Venlafaxine: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Venlafaxine appears in the FDA drug-label database. Marketed as Venlafaxine.
- Boxed warning
- The FDA label for Venlafaxine carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Dissolution Specifications: out of specification dissolution results in retained samples — Zydus Pharmaceuticals USA Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2016-07-19 |
| Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. — Zydus Pharmaceuticals (USA) Inc | Class II (FDA: may cause temporary or reversible harm) | Completed | 2025-03-21 |
| Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules. — Aurobindo Pharma USA Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2016-12-22 |
| Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals. — Zydus Pharmaceuticals (USA) Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2024-06-21 |
| Failed Dissolution Specifications: out of specification dissolution results in retained samples — Zydus Pharmaceuticals USA Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2016-07-19 |
Phase breakdown
Conditions being studied
Recruiting trials involving Venlafaxine
- Bariatric Surgery and Pharmacokinetics of Venlafaxine
- Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
- Pragmatic Trial of Obsessive-compulsive Disorder
- REDucing Hot FLASHes in Women Using Endocrine Therapy.
- The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
Common questions
Is Venlafaxine FDA-approved?
Yes, marketed as Venlafaxine. Its FDA label carries a boxed warning.
How many recruiting trials involve Venlafaxine?
5 recruiting trials across 12 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.