In short
CX11 trometamol monohydrate is an investigational chemical substance with no marketing authorisation, being studied in type 2 diabetes mellitus. One Phase 2 trial in the EU registry is testing different oral doses of CX11 tablets against placebo in 240 participants, measuring the change in HbA1c from baseline.
Key points
- CX11 trometamol monohydrate is an investigational substance with no marketing authorisation, supplied by Corxel Pharmaceuticals Inc.
- The registered trial is a Phase 2 dose-finding study in type 2 diabetes mellitus.
- The trial is randomised, double-blind and placebo-controlled, with 240 participants planned.
- CX11 is given as a tablet by mouth; the trial compares different dose levels against placebo.
- The primary outcome is change in HbA1c from baseline, a standard measure of blood sugar control.
- The trial is currently authorised in the EU Clinical Trials Information System.
What is CX11 trometamol monohydrate?
CX11 trometamol monohydrate is a chemically synthesised substance supplied by Corxel Pharmaceuticals Inc. It is an investigational medicine: the product records in the EU Clinical Trials Information System show no marketing authorisation, meaning it is not yet approved as a medicine for routine use. The registry name is CX11 trometamol monohydrate, and the product name used in the trial is simply CX11.
In the CTIS product records, CX11 appears as the test substance in two trials, placed in the therapeutic area of nutritional and metabolic diseases. The name trometamol refers to an organic amine proton acceptor, also known as tromethamine, used in pharmaceutical preparations.
How does CX11 work?
The registered trial does not state the mechanism of action of CX11. The source data describe trometamol as an organic amine proton acceptor used in the synthesis of pharmaceuticals and as an emulsifying agent. The trial in type 2 diabetes measures change in HbA1c, a marker of average blood sugar over several weeks, as its primary outcome. No further detail on how CX11 lowers blood sugar is available in the provided sources.
Which conditions is CX11 studied for?
- Type 2 diabetes mellitus — a long-term condition in which the body does not use insulin properly, leading to high blood sugar. The registered trial is testing whether CX11 tablets can improve blood sugar control in people with this condition.
How is CX11 given?
CX11 is given as a tablet taken by mouth. The registered trial is a dose-finding study, comparing different dose levels of CX11 against placebo tablets. The intervention list records placebo tablets matching two dose strengths, 80 mg and 40 mg, while the CX11 dose amounts are recorded as 0 mg, meaning the specific doses tested were not reported in the register.
What do the clinical trials show?
The registered study is a Phase 2, multicentre, randomised, double-blind, placebo-controlled dose-finding trial in type 2 diabetes mellitus. It plans to enrol 240 participants and is currently authorised in the EU Clinical Trials Information System.
The primary outcome is the change in HbA1c from baseline, a standard measure of how well blood sugar has been controlled over the preceding weeks. The stated aim is to evaluate the effect of different dose levels of CX11 on HbA1c and to show that at least one dose level is superior to placebo in the change from baseline for HbA1c.
No results from this trial are provided in the registry record, and the specific dose levels being tested are not reported.
What side effects are known?
The provided sources do not report side effects for CX11 trometamol monohydrate. As an investigational substance in Phase 2 testing, its safety profile is still being established in the registered trial.