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Etavopivat

Phase 1

Healthy Volunteers | Small molecule | Hematology |Novo Nordisk A/S|Last Updated: Jan 2, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07023029A Study on the Effect of Etavopivat on Heart Rhythm in Healthy ParticipantsPHASE1 COMPLETED 33 — — Jun 9, 2025Sep 22, 2025Jan 2, 20261 United States
NCT06581627A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese ParticipantsPHASE1 COMPLETED 24 — — Aug 26, 2024Oct 31, 2024Dec 29, 20251 China
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Study Endpoints
Primary Endpoints
Part A: Number of treatment-emergent adverse events (AEs)
From dosing (Day 1) until end of study (Day 8)

Measured as count of events.

Part B: Change from baseline in Fridericia heart rate corrected QT interval (ΔQTcF) for etavopivat
From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23

Measured as milliseconds.

AUC0-inf,etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Measured in hour\*nanogram/millilitre (h\*ng/mL).

Cmax,etavopivat: Maximum observed etavopivat plasma concentration after a single dose
From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Measured in nanograms/millilitre (ng/mL).

Weight-adjusted AUC0-inf,etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose divided by body weight
From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Measured in(hour\*nanogram/millilitre)/kilograms ((h\*ng/mL)/kg).

Weight-adjusted Cmax,etavopivat: Maximum observed etavopivat plasma concentration after a single dose divided by body weight
From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Measured in (nanograms/millilitre )/kilogram ((ng/mL)/kg).

AUC0-last,etavopivat: Area under the etavopivat plasma concentration-time curve from0 hours to the time of last quantifiable concentration
From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Measured in hour\*nanogram/millilitre (h\*ng/mL).

tmax,etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose
From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Measured in hour (h).

t½,etavopivat: Terminal half-life for etavopivat after a single dose
From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Measured in hour (h).

CL/F etavopivat: Apparent plasma clearance of etavopivat after a single dose
From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Measured in Litre/hour (L/h).

Vz/F etavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values
From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Measure in litre (L).

Secondary Endpoints
Part A: Number of treatment-emergent clinically significant abnormal findings in electrocardiogram (ECGs)
From dosing (Day 1) until end of study (Day 8)
Parts A and B: Cmax,etavopivat- Maximum observed etavopivat plasma concentration after a single dose
Day 1 (Part B)/ From day 1 to day 5 (Part A) after investigational medicinal product (IMP) administration
Parts A and B: AUC0-last,etavopivat- Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration
Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A- EtavopivatEXPERIMENTALParticipants will receive a single dose of etavopivat.
Part A- PlaceboPLACEBO_COMPARATORParticipants will receive a single dose of placebo.
Part B- EtavopivatEXPERIMENTALParticipants will receive a single dose of etavopivat.
Part B- MoxifloxacinOTHERParticipants will receive a single dose of moxifloxacin.
Part B- PlaceboPLACEBO_COMPARATORParticipants will receive a single dose of placebo.
EtavopivatEXPERIMENTALParticipants will be administered a single dose of 2 tablets of etavopivat together.
Interventions
NameTypeDescription
EtavopivatDRUGEtavopivat will be administered orally.
MoxifloxacinDRUGMoxifloxacin will be administered orally.
PlaceboDRUGPlacebo matching Etavopivat will be administered orally.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female. * Aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m\^2) (both inclusive) at screening. * Body weight above 40.0 kg at screening. * Considered to be generally...

Countries:United StatesChina
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