Product Description
Varenicline acts as a partial nicotine receptor agonist similar to cytisine. Varenicline is used as a smoking cessation aid to help people stop smoking in conjunction with education and counseling. Varenicline is the first drug of choice for smoking cessation because it has demonstrated a significant effect in preventing both short-term and long-term relapse. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK534846/)
Mechanisms of Action: nAChR Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Tobacco Use Disorder | Smoking Cessation | Keratoconjunctivitis Sicca | Dry Eye Disease
Known Adverse Events: Constipation | Flatulence | Sneezing
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Dry Eye Disease|Dry Eye Syndromes|Keratoconjunctivitis Sicca
Phase 2: Other
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| JX03003 | P1 |
Completed |
Dry Eye Disease|Keratoconjunctivitis Sicca|Dry Eye Syndromes |
2023-04-27 |
21% |
| CTR20221182 | P3 |
Completed |
Keratoconjunctivitis Sicca |
2023-04-04 |
|
| JX03002 | P3 |
Completed |
Keratoconjunctivitis Sicca|Dry Eye Disease|Dry Eye Syndromes |
2023-04-04 |
22% |
| the Olympia Study | P2 |
Completed |
Other |
2023-01-27 |