Overview
Pilocarpine is a cholinergic muscarinic receptor agonist.
Indication
Pilocarpine oral tablets are indicated for the treatment of dry mouth caused by Sjogren's Syndrome or radiotherapy for cancer of the head and neck. Pilocarpine ophthalmic formulations are used to treat presbyopia in adults, reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, manage acute angle-closure glaucoma, prevent postoperative elevated IOP associated with laser surgery, and induce miosis.
Associated Conditions
- Acute angle-closure glaucoma
- Dry Mouth
- Glaucoma, Closed-Angle
- Increased Intra Ocular Pressure (IOP)
- Narrow-angle glaucoma
- Ocular Hypertension
- Open Angle Glaucoma (OAG)
- Presbyopia
- Chronic open-angle glaucoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/08 | Not Applicable | Recruiting | |||
2025/01/20 | Early Phase 1 | Active, not recruiting | Novus Vision LLC | ||
2024/12/30 | Not Applicable | Completed | |||
2024/06/11 | Phase 3 | Not yet recruiting | |||
2022/12/12 | Phase 3 | Completed | |||
2022/11/22 | Phase 4 | Withdrawn | Gordon Schanzlin New Vision | ||
2022/10/13 | Phase 3 | Active, not recruiting | |||
2022/10/04 | Early Phase 1 | Recruiting | |||
2022/08/18 | Phase 3 | Not yet recruiting | |||
2022/05/26 | Phase 2 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Somerset Therapeutics, LLC | 70069-181 | OPHTHALMIC | 10 mg in 1 mL | 4/26/2023 | |
| Marlex Pharmaceuticals Inc | 10135-680 | ORAL | 5 mg in 1 1 | 2/26/2019 | |
| NorthStar Rx LLC | 16714-121 | ORAL | 5 mg in 1 1 | 5/7/2021 | |
| Marlex Pharmaceuticals Inc | 10135-590 | ORAL | 7.5 mg in 1 1 | 3/25/2015 | |
| Bryant Ranch Prepack | 71335-2120 | ORAL | 5 mg in 1 1 | 6/8/2023 | |
| American Health Packaging | 68084-928 | ORAL | 5 mg in 1 1 | 10/4/2022 | |
| Sandoz Inc | 61314-204 | OPHTHALMIC | 20 mg in 1 mL | 10/20/2011 | |
| Bryant Ranch Prepack | 63629-2099 | ORAL | 5 mg in 1 1 | 6/11/2020 | |
| Amneal Pharmaceuticals NY LLC | 69238-1746 | OPHTHALMIC | 20 mg in 1 mL | 12/30/2023 | |
| Amneal Pharmaceuticals NY LLC | 60219-1746 | OPHTHALMIC | 20 mg in 1 mL | 9/22/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ISOPTO CARPINE STERILE OPHTHALMIC SOLUTION 2% | SIN04712P | SOLUTION | 2% | 6/13/1990 | |
| SALAGEN TABLET 5 mg | SIN11683P | TABLET, FILM COATED | 5 mg | 9/28/2001 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Isopto Carpine 1% Eye Drops Bottle | 25294 | Medicine | A | 10/15/1991 | |
| Isopto Carpine 2% Eye Drops Bottle | 25295 | Medicine | A | 10/15/1991 | |
| Isopto Carpine 4% Eye Drops | 25297 | Medicine | A | 10/15/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OCUSERT PILO 40 | alza pharms division of alza corp | 00328200 | Implant - Intraocular | 11 MG / IMP | 12/31/1975 |
| ODAN-PILOCARPINE | odan laboratories ltd | 00627747 | Solution - Ophthalmic | 2 % | 12/31/1992 |
| PMS-PILOCARPINE 0.5% | 02239240 | Liquid - Ophthalmic | 5 MG / ML | N/A | |
| PILOCARPINE HYDROCHLORIDE 2% - LIQ OPH | rivex ophthalmics inc. | 02213044 | Liquid - Ophthalmic | 2 % | 5/7/1997 |
| MIOCARPINE OPH SOLN 1% | iolab pharmaceuticals | 00759945 | Drops - Ophthalmic | 1 % | 12/31/1988 |
| PMS-PILOCARPINE 4% | 02239243 | Liquid - Ophthalmic | 40 MG / ML | N/A | |
| MIOCARPINE OPH SOLN 4% | iolab pharmaceuticals | 00760099 | Drops - Ophthalmic | 4 % | 12/31/1988 |
| ISOPTO CARPINE | novartis pharmaceuticals canada inc | 00000841 | Liquid - Ophthalmic | 1 % | 12/31/1959 |
| PMS-PILOCARPINE 6% | 02239244 | Liquid - Ophthalmic | 60 MG / ML | N/A | |
| PILOCARPINE 1% | ivax pharmaceuticals incorporated | 02229556 | Solution - Ophthalmic | 1 % | 11/13/1996 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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