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CERC-501

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

CERC-501 · 1 trial · 1 indication

Phase 2 1
NCT02641028A Study in a Human Laboratory Model of Smoking BehaviorSmoking
COMPLETED71 Analytics
PHASE2COMPLETED
A Study in a Human Laboratory Model of Smoking Behavior
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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 to 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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Frequently asked questions about CERC-501

What is CERC-501 used for?

CERC-501 is an investigational small molecule being studied for smoking cessation. It is in Phase 2 clinical development for the treatment of smoking, a psychiatric therapeutic area. The drug is not approved and remains under investigation.

How does CERC-501 work?

CERC-501 is a small molecule developed for smoking cessation. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not detailed here.

Who makes CERC-501?

CERC-501 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical trials for smoking cessation.

What phase is CERC-501 in?

CERC-501 is in Phase 2 clinical development. It is an investigational drug for smoking cessation and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is CERC-501 in?

CERC-501 has one completed Phase 2 trial, NCT02641028, titled "A Study in a Human Laboratory Model of Smoking Behavior." This randomized, double-blind, placebo-controlled trial enrolled 71 participants in the United States and studied smoking behavior.

Is CERC-501 the same as other names?

CERC-501 is the primary name for this investigational drug. No alternative names have been associated with it in available information.