Product Description
Pilocarpine Hydrochloride is the hydrochloride salt of a natural alkaloid extracted from plants of the genus Pilocarpus with cholinergic agonist activity. As a cholinergic parasympathomimetic agent, pilocarpine predominantly binds to muscarinic receptors, thereby inducing exocrine gland secretion and stimulating smooth muscle in the bronchi, urinary tract, biliary tract, and intestinal tract. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Pilocarpine-hydrochloride)
Mechanisms of Action: AChR Agonist,mAChR Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Topical,Ophthalmic
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | Colombia | Cyprus | Denmark | Dominican Republic | Egypt | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela
Approved Indications: Hypertension | Miosis | Glaucoma | Glaucoma, Angle-Closure | Glaucoma, Open-Angle | Presbyopia
Known Adverse Events: Eye Pain | Headache | Pain Unspecified | Hyperemia
Company: Roxane Laboratories
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Presbyopia
Phase 2: Dry Eye Disease|Dry Eye Syndromes|Keratoconjunctivitis Sicca|Xerostomia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| SYH9042-001 | P3 |
Not yet recruiting |
Presbyopia |
2025-11-30 |
|
| VISION-2 | P3 |
Completed |
Presbyopia |
2022-09-20 |
38% |
| VISION-2 | P3 |
Completed |
Presbyopia |
2022-09-20 |
38% |
| ILUT-401-PRES | P2 |
Completed |
Presbyopia |
2022-09-06 |
24% |
| ILUT-401-DED | P2 |
Completed |
Dry Eye Disease|Keratoconjunctivitis Sicca|Dry Eye Syndromes |
2022-07-27 |
24% |