NCT05552755: TUPELO

A Phase 1b-2, Multicenter, Trial to Evaluate the Efficacy, Safety, Pharmacokintetics, and Pharmacodynamics of REC-4881 in Patients With Familial Adenomatous Polyposis (FAP)

Recruiting now Phase 1/Phase 2 Last updated 3 June 2026

What this trial tests

Phase 1/Phase 2 trial testing REC-4881 in Familial Adenomatous Polyposis in 67 participants. Currently enrolling.

Timeline

10 July 2023

Primary endpoint
1 June 2027

1 September 2027

Quick facts

Lead sponsor	Recursion Pharmaceuticals Inc.
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	10 July 2023
Primary completion	1 June 2027
Estimated completion	1 September 2027
Sites	17 locations across United States

Drugs / interventions tested

• REC-4881 — full drug profile →
• Placebo

Conditions studied

• Familial Adenomatous Polyposis — all drugs for Familial Adenomatous Polyposis →

Sponsor

Recursion Pharmaceuticals Inc. — full company profile →

Who can join

18 and older, any sex, with Familial Adenomatous Polyposis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Part 1: Maximum (Peak) Plasma Drug Concentration (Cmax) of REC-4881
  Time frame: Day 1 through Day 43
• Part 1: Time to Reach Cmax (Tmax) of REC-4881
  Time frame: Day 1 through Day 43
• Part 1: Area Under the Plasma Concentration-time Curve (AUC) of REC-4881
  Time frame: Day 1 through Day 43
• Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
  Time frame: Day 1 through up to Week 37
• Part 2: Number of Participants With Dose-limiting Toxicities (DLTs)
  Time frame: First 28 days of treatment
• Part 2: Number of Participants Who Discontinued Treatment
  Time frame: Day 1 through up to Week 37

Sponsor's own description

This is a multicenter, two-part trial in participants with FAP.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The changing scenario of drug discovery using AI to deep learning: Recent advancement, success stories, collaborations, and challenges.
   Chakraborty C, Bhattacharya M, Lee SS, Wen ZH, et al · · 2024 · cited 25× · PMID 39257717 · DOI 10.1016/j.omtn.2024.102295
2. The future of pharmaceuticals: Artificial intelligence in drug discovery and development.
   Fu C, Chen Q. · · 2025 · cited 18× · PMID 40893437 · DOI 10.1016/j.jpha.2025.101248
3. Updated Perspectives on the Diagnosis and Management of Familial Adenomatous Polyposis.
   Kyriakidis F, Kogias D, Venou TM, Karlafti E, et al · · 2023 · cited 11× · PMID 37600856 · DOI 10.2147/tacg.s372241
4. A New Era of Artificial Intelligence (AI): Transforming Drug Discovery and Development.
   Ali S, Tian X, Chen H, Zhou J. · · 2025 · cited 7× · PMID 41306069 · DOI 10.1021/acs.jmedchem.5c03159