Pristiq

(Desvenlafaxine)

ApprovedSmall molecule

Desvenlafaxine is used to treat depression by helping to balance certain chemicals in the brain that affect mood and emotions.[2] Pristiq is currently approved and in use across 9 indications[4].[1]

Pristiq is one of 238 small molecule programs targeting Depressive Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

237

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Depressive DisorderApproved

Dysthymic DisorderActive, not recruiting

Acute Kidney InjuryActive, not recruiting

Bipolar DisorderActive, not recruiting

Hot FlashesActive, not recruiting

Tension-Type HeadacheActive, not recruiting

MigraineActive, not recruiting

MonotherapyCompleted

Major Depressive DisorderCompleted

Depressive DisorderApproved

Approved

Dysthymic DisorderPreclinical

Active, not recruiting

Acute Kidney InjuryPreclinical

Active, not recruiting

Bipolar DisorderPreclinical

Active, not recruiting

Hot FlashesPreclinical

Active, not recruiting

Tension-Type HeadachePreclinical

Active, not recruiting

MigrainePreclinical

Active, not recruiting

MonotherapyPreclinical

Completed

Major Depressive DisorderApproved

Completed

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Pristiq

PPrism Pharmaceuticals

Approved

4 2

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 3

Ketalar

Boehringer Ingelheim

Phase 3

3 4

Sunosi

AAxsome Therapeutics, Inc.

Phase 3

1 5

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 6

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 7

Psilocybin

COMPASS Pathways

Phase 3

11 8

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 3

2 9

Aticaprant

Johnson & Johnson

Phase 3

4 10

Selective Serotonin Reuptake Inhibitor

Johnson & Johnson

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

N/AActive, not recruiting

Migraine

NCT07385755

N/AActive, not recruiting

Tension-Type Headache

NCT07359248

Clinical

Trials by Indication[1]

Major Depressive Disorder4 trials

Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

Completed· Pfizer logo

Pfizer·Phase 3·NCT00300378·480 enrolled

Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Pre- and Post-Desvenlafaxine Treatment

Completed·UUnity Health Toronto·Phase 4·NCT02859103·56 enrolled

Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

Completed·UUniversity of British Columbia·N/A·NCT01468610·47 enrolled

Show 1 more trial

A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

Completed· Biogen logo

Biogen·Phase 3·NCT04476030·440 enrolled

Depression4 trials

A Study of MD-120 in Patients With Depression

Completed·MMochida Pharmaceutical Company, Ltd.·Phase 3·NCT04345471·615 enrolled

Desvenlafaxine vs. Placebo Treatment of Chronic Depression

Completed·NNew York State Psychiatric Institute·Phase 4·NCT01537068·59 enrolled

Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression

Completed· Lundbeck logo

Lundbeck·Phase 4·NCT04448431·605 enrolled

Show 1 more trial

Omega 3 FA Supplements as Augmentation in the Treatment of Depression

Terminated·UUConn Health·Phase 2/3·NCT01803711·6 enrolled

Fibromyalgia2 trials

A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00696787·125 enrolled

Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT00424892·600 enrolled

Treatment2 trials

Efficacy of SNRI Treatment on Prefrontality in Patients With GAD and Other Comorbities

Completed·SSTART Clinic for Mood and Anxiety Disorders·Phase 4·NCT01975480·29 enrolled

Prediction of Antidepressant Treatment Response Using Machine Learning Classification Analysis

Unknown status·UUniversity of Calgary·Phase 4·NCT02330679·61 enrolled

TIA1 trial

Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway

Completed· Pfizer logo

Pfizer·Phase 1·NCT00456898·40 enrolled

13 more indications

Single Dose1 trial

Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)

