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Obeldesivir

Phase 3

COVID-19 | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Dec 24, 2024

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_CONTROLLEDDMC
Total Trials1
Total Enrollment2,011
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05715528Study of Obeldesivir in Nonhospitalized Participants With COVID-19PHASE3 COMPLETED 2,011Feb 8, 2023Jan 23, 2024Dec 24, 2024113 United States, Japan
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Study Endpoints
Primary Endpoints
Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29
First dose date up to Day 29

The time to alleviation of targeted COVID-19 symptoms by Day 29 for participants with symptom alleviation, was calculated as symptom alleviation date/time minus first dose date/time. For participants who completed Day 29 of the study or discontinued from the study before Day 29 without symptom alleviation (censored) and without inter-current events, time was calculated as last date/time on which symptom alleviation was assessed minus the first dose date/time or Day 28, whichever occurred first. Symptom alleviation was defined as, all targeted symptoms scored moderate or severe at baseline were scored as mild/none and all targeted symptoms scored mild/none at baseline were scored as none, for at least 48 consecutive hours. Targeted symptoms included: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering and feeling hot or feverish. Kaplan-Meier (KM) estimates were used in outcome measure analysis.

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
First dose date up to Day 5 plus 30 days

TEAEs were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. * Any AEs leading to premature discontinuation of study drug. Percentages were rounded off.

Percentage of Participants Experiencing Laboratory Abnormalities
First dose date up to Day 5 plus 30 days

Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off.

Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
First dose date up to Day 5 plus 30 days

Percentages were rounded off.

Secondary Endpoints
Time to COVID-19 Symptom Resolution by Day 29
Day 1 up to 29
Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29
Up to Day 29
Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29
Up to Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ObeldesivirEXPERIMENTALParticipants will receive obeldesivir 350 mg twice daily for 5 days.
Obeldesivir PlaceboPLACEBO_COMPARATORParticipants will receive obeldesivir placebo twice daily for 5 days.
Interventions
NameTypeDescription
ObeldesivirDRUGTablet administered orally without regard to food.
Obeldesivir PlaceboDRUGTablet administered orally without regard to food.
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Eligibility Criteria
Age Range12 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites113

Key Inclusion Criteria: * Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (PCR), rapid antigen test, or an approved alternative assay. Serologic tests will not be accepted. * Willing and able to complete t...

Countries:United StatesJapan
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