venlafaxine

Trade name: effexor

Small moleculeapproved

Approved

Dec 28, 1993

Venlafaxine is an arylalkanolamine serotonin-norepinephrine reuptake inhibitor, which is sold under several brand names; one of them is venlafaxine hydrochloride. Venlafaxine hydrochloride is a venlafaxine extended release tablets, which are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD. A major depressive episode (DSM-IV) implies a prominent and relatively persistent depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period. In addition, venlafaxine hydrochloride is indicated for the treatment of social anxiety (SAD), also known as social phobia. Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which others expose to unfamiliar people or to possible scrutiny the person. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The mechanism of the antidepressant action of venlafaxine in humans is believed to be associated with its potentiation of neurotransmitter activity in the CNS. Preclinical studies have shown that venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake. — NCATS

Clinical trial activity

203 trials · 182 clinical orgs · 46 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jun 1, 1995 (NCT00001483)

Timeline

1990s

Dec 28, 1993
Earliest FDA Approval
Jan 1, 1995
Earliest Phase 2 Sponsor(trial)
Oct 20, 1997
Wyeth — NDA Secondary Org
Oct 20, 1997
Upjohn — Marketing Organization
Oct 20, 1997
Pharmacia & Upjohn — NDA Secondary Org
Jan 1, 1999
Earliest Phase 3 Sponsor(trial)

2000s

Jan 1, 2001
Earliest Phase 1 Sponsor(trial)
Aug 3, 2006
Teva — Marketing Organization
Jun 25, 2007
Pliva — Marketing Organization
Jun 25, 2007
Barr Laboratories — Marketing Organization
Oct 16, 2007
Impax Laboratories — Marketing Organization
May 20, 2008
Osmotica Pharmaceutical — NDA Secondary Org
May 20, 2008
Osmotica Pharmaceutical — Marketing Organization
Jun 13, 2008
Dr. Reddy's Laboratories — Marketing Organization
Jun 13, 2008
Fosun — Marketing Organization
Jun 13, 2008
Mylan — Marketing Organization
Jun 13, 2008
Zydus Discovery DMCC — Marketing Organization
Jun 13, 2008
Chartwell Pharmaceuticals — Marketing Organization
Jan 9, 2009
Heritage Pharma — Marketing Organization

2010s

Apr 7, 2010
Aurobindo Pharma — Marketing Organization
May 11, 2010
Amneal Pharmaceuticals — Marketing Organization
Aug 4, 2010
Prinston Inc — Marketing Organization
Aug 18, 2010
Sun Pharmaceuticals — Marketing Organization
Dec 14, 2010
Alembic — Marketing Organization
Apr 14, 2011
Wockhardt — Marketing Organization
Apr 14, 2011
Atlantide Pharmaceuticals — Marketing Organization
Apr 15, 2011
Bausch Health Companies — Marketing Organization
Jun 1, 2011
Torrent Pharmaceuticals Limited — Marketing Organization
Jul 11, 2011
Orbion Pharms — Marketing Organization
Jul 11, 2011
Orchid Pharma — Marketing Organization
Mar 16, 2012
Anchen Pharmaceuticals, Inc — Marketing Organization
Mar 16, 2012
Par Pharmaceuticals — Marketing Organization
Mar 24, 2017
Nostrum Laboratories — Marketing Organization
Oct 5, 2017
Macleods Pharmaceuticals, Ltd — Marketing Organization
Oct 5, 2017
Neogen — Marketing Organization
Nov 21, 2018
Cadila Healthcare — Marketing Organization
Nov 23, 2018
Intellipharmaceutics — Marketing Organization
Jul 8, 2019
Annora Pharma — Marketing Organization
Oct 31, 2019
Dexcel Pharma Technologies Ltd. — Marketing Organization

2020s

Mar 12, 2020
Inventia Hlthcare — Marketing Organization
Oct 21, 2020
Ascent Pharmahealth — Marketing Organization
Oct 21, 2020
AbbVie — Marketing Organization
Jun 10, 2021
Alkem Labs Ltd — Marketing Organization
Jun 30, 2021
Appco Pharma — Marketing Organization
Aug 6, 2021
Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization
Jan 4, 2022
Pharmadax Inc — Marketing Organization
Jan 4, 2022
Sunny Pharmtech Inc — Marketing Organization
Nov 28, 2022
Unique Pharmaceuticals Ltd, India — Marketing Organization
Apr 12, 2023
Ajanta Pharma Ltd — Marketing Organization
May 18, 2023
Granules India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Norepinephrine transporterINHIBITOR
SLC6A2 inhibitor
- Sodium-dependent noradrenaline transporter (SLC6A2) ↗
Serotonin transporterINHIBITOR
SLC6A4 inhibitor
- Sodium-dependent serotonin transporter (SLC6A4) ↗

