Overview
An alkaloid ester extracted from the leaves of plants including coca. It is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake.
Indication
For the introduction of local (topical) anesthesia of accessible mucous membranes of the oral, laryngeal and nasal cavities.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/25 | Not Applicable | Not yet recruiting | |||
2023/04/12 | Phase 1 | Completed | |||
2022/04/19 | Phase 4 | Completed | |||
2022/04/19 | N/A | Completed | |||
2021/08/24 | Early Phase 1 | Completed | |||
2021/03/10 | Phase 4 | UNKNOWN | |||
2019/05/17 | Early Phase 1 | Terminated | |||
2019/05/06 | Early Phase 1 | Completed | |||
2018/05/08 | Early Phase 1 | Completed | |||
2018/03/20 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genus Lifesciences Inc. | 64950-362 | NASAL | 40 mg in 1 mL | 3/4/2024 | |
| OMNIVIUM PHARMACEUTICALS LLC. | 81665-301 | TOPICAL | 40 mg in 1 mL | 9/25/2023 | |
| Genus Lifesciences Inc. | 64950-359 | NASAL | 40 mg in 1 mL | 7/31/2023 | |
| LXO US INC. | 70839-362 | NASAL | 40 mg in 1 mL | 1/25/2024 | |
| Lannett Company, Inc. | 0527-1971 | TOPICAL | 40 mg in 1 mL | 9/19/2023 |
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 |
|---|---|---|---|---|---|
| PMS-COCAINE HYDROCHLORIDE TOPICAL SOL 10% | 02006308 | Liquid - Topical | 100 MG / ML | 12/31/1995 | |
| PMS-COCAINE HYDROCHLORIDE TOPICAL SOL 4% | 02006316 | Liquid - Topical | 40 MG / ML | 3/17/1997 | |
| COCAINE HYDROCHLORIDE TOP SOL 40MG/ML | 01962388 | Liquid - Topical | 40 MG / ML | 12/31/1992 | |
| COCAINE HYDROCHLORIDE TOPICAL SOL 10% | 02004062 | Liquid - Topical | 100 MG / ML | 12/31/1992 |
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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