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MK-4482

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Apr 16, 2026

Target and mechanism

ModalitySmall molecule

Also known as Molnupiravir

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

MK-4482 · 2 trials · 1 indication

Phase 1 2
NCT06816030A Clinical Study of MK-4482 in Chinese Healthy Male Participants (MK-4482-009)Healthy
COMPLETED16 Analytics
NCT06615869A Study to Evaluate Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants (MK-4482-011)Healthy
COMPLETED64 Analytics
PHASE1COMPLETED
A Clinical Study of MK-4482 in Chinese Healthy Male Participants (MK-4482-009)
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study to Evaluate Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants (MK-4482-011)
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

The Maximum Observed Plasma Concentration (Cmax) After Single Oral Dose of MK-4482 in Period 1
At designated time points up to 72 hours post-dose

Cmax of N-hydroxycytidine (NHC) after a single oral dose of MK-4482 in period 1.

Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Single Oral Dose of MK-4482 in Period 1.
At designated time points up to 72 hours post-dose

Tmax of NHC following single oral dose of MK-4482 in period 1.

Elimination Half Life (T1/2) After Single Oral Dose of MK-4482 in Period 1
At designated time points up to 72 hours post-dose

T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after a single oral dose of MK-4482 in period 1.

Apparent Total Clearance (CL/F) After Single Oral Dose of MK-4482 in Period 1
At designated time points up to 72 hours post-dose

CL/F of NHC from plasma after single oral dose of MK-4482 in period 1.

Apparent Volume of Distribution (Vz/F) After Single Oral Dose of MK-4482 in Period 1
At designated time points up to 72 hours post-dose

Vz/F of NHC during terminal phase after single oral dose of MK-4482 in period 1.

Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Single Oral Dose of MK-4482 in Period 1
At designated time points up to 72 hours post-dose

This is a measure of the average amount of NHC in the plasma over a period of 12 hours after single oral dose of MK-4482 in period 1.

Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) After Single Oral Dose of MK-4482 in Period 1
At designated time points up to 72 hours post-dose

AUC0-last of NHC following a single oral dose of MK-4482 in period 1.

Area Under The Plasma Concentration Versus Time Curve From Time Zero (pre-dose) to Extrapolated Infinite Time (AUC0-inf) After Single Oral Dose of MK-4482 in Period 1
At designated time points up to 72 hours post-dose

AUC0-inf of NHC after single oral dose of MK-4482 in period 1.

The Maximum Observed Plasma Concentration (Cmax) After Multiple Oral Doses of MK-4482 in Period 2
At designated time points up to 72 hours post-dose

Cmax of NHC after multiple oral doses of MK-4482 in period 2.

Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Multiple Oral Doses of MK-4482 in Period 2
At designated time points up to 72 hours post-dose

Tmax of NHC following multiple oral doses of MK-4482 in period 2.

Elimination Half Life (T1/2) After Multiple Oral Doses of MK-4482 in Period 2
At designated time points up to 72 hours post-dose

T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after multiple oral doses of MK-4482 in period 2.

Clearance at Steady State (CLss/F) After Multiple Oral Doses of MK-4482 in Period 2
At designated time points up to 72 hours post-dose

CLss/F of plasma NHC following multiple doses of MK-4482 in period 2.

Apparent Volume of Distribution (Vz/F) After Multiple Oral Doses of MK-4482 in Period 2
At designated time points up to 72 hours post-dose

Vz/F of NHC during terminal phase after multiple doses of MK-4482 in period 2.

Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Multiple Oral Doses of MK-4482 in Period 2
At designated time points up to 72 hours post-dose

This is a measure of the average amount of NHC in the plasma over a period of 12 hours after multiple oral doses of MK-4482 in period 2.

The Minimum Concentration (Ctrough) After Multiple Oral Doses of MK-4482 in Period 2
At designated time points up to 72 hours post-dose

Ctrough of NHC that occurred following multiple doses of MK-4482 in period 2.

Accumulation Ratio on Cmax After Multiple Oral Doses of MK-4482 in Period 2
At designated time points up to 72 hours post-dose

The maximum concentration at steady state following multiple doses of MK-4482 in period 2 divided by the maximum concentration following the initial dosing in Period 1.

