MedPath

Tianeptine

Generic Name
Tianeptine
Drug Type
Small Molecule
Chemical Formula
C21H25ClN2O4S
CAS Number
72797-41-2
Unique Ingredient Identifier
0T493YFU8O

Overview

Tianeptine is a drug used primarily in the treatment of major depressive disorder and has been studied in the treatment of irritable bowel syndrome (IBS) . Structurally, it is classified as a tricyclic antidepressant (TCA), however, it possesses different pharmacological properties than typical tricyclic antidepressants . Tianeptine was discovered and patented by The French Society of Medical Research in the 1960s . Currently, tianeptine is approved in France and manufactured and marketed by Laboratories Servier SA; it is also marketed in several other European countries under the trade name “Coaxil” as well as in Asia (including Singapore) and Latin America as “Stablon” and “Tatinol” but it is not available in Australia, Canada, New Zealand, the U.K. or the U.S.

Indication

Used primarily in the treatment of major depressive disorder and anxiety . It is currently being studied for fibromyalgia pain treatment .

Associated Conditions

  • Major Depressive Disorder (MDD)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2023/08/25
Phase 2
Recruiting
Military Institute od Medicine National Research Institute
2023/07/07
Not Applicable
Completed
National Cancer Institute, Egypt
2020/06/24
N/A
Completed
2020/01/31
Phase 4
Terminated
2019/10/30
Not Applicable
UNKNOWN
2014/04/04
Phase 1
Completed
2014/01/30
Phase 1
Completed
2011/03/07
Phase 4
Completed
2009/04/10
Phase 3
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

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
STABLON TABLET 12.5 mg
SIN11182P
TABLET, SUGAR COATED
12.5 mg
10/7/1999

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
No TGA approvals found for this drug.

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