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Maribavir

Phase 3

Cytomegalovirus (CMV) | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: May 22, 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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials7
Total Enrollment1,184
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06439342A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) InfectionsPHASE3 RECRUITING 20Dec 16, 2024Dec 31, 2026Mar 2, 202612 China
NCT05319353A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)PHASE3 RECRUITING 80Nov 13, 2023Jan 18, 2027May 22, 202653 United States, Australia +9
NCT05137717A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) InfectionPHASE3 COMPLETED 41Jan 18, 2022Jun 27, 2023Jul 9, 202420 Japan
NCT02927067A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell TransplantsPHASE3 COMPLETED 553Apr 14, 2017Jul 1, 2022Mar 3, 2023129 United States, Australia +21
NCT02931539Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or CidofovirPHASE3 COMPLETED 352Dec 22, 2016Aug 17, 2020Nov 3, 2021134 United States, Australia +12
NCT01611974Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant RecipientsPHASE2 COMPLETED 120Jul 17, 2012Dec 5, 2014Jun 2, 202132 United States
NCT02775240Study of SHP620 (Maribavir) in Healthy AdultsPHASE1 COMPLETED 18Jul 21, 2016Sep 12, 2016Jun 3, 20211 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE), and Adverse Events of Special interest (AESIs)
From first dose of study drug up to Week 20

TEAEs will be defined as those with a start date on or after the first dose of study treatment, or with a start date before the date of first dose of study treatment but increasing in severity after the first dose of study treatment. An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria. AESIs is defined as any adverse event of special interest.

Number of Participants With Clinically Significant Changes in Vital Signs
From first dose of study drug up to Week 20

Vital signs will include temperature, arterial blood pressure (systolic and diastolic) and pulse. Any change in vital signs assessments which will be deemed clinically significant by the investigator will be reported.

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
From first dose of study drug up to Week 20

Clinical laboratory parameters will include chemistry, hematology, and urinalysis. Any clinical laboratory abnormalities which will be deemed clinically significant by the investigator will be recorded.

Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
From first dose of study drug up to Week 20

12-lead ECG will be evaluated. Any ECG assessments which will be deemed clinically significant by the investigator will be reported.

Number of Participants Who will Discontinue From the Study Drug and Study
From first dose of study drug up to Week 20

Participants discontinuing the study drug treatment and the study will be reported.

Maximum Observed Plasma Concentration (Cmax) of Maribavir
Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

Cmax of maribavir will be evaluated.

Time to Maximum Observed Concentration (Tmax) of Maribavir
Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

Tmax of maribavir will be evaluated.

Minimum Plasma Concentration (Cmin) of Maribavir
Pre-dose; (0.5, 1.5, 3, 4, 6, and 8 hours post-dose) on Day 7 (Week 1); Pre-dose on Day 28 (Week 4); Pre-dose; (2 to 4 hours post-dose) on Day 56 (Week 8)

Cmin of maribavir will be evaluated.

Area Under the Plasma Concentration-Time Curve Over the 1 Dosing Interval of 12 Hours at Steady State (AUC0-tau) of Maribavir
Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

AUC0-tau of maribavir will be evaluated.

Half-Life (t1/2) of Maribavir
Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

t1/2 of maribavir will be evaluated.

Terminal Elimination Rate Constant (lambdaz) of Maribavir
Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

Lambdaz of maribavir will be evaluated.

Apparent Volume of Distribution (Vz/F) of Maribavir
Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

Vz/F of maribavir will be evaluated.

Apparent Oral Clearance (CL/F) of Maribavir
Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

CL/F of maribavir will be evaluated.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From start of study drug administration up to follow-up (Week 20)

An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily be considered related to investigational product. SAE is any untoward medical occurrence (whether considered related to investigational product or not) that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, or is an important medical event.

Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8
At Week 8

The confirmed viremia clearance was defined as a plasma CMV DNA concentration below the lower limit of quantification (LLOQ) (that is \[i.e.\], less than \[\<\] 34.5 international units per milliliter \[IU/mL\]) when assessed by the COBAS® 8800/COBAS® CMV Test, in two consecutive post-baseline samples, separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed).

