In short
REC-4881 is an investigational substance being studied for familial adenomatous polyposis (FAP), a rare inherited condition where many polyps form in the large intestine. One Phase 2 clinical trial, authorised but not yet recruiting, plans to enrol 105 participants to test the medicine's safety, tolerability, and effect on polyp burden. The study will also measure how the body processes REC-4881 after oral dosing.
Key points
- REC-4881 is an investigational medicine for familial adenomatous polyposis (FAP).
- The only registered trial is a Phase 2 study with planned enrolment of 105 participants.
- The trial is currently authorised, meaning it has regulatory approval to start but is not yet recruiting.
- REC-4881 is given as a 999 mg oral capsule; the study includes a placebo arm.
- The main measures are safety, tolerability, and change in polyp burden after 12, 25, and 37 weeks.
What is REC-4881?
REC-4881 is an investigational substance with no marketing authorisation in these records. The full chemical name is (R)-3-(2,3-DIHYDROXYPROPYL)-6-FLUORO-5-(2-FLUORO-4-IODOPHENYLAMINO)-8-METHYLPYRIDO[2,3-D]PYRIMIDINE-4,7(3H,8H)-DIONE. It is being developed as a potential treatment for familial adenomatous polyposis (FAP), a rare inherited condition in which numerous polyps form in the large intestine and, if untreated, can become cancerous.
How does REC-4881 work?
The registry record does not state the mechanism of action for REC-4881. The trial focuses on measuring its effect on polyp burden, safety, and tolerability rather than explaining the molecular target.
Which conditions is REC-4881 studied for?
- Familial adenomatous polyposis (FAP) — a hereditary disorder where hundreds to thousands of polyps grow in the colon and rectum, often starting in adolescence. Without treatment, the risk of colorectal cancer is very high. The Phase 2 trial tests whether REC-4881 can reduce the number or size of these polyps.
How is REC-4881 given?
In the registered trial, REC-4881 is given as an oral capsule at a dose of 999 mg. The placebo arm uses capsules made from inactive components of the REC-4881 4 mg formulation, including mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.
What do the clinical trials show?
One Phase 2 trial is registered for REC-4881 in familial adenomatous polyposis. The trial is authorised but not yet recruiting, with a planned enrolment of 105 participants. The study has two parts. Part 1 evaluates the pharmacokinetics of REC-4881 — how the drug is absorbed, distributed, metabolised, and excreted — by measuring plasma drug concentration over time, including maximum concentration (Cmax), time to reach maximum concentration (Tmax), and area under the concentration-time curve (AUC). Part 2 aims to identify the recommended Phase 2 dose, assess safety and tolerability, and evaluate the effect of REC-4881 on polyp burden. Polyp burden is measured as the percent change from baseline after 12 weeks, 25 weeks, and 37 weeks for the interval dosing regimen, and at end of treatment. Safety measures include treatment-emergent adverse events, dose-limiting toxicities, serious adverse events, and treatment discontinuation or dose modification due to toxicity.
What side effects are known?
No side effect data are available from the provided sources, because the trial is authorised but has not yet reported results. The study will collect treatment-emergent adverse events and serious adverse events as primary outcome measures.