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REC-4881

Phase 1

Familial Adenomatous Polyposis | Small molecule | Gastrointestinal |Recursion Pharmaceuticals, Inc.|Last Updated: Jun 5, 2026

Target and mechanism

Molecular targetMEK
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

PLACEBO_CONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

ORPHAN_DRUGFAST_TRACK

Clinical trial landscape

REC-4881 · 1 trial · 1 indication

Phase 1 1
NCT05552755Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)Familial Adenomatous Polyposis
RECRUITING67 Analytics
PHASE1RECRUITING
Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
Familial Adenomatous PolyposisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Part 1: Number of Participants With TEAEs and SAEs
Day 1 through Day 29
Part 1: Number of Participants Who Discontinued Treatment
Day 1 through Day 29
Part 1: Number of Participants With Dose Modification Due to Toxicity
Day 1 through Day 29
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo (Part 1)PLACEBO_COMPARATORParticipants will receive a single dose of placebo administered orally and then, following 14-28 days, participants will begin once daily (QD) dosing for another 14 days.
REC-4881 4 mg (Part 1)EXPERIMENTALParticipants will receive REC-4881 4 milligrams (mg) administered orally and then, following 14-28 days, participants will begin QD dosing for another 14 days.
REC-4881 4 mg (Part 2): QD Treatment RegimenEXPERIMENTALParticipants will receive REC-4881 4 mg administered orally QD for 12 weeks followed by a 12 week off-treatment period.
REC-4881 8 mg (Part 2): QD Treatment RegimenEXPERIMENTALParticipants will receive REC-4881 8 mg administered orally QD for 12 weeks followed by a 12 week off-treatment period.
REC-4881 4 mg (Part 2): Interval Dosing Treatment RegimenEXPERIMENTALParticipants will receive REC-4881 4 mg administered orally in a 7 day on and off schedule for 24 weeks.

Interventions

NameTypeDescription
REC-4881DRUGREC-4881 capsules
PlaceboDRUGPlacebo capsules
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: 1. Male or female and ≥ 18 years of age 2. Have provided written informed consent to participate in the study 3. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site. 4. Genetic diagnosis of...

Countries:United States
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Frequently asked questions about REC-4881

What is REC-4881 used for?

REC-4881 is an investigational small molecule being developed for Familial Adenomatous Polyposis (FAP), a gastrointestinal condition. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does REC-4881 target?

REC-4881 targets MEK, a protein involved in cell signaling. By inhibiting MEK, the drug aims to interfere with pathways that contribute to the growth of polyps in Familial Adenomatous Polyposis.

Who makes REC-4881?

REC-4881 is being developed by Recursion Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol RXRX.

What phase is REC-4881 in?

REC-4881 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Orphan Drug and Fast Track designations by the FDA.

What clinical trials is REC-4881 in?

REC-4881 is being studied in a Phase 1 clinical trial with the identifier NCT05552755. This trial is recruiting participants with Familial Adenomatous Polyposis in the United States and has an estimated enrollment of 67 participants.

Is REC-4881 the same as any other drug?

REC-4881 is a unique investigational compound developed by Recursion Pharmaceuticals. No alternative names for this drug have been reported.