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
From first dose of study drug up to Week 20

A TEAEs was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product or medicinal product. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability / incapacity, was a congenital anomaly / birth defect or was medically important due to other reasons than the above mentioned criteria.

Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir
From first dose of study drug up to Week 20

The number of participants with TEAEs leading to maribavir study treatment discontinuation (including treatment interruption or withdrawal) were reported.

Number of Participants With Clinically Meaningful Changes in Vital Signs
From first dose of study drug up to Week 20

Vital sign assessments included blood pressure, pulse, respiratory rate and body temperature. Any clinically meaningful change in vital signs which were deemed clinically significant by the investigator were reported.

Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings
From first dose of study drug up to Week 20

Physical examination included assessments of the head, eyes, ears, nose, throat, neck, lymph nodes, and the cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems. Any clinically meaningful change in physical examination which were deemed clinically significant by the investigator were reported.

Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters
From first dose of study drug up to Week 20

Clinical laboratory parameters included evaluations of hematology, chemistry, urinalysis. Any clinically meaningful change in clinical laboratory parameters which were deemed clinically significant by the investigator were reported.

Number of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs)
From first dose of study drug up to Week 20

12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically meaningful by the investigator were reported.

Number of Participants With Events of Immunosuppressant Drug Level Increased in Blood
From first dose of study drug up to Week 8

Immunosuppressant drug concentration testing was solely for participants who received immunosuppressive therapy with tacrolimus, cyclosporine, or everolimus. The number of participants with an increased level of at least one immunosuppressant drug was reported.

Number of Participants With TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss
From first dose of study drug up to Week 20

New onset of acute or chronic GVHD assessed as TEAEs, and graft rejection, or graft loss assessed were reported.

Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8
Week 8

Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \<137 International units per milliliter \[IU/mL\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed).

Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8
Week 8

Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration less than (\<) lower limit of quantification (LLOQ) that is, \<137 International Units per milliliter (IU/mL) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of participants with confirmed CMV viremia clearance at end of study Week 8 regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy, and could not have received alternative anti-CMV treatment were reported.

Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks
6 weeks

Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 consecutive post-baseline, on-treatment undetectable results separated by \>/= 5 days (assessed by the central laboratory). Samples were collected on Days 1 and 8, weekly during Weeks 2-6, and once in Weeks 8, 10, 12, 16, 20, 24 (treatment) and Weeks 1, 4, 8, 12 (follow-up). Permissible assessment windows were: Days 8-15 +/- 1 day; Weeks 3-4 +/- 2 days; Weeks 5-6 +/- 3 days; Weeks 8-12 +/- 4 days; Weeks 16-24 +/- 7 days (treatment) and Weeks 1-4 +/- 2 days; Weeks 8-12 +/- 4 days (follow-up).

Number of Participants With a Treatment Emergent Adverse Event (TEAE).
25 weeks

Treatment-emergent adverse events are those events that occurred on or after study drug administration through 7 days after the last dose of study drug, or are events that occurred prior to study drug administration and recurred with increased severity after taking study drug through 7 days after the last dose of study drug.

Maximum Observed Plasma Concentration (Cmax) of Digoxin
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Cmax is the maximum observed plasma concentration of digoxin.

Maximum Observed Plasma Concentration (Cmax) of Dextromethorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Cmax is the maximum observed plasma concentration of dextromethorphan.

Maximum Observed Plasma Concentration (Cmax) of Dextrorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Cmax is the maximum observed plasma concentration of dextrorphan, the metabolite of dextromethorphan.

Time to Reach Maximum Plasma Concentration (Tmax) of Digoxin
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Tmax is the time to reach the maximum observed drug concentration in plasma during a dosing interval.

Time to Reach Maximum Plasma Concentration (Tmax) of Dextromethorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Tmax is the time to reach the maximum observed drug concentration in plasma during a dosing interval.

Time to Reach Maximum Plasma Concentration (Tmax) of Dextrorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Tmax is the time to reach the maximum observed drug concentration in plasma during a dosing interval.

