Last reviewed · How we verify
Miochol-E (ACETYLCHOLINE)
Miochol-E, an acetylcholine-based drug marketed by an unspecified company, stimulates the muscarinic acetylcholine receptor M3 to treat symptoms of acetylcholine chloride reactions, with a key composition patent expiring in 2028. Its primary competitive advantage lies in its distinct mechanism of action compared to older off-patent drugs like carbachol and neostigmine, which are widely available as generics. The primary risk is the presence of multiple same-class competitors, including pilocarpine and demecarium, which may limit market share and revenue potential.
At a glance
| Generic name | ACETYLCHOLINE |
|---|---|
| Sponsor | Novartis |
| Drug class | Cholinergic Receptor Agonist |
| Target | Muscarinic acetylcholine receptor M3 |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
| First approval | 1973 |
Approved indications
- Symptoms of acetylcholine chloride reaction
Common side effects
Key clinical trials
- An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis (PHASE3)
- A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis (PHASE2,PHASE3)
- COronoary Microcirculation Analysis NETwork (NA)
- Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (PHASE3)
- PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis (PHASE3)
- Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis (PHASE3)
- Improving Neurological Health With Acetylcholine Via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment (NA)
- Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity (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:
- Miochol-E CI brief — competitive landscape report
- Miochol-E updates RSS · CI watch RSS