Overview
Pilocarpine is a cholinergic muscarinic receptor agonist.
Background
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 |
|---|---|---|---|---|---|
2025/01/20 | 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2022/11/22 | Phase 4 | Withdrawn | Gordon Schanzlin New Vision | ||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2022/05/26 | Phase 2 | Withdrawn | |||
2021/11/17 | Phase 2 | Completed |
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 |
|---|---|---|---|---|---|
| Pilocarpine Nitrate Eye Drops | 国药准字H42021102 | 化学药品 | 眼用制剂(滴眼剂) | 6/29/2020 | |
| Pilocarpine Nitrate Eye Drops | 国药准字H20023807 | 化学药品 | 眼用制剂(滴眼剂) | 7/8/2020 | |
| Pilocarpine Nitrate Eye Drops | 国药准字H20058779 | 化学药品 | 眼用制剂 | 9/25/2024 | |
| Pilocarpine Nitrate Eye Drops | 国药准字H20013263 | 化学药品 | 滴眼剂 | 8/12/2020 | |
| Pilocarpine Nitrate Eye Drops | 国药准字H20023806 | 化学药品 | 眼用制剂(滴眼剂) | 7/8/2020 | |
| Pilocarpine Nitrate Eye Drops | 国药准字H20074049 | 化学药品 | 眼用制剂 | 5/25/2022 | |
| Pilocarpine Nitrate Eye Drops | 国药准字H20073921 | 化学药品 | 眼用制剂 | 5/25/2022 | |
| Pilocarpine Nitrate Eye Drops | 国药准字H20103140 | 化学药品 | 滴眼剂 | 12/3/2019 | |
| Pilocarpine Nitrate Eye Drops | 国药准字H20058062 | 化学药品 | 眼用制剂 | 6/19/2020 | |
| Pilocarpine Nitrate Eye Drops | 国药准字H20020038 | 化学药品 | 滴眼剂 | 4/24/2020 |
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 |