Approval history

approvedDec 28, 1993

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc(C(CN(C)C)C2(O)CCCCC2)cc1

Mol. weight: 277.41 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Black box warning

Sources

Also known as

alventa xl
amphero xl
bonilux xl
depefex xl
efexor
efexor
efexor xl
efexor xl
effexor
effexor
effexor
effexor
effexor xr
effexor xr
elafax
elafax
foraven xl
mentaven xl
politid xl
ranfaxine xl
rodomel xl
sunveniz xl
tardcaps xl
tifaxin xl
tonpular xl
trixat xl
vaxalin xl
velafax
venalafaxine hydrochloride
venalfaxine
venaxx xl
venlablue xl
venladex xl
venlafaxin
venlafaxin
venlafaxin
venlafaxina
venlafaxina
venlafaxine
venlafaxine
venlafaxine
venlafaxine
venlafaxine
venlafaxine
venlafaxine
venlafaxine
venlafaxine
venlafaxine
(+/-)-venlafaxine
venlafaxine hcl
venlafaxine hcl
venlafaxine hcl
venlafaxine hydrochloride
venlafaxine hydrochloride
venlafaxine hydrochloride
venlafaxine hydrochloride
venlafaxinum
venlafaxinum
venlafexine
venlalic xl
venlaneo xl
vensir xl
vexarin xl
viepax
viepax xl
winfex xl
wy-45030
wy-45030
wy-45,030

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07186751	N/A	Sep 20, 2025	Anhui Medical University, Capital Medical University, Guangxi Medical University, Nanchang University, Peking University, Shandong University, Xinjiang Medical University
NCT07230171	N/A	Sep 15, 2025	Capital Medical University
NCT07025590	N/A	Apr 22, 2025	Shantou University
NCT06965569	Phase 1	Apr 21, 2025	Alar Pharmaceuticals Inc.
NCT06803485	Phase 4	Mar 11, 2025	All India Institute of Medical Sciences
NCT06295562	Phase 4	Oct 14, 2024	China Medical University
NCT06278038	N/A	Feb 22, 2024	Zhejiang University
NCT06106529	Phase 3	Jan 8, 2024	Reinier de Graaf Groep
NCT05973786	Phase 4	Nov 1, 2023	University of Munster, Utrecht University
NCT05603104	Phase 4	Aug 1, 2023	University of Munster, Utrecht University
NCT05724849	Phase 2	Aug 1, 2023	Vanderbilt University
NCT05884268	Phase 1/Phase 2 (Phase 2)	May 30, 2023	Mansoura University
NCT05875610	Phase 4	May 1, 2023	Mit Ghamr Oncology Center
NCT06131268	Phase 4	Mar 1, 2022	A.O. Ospedale Maggiore di Lodi
NCT05104918	Phase 3	Feb 28, 2022	Rawalpindi Medical College, Pakistan, Scotmann Pharmaceuticals
NCT04977271	Phase 4	Jan 31, 2022	University of Alabama, Birmingham
NCT04973930	Phase 3	Nov 1, 2021	Columbia University
NCT04961190	Phase 4	Nov 1, 2021	Department of Veteran Affairs, Patient-Centered Outcomes Research Institute, University of Pennsylvania, Vanderbilt University
NCT05023278	Phase 4	May 10, 2021	Orthopedic Research and Education Foundation, University of California, San Francisco
NCT04597190	Phase 4	Apr 1, 2021	Boston University, Patient-Centered Outcomes Research Institute, Stanford University, University of Washington, Washington State University

Showing 20 of 203 trials

Page 1 / 11

Organizations

Research & Development (182)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Institute of Mental Health (NIMH)	Government	22	3	4	1995
Pfizer	For profit	22	21	3	1999
Wyeth	For profit	21	0	4	1999
Columbia University	Academic/Hospital	9	9	4	1999
University of Pittsburgh	Academic/Hospital	8	7	3	2000
Otsuka	For profit	7	5	3	2004
The University of Texas, Dallas	Academic/Hospital	7	1	3	2001
University of Pennsylvania	Academic/Hospital	7	5	4	2001
University of Toronto	Academic/Hospital	7	6	4	2001
Harvard University	Academic/Hospital	6	5	3	2003
Johnson and Johnson	For profit	6	6	2	2011
Eli Lilly	For profit	5	4	2	2003
SFBC Anapharm	For profit	5	0	1	2002
Shire	For profit	5	5	3	2009
Teva	For profit	5	5	1	2002
University of California, Los Angeles	Academic/Hospital	5	5	1	1996
University of Washington	Academic/Hospital	5	5	2	2004
Capital Medical University	Academic/Hospital	4	4	2	2013
Mayo Clinic	Academic/Hospital	4	3	3	2002
Vanderbilt University	Academic/Hospital	4	2	3	2000

