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Venlafaxine

Phase 4FDA approved

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jan 19, 2012

Venlafaxine development status

FDA approval on record Mar 11, 1999 as Effexor Xr
Approval holderUpjohn
ApplicationNDA020699
Highest phase Phase 4 run by Novartis Pharmaceuticals (NCT01436643)
Phase scored for RDYPhase 1
Registered trials 18 across 10 sponsors since Jul 2005

Label indication Effexor XR is indicated in adults for the treatment of: • Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ] • Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ] • Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ] • Panic Disorder (PD) [see Clinical Studies (14.4) ] Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with:… FDA label

Venlafaxine target and mechanism

Molecular targetSLC6A2, SLC6A4
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL637

Also known as Effexor XR

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Venlafaxine clinical trials

Venlafaxine · 1 trial · 1 indication

Phase 1 1
NCT01512459Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed ConditionsHealthy
COMPLETED33 Analytics
PHASE1COMPLETED
Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions
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Study Endpoints

Primary Endpoints

Area Under Curve (AUC)
predose, 1.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Venlafaxine MR Capsules 150EXPERIMENTALVenlafaxine MR Capsules 150 of Dr.Reddy's Laboratories Limited
Effexor XR 150 mg CapsulesACTIVE_COMPARATOREffexor XR 150 mg Capsules of Wyeth Laboratories Philadelphia, PA, USA

Interventions

NameTypeDescription
VenlafaxineDRUGVenlafaxine MR Capsules 150 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects must fulfill all of the following criteria to be considered for inclusion into this study: * Subjects who will provide written informed consent. * Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg. * Having a Body mass ...

Countries:India
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Frequently asked questions about Venlafaxine

What is Venlafaxine?

Venlafaxine is a small molecule drug candidate that Dr. Reddy's Laboratories Ltd is developing. It is being studied in a Phase 1 clinical program, with one completed trial in healthy volunteers. The specific medical conditions it is intended to treat have not been publicly disclosed.

What does Venlafaxine target?

Venlafaxine targets SLC6A2 and SLC6A4. It acts as an inhibitor of these targets. SLC6A2 is the norepinephrine transporter and SLC6A4 is the serotonin transporter, so the drug inhibits the reuptake of norepinephrine and serotonin.

Who is developing Venlafaxine?

Venlafaxine is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical program for this drug candidate.

What phase is Venlafaxine in?

Venlafaxine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication based on the available development information.

What clinical trials is Venlafaxine in?

Venlafaxine has been studied in one completed Phase 1 trial, NCT01512459, titled Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions. The trial enrolled 33 healthy adult volunteers in India and used an active-controlled, randomized design without blinding.