Drugs / TNX-201
TNX-201
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02290379 | Nov 2014 → May 2015 | — | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT02423408 | Jun 2015 → Feb 2016 | — | Tonix Pharmaceuticals, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2022-05-23 | Tenax Therapeutics, Inc. | Results Tenax Therapeutics Announces Successful Comparative Pharmacokinetic Study of TNX-201 for the Treatment of Pulmonary Arterial Hypertension tenaxthera.com ↗
The pharmacokinetic data from this trial showed that TNX-201 significantly exceeded Tenax’ relative bioavailability threshold (area under the curve (AUC)) when compared to reference Gleevec® tablets. |
| 2016-02-16 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports Top Line Results From Phase 2 Proof-of-Concept Clinical Study of TNX-201 in Episodic Tension-Type Headache tonixpharma.com ↗
Based on preliminary analysis of the results from this exploratory study, Tonix has determined that the study did not achieve its primary efficacy endpoint of participants achieving headache pain-free status at two hours after dosing. |
| 2015-06-22 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Non-clinical Data on TNX-201 at the 57th Annual Scientific Meeting of the American Headache Society tonixpharma.com ↗ |
| 2015-01-09 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Clinical Progress on Potential Treatment for Headache tonixpharma.com ↗
In this single ascending dose, placebo-controlled trial, TNX-201 was well-tolerated at all doses studied, and showed a dose-related increase in pharmacokinetic parameters. |
| 2014-10-21 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Receives IND Clearance for TNX-201 in Episodic Tension-Type Headache tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to study TNX-201 for the treatment of episodic tension-type headache. |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TNX-201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02290379 ↗ |
| Known as | Dexisometepteno | ChEMBL registry synonym — accepted as the source's own label CHEMBL1476245 ↗ |
| Known as | DEXISOMETHEPTENE MUCATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1476245 ↗ |
| Modality | Small molecule | — CHEMBL1476245 ↗ |