Cytisinicline
Smoking Cessation, Vaping Cessation
Phase III
Active Not Recruiting
Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers
May 24, 2024
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Cytisinicline
Smoking Cessation
Phase I
Completed
Study to Evaluate Effect of Food on Bioavailability of Single 3 mg Tablet and Pharmacokinetics (PK) of Multiple 3 mg Doses in Healthy Adult Smokers
Aug 01, 2023
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Cytisinicline
Renal Impairment
Phase I
Completed
Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose
Oct 18, 2022
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Moxifloxacin, Cytisinicline
Smoking Cessation
Phase I
Completed
Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers
Sep 30, 2022
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Behavioral Support, Cytisinicline
Vaping, E-Cig Use
Phase II
Completed
A Study of Cytisinicline for Vaping Cessation in Adult Smokers
Jun 20, 2022
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Behavioral Support, Cytisinicline
Smoking Cessation
Phase III
Completed
A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers
Jan 12, 2022
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Behavioral Support, Cytisinicline
Smoking Cessation
Phase III
Completed
A Study of Cytisinicline for Smoking Cessation in Adult Smokers
Sep 25, 2020
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Cytisine
Smoking Cessation
Phase I
Completed
A Single Dose-escalation Study of Cytisine in Adult Smokers
Feb 19, 2019
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Cytisine, Behavioral Support
Smoking Cessation
Phase II
Completed
Trial of Cytisine in Adult Smokers
Oct 15, 2018
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Cytisine
Smoking Cessation
Phase I
Completed
A Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation
Apr 17, 2018
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Achieve Life Sciences Inc (SP4P) have in its pipeline
SP4P is currently developing the following drugs: Cytisinicline, Cytisinicline, Cytisinicline. These drug candidates are in various stages of clinical development as the company works toward FDA approval.