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EXS21546 for

Phase 1

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

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 used for?

EXS21546 is an investigational small molecule being developed for oncology. It is being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamics in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

Who makes EXS21546?

EXS21546 is being developed by Recursion Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker RXRX. The company is conducting clinical research on this investigational oncology small molecule.

What phase is EXS21546 in?

EXS21546 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation for oncology.

What clinical trials is EXS21546 in?

EXS21546 has one completed Phase 1 clinical trial, registered as NCT04727138. The study was a 3-part trial assessing safety, tolerability, pharmacokinetics, and pharmacodynamics in oncology, enrolling 64 participants in the United Kingdom, including healthy volunteers.

Is EXS21546 the same as any other drug?

No alternative names for EXS21546 have been identified. The drug is referred to solely as EXS21546 in clinical trial records and development documentation. It is a distinct investigational small molecule being developed by Recursion Pharmaceuticals.