182 organizations

Page 1 / 10

Marketing (60)

Organization	Org type	Relationship	Date
AbbVie	For profit	MKTG	Oct 21, 2020
Ajanta Pharma Ltd	For profit	MKTG	Apr 12, 2023
Alembic	For profit	SYN	Jun 6, 2024
Alembic	For profit	MKTG	Dec 14, 2010
Alkem Labs Ltd	For profit	MKTG	Jun 10, 2021
American Home Products	For profit	NDA	—
Amneal Pharmaceuticals	For profit	MKTG	May 11, 2010
Anchen Pharmaceuticals, Inc	For profit	MKTG	Mar 16, 2012
Annora Pharma	For profit	MKTG	Jul 8, 2019
Appco Pharma	For profit	MKTG	Jun 30, 2021
Ascent Pharmahealth	For profit	MKTG	Oct 21, 2020
Atlantide Pharmaceuticals	For profit	MKTG	Apr 14, 2011
Aurobindo Pharma	For profit	MKTG	Apr 7, 2010
Aurobindo Pharma	For profit	SYN	Apr 14, 2011
Barr Laboratories	For profit	MKTG	Jun 25, 2007
Bausch Health Companies	For profit	MKTG	Apr 15, 2011
Cadila Healthcare	For profit	MKTG	Nov 21, 2018
Chartwell Pharmaceuticals	For profit	MKTG	Jun 13, 2008
Dexcel Pharma Technologies Ltd.	For profit	MKTG	Oct 31, 2019
Dexcel Pharma Technologies Ltd.	For profit	SYN	Oct 31, 2019
Dr. Reddy's Laboratories	For profit	MKTG	Jun 13, 2008
Fosun	For profit	MKTG	Jun 13, 2008
Fosun	For profit	SYN	May 28, 2015
Granules India	For profit	MKTG	May 18, 2023
Heritage Pharma	For profit	MKTG	Jan 9, 2009
Heritage Pharma	For profit	SYN	Jan 9, 2009
Impax Laboratories	For profit	MKTG	Oct 16, 2007
Intellipharmaceutics	For profit	MKTG	Nov 23, 2018
Inventia Hlthcare	For profit	MKTG	Mar 12, 2020
Macleods Pharmaceuticals, Ltd	For profit	MKTG	Oct 5, 2017
Mylan	For profit	MKTG	Jun 13, 2008
Neogen	For profit	MKTG	Oct 5, 2017
Nostrum Laboratories	For profit	MKTG	Mar 24, 2017
Nostrum Laboratories	For profit	SYN	Apr 4, 2023
Orbion Pharms	For profit	MKTG	Jul 11, 2011
Orchid Pharma	For profit	MKTG	Jul 11, 2011
Osmotica Pharmaceutical	For profit	NDA2	May 20, 2008
Osmotica Pharmaceutical	For profit	MKTG	May 20, 2008
Par Pharmaceuticals	For profit	MKTG	Mar 16, 2012
Pharmacia & Upjohn	For profit	NDA2	Oct 20, 1997
Pharmadax Inc	For profit	MKTG	Jan 4, 2022
Pliva	For profit	MKTG	Jun 25, 2007
Prinston Inc	For profit	MKTG	Aug 4, 2010
Sun Pharmaceuticals	For profit	MKTG	Aug 18, 2010
Sun Pharmaceuticals	For profit	SYN	Jun 13, 2008
Sun Pharmaceuticals	For profit	SYN	Aug 18, 2010
Sunny Pharmtech Inc	For profit	MKTG	Jan 4, 2022
Teva	For profit	MKTG	Aug 3, 2006
Torrent Pharmaceuticals Limited	For profit	MKTG	Jun 1, 2011
Torrent Pharmaceuticals Limited	For profit	SYN	Jun 1, 2011
Unique Pharmaceuticals Ltd, India	For profit	MKTG	Nov 28, 2022
Upjohn	For profit	MKTG	Oct 20, 1997
Wockhardt	For profit	MKTG	Apr 14, 2011
Wockhardt	For profit	SYN	Apr 14, 2011
Wyeth	For profit	NDA2	Oct 20, 1997
Wyeth	For profit	SYN	Dec 28, 1993
Yichang Humanwell Pharmaceutical Co.,Ltd	For profit	MKTG	Aug 6, 2021
Zydus Discovery DMCC	For profit	MKTG	Jun 13, 2008
Zydus Discovery DMCC	For profit	SYN	Apr 14, 2011
Zydus Discovery DMCC	For profit	SYN	Aug 30, 2022