Completed· Pfizer logo

Pfizer·Phase 1·NCT00440427·12 enrolled

Postpartum Depression1 trial

Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine

Completed·—·Phase 3·NCT01527786·25 enrolled

Migraine1 trial

Desvenlafaxine for Preventive Treatment of Frequent Migraines

Active, not recruiting·TTongji Hospital·N/A·NCT07385755·440 enrolled

Hot flashes1 trial

A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

Active, not recruiting· Astellas logo

Astellas··NCT06049797·999 enrolled

Bipolar Disorder1 trial

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Opioid1 trial

Desvenlafaxine in Opioid-Dependent Patients

Completed·—·Phase 4·NCT02200406·18 enrolled

Monotherapy1 trial

Desvenlafaxine Monotherapy in Dysthymia

Completed·CCentre for Addiction and Mental Health·N/A·NCT01948895·30 enrolled

Cohort Study1 trial

Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea

Completed· Pfizer logo

Pfizer··NCT04446039·370,212 enrolled

Acute Kidney Injury1 trial

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02320240·3,255,526 enrolled

Antidepressants1 trial

Effect of Antidepressants on White Matter Structure

Unknown status·—·Phase 4·NCT01492621·40 enrolled

Oral1 trial

Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

Completed· Pfizer logo

Pfizer·Phase 1·NCT01443208·36 enrolled

Tension-type headache1 trial

Desvenlafaxine for Preventive Treatment of Frequent Episodic Tension-type Headache

Active, not recruiting·TTongji Hospital·N/A·NCT07359248·432 enrolled

Cognitive Function1 trial

Switching From SSRI to Desvenlafaxine on Cognitive Functioning

Unknown status·CCorporacion Parc Tauli··NCT03432221·36 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 29, 2008

PRISTIQ

NDA NDA021992

Jan 30, 2009

PRISTIQ

NDA NDA021992

Apr 23, 2009

PRISTIQ

NDA NDA021992

Aug 31, 2009

PRISTIQ

NDA NDA021992

Aug 31, 2009

PRISTIQ

NDA NDA021992

Nov 9, 2009

PRISTIQ

NDA NDA021992

Nov 9, 2009

PRISTIQ

NDA NDA021992

Feb 16, 2010

PRISTIQ

NDA NDA021992

Jul 9, 2010

PRISTIQ

NDA NDA021992

Sep 8, 2010

PRISTIQ

NDA NDA021992

Oct 18, 2010

PRISTIQ

NDA NDA021992

Dec 29, 2010

PRISTIQ

NDA NDA021992

Jan 31, 2011

PRISTIQ

NDA NDA021992

Mar 4, 2011

PRISTIQ

NDA NDA021992

Apr 11, 2011

PRISTIQ

NDA NDA021992

Mar 7, 2012

PRISTIQ

NDA NDA021992

Dec 7, 2012

PRISTIQ

NDA NDA021992

Feb 14, 2013

PRISTIQ

NDA NDA021992

Feb 14, 2013

PRISTIQ

NDA NDA021992

Mar 4, 2013

DESVENLAFAXINE

NDA NDA204150

Apr 19, 2013

PRISTIQ

NDA NDA021992

Jul 10, 2013

KHEDEZLA

NDA NDA204683

Oct 11, 2013

DESVENLAFAXINE

NDA NDA205208

Dec 10, 2013

PRISTIQ

NDA NDA021992

Dec 23, 2013

PRISTIQ

NDA NDA021992

Jan 28, 2014

DESVENLAFAXINE

NDA NDA205583

Jul 17, 2014

PRISTIQ

NDA NDA021992

Aug 20, 2014

PRISTIQ

NDA NDA021992

Aug 20, 2014

PRISTIQ

NDA NDA021992

Mar 16, 2016

PRISTIQ

NDA NDA021992

Aug 26, 2016

PRISTIQ

NDA NDA021992

Jan 4, 2017

PRISTIQ

NDA NDA021992

Dec 19, 2017

PRISTIQ

NDA NDA021992

Feb 6, 2018

PRISTIQ

NDA NDA021992

Sep 20, 2021

PRISTIQ

NDA NDA021992

Nov 10, 2021

PRISTIQ

NDA NDA021992

Aug 18, 2023

PRISTIQ

NDA NDA021992

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Desvenlafaxine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Pristiq drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Desvenlafaxine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Desvenlafaxine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021992). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Pristiq. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Prism Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Norepinephrine Transporter Inhibitor; Serotonin Transporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPrism Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Jul 5, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8269040Jul 5, 2027

Pristiq

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Major Depressive Disorder4 trials

Depression4 trials

Fibromyalgia2 trials

Treatment2 trials

TIA1 trial

Single Dose1 trial

Postpartum Depression1 trial

Migraine1 trial

Hot flashes1 trial

Bipolar Disorder1 trial

Opioid1 trial

Monotherapy1 trial

Cohort Study1 trial

Acute Kidney Injury1 trial

Antidepressants1 trial

Oral1 trial

Tension-type headache1 trial

Cognitive Function1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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