Clinical Trials

Several clinical trials evaluate desvenlafaxine across Phase 1, Phase 3, and Phase 4 studies targeting major depressive disorder, menopausal vasomotor symptoms, opioid dependence with comorbid depression, and safety in healthy subjects. Sponsored by pharmaceutical entities such as Pfizer and Wyeth alongside academic medical centers, these completed protocols examine the pharmacokinetics, safety, and therapeutic outcomes of desvenlafaxine across diverse volunteer and patient cohorts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02637193 Completed
Healthy Subjects
Pfizer''s Upjohn has merged with Mylan to form Viatris Inc.|Pfizer
 2015-12 Phase 1
NCT02200406 Completed
Depression|Opioid Dependence|Methadone Treatment
Centre hospitalier de l''Université de Montréal (CHUM)|Pfizer
 2014-07 Phase 4
NCT00888862 Unknown status
Major Depressive Disorder|Menopausal Staging and Vasomotor Symptoms (for Females)
Hamilton Health Sciences Corporation|Wyeth is now a wholly owned subsidiary of Pfizer|St. Joseph''s Healthcare Hamilton|McMaster University
 2009-06 Phase 3
NCT00818155 Completed
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
 2009-01 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Desvenlafaxine acts as a dual serotonin and norepinephrine reuptake inhibitor, binding to the serotonin transporter (Ki = 40.2 nM) and norepinephrine transporter (Ki = 558.4 nM) to prevent monoamine reuptake into presynaptic neurons. This sustained inhibition increases extracellular concentrations of serotonin and norepinephrine in the central nervous system, thereby enhancing monoaminergic neurotransmission to relieve symptoms associated with major depressive disorder and related clinical indications.

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.