Last reviewed 2026-05-19 · How we verify

MT1988 High Dose

Monument Therapeutics Limited · Phase 1 active Small molecule ✓ Verified May 2026

MT1988 High Dose is a Small molecule drug developed by Monument Therapeutics Limited. It is currently in Phase 1 development.

MT1988 is a small molecule intervention being studied for Clinical High Risk for Psychosis (CHR), with a clinical trial (NCT07226895) comparing its high dose, low dose, and placebo. The mechanism of MT1988 is not explicitly stated in the provided information, but it is known to be a small molecule with some of its effects attributed to cotinine, a known metabolite of nicotine.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	MT1988 High Dose
Sponsor	Monument Therapeutics Limited
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis (PHASE1, PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

MT1988 High Dose CI brief — competitive landscape report
MT1988 High Dose updates RSS · CI watch RSS
Monument Therapeutics Limited portfolio CI

Frequently asked questions about MT1988 High Dose

What is MT1988 High Dose?

MT1988 High Dose is a Small molecule drug developed by Monument Therapeutics Limited.

Who makes MT1988 High Dose?

MT1988 High Dose is developed by Monument Therapeutics Limited (see full Monument Therapeutics Limited pipeline at /company/monument-therapeutics-limited).

What development phase is MT1988 High Dose in?

MT1988 High Dose is in Phase 1.

Manufacturer: Monument Therapeutics Limited — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing