Last reviewed · How we verify
Evoxac (CEVIMELINE)
Evoxac (cevimeline) is a cholinergic receptor agonist developed by Daiichi Sankyo and currently owned by Cosette. It targets the muscarinic acetylcholine receptor M1 to treat xerostomia (dry mouth) secondary to Sjogren's syndrome. Evoxac is a small molecule drug that was FDA-approved in 2000 and is now available as a generic medication. There are currently 9 generic manufacturers of Evoxac, and it is off-patent. As a result, Evoxac is widely available and accessible to patients.
At a glance
| Generic name | CEVIMELINE |
|---|---|
| Sponsor | Cosette |
| Drug class | Cholinergic Receptor Agonist |
| Target | Muscarinic acetylcholine receptor M1 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2000 |
Approved indications
- Xerostomia Secondary to Sjogren's Syndrome
Common side effects
- Excessive Sweating
- Nausea
- Rhinitis
- Diarrhea
- Excessive Salivation
- Urinary Frequency
- Asthenia
- Flushing
- Polyuria
- Headache
- Sinusitis
- Upper Respiratory Tract Infection
Key clinical trials
- Evaluation of BTV100 in Subjects With Dry Eye Disease (PHASE2)
- Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva (NA)
- Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions (EARLY_PHASE1)
- Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions (EARLY_PHASE1)
- Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia (PHASE4)
- Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer (PHASE3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Evoxac CI brief — competitive landscape report
- Evoxac updates RSS · CI watch RSS
- Cosette portfolio CI