Clinical Trials

Several clinical trials encompassing Phase 1, Phase 3, Phase 4, and unclassified protocols evaluate venlafaxine for major depressive disorder, bipolar affective disorder, obsessive-compulsive disorder, morbid obesity, healthy subjects, and post-bariatric surgery pharmacokinetics. Sponsored by academic institutions and industry leaders—including Mayo Clinic, Biohaven Pharmaceuticals, and Pfizer—investigations explore topics such as neuroplasticity in depression and drug absorption following Roux-en-Y gastric bypass or sleeve gastrectomy. These protocols exhibit recruitment statuses ranging from completed to active recruiting and enrolling by invitation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06131268 Recruiting
Major Depressive Disorder|Bipolar Affective Disorder Currently Depressed Moderate
Fondazione IRCCS Ca'' Granda Ospedale Maggiore Policlinico
 2022-03-01 Phase 4
NCT04708834 Enrolling by invitation
Obsessive Compulsive Disorder
Biohaven Pharmaceuticals Inc.
 2021-03-30 Phase 3
NCT03532477 Recruiting
Obesity Morbid
Norwegian University of Science and Technology|St. Olavs Hospital|Volvat Medisinsk Senter Stokkan|Namsos Hospital|Alesund Hospital
 2016-11-02 --
NCT02637193 Completed
Healthy Subjects
Pfizer''s Upjohn has merged with Mylan to form Viatris Inc.|Pfizer
 2015-12 Phase 1
NCT02005107 Completed
Roux en Y Gastric Bypass|Sleeve Gastrectomy
North Dakota State University|Neuropsychiatric Research Institute Fargo North Dakota
 2013-12 Phase 4
NCT01867255 Completed
Bariatric Surgery|Gastric Bypass|Roux-en-Y Gastric Bypass
Mayo Clinic
 2013-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Venlafaxine selectively binds to and inhibits the presynaptic serotonin and norepinephrine reuptake transporters, thereby blocking the reuptake of these monoamine neurotransmitters and elevating their extracellular concentrations in the synaptic cleft. This sustained enhancement of central serotonergic and noradrenergic neurotransmission modulates neural signaling pathways, providing therapeutic efficacy for evaluated clinical trial conditions including major depressive disorder and obsessive-compulsive disorder.

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>).

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Note: Technical data last updated: Sep 1, 2026.