Section 3 of 6
Product information and disease description
67 evidence topics · 47 sources
Product description
Phase of product development
Regulatory submission: NDA resubmission planned for the fourth quarter of 2026
Unfinished product labeling in the complete response letter
Launch: Anticipated after potential approval in the first half of 2027
Product information
Generic, brand name and therapeutic class of product
Manufacturer: Achieve Life Sciences
| Field | Quoted record |
|---|---|
| Developer | “Achieve Life Sciences, Inc.” |
Therapeutic class
| Receptor activity | Quoted class |
|---|---|
| Activity at the α4β2 nicotinic acetylcholine receptor | “partial agonist” |
U.S. brand name
No evidence found.
Dosage forms and strengths
U.S. investigational phase 3 formulation
MedChemExpress research reagent, HY-N0175
Average sales price and wholesale acquisition cost
United States average sales price and wholesale acquisition cost
Not applicable.
American hospital formulary service (AHFS), or other drug classification
United Kingdom ATC classification
| Classification system | Quoted code |
|---|---|
| ATC | “N07BA04” |
Indication
Proposed U.S. indication
Pharmacology
Mechanism of action
Pharmacodynamics
Pharmacokinetics
Contraindications/Warnings/Precautions/Adverse effects
Warnings and precautions
Contraindications: United Kingdom cytisinicline 1.5 mg tablets
“Unstable angina,” (opens the source at this quote in a new tab)
“A history of recent myocardial infarction,” (opens the source at this quote in a new tab)
“Clinically significant arrhythmias,” (opens the source at this quote in a new tab)
“A history of recent stroke,” (opens the source at this quote in a new tab)
“Pregnancy and breastfeeding.” (opens the source at this quote in a new tab)
Pooled serious adverse-event evidence
Approved U.S. warnings and precautions
Not applicable.
Special populations
United Kingdom 1.5 mg labeling: populations without recommended use
| Population | Quoted recommendation |
|---|---|
| Renal or hepatic impairment; adults older than 65 years; persons younger than 18 years | “not recommended” |
Drug/Drug, drug/disease interactions
Effects of other drugs on Cytisinicline
United Kingdom labeling: concomitant antituberculosis drugs
Effects of Cytisinicline on other drugs
United Kingdom labeling: systemic hormonal contraceptives
| Question | Quoted evidence status |
|---|---|
| Whether cytisinicline reduces the effectiveness of systemic hormonal contraceptives | “currently unknown” |
| Additional contraceptive precaution in the label | “add a second barrier method” |
Dosing and administration
Dosage
United Kingdom 1.5 mg regimen: course duration
| Regimen characteristic | Quoted duration |
|---|---|
| Labeled treatment course | “25 days” |
Administration
United Kingdom 1.5 mg tablets: oral administration
Access and distribution
United Kingdom 1.5 mg tablets: distributor
| Distribution role | Quoted organization |
|---|---|
| Distributor named in the patient leaflet | “Consilient Health Ltd.” |
Co-prescribed/Concomitant therapies
Effect of Cytisinicline on quality measures
Tobacco use screening and cessation intervention measure
Cytisinicline-specific effect on quality-measure performance
No evidence found.
Product comparison
Cochrane: cytisine versus placebo
Systematic review and meta-analyses
| Comparison | Quoted relative effect | Participants | Certainty |
|---|---|---|---|
| Cytisine versus placebo or no medication | “RR 2.65 (1.50 to 4.67)” | “5194” | “Moderate” |
| Cytisine versus nicotine-replacement therapy | “RR 1.36 (1.06–1.73)” | “1511” | “Moderate” |
| Cytisine versus varenicline | “RR 0.96 (0.63–1.45)” | “2508” | “Low” |
| Longer versus shorter treatment duration | “RR 1.29 (1.02–1.63)” | “1009” | “Moderate” |
Place of product in therapy
Disease description
Definition and etiology
Nicotine addiction and tobacco dependence
Epidemiology
Incidence of Smoking cessation
Recent successful quitting among U.S. adults in 2022
Prevalence of Smoking cessation
Current cigarette smoking among U.S. adults in 2022
| Measure | Quoted estimate |
|---|---|
| Adult prevalence | “11.6%” |
| Estimated number of adults | “28.8 million” |
Natural history, survival, and mortality
Mortality from smoking and secondhand smoke in the United States
Pathophysiology
Diagnosis
Assessment of tobacco use
Clinical presentation - signs and symptoms
Nicotine withdrawal: cravings
Nicotine withdrawal: irritability and restlessness
Nicotine withdrawal: impaired concentration
Nicotine withdrawal: sleep disturbance
Nicotine withdrawal: appetite and weight
Nicotine withdrawal: anxiety and depressed mood
Long-term morbidity
Smoking-related disease in the United States
Burden of Smoking cessation
Humanistic burden and health-related quality of life
Quality of life after smoking cessation
Economic burden and healthcare resource utilization
United States economic costs of cigarette smoking in 2018
| Cost component | Quoted estimate |
|---|---|
| Total cost | “more than an estimated $600 billion” |
| Healthcare spending | “More than $240 billion” |
| Lost productivity from smoking-related illness | “Nearly $185 billion” |
| Lost productivity from smoking-related premature death | “Nearly $180 billion” |
| Lost productivity from premature death caused by secondhand smoke | “About $7 billion” |
Economic impact of Smoking cessation on families
Economic impact of diagnostic testing
Not applicable.
Approaches to treatment
Current treatment options and standard of care
Nicotine replacement therapy
USPSTF recommendation on tobacco cessation interventions
Aminoketone antidepressants
Recommended non-nicotine antidepressant therapy
| Guideline-listed treatment | Quoted medication |
|---|---|
| USPSTF smoking-cessation pharmacotherapy | “bupropion sustained-release” |
Nicotinic acetylcholine receptor partial agonists
Behavioral counseling
Behavioral interventions combined with pharmacotherapy
Digital interventions
Digital adjuncts and self-management tools
Electronic cigarettes
USPSTF assessment of electronic cigarettes for tobacco cessation
| Assessment | Quoted evidence status |
|---|---|
| Evidence to assess the balance of benefits and harms in adults, including pregnant persons | “insufficient” |
Limitations of current therapies
Summary
In the 2022 U.S. survey, 38.3% of adults who tried to quit used counseling or medication, and recent successful cessation was reported by 8.8%. The cytisine-versus-varenicline evidence in the 2024 meta-analysis was rated low certainty. The Cochrane review identified imprecision in the evidence concerning serious adverse events.
Smoking cessation and treatment utilization
Place in treatment, anticipated use, and care setting
Summary
The proposed U.S. indication is smoking cessation in adults. Development studied oral cytisinicline with behavioral support. WHO includes cytisine among recommended tobacco-cessation pharmacotherapies and recommends combining medication with behavioral interventions. U.S. commercial use remains contingent on FDA approval; the sponsor anticipated potential approval in the first half of 2027.
Heterogeneity of treatment effect
Care management intervention strategies
Other product development or post-marketing obligations required by the FDA
Not applicable.
Ongoing post-approval monitoring
United Kingdom 1.5 mg tablets: suspected adverse-reaction reporting
| Reporting route | Quoted scheme |
|---|---|
| National adverse-reaction reporting system | “Yellow Card Scheme” |
U.S. post-approval monitoring
Not applicable.