Time to Reach Maximum Plasma Concentration (Tmax) of Maribavir
Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13

Tmax is the time to reach the maximum observed drug concentration in plasma during a dosing interval.

Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Digoxin
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

AUC0-infinity is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration.

Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Dextromethorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

AUC0-infinity is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration.

Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Dextrorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

AUC0-infinity is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration.

Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Digoxin
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

AUClast is the area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration.

Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Dextromethorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

AUClast is the area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration.

Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Dextrorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

AUClast is the area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration.

Parent/Metabolite Ratio of Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) for Dextromethorphan Over AUClast for Dextrorphan (AUClast Parent/Metabolite Ratio)
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

AUClast parent/metabolite ratio is the ratio of AUClast for dextromethorphan over AUClast for dextrorphan.

Parent/Metabolite Ratio of Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) for Dextromethorphan Over AUC0-infinity for Dextrorphan (AUC0-infinity Parent/Metabolite Ratio)
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

AUC0-infinity parent/metabolite ratio is the ratio of AUC0-infinity for dextromethorphan over AUC0-infinity for dextrorphan.

Area Under the Plasma Concentration Versus Time Curve From Time Zero to the End of the Dosing Interval at Steady-State (AUCtau) of Maribavir
Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13

AUCtau is the area under the plasma concentration versus time curve from the time zero to the end of the dosing interval at steady-state.

First-order Rate Constant (Lambda z) Associated With the Terminal (Log-linear) Portion of the Curve of Digoxin
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Lambda z is the first-order rate constant associated with the terminal (log-linear) portion of the plasma concentration versus time curve, determined as the negative slope of the terminal log-linear phase of the curve.

First-order Rate Constant (Lambda z) Associated With the Terminal (Log-linear) Portion of the Curve of Dextromethorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Lambda z is the first-order rate constant associated with the terminal (log-linear) portion of the plasma concentration versus time curve, determined as the negative slope of the terminal log-linear phase of the curve.

First-order Rate Constant (Lambda z) Associated With the Terminal (Log-linear) Portion of the Curve of Dextrorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Lambda z is the first-order rate constant associated with the terminal (log-linear) portion of the plasma concentration versus time curve, determined as the negative slope of the terminal log-linear phase of the curve.

Terminal Half-life (t1/2) of Digoxin
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Terminal half-life (t1/2) is the time in hours required for the concentration of the drug to reach half of its original value.

Terminal Half-life (t1/2) of Dextromethorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Terminal half-life (t1/2) is the time in hours required for the concentration of the drug to reach half of its original value.

Terminal Half-life (t1/2) of Dextrorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Terminal half-life (t1/2) is the time in hours required for the concentration of the drug to reach half of its original value.

Terminal Half-life (t1/2) of Maribavir
Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13

Terminal half-life (t1/2) is the time in hours required for the concentration of the drug to reach half of its original value.

Apparent Oral Clearance (CL/F) of Digoxin
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

CL/F is equal to dose/AUC0-infinity (dose divided by area under the plasma concentration versus time curve extrapolated to infinity \[AUC0-infinity\]).

Apparent Oral Clearance (CL/F) of Dextromethorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

CL/F is equal to dose/AUC0-infinity (dose divided by area under the plasma concentration versus time curve extrapolated to infinity \[AUC0-infinity\])

Concentration at the End of Dosing Interval (Ctau) of Maribavir
Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13

Ctau is the concentration of maribavir at the end of the dosing interval.

Volume of Distribution Divided by the Fraction of Dose Absorbed (Vz/F) of Digoxin
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Vz/F is the volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed.

Volume of Distribution Divided by the Fraction of Dose Absorbed (Vz/F) of Dextromethorphan
Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B

Vz/F is the volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed.

Pre-dose Concentration (C0) of Maribavir
Pre-dose on Day 13

C0 is the lowest concentration reached by a drug before the next dose is administered.

