drugset
Drugs / TNX-601 ER
last change Oct 2023 re-read 3 minutes ago

TNX-601 ER

Developed for
major depressive disorder
Investigated by
Rho, Inc. · Tonix Pharmaceuticals, Inc.

Trials 1

today NCT05686408 · Ph 2
202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT05686408 Mar → Sep 2023 major depressive disorder Tonix Pharmaceuticals, Inc. Completed Missed primary

Press releases naming this drug 7 releases

DateIssuerRelease
2023-10-31 Tonix Pharmaceuticals, Inc. 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 ↗
2023-10-16 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Completes Clinical Stage of Phase 2 UPLIFT Study of TNX-601 ER for the Treatment of Major Depressive Disorder tonixpharma.com ↗
2023-07-26 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces Accelerating Completion of Enrollment in Phase 2 UPLIFT Study of TNX-601 ER (Racemic Tianeptine) for Major Depressive Disorder: Topline Data Now Expected in Fourth Quarter 2023 tonixpharma.com ↗
2023-05-17 Tonix Pharmaceuticals, Inc. 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 ↗
2023-03-16 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Initiates Enrollment in Phase 2 ‘UPLIFT’ Study of TNX-601 ER (Tianeptine Hemioxalate Extended-Release Tablets) for the Treatment of Major Depressive Disorder (MDD) tonixpharma.com ↗
2022-10-03 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces IND Clearance for TNX-601 ER as a Potential Treatment for Major Depressive Disorder tonixpharma.com ↗
2022-07-11 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces Development of TNX-601 ER, a Potential Abuse Deterrent, Extended-Release Formulation of Tianeptine Oxalate for the Treatment of Major Depressive Disorder tonixpharma.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as TNX-601 ER ClinicalTrials.gov intervention name — accepted as the source's own label NCT05686408 ↗
Route Oral “Patients will take 1 tablet orally once daily for 6 weeks.” NCT05686408 ↗