Last reviewed · How we verify
Salagen (PILOCARPINE)
Pilocarpine (Salagen) is a marketed drug primarily indicated for dry mouth due to radiotherapy, with a key composition patent expiring in 2028. Its mechanism of action through the stimulation of the muscarinic acetylcholine receptor M4 provides a unique advantage in increasing fluid drainage and saliva production. The primary risk is competition from cevimeline, an off-patent drug with nine generics available, which may erode market share.
At a glance
| Generic name | PILOCARPINE |
|---|---|
| Drug class | Cholinergic Receptor Agonist |
| Target | Muscarinic acetylcholine receptor M4 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1974 |
Approved indications
- Dry mouth due to radiotherapy
- Dry mouth in Sjogren's syndrome
Common side effects
- Sweating
- Nausea
- Rhinitis
- Diarrhea
- Chills
- Flushing
- Urinary Frequency
- Dizziness
- Asthenia
- Headache
- Dyspepsia
- Lacrimation
Drug interactions
- beta adrenergic antagonists
- drugs with parasympathomimetic effects
- anticholinergic drugs (e.g., atropine, inhaled ipratropium)
Key clinical trials
- Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia (PHASE3)
- Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function (NA)
- Pilocarpine Use After Kahook Goniotomy (PHASE3)
- Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia (PHASE2)
- Optimal Treatment Protocol for Selective Laser Trabeculoplasty (NA)
- Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial (NA)
- Evaluation of NV701 (Pilocarpine 1.25%) Compared With Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects With Presbyopia (EARLY_PHASE1)
- Quality of Life in Presbyopic Patients Who Are Treated With Qlosi (PHASE4)
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:
- Salagen CI brief — competitive landscape report
- Salagen updates RSS · CI watch RSS