Overview
A propylamine formed from the cyclization of the side chain of amphetamine. This monoamine oxidase inhibitor is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in panic and phobic disorders (From AMA Drug Evaluations Annual, 1994, p311). Tranylcypromine is a racemate comprising equal amounts of (1R,2S)- and (1S,2R)-2-phenylcyclopropan-1-amine with the chiral centers both located on the cylopropane ring. An irreversible monoamine oxidase inhibitor that is used as an antidepressant (INN tranylcypromine).
Indication
用于抑郁症。
Associated Conditions
- Depressive Episodes
Research Report
Tranylcypromine (DB00752): A Comprehensive Clinical and Pharmacological Monograph
Executive Summary
Tranylcypromine is a potent, non-selective, and irreversible monoamine oxidase inhibitor (MAOI) with a unique chemical structure derived from amphetamine.[1] First approved by the U.S. Food and Drug Administration (FDA) in 1961, it occupies a critical, albeit niche, position in the psychiatric armamentarium.[3] Its primary clinical indication is for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressant therapies.[4] It is particularly valued for its high efficacy in cases of treatment-resistant depression (TRD) and atypical depression, where its broad mechanism of action may succeed after more selective agents have failed.[1]
The therapeutic utility of tranylcypromine is inextricably linked to a demanding and complex safety profile. Its irreversible inhibition of MAO necessitates strict adherence to a tyramine-restricted diet to prevent potentially fatal hypertensive crises.[1] Furthermore, its co-administration with a wide range of medications, particularly serotonergic agents like selective serotonin reuptake inhibitors (SSRIs), is absolutely contraindicated due to the risk of life-threatening serotonin syndrome.[1] These risks mandate a high level of expertise from the prescribing clinician and a deep commitment to education and adherence from the patient.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/05/30 | Not Applicable | Completed | |||
2023/11/02 | N/A | Active, not recruiting | Ankara Etlik City Hospital | ||
2016/03/24 | Phase 1 | UNKNOWN | Michael Luebbert | ||
2015/03/02 | Phase 3 | Terminated | |||
2014/10/23 | Phase 1 | Completed | |||
2014/10/10 | Phase 1 | UNKNOWN | |||
2013/07/11 | Not Applicable | UNKNOWN | |||
2011/09/08 | Phase 4 | Completed | |||
2009/12/15 | Phase 4 | Terminated | |||
2008/04/04 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Concordia Pharmaceuticals Inc. | 59212-447 | ORAL | 10 mg in 1 1 | 3/1/2021 | |
Par Pharmaceutical, Inc. | 49884-032 | ORAL | 10 mg in 1 1 | 11/19/2019 | |
Marlex Pharmaceuticals, Inc. | 10135-739 | ORAL | 10 mg in 1 1 | 3/3/2023 | |
Strides Pharma Science Limited | 64380-176 | ORAL | 10 mg in 1 1 | 5/26/2023 | |
Actavis Pharma, Inc. | 0591-5590 | ORAL | 10 mg in 1 1 | 3/1/2021 | |
Lannett Company, Inc. | 0527-3010 | ORAL | 10 mg in 1 1 | 7/7/2022 | |
Solco Healthcare US, LLC | 43547-655 | ORAL | 10 mg in 1 1 | 7/7/2022 | |
Novitium Pharma LLC | 70954-538 | ORAL | 10 mg in 1 1 | 6/18/2021 |
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 |
---|---|---|---|---|---|
TRANYLCYPROMINE ASP tranylcypromine (as sulfate) 10 mg tablet blister pack | 387624 | Medicine | A | 2/7/2025 | |
TRANAMEF tranylcypromine (as sulfate) 10 mg tablet bottle | 444810 | Medicine | A | 4/16/2025 | |
TRANYLCYPROMINE NRIM tranylcypromine (as sulphate) 10mg film coated tablet blister pack | 224231 | Medicine | A | 5/15/2015 | |
PARNATE Tranylcypromine 10mg film coated tablet | 174086 | Medicine | A | 10/21/2010 | |
TRANYLCYPROMINE MEDTAS tranylcypromine (as sulfate) 10 mg tablet blister pack | 387623 | Medicine | A | 2/7/2025 |
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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