Drugs / Tianeptine
Tianeptine
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02103985 | May → Jun 2009 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT02049697 | Apr → May 2009 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06012552 | Feb 2023 → Apr 2027 expected | nervous system disorder | Military Institute od Medicine National Research Institute | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04249596 | Oct 2020 → Aug 2024 | — | Jonathan A. Javitch, MD, PhD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01309776 | Mar 2011 → Sep 2012 | major depressive disorder | Samsung Medical Center | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04145076 | Dec 2014 → Feb 2023 | autism spectrum disorder | King's College London | Unknown | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT00879372 Comparator | Mar 2009 → May 2013 | bipolar disorder | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| — | NCT05935059 Comparator | Jun 2023 → Mar 2025 | myofascial pain syndrome | National Cancer Institute, Egypt | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-10-31 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept Study of TNX-601 ER for the Treatment of Major Depressive Disorder tonixpharma.com ↗
The primary efficacy endpoint of change from baseline in depression severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, did not achieve clinical or statistical significance. |
| 2023-07-24 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Data Supporting the Memory- and Cognition-Enhancing Effects of Racemic Tianeptine and (S)-Tianeptine, but not (R)-Tianeptine, in the In Vivo Rat Novel Object Recognition (NOR) Test tonixpharma.com ↗
The findings reported today show that tianeptine and estianeptine improve memory and cognition as measured in the rat Novel Object Recognition (NOR) test. |
| 2023-06-05 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Presentation of Data Supporting Development of Racemic and Single (S)-Isomer Tianeptine, Plastogen Anti-Depressants, at the American Society of Clinical Psychopharmacology Meeting tonixpharma.com ↗
The (S) -isomer of tianeptine activates PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and lacks µ-opioid liability. |
| 2023-05-17 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Pharmacology and Medicinal Chemistry Results that Reveal the Molecular Mechanism of Action of Tianeptine, the Active Ingredient of TNX-601 ER, in Treating Depression tonixpharma.com ↗
The new findings show that selective activation of nuclear PPAR-β/δ and PPAR-γ in neurons and supporting glia appears to be a more direct mechanism to achieve the goal of restoring neuronal connectivity, which is called neuroplasticity. |
| 2022-10-03 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces IND Clearance for TNX-601 ER as a Potential Treatment for Major Depressive Disorder tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation of tianeptine as a potential treatment for major depressive disorder (MDD) 1 . |
| 2021-11-09 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Phase 1 Formulation Development Data for TNX-601 CR in a Poster Presentation at CNS Summit 2021 tonixpharma.com ↗
The study showed that the selected TNX-601 MR1 demonstrated pharmacokinetics appropriate for once-daily dosing with minimal food effect, which is a potential treatment adherence advantage over three times per day dosing of immediate release tianeptine sodium. |
| 2019-12-16 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Plan to Develop TNX-601 CR Tablets for Once-Daily Treatment of Major Depressive Disorder, in Addition to PTSD, After Successful Completion of Phase 1 Pharmacokinetic Study tonixpharma.com ↗
The Company believes that the Phase 1 study demonstrated that TNX-601 CR was well tolerated and the side effects were consistent with the known safety profile of tianeptine sodium. |
All press releases naming this drug 11 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tianeptine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00879372 ↗ |
| Known as | Gas station heroin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289110 ↗ |
| Known as | JNJ-39823277 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02103985 ↗ |
| Known as | S-1574 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289110 ↗ |
| Known as | Stablon | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289110 ↗ |
| Known as | Tianeptina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289110 ↗ |
| Known as | TPI 1062 | “Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 (TPI 1062) After a Single Oral Dose in Healthy Male Subjects” NCT02049697 ↗ |
| Action | Activate | “Work in our laboratories has shown that tianeptine acts as a selective agonist of MOR” NCT04249596 ↗ |
| Modality | Small molecule | — CHEMBL1289110 ↗ |
| Route | Oral | “tianeptine is approved to be used orally in humans” NCT00879372 ↗ |