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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
2025/07/01
Not Applicable
Not yet 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
Not yet recruiting
2025/04/04
Phase 2
Not yet recruiting
Dickran Kazandjian, MD

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
Proparacaine Hydrochloride Eye Drops
国药准字H20253428
化学药品
眼用制剂
2/20/2025
Proparacaine Hydrochloride Eye Drops
alcon nv
国药准字HJ20160133
化学药品
眼用制剂
2/9/2021
Proparacaine Hydrochloride Eye Drops
国药准字H20143168
化学药品
眼用制剂
10/14/2021
Proparacaine Hydrochloride Eye Drops
国药准字H20103352
化学药品
眼用制剂
6/22/2020
Proparacaine Hydrochloride Eye Drops
国药准字H20084062
化学药品
眼用制剂
5/5/2023
Lenalidomide Capsules
国药准字HJ20200047
化学药品
胶囊剂
12/7/2023
Lenalidomide Capsules
国药准字HJ20210078
化学药品
胶囊剂
12/8/2021
Lenalidomide Capsules
国药准字HJ20210077
化学药品
胶囊剂
12/8/2021
Lenalidomide Capsules
国药准字H20233668
化学药品
胶囊剂
7/18/2023
Lenalidomide Capsules
国药准字H20170010
化学药品
胶囊剂
11/22/2022

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

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