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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
DESFAX desvenlafaxine 50mg modified release tablets bottle | 218079 | Medicine | A | 11/26/2014 | |
DESLAXA desvenlafaxine 100 mg extended release tablet blister pack | 379768 | Medicine | A | 11/10/2022 | |
DESVENLAFAXINE-WGR XR desvenlafaxine 50 mg extended release tablet blister pack | 439473 | Medicine | A | 5/3/2024 | |
DESLAXA desvenlafaxine 50 mg extended release tablet blister pack | 379762 | Medicine | A | 11/10/2022 | |
MEDVEN desvenlafaxine 100mg modified release tablets bottle | 218072 | Medicine | A | 11/26/2014 | |
DESFAX desvenlafaxine 100mg modified release tablets blister | 218061 | Medicine | A | 11/26/2014 | |
DESFAX desvenlafaxine 50mg modified release tablets blister | 218075 | Medicine | A | 11/26/2014 | |
DESVENLAFAXINE SANDOZ desvenlafaxine 50mg modified release tablets bottle | 218077 | Medicine | A | 11/26/2014 | |
MEDVEN desvenlafaxine 100mg modified release tablets blister | 218076 | Medicine | A | 11/26/2014 | |
DESVENLAFAXINE ALEMBIC desvenlafaxine 100 mg extended release tablet blister pack | 379751 | Medicine | A | 11/10/2022 |
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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