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CERC-501

Phase 2

Smoking | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 27, 2025

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 Trials1
Total Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02641028A Study in a Human Laboratory Model of Smoking BehaviorPHASE2 COMPLETED 71Dec 31, 2015Dec 31, 2016Apr 27, 20253 United States
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Study Endpoints
Primary Endpoints
Latency
50 min

Latency (in minutes and seconds) to time of first cigarette smoked during the delay period

Number of Cigarettes smoked
60 min

Number of cigarettes smoked during the self administration period

Secondary Endpoints
Tobacco Craving
Up to 4 days ( 2 each period)
Mood Scores
Up to 4 days ( 2 each period)
Nicotine Withdrawal
Up to 4 days ( 2 each period)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CERC-501EXPERIMENTALAdministered orally once daily, 15mg daily, 8 days.
PlaceboPLACEBO_COMPARATORAdministered orally daily, 8 days.
Interventions
NameTypeDescription
CERC-501DRUGCERC-501
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range21 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Provides written informed consent and agrees to complete required clinic visits 2. Male or female 21 to 60 years of age inclusive 3. Body mass index (BMI) 18.5 to 40 kg/m2 inclusive 4. Heavy Smokers 5. Currently not seeking smoking cessation therapy 6. In otherwise good gener...

Countries:United States
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