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EXS21546 for

Phase 1

Oncology | Small molecule | Oncology |Recursion Pharmaceuticals, Inc.|Last Updated: May 16, 2022

Target and mechanism

ModalitySmall molecule

Also known as EXS21546 Powder for Oral Suspension

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

EXS21546 for · 1 trial · 1 indication

Phase 1 1
NCT047271383-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546Oncology
COMPLETED64 Analytics
PHASE1COMPLETED
3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546
OncologyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment emergent Adverse Events
1 month
EXS21546 and Metabolite Area under the plasma concentration versus time curve (AUC)
17 days
EXS21546 and Metabolite Peak Plasma Concentration (Cmax)
17 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EXS21546 Powder for Oral SuspensionEXPERIMENTALEXS21546 Powder for Oral Suspension
PlaceboPLACEBO_COMPARATORPlacebo Powder for Oral Suspension
EXS21546 Granule in CapsuleEXPERIMENTALEXS21546 Granule in Capsule

Interventions

NameTypeDescription
EXS21546 Powder for Oral SuspensionDRUGEXS21546 Powder for Oral Suspension
EXS21546 Granule in CapsuleDRUGEXS21546 Granule in Capsule
MidazolamOTHERInteraction
Food EffectOTHERFed/Fasted
Placebo Powder for Oral SuspensionOTHERPlacebo Powder for Oral Suspension
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BMI 18.0 to 30.0 kg/m2 * Weight ≥60 kg * Must adhere to contraception requirements Exclusion Criteria: * Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1 * Subjects who have previously been administered IMP in this study. * Ev...

Countries:United Kingdom
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Frequently asked questions about EXS21546 for

What is EXS21546?

EXS21546 is an investigational small molecule developed by Recursion Pharmaceuticals, Inc. (ticker RXRX) for oncology. It is a powder for oral suspension and has been studied in a Phase 1 clinical trial. It is not an approved medicine and remains in clinical development.

What is EXS21546 used for?

EXS21546 is being developed for oncology indications. Its only recorded clinical study enrolled healthy adult male volunteers rather than patients, so the trial evaluated safety, tolerability, pharmacokinetics and pharmacodynamics rather than antitumor activity. The drug is investigational and has no approved use.

Who makes EXS21546?

EXS21546 is developed by Recursion Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker RXRX. The company sponsored the Phase 1 study of the compound conducted in the United Kingdom.

What phase is EXS21546 in?

EXS21546 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The study was a randomized, double-blind, placebo-controlled three-part trial that enrolled 64 participants. EXS21546 is investigational and has not been approved by the FDA.

What clinical trials is EXS21546 in?

EXS21546 has been studied in one completed Phase 1 trial, NCT04727138, titled a 3-part study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of EXS21546. It enrolled 64 healthy male volunteers aged 18 years and older in the United Kingdom. No trials are currently active.

Is EXS21546 the same as EXS21546 Powder for Oral Suspension?

Yes. EXS21546 Powder for Oral Suspension is another name for EXS21546, the investigational oncology small molecule from Recursion Pharmaceuticals, Inc. (RXRX). The oral suspension is the formulation used in its Phase 1 clinical study.