Phenelzine sulfate Clinical Trials

Size	Price	Qty
5mg	USD 147
100mg	USD 690

Clinical Trials

Multiple clinical trials spanning Phases 1, 2, and 4 evaluate phenelzine sulfate for major depressive disorder, oncology—specifically recurrent prostate adenocarcinoma and metastatic breast cancer—and safety in healthy volunteers. Sponsored by academic institutions such as USC, UCSF, and OHSU alongside pharmaceutical companies like Celgene and Boehringer Ingelheim, these studies examine therapeutic efficacy, safety, and drug interactions. Recruitment statuses across these trials encompass completed, terminated, and active studies enrolling by invitation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06580041	ENROLLING_BY_INVITATION	Major Depressive Disorder; Depression; Depressive Disorder, Major	University of California, San Francisco	2024-11-12	PHASE4
NCT04978298	COMPLETED	Healthy Volunteers	Celgene	2021-07-19	PHASE1
NCT02217709	COMPLETED	Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer	University of Southern California	2014-09-08	PHASE2
NCT03979820	TERMINATED	Healthy	Boehringer Ingelheim	2019-07-31	PHASE1
NCT03505528	COMPLETED	Metastatic Breast Cancer	EpiAxis Therapeutics	2017-08-17	PHASE1
NCT02153281	COMPLETED	Major Depressive Disorder	Centre for Addiction and Mental Health	2014-06
NCT03694119	COMPLETED	Healthy Volunteer	Celgene	2018-07-24	PHASE1
NCT01253642	TERMINATED	Hormone-Resistant Prostate Cancer; Metastatic Prostatic Adenocarcinoma; Prostate Adenocarcinoma; Recurrent Prostate Carcinoma	OHSU Knight Cancer Institute	2010-07-12	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-09-05)

Check the Phenelzine sulfate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phenelzine sulfate covalently binds to and irreversibly inhibits monoamine oxidase enzymes, preventing the oxidative degradation of critical biogenic monoamine neurotransmitters. This blockade suppresses monoamine catabolism and alters nuclear epigenetic signaling, thereby modulating neuronal excitability and malignant cellular proliferation relevant to its clinical evaluation in major depressive disorder and prostate cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).