PHENELZINE SULFATE · NOVEL LABS INC
Phenelzine sulfate is an antidepressant indicated for the treatment of patients with depression characterized as "atypical," "nonendogenous," or "neurotic." These patients often present with a combination of anxiety and depression, alongside phobic or hypochondriacal features. Due to its clinical profile and the potential for serious drug and dietary interactions, phenelzine is rarely used as a first-line treatment; it is typically reserved for patients who have failed to respond to more commonly used antidepressants, such as SSRIs or SNRIs.
How PHENELZINE SULFATE Works
Phenelzine is a potent, non-selective, and irreversible inhibitor of the enzyme monoamine oxidase (MAO). MAO normally degrades biogenic amine neurotransmitters, including norepinephrine, serotonin, and dopamine. By inhibiting this enzyme, phenelzine increases the concentration of these neurotransmitters in the central nervous system, which is believed to mediate its antidepressant effect. Additionally, phenelzine and its metabolites inhibit GABA transaminase, leading to increased brain levels of gamma-aminobutyric acid (GABA), which may contribute to its efficacy in treating anxiety symptoms.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1961-06-09
- Routes
- ORAL
- Dosage Forms
- TABLET
PHENELZINE SULFATE Approval History
What PHENELZINE SULFATE Treats
3 indicationsPHENELZINE SULFATE is approved for 3 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Depression
- Anxiety
- Phobia
PHENELZINE SULFATE Boxed Warning
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Phenelzine Sulfate Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk ...
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Phenelzine Sulfate Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Phenelzine Sulfate Tablets is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk , Precautions: Information for Patients , and Precautions: Pediatric Use )
PHENELZINE SULFATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PHENELZINE SULFATE
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02217709 results posted | 4P-14-1 NCI-2014-01791, HS-14-00331 | Ph 2 | completed | Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer |
| NCT03979820 results posted | 1386.16 2018-003965-32 | Ph 1 | terminated | A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure |
| NCT03505528 Epi-PRIMED | EpiAxis 001-0716 | Ph 1 | completed | An Early Phase Study of Abraxane Combined With Phenelzine Sulfate in Patients With Metastatic or Advanced Breast Cancer |
| NCT01253642 results posted | IRB00005688 NCI-2010-02037, SOL-09105-LM | Ph 2 | terminated | Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PHENELZINE SULFATE FDA Label Details
Indications & Usage
Phenelzine Sulfate Tablets, USP has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness with severely depressed patients with endogenous features. Phenelzine Sulfate Tablets should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use ...
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NARDIL
Full clinical data, patents, trials, and competitive landscape for phenelzine sulfate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment