Last reviewed · How we verify
Short-Term Varenicline (short-term-varenicline)
Short-Term Varenicline (generic name: short-term-varenicline) is a varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg t drug developed by Pfizer Inc.. It is currently in preclinical development.
varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg t
Varenicline is a small molecule that acts as a partial agonist of the neuronal acetylcholine receptor alpha4/beta2. It has been studied for its potential to treat conditions such as smoking, tobacco use disorder, opioid-use disorder, nicotine dependence, and heavy drinking.
-
Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | short-term-varenicline |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg t |
| Therapeutic area | Other |
| Phase | preclinical |
Mechanism of action
Varenicline works by attaching to nicotinic receptors in your brain—the same receptors that nicotine normally stimulates. Unlike nicotine itself, which fully activates these receptors and produces a strong reward signal, varenicline only partially activates them. This partial activation is enough to satisfy much of your brain's desire for nicotine stimulation, significantly reducing the intense cravings and withdrawal discomfort that typically make quitting difficult. At the same time, varenicline blocks nicotine molecules from fully activating these same receptors. So if you do smoke while taking varenicline, the nicotine won't produce the satisfying, rewarding sensation you're accustomed to. This dual action—reducing cravings while removing the pleasure from smoking—addresses both the physical and behavioral aspects of nicotine addiction, making it easier to stay abstinent. This approach is different from nicotine replacement therapy, which simply provides nicotine in a different form without blocking it. Varenicline's ability to both satisfy withdrawal and prevent reward if you slip makes it particularly effective for short-term intensive quit attempts, especially during the critical first weeks when relapse risk is highest.
Approved indications
Pipeline indications
- Tobacco Use Disorder — preclinical
Common side effects
Key clinical trials
- Long-term Varenicline Treatment for Smoking Cessation (Phase 4)
- Smoking Cessation Program in the Preadmission Clinic (N/A)
- A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Ce (Phase 3)
- 12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessa (Phase 2)
- Maintaining Nonsmoking (Phase 3)
- A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for (Phase 3)
- A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for (Phase 3)
- A Trial of Directly Observed and Long-term Varenicline (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Short-Term Varenicline CI brief — competitive landscape report
- Short-Term Varenicline updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Short-Term Varenicline
What is Short-Term Varenicline?
How does Short-Term Varenicline work?
Who makes Short-Term Varenicline?
What is the generic name of Short-Term Varenicline?
What drug class is Short-Term Varenicline in?
What development phase is Short-Term Varenicline in?
Related
- Drug class: All varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg t drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing