MedPath

Proparacaine

Generic Name
Proparacaine
Brand Names
Alcaine, Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka), Revlimid, Lenalidomide Mylan, Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto), Lenalidomide Accord
Drug Type
Small Molecule
Chemical Formula
C16H26N2O3
CAS Number
499-67-2
Unique Ingredient Identifier
B4OB0JHI1X

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

Continue reading the full research report

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
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

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.

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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.