Overview
Proparacaine is a topical anesthetic drug of the amino ester group. It is found in ophthalmic solutions at a concentration of 0.5% as the hydrochloride salt.
Indication
Used as a local (ophthalmic) anesthetic.
Associated Conditions
- Chronic Lymphocytic Leukemia (CLL) - Refractory
- Follicular Lymphoma ( FL)
- Mantle Cell Lymphoma (MCL)
- Marginal Zone Lymphoma (MZL)
- Multiple Myeloma (MM)
- Myelodysplastic Syndrome
- Primary Amyloidosis
- Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Research Report
Published: Jun 9, 2025
Proparacaine: A Comprehensive Pharmacological and Clinical Review
I. Introduction to Proparacaine
A. Overview and Significance
Proparacaine is a topical anesthetic agent extensively employed in ophthalmic practice. Its primary utility lies in its capacity to induce rapid-onset, short-duration anesthesia of the corneal surface, thereby facilitating a wide array of diagnostic and minor surgical procedures that would otherwise be uncomfortable or impracticable.[1] The ability of Proparacaine to provide effective local anesthesia is crucial for ensuring patient comfort and cooperation during these interventions. This report aims to provide a comprehensive examination of Proparacaine, referencing its DrugBank ID DB00807 and CAS Number 499-67-2, and its classification as a Small Molecule topical anesthetic.[1] The widespread application of Proparacaine highlights a significant clinical requirement for reliable and fast-acting topical anesthesia in ophthalmology. Its effectiveness is, however, counterbalanced by specific safety considerations, particularly regarding corneal health, which necessitate informed and cautious clinical application.
B. Chemical Nature and Formulation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/31 | Not Applicable | Not yet recruiting | |||
2025/07/01 | Not Applicable | Recruiting | PETHEMA Foundation | ||
2025/06/22 | Phase 2 | Not yet recruiting | |||
2025/06/12 | Phase 2 | Not yet recruiting | |||
2025/05/30 | Phase 2 | Not yet recruiting | |||
2025/05/16 | Phase 2 | Recruiting | |||
2025/05/11 | Phase 3 | Not yet recruiting | |||
2025/04/17 | Phase 3 | Not yet recruiting | European Myeloma Network B.V. | ||
2025/04/17 | Phase 2 | Not yet recruiting | |||
2025/04/09 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Apotex Corp. | 60505-4534 | ORAL | 10 mg in 1 1 | 4/15/2023 | |
| Aurobindo Pharma Limited | 59651-347 | ORAL | 25 mg in 1 1 | 5/17/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1034 | ORAL | 20 mg in 1 1 | 2/10/2024 | |
| NuCare Pharmaceuticals,Inc. | 68071-5139 | OPHTHALMIC | 5 mg in 1 mL | 2/22/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-1937 | ORAL | 10 mg in 1 1 | 5/15/2022 | |
| MWI | 13985-611 | OPHTHALMIC | 5 mg in 1 mL | 3/27/2015 | |
| Celgene Corporation | 59572-415 | ORAL | 15 mg in 1 1 | 8/31/2021 | |
| Exelan Pharmaceuticals, Inc. | 76282-701 | ORAL | 25 mg in 1 1 | 10/13/2022 | |
| Camber Pharmaceuticals, Inc. | 31722-257 | ORAL | 2.5 mg in 1 1 | 7/13/2023 | |
| Cipla USA Inc. | 69097-384 | ORAL | 20 mg in 1 1 | 2/2/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/14/2007 | ||
Authorised | 6/14/2007 | ||
Authorised | 12/18/2020 | ||
Authorised | 9/20/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LENANGIO 10 CAPSULES 10 MG | SIN16308P | CAPSULE | 10 mg | 8/24/2021 | |
| LENALIDOMIDE-TEVA CAPSULE 25MG | SIN16478P | CAPSULE | 25 mg | 4/14/2022 | |
| LINADEX 5 CAPSULES 5 MG | SIN16764P | CAPSULE | 5.000 mg | 4/18/2023 | |
| LINADEX 10 CAPSULES 10 MG | SIN16763P | CAPSULE | 10.000 mg | 4/18/2023 | |
| Revlimid Capsules 25 mg | SIN13665P | CAPSULE | 25.0 mg | 6/23/2009 | |
