Overview
Phenelzine, with the formula β-phenylethylhydrazine, is a monoamine oxidase inhibiting antidepressant that is effective in the treatment of panic disorder and social anxiety disorder. It was developed by Parke Davis and originally FDA approved on June 9th, 1961. It is currently approved under prescription by the name of Nardil.
Indication
Phenelzine is indicated for the treatment of nonendogenous, neurotic or atypical depression for patients that do not tolerate other forms of therapy. Atypical depression has a high prevalence rate, starts in early life, tends to last longer, is more likely to occur in people with bipolar disorder, has a high comorbidity with anxiety disorder and carries more risk of suicidal behavior. It is important to specify the atypical feature to predict the clinical course of depression and hence generate the best treatment and service. The featuring symptoms of the atypical feature include mood reactivity, two or more of this symptoms: 1) increased appetite, 2) increased sleep, 3) leaden paralysis and 4) interpersonal rejection sensitivity and should not have melancholic or catatonic features of depression. Neurotic depression is a depression of an emotionally unstable person. It is a secondary condition to major personality disorder, neuroses and drug use disorders. Likewise, a primary depression with a family history of depression spectrum disease would fit in this category. A nonendogenous depression is characterized by a disturbance in mood and general outlook. The physical symptoms tend to be less severe and it often occurs in response to stressful life events that keep occurring over a large period of time generating a continuous stress in the daily living.
Associated Conditions
- Exogenous depression
- Neurotic depression
- Atypical Depressive disorder
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/08/30 | Phase 4 | ENROLLING_BY_INVITATION | |||
2021/07/27 | Phase 1 | Completed | |||
2019/06/07 | Phase 1 | Terminated | |||
2018/10/03 | Phase 1 | Completed | |||
2018/04/23 | Phase 1 | Completed | EpiAxis Therapeutics | ||
2014/08/15 | Phase 2 | Completed | |||
2010/12/03 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Greenstone LLC | 59762-0119 | ORAL | 15 mg in 1 1 | 12/9/2020 | |
Mylan Pharmaceuticals Inc. | 59762-0119 | ORAL | 15 mg in 1 1 | 12/9/2020 | |
Novel Laboratories, Inc. | 40032-360 | ORAL | 15 mg in 1 1 | 9/30/2014 | |
Parke-Davis Div of Pfizer Inc | 0071-0350 | ORAL | 15 mg in 1 1 | 12/9/2020 |
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 |
---|---|---|---|---|---|
NARDIL phenelzine 15mg (as sulfate) tablet bottle | 462329 | Medicine | A | 11/6/2024 |
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