History of Tianeptine in Timeline

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Tianeptine

Tianeptine is an atypical tricyclic antidepressant primarily used to treat major depressive disorder. Marketed under brand names like Stablon, Tatinol, and Coaxil, it has also been prescribed for anxiety, asthma, and irritable bowel syndrome. As an antidepressant, Tianeptine distinguishes itself from other tricyclics with its unique pharmacological profile and mechanism of action, making it a subject of interest in the treatment of mood disorders.

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1983: Tianeptine Introduced in France Under the Brand Name Stablon

In 1983, Tianeptine was introduced for medical use in France under the brand name Stablon.

1983: Introduction of Tianeptine for medical use in France

In 1983, Tianeptine was introduced for medical use in France.

1989: Recreational Use Cases Identified in France

Between 1989 and 2004, in France 141 cases of recreational use of Tianeptine were identified, correlating to an incidence of 1 to 3 cases per 1000 persons treated with tianeptine.

August 1998: Tianeptine effective for Asthma

In August 1998, Dr. Fuad Lechin and colleagues published the results of a 52-week randomized controlled trial of asthmatic children that showed the children in the groups who received tianeptine had a sharp decrease in clinical rating and increased lung function.

2001: Singapore Restricts Tianeptine Prescribing

In 2001, Singapore's Ministry of Health restricted tianeptine prescribing to psychiatrists due to its recreational potential.

2003: Bahrain Classifies Tianeptine as Controlled Substance

In 2003, Bahrain classified tianeptine a controlled substance due to increasing reports of misuse and recreational use.

November 2004: Effectiveness of Tianeptine for Asthma Shown

By November 2004, two double-blind placebo-controlled crossover trials and an under-25,000 person open-label study lasting over seven years, both showing effectiveness of Tianeptine for Asthma.

2004: Recreational Use Cases Identified in France

Between 1989 and 2004, in France 141 cases of recreational use of Tianeptine were identified, correlating to an incidence of 1 to 3 cases per 1000 persons treated with tianeptine.

2005: Efficacy of Tianeptine in treating depression and erectile dysfunction

A 2005 study in Egypt showed Tianeptine to be effective in men with depression and erectile dysfunction.

2006: Cases of Recreational Use Identified in France

Between 2006 and 2011, 45 cases of recreational use of Tianeptine were identified in France.

January 2007: Clinical trial shows Tianeptine effective in treating fibromyalgia pain

In January 2007, a clinical trial in Spain showed that tianeptine is effective in treating pain due to fibromyalgia.

2007: Servier Modifies Tianeptine Drug Label

In 2007, Tianeptine's manufacturer Servier agreed to modify the drug's label, following problems with dependency, according to French Health Products Safety Agency.

June 2009: Phase I Clinical Trials Completed in the US

In June 2009, Phase I clinical trials of tianeptine for the treatment of major depressive disorder were completed in the United States.

2011: Cases of Recreational Use Identified in France

Between 2006 and 2011, 45 cases of recreational use of Tianeptine were identified in France.

January 2012: Development of Tianeptine Discontinued in the US and Belgium

In January 2012, development of tianeptine for the treatment of major depressive disorder was discontinued in both the United States and Belgium for unclear reasons.

2012: Janssen Patented Slower-Releasing Formulation of Tianeptine

In 2012, Janssen patented tianeptine sulfate, a slower-releasing formulation of Tianeptine.

2014: Increase in Tianeptine Exposure Calls

In 2014, The U.S. National Poison Data System showed a nationwide increase in tianeptine exposure calls.

2014: Tianeptine Found to be a μ-opioid Receptor Full Agonist

In 2014, tianeptine was found to be a μ-opioid receptor (MOR) full agonist using human proteins. It was also found to act as a full agonist of the δ-opioid receptor (DOR), although with approximately 200-fold lower potency.

2017: Increase in Tianeptine Abuse and Misuse Calls

In 2017, The U.S. National Poison Data System data showed a nationwide increase in calls related to abuse and misuse of Tianeptine.

April 2018: Michigan Outlaws Tianeptine Sodium

On 6 April 2018, Michigan became the first US state to outlaw tianeptine sodium, classifying it as a schedule II controlled substance.

July 2018: Scheduling of Tianeptine Sodium in Michigan is Effective

The scheduling of tianeptine sodium in Michigan as a schedule II controlled substance became effective on July 4, 2018.

2018: Review Finds Articles Involving Tianeptine Abuse or Dependence

A literature review conducted in 2018 found 25 articles involving 65 patients with tianeptine abuse or dependence.

March 13, 2020: Italy Outlaws Tianeptine

On March 13, 2020, Italy became the first European country to outlaw tianeptine considering it a Class I controlled substance.

March 15, 2021: Alabama Outlaws Tianeptine

On March 15, 2021, Alabama outlawed tianeptine, initially classifying it as a schedule II controlled substance.

July 1, 2022: Tennessee Outlaws Tianeptine

On July 1, 2022, Tennessee outlawed tianeptine, classifying it as a schedule II controlled substance.

December 22, 2022: Ohio Outlaws Tianeptine

On December 22, 2022, Ohio outlawed tianeptine, classifying it as a schedule I controlled substance.

2022: FDA Approved Tonix Pharmaceuticals to Conduct Phase II Clinical Trials on Tianeptine Hemioxalate Extended-Release Tablets

In 2022, Tonix Pharmaceuticals received permission from the US FDA to conduct phase II clinical trials on tianeptine hemioxalate extended-release tablets designed for once-daily use.

March 23, 2023: Kentucky Outlaws Tianeptine

On March 23, 2023, Kentucky outlawed tianeptine, classifying it as a schedule I substance.

September 20, 2023: Florida Outlaws Tianeptine

On September 20, 2023, Florida outlawed tianeptine, classifying it as a schedule I substance.

October 2023: Tonix Pharmaceuticals Discontinued Development of Tianeptine

In October 2023, Tonix Pharmaceuticals announced that it had discontinued its development of tianeptine as a monotherapy for major depressive disorder after disappointing phase-2 clinical trial results.

2023: Tonix Pharmaceuticals Discontinued Phase II Clinical Trials on Tianeptine Hemioxalate Extended-Release Tablets

In late 2023, Tonix Pharmaceuticals discontinued phase II clinical trials on tianeptine hemioxalate extended-release tablets designed for once-daily use because of disappointing results in clinical trials.

January 2024: FDA Warns of Dangers of Recreational Tianeptine Use

As recently as January 2024, the Food and Drug Administration (FDA) has issued warnings about the dangers of recreational tianeptine use and the risks posed by adulterated dietary supplements containing undeclared tianeptine.