| Revlimid Capsules 5mg | SIN13662P | CAPSULE | 5.0 mg | 6/23/2009 | |
| Revlimid Capsules 10mg | SIN13663P | CAPSULE | 10.0 mg | 6/23/2009 | |
| LINADEX 15 CAPSULES 15 MG | SIN16762P | CAPSULE | 15.000 mg | 4/18/2023 | |
| LENLI CAPSULES 25MG | SIN16190P | CAPSULE | 25.0 mg | 5/11/2021 | |
| MYOLID CAPSULES 15 MG | SIN16953P | CAPSULE | 15mg | 2/19/2024 |
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 |
|---|---|---|---|---|---|
| LENALEX lenalidomide 2.5 mg capsules blister pack | 338528 | Medicine | A | 7/23/2021 | |
| LENALIDOMIDE-RZ lenalidomide 7.5 mg capsule blister pack | 294138 | Medicine | A | 7/10/2021 | |
| LENALIDOMIDE DR.REDDY'S lenalidomide 15 mg capsule blister pack | 294075 | Medicine | A | 7/10/2021 | |
| LENALIDOMIDE VIATRIS lenalidomide 7.5 mg capsule blister pack | 377101 | Medicine | A | 8/18/2022 | |
| Lenalidomide RAN lenalidomide 7.5 mg capsule blister pack | 386050 | Medicine | A | 1/10/2023 | |
| Lenalidomide RBX lenalidomide 10 mg capsule blister pack | 386042 | Medicine | A | 1/10/2023 | |
| Lenalidomide SUN lenalidomide 25 mg capsule blister pack | 386052 | Medicine | A | 1/10/2023 | |
| Lenalidomide RAN lenalidomide 10 mg capsule blister pack | 386044 | Medicine | A | 1/10/2023 | |
| LENALIMID lenalidomide 5 mg capsule blister pack | 307066 | Medicine | A | 10/8/2019 | |
| LENALIDE lenalidomide 2.5 mg capsules blister pack | 338520 | Medicine | A | 7/23/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| EUGIA-LENALIDOMIDE | eugia pharma inc. | 02543788 | Capsule - Oral | 20 MG | N/A |
| TARO-LENALIDOMIDE | 02507862 | Capsule - Oral | 2.5 MG | 6/13/2022 | |
| REVLIMID | bristol-myers squibb canada | 02317710 | Capsule - Oral | 25 MG | 10/10/2008 |
| TARO-LENALIDOMIDE | 02507889 | Capsule - Oral | 10 MG | 6/13/2022 | |
| SANDOZ LENALIDOMIDE | 02518600 | Capsule - Oral | 20 MG | 9/7/2021 | |
| APO-LENALIDOMIDE | 02507978 | Capsule - Oral | 20 MG | 9/1/2021 | |
| REVLIMID | bristol-myers squibb canada | 02317699 | Capsule - Oral | 15 MG | 10/10/2008 |
| REVLIMID | bristol-myers squibb canada | 02440601 | Capsule - Oral | 20 MG | 9/28/2015 |
| LENALIDOMIDE | natco pharma (canada) inc | 02493926 | Capsule - Oral | 2.5 MG | N/A |
| JAMP LENALIDOMIDE | 02506157 | Capsule - Oral | 10 MG | 2/2/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LENALIDOMIDA ACCORD 20 MG CAPSULAS DURAS EFG | 1181316010 | CÁPSULA DURA | Uso Hospitalario | Commercialized | |
| LENALIDOMIDA ZENTIVA 20 MG CAPSULAS DURAS EFG | 85424 | CÁPSULA DURA | Uso Hospitalario | Commercialized | |
| LENALIDOMIDA SUN 10 MG CAPSULAS DURAS EFG | 86238 | CÁPSULA DURA | Uso Hospitalario | Commercialized | |
| LENALIDOMIDA TARBIS 15 MG CAPSULAS DURAS EFG | Tarbis Farma S.L. | 85436 | CÁPSULA DURA | Uso Hospitalario | Commercialized |
| LENALIDOMIDA DR. REDDYS 10 MG CAPSULAS DURAS EFG | Reddy Pharma Iberia S.A. | 85603 | CÁPSULA DURA | Uso Hospitalario | Not Commercialized |
| LENALIDOMIDA GLENMARK 20 MG CAPSULAS DURAS EFG | 85674 | CÁPSULA DURA | Uso Hospitalario | Not Commercialized | |
| LENALIDOMIDA CIPLA 20 MG CAPSULAS DURAS EFG | Cipla Europe | 84939 | CÁPSULA DURA | Uso Hospitalario | Not Commercialized |
| LENALIDOMIDA OLAINFARM 15 MG CAPSULAS DURAS EFG | 86358 | CÁPSULA DURA | Uso Hospitalario | Not Commercialized | |
| LENALIDOMIDA QILU 5 MG CÁPSULAS DURAS EFG | 89874 | CÁPSULA DURA | Uso Hospitalario | Not Commercialized | |
| LENALIDOMIDA ZENTIVA 5 MG CAPSULAS DURAS EFG | 85426 | CÁPSULA DURA | Uso Hospitalario | Commercialized |
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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