MedPath

Desvenlafaxine

Generic Name
Desvenlafaxine
Brand Names
Pristiq
Drug Type
Small Molecule
Chemical Formula
C16H25NO2
CAS Number
93413-62-8
Unique Ingredient Identifier
NG99554ANW

Overview

Desvenlafaxine (O-desmethylvenlafaxine) is the 0-demetyhlated active metabolite of venlafaxine. Like its parent drug, desvenlafaxine is also an antidepressant belonging to the class of serotonin-norepinephrine reuptake inhibitor (SNRI) class. It was approved by the FDA in 2008 for the treatment of adults with major depressive disorder (MDD). MDD is a highly prevalent psychiatric disorder, with a lifetime prevalence estimate of 16% in the US alone and 12.8% in Europe. Although the exact mechanism of pathophysiology is still unknown, imbalances or deficiencies of monoamines have been heavily implicated, thus the rationale behind the use of SNRI to treat MDD. Desvenlafaxine has a very similar pharmacological, efficacy, and safety profile as venlafaxine. The major difference is the potential for drug interaction since venlafaxine is mainly metabolized by CYP2D6 while desvenlafaxine is conjugated by UGT; therefore, desvenlafaxine is less likely to cause drug-drug interaction when taken with medications affecting the CYP2D6 pathway.

Indication

Desvenlafaxine is indicated for the treatment of major depressive disorder in adults. It has also been used off-label to treat hot flashes in menopausal women.

Associated Conditions

  • Hot Flashes
  • Major Depressive Disorder (MDD)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/02/21
Not Applicable
Recruiting
Jiangsu Province Nanjing Brain Hospital
2023/09/22
N/A
Active, not recruiting
2022/03/10
Phase 4
Active, not recruiting
David Steffens
2020/07/17
Phase 3
Completed
2020/06/25
Phase 4
Completed
2020/06/24
N/A
Completed
2020/04/28
Phase 3
Completed
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2020/04/14
Phase 3
Completed
Mochida Pharmaceutical Company, Ltd.
2018/11/07
Phase 1
Completed
2018/02/14
N/A
UNKNOWN
Corporacion Parc Tauli

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Direct_rx
72189-567
ORAL
50 mg in 1 1
5/12/2025
Greenstone LLC
59762-1211
ORAL
50 mg in 1 1
8/1/2023
Bryant Ranch Prepack
71335-1815
ORAL
100 mg in 1 1
5/29/2022
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
0008-1222
ORAL
100 mg in 1 1
8/30/2023
Advagen Pharma Ltd
72888-143
ORAL
50 mg in 1 1
12/19/2023
Bryant Ranch Prepack
71335-1700
ORAL
50 mg in 1 1
4/20/2018
Marlex Pharmaceuticals, Inc.
10135-822
ORAL
100 mg in 1 1
7/1/2025
A-S Medication Solutions
50090-5293
ORAL
50 mg in 1 1
12/1/2021
Alembic Pharmaceuticals Limited
46708-152
ORAL
50 mg in 1 1
1/27/2023
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
0008-1210
ORAL
25 mg in 1 1
8/30/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
Pristiq Extended-Release Tablet 50mg
SIN13859P
TABLET, EXTENDED RELEASE
50 mg
8/30/2010

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DESVENLAFAXINE
sanis health inc
02535106
Tablet (Extended-Release) - Oral
50 MG
5/25/2023
APO-DESVENLAFAXINE
02466996
Tablet (Extended-Release) - Oral
100 MG
10/20/2017
APO-DESVENLAFAXINE
02466988
Tablet (Extended-Release) - Oral
50 MG
10/20/2017
DESVENLAFAXINE
PRO DOC LIMITEE
02543680
Tablet (Extended-Release) - Oral
100 MG
4/12/2024
SANDOZ DESVENLAFAXINE
02538423
Tablet (Extended-Release) - Oral
100 MG
5/30/2024
DESVENLAFAXINE
sivem pharmaceuticals ulc
02554976
Tablet (Extended-Release) - Oral
100 MG
5/13/2025
SANDOZ DESVENLAFAXINE
02538415
Tablet (Extended-Release) - Oral
50 MG
5/30/2024
DESVENLAFAXINE
PRO DOC LIMITEE
02543672
Tablet (Extended-Release) - Oral
50 MG
4/12/2024
DESVENLAFAXINE
sivem pharmaceuticals ulc
02554968
Tablet (Extended-Release) - Oral
50 MG
5/13/2025

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
DESVENLAFAXINA NORMON 50 MG COMPRIMIDOS DE LIBERACIÓN PROLONGADA EFG
Laboratorios Normon S.A.
89360
COMPRIMIDO DE LIBERACIÓN PROLONGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
DESVENLAFAXINA NORMON 100 MG COMPRIMIDOS DE LIBERACIÓN PROLONGADA EFG
Laboratorios Normon S.A.
89361
COMPRIMIDO DE LIBERACIÓN PROLONGADA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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