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, Ophthalmic, Topical
FDA Designation: *
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: None
Known Adverse Events: None
Company: Roxane Laboratories
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Presbyopia
Phase 2: Xerostomia
Phase 1: Miosis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06783686 |
Pilocarpine 1.25% | P1 |
Completed |
Miosis |
2025-04-04 |
12% |
2025-09-06 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2018-004352-38 |
xero2019 | P2 |
Active, not recruiting |
Xerostomia |
2019-08-06 |
2022-03-13 |
Treatments |
|
NCT06451666 |
SYH9042-001 | P3 |
Not yet recruiting |
Presbyopia |
2025-11-30 |
5% |
2024-07-05 |
|
CTR20242702 |
CTR20242702 | P1 |
Completed |
Presbyopia |
2024-09-30 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20242374 |
CTR20242374 | P1 |
Completed |
Presbyopia |
2024-09-13 |
2025-07-27 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20242701 |
CTR20242701 | P3 |
Completed |
Presbyopia |
2025-09-24 |
2025-11-30 |
||
CTR20242485 |
CTR20242485 | P3 |
Completed |
Presbyopia |
2025-09-19 |
2025-11-23 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20244733 |
CTR20244733 | P3 |
Completed |
Presbyopia |
2025-12-11 |
2026-01-04 |
||
CTR20254911 |
CTR20254911 | P1 |
Completed |
Presbyopia |
2025-09-13 |
2025-12-25 |
Treatments |
|
CTR20252115 |
CTR20252115 | P1 |
Completed |
Presbyopia |
2025-06-19 |
2025-07-15 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/27/2026 |
News Article |
/C O R R E C T I O N -- Orasis Pharmaceuticals/ |
|
01/27/2026 |
News Article |
NEW DATA DEMONSTRATE QLOSI™ IS PUPIL SELECTIVE WITH CILIARY MUSCLE MOVEMENT NO DIFFERENT THAN A BALANCED SALT SOLUTION (BSS) CONTROL |
|
11/13/2025 |
News Article |
ORASIS PHARMACEUTICALS EXPANDS ACCESS TO QLOSI™ WITH NEW STARTER PACKS FOR EYE CARE PROFESSIONALS, BOLSTERING COMMERICAL ROLLOUT |
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12/06/2024 |
News Article |
Ophthalmic Packaging Market Size Expected to Reach USD 15.89 Bn by 2034 |