Recent Updates
Recently added Catalysts

EVT 302

Phase 2

Smoking Cessation | Small molecule | Psychiatry |Evotec SE|Last Updated: May 29, 2009

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment490

FDA Designations

No designations recorded

Clinical trial landscape

EVT 302 · 2 trials · 1 indication

Phase 2 2
NCT00738595Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.Smoking Cessation
COMPLETED400 Analytics
NCT00622752Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of CigarettesSmoking Cessation
COMPLETED90 Analytics
PHASE2COMPLETED
Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.
Smoking CessationUnlock trial analytics
PHASE2COMPLETED
Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
Smoking CessationUnlock trial analytics

Study Endpoints

Primary Endpoints

The four-week continuous quit rate over the last four weeks of treatment
Last 4 weeks of therapy
Reduction in Craving and withdrawal
Within 12 hours of the last cigarette

Secondary Endpoints

7 -week abstinence
7 weeks post quit day
7-day point prevalence quit rate
weekly for 7 weeks
Daily cigarettes smoked
Daily
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEVT 302, 5 mg once Daily
2PLACEBO_COMPARATORPlacebo once daily
3EXPERIMENTALEVT 302 plus open label Nicotine replacement
4ACTIVE_COMPARATORPlacebo plus nicotine replacement therapy

Interventions

NameTypeDescription
EVT 302DRUGEVT 302 5 mg once daily
PlaceboDRUGPlacebo to match EVT 302, 5 mg
EVT 302 plus open label Nicotine replacementDRUGDouble-blind EVT 302 plus open label nicotine replacement
Placebo plus open label Nicotine ReplacementDRUGDouble-blind placebo plus open label Nicotine replacement patch 21 mg once daily.
EVT 302, 10 mgDRUG2 X EVT 302, 5 mg tablets
Nicotine replacement therapy (NRT)DRUGNRT patch containing 21 mg of nicotine
NRT placeboDEVICEMedically inert plaster cut to match the NRT plaster
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Smoker of at least 10 cigarettes daily * Motivated to quit smoking * Reports at least one unsuccessful attempt to quit in the last 2 years * In generally good health * Provides written informed consent to participate in the sudy Exclusion Criteria: * Pregnant or nursing fema...

Countries:Germany
Unlock Eligibility Criteria

Frequently asked questions about EVT 302

What is EVT 302 used for?

EVT 302 is an investigational small molecule being developed for smoking cessation. It is in Phase 2 clinical development and has been studied in two completed trials in Germany, with a total enrollment of 490 participants.

Who makes EVT 302?

EVT 302 is being developed by Evotec SE, a company listed on the stock exchange under the ticker EVO. The drug is currently in Phase 2 clinical trials for smoking cessation.

What phase is EVT 302 in?

EVT 302 is in Phase 2 clinical development. It has completed two Phase 2 trials, and it is not yet approved by regulatory authorities. The drug remains investigational and is being studied for smoking cessation.

What clinical trials is EVT 302 in?

EVT 302 has been studied in two completed Phase 2 trials. NCT00622752 evaluated its effects with or without nicotine replacement therapy on craving and withdrawal in healthy male smokers, enrolling 90 participants. NCT00738595 assessed its effectiveness in smoking cessation, enrolling 400 participants. Both trials were conducted in Germany.

Is EVT 302 the same as any other drug?

EVT 302 is the only name provided for this drug in the available data. No alternative names have been reported, so it is not known to be the same as any other marketed or investigational drug.