Accumulation Ratio on AUC0-12hr After Multiple Oral Doses of MK-4482
At designated time points up to 72 hours post-dose

The AUC0-12hr at steady state following multiple doses of MK-4482 in period 2 divided by the AUC0-12hr following the initial dosing in Period 1.

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B
Pre-dose, and at designated timepoints up to 72 hours postdose

AUC0-inf of NHC in plasma will be determined.

Area Under the Concentration-Time Curve From Time Zero to last measurable timepoint (AUC0-last) of NHC in plasma: Treatment A versus Treatment B
Pre-dose, and at designated timepoints up to 72 hours postdose

AUC0-last of NHC in plasma will be determined.

Area Under the Concentration-Time Curve From Time Zero to 12 hours (AUC0-12) of (NHC) in plasma: Treatment A versus Treatment B
Pre-dose, and at designated timepoints up to 12 hours postdose

AUC0-12 of NHC in plasma will be determined.

Maximum plasma concentration (Cmax) of NHC: Treatment A versus Treatment B
Pre-dose, and at designated timepoints up to 72 hours postdose

Cmax of NHC in plasma will be determined.

Time to maximum plasma concentration (Tmax) of NHC: Treatment A versus Treatment B
Pre-dose, and at designated timepoints up to 72 hours postdose

Tmax of NHC in plasma will be determined.

Apparent terminal half-life (t1/2) of NHC in plasma: Treatment A versus Treatment B
Pre-dose, and at designated timepoints up to 72 hours postdose

t1/2 of NHC in plasma will be determined.

Apparent Clearance (CL/F) of NHC in plasma: Treatment A versus Treatment B
Pre-dose, and at designated timepoints up to 72 hours postdose

CL/F of NHC in plasma will be determined.

Apparent volume of distribution during terminal phase (Vz/F) of NHC in plasma: Treatment A versus Treatment B
Pre-dose, and at designated timepoints up to 72 hours postdose

Vz/F of NHC in plasma will be determined.

Secondary Endpoints

Number of Participants Who Experience an Adverse Event (AE)
Up to ~ 5.5 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Up to ~ 5.5 weeks
AUC0-inf of NHC in plasma: Treatment B versus Treatment C
Pre-dose, and at designated timepoints up to 72 hours postdose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
MK-4482EXPERIMENTALParticipants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses.
Molnupiravir Treatment AEXPERIMENTALParticipants receive molnupiravir reference capsule.
Molnupiravir Treatment BEXPERIMENTALParticipants receive molnupiravir Formulation 1.
Molnupiravir Treatment CEXPERIMENTALParticipants receive molnupiravir Formulation 1 after a high-fat meal.
Molnupiravir Treatment DEXPERIMENTALParticipants receive molnupiravir Formulation 2.

Interventions

NameTypeDescription
MK-4482DRUGParticipants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses.
MolnupiravirDRUGOral Administration.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Has a Body Mass Index (BMI) of 19 to 24 weight (kg)/height (m)2, inclusive, and body weight of ≥ 50 kg at the screening visit. Exclusion Criteria: The main exclusion criteria include but are not limi...

Countries:ChinaUnited States
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Frequently asked questions about MK-4482

What is MK-4482 used for?

MK-4482, also known as Molnupiravir, is an investigational small molecule being studied for Coronavirus Disease (COVID-19), Renal Impairment, Respiratory Syncytial Virus, Hepatic Impairment, Influenza Infection, and in Healthy participants. It is in Phase 1 clinical development.

What does MK-4482 target?

MK-4482, also known as Molnupiravir, is a small molecule antiviral. Its specific molecular target has not been disclosed in the available clinical trial information.

Who makes MK-4482?

MK-4482, also known as Molnupiravir, is being developed by Merck & Company, Inc. (ticker: MRK).

What phase is MK-4482 in?

MK-4482, also known as Molnupiravir, is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is MK-4482 in?

MK-4482, also known as Molnupiravir, has been studied in several Phase 1 trials, including NCT05386758 in participants with severe renal impairment, NCT05818124 in healthy participants inoculated with experimental influenza virus, NCT06615869 comparing tablet and capsule formulations, and NCT06816030 in Chinese healthy male participants.

Is MK-4482 the same as Molnupiravir?

Yes, MK-4482 is also known as Molnupiravir. Both names refer to the same investigational drug being developed by Merck & Company, Inc.