Overview
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Indication
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Associated Conditions
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Research Report
A Comprehensive Pharmacological and Clinical Review of Policresulen and Dibucaine Hydrochloride
1.0 Executive Summary & Therapeutic Overview
1.1 Introduction to the Combination Therapy
The combination of Policresulen and Dibucaine hydrochloride is a topical therapeutic agent formulated for the treatment of localized anorectal and gynecological conditions.[1] This product leverages a synergistic mechanism, uniting the distinct pharmacological actions of its two active pharmaceutical ingredients. Policresulen contributes antiseptic, hemostatic, and tissue-regenerating properties, while Dibucaine hydrochloride provides potent local anesthetic effects to alleviate pain and pruritus.[1] The primary clinical indications for this combination therapy include the management of hemorrhoids (piles), particularly those associated with inflammation and bleeding, and anal fissures.[3] It is available in formulations such as rectal ointments and suppositories to facilitate direct application to the affected mucosal tissues.[2]
1.2 Therapeutic Rationale and Clinical Positioning
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/29 | Phase 1 | Not yet recruiting | |||
2024/01/10 | Phase 1 | Terminated | |||
2022/02/08 | Phase 1 | UNKNOWN | |||
2019/03/11 | Phase 1 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
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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