Summary
Venlafaxine Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Anxiety Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Anxiety Disorders. ClinicalTrials.gov lists 8 registered trials linking Venlafaxine Hydrochloride to Anxiety Disorders: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00546923). The largest enrolment is 480 participants (NCT00122850). Registration activity spans 1999 to 2023. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2005 to 2010. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Anxiety ranks 535 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: GAD: spontaneous remission in ~25-30% at 1 year without treatment; social anxiety: 36% remission at 12 years untreated; panic disorder: 50-65% spontaneous partial remission but relapse common; 40-60% remain symptomatic at 5 years.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 48.0 (trials 24.0, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 3 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00592384 | Project to Improve Symptoms and Mood in People With Spinal Cord Injury 2007 | completed | Phase 4 | 133 |
| NCT00546923 | Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients 2004 | completed | Phase 4 | 210 |
| NCT00238719 | Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder 1999 | completed | Phase 3 | 293 |
| NCT00122850 | A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder 2004 | completed | Phase 3 | 480 |
| NCT04965272 | A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone 2021 | withdrawn | Phase 2 | — |
| NCT06659094 | Reducing Maximal Support in OCD: Efficacy of Stepped-Care Online CBT 2023 | completed | Not applicable | 95 |
| NCT02012504 | Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients 2013 | status unknown | Not applicable | 50 |
| NCT04396314 | Effectiveness of Basic Body Awareness Therapy in Post-traumatic Stress Disorders: A Randomized Clinical Trial 2021 | status unknown | Not applicable | 54 |
Published literature
- Clinical trial publication Time to relapse after 6 and 12 months' treatment of generalized anxiety disorder with venlafaxine extended releaseRickels K, Etemad B, Khalid-Khan S et al. · Archives of general psychiatry · 2010 · PMID 21135327
- Clinical trial publication Venlafaxine extended release vs placebo and paroxetine in social anxiety disorderLiebowitz MR, Gelenberg AJ, Munjack D · Archives of general psychiatry · 2005 · PMID 15699296
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Venlafaxine Hydrochloride approved for Anxiety Disorders?
Venlafaxine Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Anxiety Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Anxiety Disorders. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Venlafaxine Hydrochloride in clinical trials for Anxiety Disorders?
ClinicalTrials.gov lists 8 registered trials linking Venlafaxine Hydrochloride to Anxiety Disorders: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00546923). The largest enrolment is 480 participants (NCT00122850). Registration activity spans 1999 to 2023.
What does the evidence show for Venlafaxine Hydrochloride in Anxiety Disorders?
Venlafaxine Hydrochloride has 5 completed trials and 2 linked publications for Anxiety Disorders. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.