from cylinder through gates to a laboratory motif.
    Conceptual illustration of a development sequence — not evidence that any gate is completed.
    What supports this? 2 sources

    1. Study progress — Phase 2B protocol finalisation (in progress)

      Website page

      Relates to
      NWPT-SM32300 programme
      Source type
      Company records
      Record date
      23 February 2026 (as reported)
      Website page reviewed
      23 September 2026
      Limitations
      Company record; not published.

    2. Public study synopsis

      Website page

      Relates to
      NWPT-SM32300 programme
      Source type
      Company records
      Source date
      No separate issue date (company web page)
      Website page reviewed
      21 September 2026
      Limitations
      An overview, not a locked protocol.

  5. Stage 5 · Phase 2B

    The planned Phase 2B study in people at clinical high risk

    Link to this topic
    Work status
    Proposed Planned. Not recruiting. No start date announced
    Sources used
    Published research Company records

    The question

    What would the planned Phase 2B study investigate?

    What is known

    • Status: planned. Not recruiting. The protocol is being finalised.
    • The Phase 2B study can start only after regulatory and research ethics approval.
    • Oversight arrangements for the Phase 2B study have not yet been published.
    • A larger UK trial of cannabidiol in this group (CANTOP-RCT) did not start owing to challenges in securing supply of the study drug, which is one reason this question remains open.
    • A small 21-day study of another CBD product in this group was published in 2024. Its findings are early, have not been confirmed in a larger trial, and do not apply directly to NWPT-SM32300.

    What further research would establish

    If it goes ahead: whether NWPT-SM32300 shows a dose response, changes symptoms, and is safe and tolerable in people at clinical high risk of psychosis.

    Three abstract research networks around a shared centre.
    Conceptual research-network illustration — does not depict participating sites or institutional endorsement.
    What supports this? 3 sources

    1. Study progress — current stage, aims and oversight

      Website page

      Relates to
      NWPT-SM32300 programme
      Source type
      Company records
      Source date
      NWPharmaTech, September 2026
      Website page reviewed
      23 September 2026
      Limitations
      Phase 2B oversight arrangements not yet published.

    2. Bhattacharyya S, Davies C, et al. — Cannabidiol as a treatment for patients who are clinically at high risk of developing psychosis: learnings from the CANTOP-RCT, NIHR Journals Library

      Evidence library entry Original source: DOI Original source: PubMed

      Relates to
      Other CBD products — not NWPT-SM32300
      Source type
      Published research
      Library assessment
      Not conducted
      Source date
      Published March 2025 (NIHR Journals Library PDF and PubMed record)
      Journal citation
      Efficacy Mech Eval 2026;13(7):197–214 (recommended citation on the current NIHR PDF)
      Limitations
      Produced no efficacy results; included to explain why a larger trial is still missing.

    3. Bhattacharyya et al. — 21-day symptom study of another CBD product in clinical high risk, World Psychiatry

      Evidence library entry Original source: DOI Original source: PubMed

      Relates to
      Other CBD products — not NWPT-SM32300
      Source type
      Published research
      Library assessment
      Emerging evidence
      Source date
      Published 2024
      Limitations
      Very small, three weeks, short-letter format; not yet confirmed in a larger trial.

  6. Stage 6 · Longer term

    Could psychosis be delayed or prevented?

    Link to this topic
    Work status
    Open question A longer-term question, not the current primary aim
    Sources used
    Published research Company records

    The question

    Can transition to psychosis be delayed or prevented?

    What is known

    • No preventive intervention has been shown to work better than the others.
    • This is a longer-term question, not the current primary aim of the programme.

    What further research would establish

    An adequately powered trial with long follow-up, if prevention were pursued as a primary objective. Positive results on symptoms would not, by themselves, show prevention.

    What supports this? 2 sources

    1. Davies et al. — no preventive intervention shown to be better than others, World Psychiatry

      Evidence library entry Original source: DOI Original source: PubMed

      Relates to
      The CHR-P field — no specific medicine
      Source type
      Published research
      Library assessment
      Established; inconclusive result
      Source date
      Published 2018
      Limitations
      Few, small trials per intervention.

    2. Science — what is known and what remains open

      Website page

      Relates to
      NWPT-SM32300 programme
      Source type
      Company records
      Source date
      No separate issue date (company web page)
      Website page last updated
      22 September 2026 (site map record; no review date is shown on the page)
      Limitations
      Summarises the questions; not a result.

Where are we now?

NWPT-SM32300 is an investigational 300 mg oral softgel of highly purified cannabidiol in a self-emulsifying (micellar) lipid formulation. It is not approved for any use.

  • Completed

    Phase 1 study

    14 healthy volunteers. Study activity ended on 10 December 2025. Results have not yet been published.

    Stage 3: Phase 1
  • In progress (reported)

    Phase 2B protocol

    Finalisation reported as in progress on 23 February 2026. No completion date has been announced.

    Stage 4: Protocol
  • Proposed

    Phase 2B study

    Planned. Not recruiting. It can start only after regulatory and research ethics approval.

    Stage 5: Phase 2B
  • Open question

    Whether it helps

    Whether NWPT-SM32300 helps people at clinical high risk of psychosis. Finding out is the purpose of the research.

    Open questions

Dated milestones

DateMilestoneWork statusRecord
Before Phase 1 dosing (2025); exact date not availableFinal formulation and GMP clinical supply for Phase 1CompletedNWPharmaTech records (not published)
27 August 2025Phase 1: first participants consentedCompletedPhase 1 study records (NWPharmaTech)
10 December 2025Phase 1: last study activityCompletedPhase 1 study records (NWPharmaTech)
23 February 2026 (as reported)Phase 2B: protocol finalisationIn progress (reported)NWPharmaTech records (not published)
11 March 2026Phase 1: database lockedCompletedNWPharmaTech records (not published)
30 March 2026Phase 1: analysis outputs deliveredCompletedNWPharmaTech records (not published)

From Study progress (website page reviewed 23 September 2026). Dates are those given in the records; none is a forecast.

Open questions

What the research does not yet know. Each question opens the evidence behind it.

Go deeper

Sources on this page come from the evidence library and the study records. This page last reviewed 26 September 2026. Corrections are listed in the corrections log.