Secondary Endpoints
Percentage of Participants With Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) (CMV Viremia Clearance) at Week 8
At Week 8
Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Weeks 8, 12, 16, and 20
At Weeks 8, 12, 16 and 20
Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 (After Completion of 8 Weeks Therapy)
At Week 8
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MaribavirEXPERIMENTALParticipants will receive maribavir 400 milligrams (mg), tablets, orally twice a day (BID) for up to 8 weeks.
Cohort 1: Maribavir 400, 200 or 100 mgEXPERIMENTALParticipants with greater than or equal to (\>=) 12 to less than (\<) 18 years of age will receive maribavir 400 milligrams (mg) (2\*200 mg tablets or powder for oral suspension) twice daily (BID) based on body weight \>= 25 kilogram (kg); or 200 mg tablet or powder for oral suspension BID based on body weight 14 to \< 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to \< 14 kg for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8).
Cohort 2: Maribavir 400, 200 or 100 mgEXPERIMENTALParticipants with \>= 6 to \< 12 years of age will receive maribavir 400 mg (2\*200 mg tablets or powder for oral suspension) BID based on body weight \>= 25 kg; or 200 mg tablet or powder for oral suspension BID based on body weight 14 to \< 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to \< 14 kg orally for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8).
Cohort 3: Maribavir 400, 200, 100 or 50 mgEXPERIMENTALParticipants with 0 to \< 6 years of age will receive maribavir 400 mg (2\*200 mg tablets or powder for oral suspension) BID based on body weight \>= 25 kg; or 200 mg tablet or powder for oral suspension BID based on body weight 14 to \< 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to \< 14 kg; or 50 mg powder for oral suspension BID based on body weight 7 to \< 10 kg; or 50 mg powder for oral suspension once daily (QD) based on body weight 5 to \<7 kg for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8).
Valganciclovir 900 mg BIDACTIVE_COMPARATORParticipants received 900 milligrams (mg) of valganciclovir along with a placebo matched to maribavir, twice daily (BID) orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.
Maribavir 400 mg BIDEXPERIMENTALParticipants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.
Maribavir TreatmentEXPERIMENTALParticipants will receive 400 milligrams (mg) (2x200 mg tablets) maribavir twice daily orally (doses separated by a minimum of 8 hours) for 8 weeks.
Investigator-Assigned TreatmentACTIVE_COMPARATORParticipants will receive anti-CMV agent best suited to treat the respective participant as per the investigator's prescribed dosing regimen for 8 weeks. Agents of choice include: ganciclovir, valganciclovir, foscarnet, or cidofovir.
Maribavir 400 mg twice dailyEXPERIMENTAL -
Maribavir 800 mg twice dailyEXPERIMENTAL -
Maribavir 1200 mg twice dailyEXPERIMENTAL -
DigoxinACTIVE_COMPARATOROn Day 1, subjects will receive a single 0.5 mg (2 x 0.25 mg) oral dose of digoxin.
DextromethorphanACTIVE_COMPARATOROn Day 1, subjects will receive a single 30 mg oral dose of dextromethorphan.
Interventions
NameTypeDescription
MaribavirDRUGMaribavir tablets
ValganciclovirDRUGParticipants will receive valganciclovir tablets orally.
PlaceboOTHERParticipants will receive placebo tablets matched to either maribavir or valganciclovir.
GanciclovirDRUGGanciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
FoscarnetDRUGFoscarnet as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
CidofovirDRUGCidofovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
DigoxinDRUG0.5 mg (2 x 0.25 mg) Digoxin oral dose
DextromethorphanDRUG30 mg oral dose
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria * The participant or the participant's legally acceptable representative is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator. * The participant/participant's legally representative has provided informed con...

Countries:ChinaUnited StatesAustraliaBelgiumBrazilFranceGermanyIsraelJapanSpainUnited KingdomAustriaCanadaCroatiaCzechiaGreeceHungaryItalyNew ZealandPolandRussiaSingaporeSouth KoreaSwitzerlandTurkey (Türkiye)Denmark
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06439342primaryCompletionDate: changed
LOWMay 26, 2026NCT05319353primaryCompletionDate: changed
LOWMay 24, 2026NCT06439342studyFirstPostDate: changed
LOWMay 24, 2026NCT05319353studyFirstPostDate: changed